The “Single Source of Truth” principle in biotech quality assurance

Quality assurance professionals use the single source of truth principle to ensure everyone in the company acts with confidence on the most current and accurate data.

The single source of truth principle (SSOT), stated in a few ways

SSOT is a data storage principle that originated in business software. The principle directs you to always source a particular piece of information from one place. It means that everyone in the company agrees that one view of data is the real, trusted number.

Stakeholders in a biotech or laboratory environment follow SSOT to make all scientific and quality decisions based on a single, definitive record that they all have appropriate access to.

SSOT also refers to the practice of aggregating the data from many systems within an organization to a single location. This does not mean all data is stored in this location, but that this hub contains accurate references to the definitive location of this data.

What are the advantages of an SSOT approach?

An SSOT approach will help achieve:

  • Clarity
  • Accessibility
  • A definitive record and a definitive analysis (i.e. avoiding duplicate records and analyses)
  • Accuracy (i.e. avoiding inconsistencies)

Where did this principle originate?

The field of quality has a long and laudable history of adapting successful practices from other industries and companies and promoting their spread.

The most celebrated example is the adoption of improved production processes from Japanese automakers after American automakers fell into universally poor quality in the decades after World War II.

Another example is the spread of checklists from aviation into surgery and other medical procedures. These checklists helped to reduce the frequency of “never events” (so called because they are completely unacceptable) such as leaving instruments inside a person or operating on the wrong body part.

SSOT’s origin is in enterprise software. Large companies especially deal with copious data from multiple siloed sources. They manage multiple computerized systems with software from various vendors. This leads to inefficiencies, redundancies, inconsistencies and the like between systems and individual data points.

A classic example is when the sales team uses one set of software and supply chain/order fulfillment uses another. When the two systems do not communicate with each other, and multiple workarounds are implemented to bypass this for routine work, the system can break down and cause a large order or non-routine work to be botched.

In recent years vendors have promoted solutions to fix this issue with (you guessed it) more software. These systems, one level above the rest in data abstraction, promise to aggregate all relevant computerized data in one single reference point. This solution sometimes works and sometimes amounts to an expensive extra layer of data and computerized workflows.

In this article I will explain how QA professionals in biotech can adopt the SSOT principle in their work. I do not necessarily promote the cloud computing solutions proffered on the market. I endorse continuing the spirit of adopting successful practices from other industries. I would like you to picture not just a software that further aggregates data, but the broader application of the SSOT principle. Think of examples in your company where a single definitive record would solve problems. I will provide several below.

SSOT is a data integrity principle

Data integrity is the overall accuracy, consistency and completeness of data. Data integrity also refers to the safety of data with respect to regulatory compliance, such as GMP compliance.

This data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA).

You won’t find SSOT referenced in any regulation. But language on data integrity requirements regarding “original or true copies” is found in 21 CFR Part 211:

“Records required under this part may be retained either as original records or as true copies such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records.”

21 Code of Federal Regulations Part 211.194 Laboratory records also states:

“Laboratory records shall include complete data derived from all tests necessary to assure compliance with established specifications and standards, including examinations and assays” 


“A statement of each method used in the testing of the sample. The statement shall indicate the location of data that establish that the methods used in the testing of the sample meet proper standards of accuracy and reliability as applied to the product tested.”

The requirement on accuracy is found in:


“Appropriate controls shall be exercised over computer or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. Input to and output from the computer or related system of formulas or other records or data shall be checked for accuracy. The degree and frequency of input/output verification shall be based on the complexity and reliability of the computer or related system. A backup file of data entered into the computer or related system shall be maintained except where certain data, such as calculations performed in connection with laboratory analysis, are eliminated by computerization or other automated processes. In such instances a written record of the program shall be maintained along with appropriate validation data. Hard copy or alternative systems, such as duplicates, tapes, or microfilm, designed to assure that backup data are exact and complete and that it is secure from alteration, inadvertent erasures, or loss shall be maintained.”


“Batch production and control records shall be prepared for each batch of drug product produced and shall include complete information relating to the production and control of each batch. These records shall include an accurate reproduction of the appropriate master production or control record, checked for accuracy, dated, and signed.”

Side note: What is a principle?

QA is a technical field but it is nonetheless guided by principles. With the right set of principles, you can develop the specific practices (or tools or techniques) to fit any situation.

To go back a step further, principles flow from values. In biotech our values might include the promotion of human health through safe and effective devices and drugs. Principles that flow from this value might include, “All data we produce or make decisions on should be accurate and complete.” And a technique or requirement that flows from this principle might include, “All study-related raw data will be automatically stored in a central, read-only repository with full audit trail capability.”

SSOT is a principle because it guides our behavior without specifying the practices we need to do to accomplish a goal. If you understand SSOT, you will be able to apply it flexibly in your audits/inspections, SOPs and validations.

Simple examples

A problem with a hard-to-see asset tag

During routine lab activities an analyst must frequently document the asset number and calibration due date for various equipment such as vortexers, incubators and spectrophotometers.

If the asset tag and calibration sticker are located on the back of the equipment in a hard-to-see place, the analyst may invent a workaround and write this info on a piece of lab tape with a marker and place this on the front of the equipment where it is easier referenced, saving several moments of searching each time this info must be recorded.

To the analyst, this is a good example of problem solving and efficiency. But it compromises the equipment data recorded on the form. Suppose the true asset tag were replaced but the improvised sticky note containing old information continued to be used to record the equipment identity.

A solution to a hard-to-see asset tag

The SSOT perspective tells us that the improvised sticker is an unreliable copy. The true source of the equipment info is a little hard to define. In this case, reliability exists along a continuum.

The least reliable source is the asset tag and calibration sticker. These may be placed by a single equipment/calibration coordinator without a verifier. They may be misplaced, handwritten, difficult to read, etc. The calibration sticker might have been placed by an outside vendor in an inconsistent format across equipment.

The next most reliable source may be the equipment database. An Excel spreadsheet is unreliable. An actual database in Access might be better because of the ability to pull reports. A piece of software such as Qualcy Calibration/PM Software will provide much greater functionality and accuracy.

But even these databases must be fed with data, often transcribed, from the calibration certificate, equipment validation record, and asset number log. This leaves open the question of what the single source of truth is.

To address all these difficulties, apply the SSOT principle: The calibration coordinator must place the equipment tags in an easy-to-see place for the analyst to reference. The coordinator should convert the outside vendor’s calibration sticker into an internally developed sticker that is consistent across equipment with respect to date format, placement, and required fields. Transcription from certificates, manuals and validations into the equipment database should be verified and reviewed wherever possible. And the analyst’s SOPs and forms should clearly indicate where they get required equipment information, and who to notify when it appears to be missing.

The problem of duplicate entries

In the various spreadsheets and databases of biotech quality assurance, duplicate entries are a classic problem. 

A solution to duplicate entries

A database can get around this problem by assigning each row or column a Primary Key number, which is a unique identifier referring to all the information in that row or column. 

A lot number assignment problem

Laboratory staff must often assign lot numbers for in-process components or for a testing procedure. Lot numbers are often assigned in a way that encodes the date of the procedure. If several people are at work at once, they risk duplicating the lot number.

A lot number assignment solution

Apply the SSOT principle to establish a definitive record of lot number assignment. SOPs should define in detail how lot numbers are assigned and explain any prohibited practices.

You may choose to establish a single paper logbook, centrally located, for assigning lot numbers. This avoids the problem of two remote users trying to create a new record at once and duplicating the new lot number entry.

You may detail procedural controls: the operator or analyst must assign the lot before beginning work, not during or after producing a component successfully. They assign this lot number before entering the lab and beginning work, not “when they have a moment.”

You may establish a QA-issued lot number assignment log. All lots are issued by QA, handwritten or printed on a QA-issued batch record. Controlled work may only be conducted on these forms. The forms will be clearly marked when they are QA-issued so that analysts will easily notice when they are using a form that was not issued appropriately.

More complex examples of the problem

Problem of a complicated but critical spreadsheet

Supplier qualification produces voluminous records. As your quality system grows, you may have implemented a spreadsheet as a quick fix to track the file location and contents for each supplier. 

As this system grows, the spreadsheet will inevitably become more unstable and inaccurate, especially if it was never validated for this purpose.

One of the most important bits of information in this supplier information repository is the status of the supplier: is it low-risk, medium-risk, or high-risk, and is it approved? If this information exists in a spreadsheet accessed by any staff member who may submit a purchase order, by purchasing, by quality, and others, then the risk of inadvertent changes to these supplier status cells is too great to leave to chance.

A solution to a complicated but critical spreadsheet

You may consider clearly defining the spreadsheet as a document that only references the actual supplier qualification record. You may insist in your procedural controls that staff reference only the original records when purchasing a component from a supplier.

But even with these controls, people will naturally use the accessible and easy to use spreadsheet instead of pulling up scanned or archived records containing the original supplier designations.

To address this, apply the SSOT principle and provide easy access to the supplier qualification records and the true, current supplier status. Ensure that anyone who orders can see these records without hassle. When a supplier’s status is changed, the previous records should be clearly marked so or obsolesced. Detail in an SOP that the reviewer of the purchase order will verify the supplier status before signing off. Validate the spreadsheet or supplier management software and audit it regularly (perhaps once a year) for accuracy against the supplier records. Ensure that no one feels compelled to use a second-hand file when ordering raw materials.

The problem of paper copies

Biotech and research are paper-dominated industries. We are far from replacing handwritten records, although we are getting there slowly. Consequently every firm must decide how to treat copies of paper records.

For example, how does one mark a copy as a copy? What does “exact copy” or “working copy” mean? Can you write on the copy? Can you retain a contaminated original in the lab and continue working on a copy outside the lab for review and approval? Is there a record of how many copies were made? If a significant change was made to the original, is there a way to track down all the copies and make sure the change is reflected in each one of them, or that they are replaced with the current, updated copies? For which purpose should I look into the original data set and which process can safely use data from the copy?

A solution to paper copies

Apply the SSOT principle to insist that the original be used wherever possible.

Implement procedural controls such as the following by detailing them in your SOP that covers good documentation practices:

  • Copies will only be clearly marked as such by the person who made the copy.
  • All copies will be made in a certain color paper that is unmistakable (pink or green for example).
  • All copies will have an expiration date.
  • Beyond this expiration date, the copy must be shredded.
  • Copies can be used only for analysis and are not considered raw data for scientific, quality or business decisions.

Prohibit copies from being filed in additional physical folders when a reference to the original would suffice.

Ensure that each original record pertaining to a quality subsystem (e.g. CAPA, nonconformance, validations, internal audits) has a numbering system that allows for a unique identifier, which allows easy and unambiguous reference. 

Ensure that the record can be pulled up easily in a repository of scans by those who may need to reference them. Ensure that all scans have a watermark superimposed on them to clearly indicate they are not originals.

The problem of multiple document control statuses

Your company has two separate document control systems, one for controlled procedures and one for pilot procedures. Which is the one for released products? Are they totally segregated? Do they feed into each other regularly or with specific exceptions? Do pilot documents sometimes accidentally get used as controlled documents, and vice versa?

A solution to multiple document control statuses

A biotech company must segregate design and development work from controlled production. Design and development benefit from having more flexible procedures. But the experimental components must not mix inadvertently with the controlled outputs. One way to do this is to unambiguously separate them and implement procedural controls to prevent this. 

Components generated under pilot status must be marked unambiguously. The documents used in these procedures must be clearly marked as pilot procedures. These designations must carry through to any components generated using these pilot components as starting materials.

A problem of inaccessible records

Quality system records such as nonconformance reports, planned deviations and CAPAs are locked in a repository that only QA has access to. Production and research staff need the specifics in these folders in order to do their job (for example, to carry out the planned deviation or to understand the corrective action prescribed after a nonconformance). If the finalized document is in a physical folder on someone’s desk or in archives, and laboratory staff is working off of a Word draft or a copy of the in-process record from before it was finalized, then they may be using incorrect or incomplete information.

You may even have the problem of individual staff running their own version of archives right in their office. This is unacceptable, but it happens. An individual finds they are working on so many files so frequently, that they no longer abide by the archival procedure and they set up their own cabinet brimming with records. People who need access to originals find they must search through the controlled archives and also message scattershot an array of individuals who also might have the file.

A solution to inaccessible records

Apply an SSOT approach. Staff need access to the finalized folder or an accurate, current version of it. They should not rely on drafts and incomplete versions of the plan when doing their work. They could access this in a network repository where the scan of the finalized record is housed. They could reference only the original record, if the building is small and the record can be physically brought into the lab.

Ideally, you will migrate your quality system procedures into a third party software or one that was developed in-house. This software will make these procedural controls inherent in the design. For example, instead of relying on a user to remember to copy stamp a sheet of paper, the software will imprint the sheet with a copy watermark and a printed expiration date.

Software will not fix all problems and it may create new ones. For example, if your document software comes with a limited set of licences, and staff cannot access the forms they need at the right time, they may resort to hoarding of forms or accessing unfinished copies that are not as reliable. This brings you back to the original problem.

There is a continuum of truth and reliability

Often you must proceed with imperfect data to avoid not proceeding at all. In these instances you should assess where along the reliability continuum your information lies.

Suppose your company produces vast quantities of data in support of regulatory approval for a medical device. To finalize your application for approval, you must assemble data from many sources of varying reliability.

At the bottom of the reliability continuum is information floating around in email, Microsoft Teams messages and Slack. Next up is various spreadsheets, PDFs and statistical software containing analyses. Next up is memos and internal reports generated without a formal review process. Next is reports from outside labs (which must be interpreted within their predefined scope). At the highest level of reliability are reports and other documents generated internally according to a written procedure for review and approval.

What does ISO 13485 say about SSOT?

The international standard ISO 13485 (2016 revision) on quality management systems for medical device makers states that:

  • The company will ensure that relevant versions of applicable documents are available at points of use.
  • The organization shall document procedures to define the controls needed for the identification, storage, security and integrity, retrieval, retention time and disposition of records
  • Records shall remain legible, readily identifiable and retrievable. Changes to a record shall remain identifiable

Think about how you can meet these requirements using an SSOT approach. The concepts of a definitive record, an SSOT, and document control are closely intertwined and they feed off each other in the upward spiral of quality.

Example from a regulation

FDA’s GMP regulations state:

  • Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.
  • Each manufacturer shall maintain a quality system record (QSR). The QSR shall include, or refer to the location of, procedures and the documentation of activities required by this part.
  • The equipment identification, calibration dates, the individual performing each calibration, and the next calibration date shall be documented. These records shall be displayed on or near each piece of equipment or shall be readily available to the personnel using such equipment and to the individuals responsible for calibrating the equipment.

As you can see, the required documents such as the device history file can reference the original without having to contain a copy in the file.

Calibration records must be “readily available” to users. “Readily available” is an extension of the ALCOA principles cited above and sometimes stated as ALCOA+: “complete, consistent, enduring and available.” These last four principles extend beyond the immediate recording and disposition of data and indicate it must be available for inspection over the lifetime of the record.

Example from an FDA warning letter

In this warning letter to a large American device maker, the FDA cited the following:

“Your firm failed to follow its CAPA procedures when evaluating a third party report, in that your firm released a product risk assessment, an updated risk assessment and its corresponding corrective action, before approving the CAPA request for this issue. Your firm conducted a risk assessment and a corrective action outside of your CAPA system. Your firm did not confirm all required corrective and preventive actions were completed, including a full root cause investigation and the identification of actions to correct and prevent recurrence of potential cybersecurity vulnerabilities, as required by your CAPA procedures. Additionally, your firm did not confirm that verification or validation activities for the corrective actions had been completed, to ensure the corrective actions were effective and did not adversely affect the finished device.”

In this case, the company perhaps paid big bucks to a third party to conduct a risk assessment in response to a CAPA. When the risk assessment was completed, the company failed to fold it into the quality system. Perhaps it was locked in a lengthy report in unwieldy PDF format. 

To meet the requirements of 21 CFR 820.100(a), and their own CAPA procedures, the company should have conducted this CAPA within the quality system in a closed-loop manner and not allowed the outside risk assessment to sit there independently and feed into product release decisions independently of the CAPA system.

Last word

The single source of truth is a principle from enterprise software that applies to biotech quality assurance. Apply this principle in biotech QA to ensure your people act confidently from a single, agreed-upon source of information.


From other industries

This fascinating article explains why Google stores billions of lines of code in a single repository.

From the medical device industry

This article from a Greenlight Guru leader extolls following SSOT principles for medical device CAPA systems and promotes their software for doing so. One reason among several cited is that a CAPA seldom affects only one quality subsystem.

About the photo

My birding friend and I visited Mirror Lake in the Mount Hood National Forest in Oregon. Gray jays are bold and inquisitive. They approached us and ate our peanuts as we snacked next to this frozen alpine lake.

Knowing when to compromise in quality assurance

Quality assurance professionals in the biotech and research sector must hold technical staff to exacting standards. However, few things in life are truly black and white. In this article I will outline several tools and mental habits that support prioritization and compromise.

Follow your written procedures

At the level of forms and work instructions, your written procedures should be fairly clear and unambiguous, to the point where a person from outside your organization could follow along and perform the task at hand.

At the higher level of SOPs and policy documents, the written instruction is more general because they must apply to the wide scope of work that is done. This general language, even when it is of a technical nature, introduces room for drift and ambiguity.

Below are two examples from my experience where technical staff followed the immediate procedures exactly as written. But their analysis and treatment of data fell outside of the higher-level SOPs that guide the work of the organization.

Example 1: Inappropriate rounding of numerical results

The problem

At my company, we had an SOP on data analysis. Having this SOP aligns with the requirement of ISO 13485 that states, “The organization shall document procedures to determine, collect and analyse appropriate data to demonstrate the suitability, adequacy and effectiveness of the quality management system. The procedures shall include determination of appropriate  methods, including statistical techniques and the extent of their use.”

One requirement of this SOP was that intermediate rounding be avoided. Instead, all digits are to be retained and only the final result will be rounded to the appropriate number of significant digits.

This requirement is straightforward and it is in fact taught to high schoolers and below. It’s easy to demonstrate how intermediate rounding (i.e. averaging an average) can lead to erroneous results. For a standardized ISO study such as a cell genetic toxicity assay with quantitative cutoffs between passing and failing, inappropriate rounding could lead to reporting an erroneous scientific conclusion about the test article.

In practice however, this rule is not straightforward to explain or implement throughout a study, especially a study involving handoffs and sequences of testing. In my reviews of scientific reports and assay validations, I found that scientists were wedded to their way of doing things. This way of doing things often involved rounding a set of results from an initial set of testing, and later rounding the numbers again after the next set of testing was complete.

For the most part, this was inconsequential and did not change the study conclusion. But borderline cases could be problematic. And the practice went against the statistical methods SOP.

When I identified this problem and pushed for adherence to the SOP I was met with resistance. The scientists involved acknowledged that clients had questioned the practice in the past. They said, “We have always done it this way.” And they said that rounding intermediate numbers made sense because the rounding was done at discrete phases of the study, and the dropped digits are so small that their removal had only a small effect on the final results.

I took a step back and considered the wider context. I realized that it’s hard to change the way you do things immediately upon identifying a problem. I examined the spreadsheets used to do this analysis. The spreadsheets were ancient and had never been validated. They were retained in an uncontrolled folder and maintained by the scientists responsible for that study. In fact, anyone could edit these Excel files because Excel files are notorious for their lack of attributability for changes and for relying on laborious, error-prone, manual change control. The spreadsheets were often inherited from another scientist from years previously. They were initiated in a long-obsolesced version of Excel.

On top of that, our spreadsheet validation process at the time was labor-intensive, unclear and uninviting to the scientists. They saw the process as taking away their flexibility and as being an exercise in documentation with no benefit to their studies and to the quality and integrity of the data. In a sense, they were correct in that a validation is said to “lock down” a spreadsheet. They were also correct that the validation process was labor-intensive and involved multiple handoffs. (I detailed the efforts of my team and I to correct this in another article.)

My response

Ultimately, I placed this issue in the context of many competing priorities. Hence I moved it down the list. Instead of taking up the issue urgently, I acknowledged its importance but relative lack of urgency and chose to address the root cause.

Addressing the root cause entailed updating the statistical methods outlined in the SOP on analysis of data. With the consultation of my manager, I added clear examples and further clarity on what intermediate rounding was and why this practice was not allowed.

I also updated the spreadsheet validation process to make it easier for a spreadsheet owner to get their spreadsheet validated. I added a revalidation form to ensure that they could easily update the spreadsheet (with the appropriate checks) instead of having to redo the entire validation.

Example 2: Incorrect use of a statistical formula in Excel

The problem

Scientists in my organization were using a subtype of a descriptive statistical tool that can give skewed results.

Take the following table of pH values and two standard deviation calculations:

Entering the STDEV.S formula into Excel gives you the standard deviation for a sample. This formula is used when you have a subset of values but not the values for the entire population. This got us 0.41.

Entering the STDEV.P formula gives you the standard deviation for the entire population. This formula is used when you have values for the entire population, as we do above (i.e. all 4 pH results). This got us 0.35.

The third value is another of Excel’s standard deviation formulas. It is provided only for compatibility with previous versions of Excel. In Excel’s drop-down list, it is flagged in yellow to indicate this. And it also gives you the sample standard deviation, which is 0.41 again.

The sample standard deviation in this comparison is 17% higher than the population standard deviation. This is an overestimate of the variation in the original pH readings.

The problem at my organization was the use of the sample standard deviation even when all the values in the population were available. It arose from the use of ancient spreadsheets and a lack of awareness that there was more than one method of calculating a standard deviation. 

Firstly, the ancient spreadsheets defaulted to this sample standard deviation even when the population standard deviation was the appropriate method.

Secondly, the scientists who “owned” the spreadsheets were sometimes not aware that since they were reporting a set of pH’s, or a set of animal weights, or a set of rates of cell death, they possessed the complete population and should thus use the population standard deviation.

Excel has many historical quirks. This is one of them. 

My response

I took the same approach as above. I compromised. I chose to educate. And I addressed the root cause by paying close attention to this formula in reviews of spreadsheet validations. I also clarified the SOP cited above by providing examples of the two types of formulas and a clear explanation of when to use each one.

Three tools of incremental improvement

Compromise when appropriate

Follow your written procedures. This is a must.

However, consider the broader context.

Divide the problems of the day into four quadrants:

You must address the problems in quadrant 1 because you have little choice in a typical day. But doing this is reactive, not proactive, in nature. Your long-term goal is to reduce the severity and frequency of these issues.

You do this by spending more and more of your time working on the problems in quadrant 2. This is where most of your time is (ideally) spent. It is the realm of proactiveness and prioritization.

Problems in quadrant 3 might include answering office messaging notifications or fixing small safety lapses you come across. You should optimize them out of your life as much as possible, when there is time.

Quadrant 4 problems should be eliminated from your work and your mind entirely.

After using a tool or heuristic like the ones above, decide which problems to drive toward a resolution immediately, and which ones to go further upstream to fix. Decide what to escalate and what to analyze further.

Run a dialectical thinking exercise

Dialectical thinking refers to the ability to view issues from multiple perspectives and to arrive at the most economical and reasonable reconciliation of seemingly contradictory information and postures.”

This approach is an antidote to black-and-white thinking.

You start with a statement or rule that is putatively “always true.” You then conceive an instance where this rule is not true. You then conceive a rule or principle that can help you decide when the original statement is true and when you are dealing with an exception.

The three steps (the always true statement, followed by an exception, followed by a rule for distinguishing) are also referred to as thesis, antithesis, and synthesis.

An example is the following: 

Thesis: In my company, raw data must always be printed and then signed and dated in wet ink by the originator and then placed in the study folder.

Antithesis: However, some analytical instruments produce prodigious data. A large study, or one with retests, would swamp the archives, produce waste and other impracticalities, and require off-site storage.

Synthesis: For certain analytical instruments that produce prodigious data, the originator will instead sign and date (in wet ink) a controlled record indicating the electronic repository where such data is retained. Use of the repository will meet all the data integrity regulations and standards the company has incorporated into its record retention SOPs.

At the end of this exercise, you will have developed more flexible thinking. And you may recast the original statement as less of an ironclad rule and more of a precept (a general rule intended to regulate behavior or thought.).

You will more clearly see when it applies and when it does not. You will have done the hard work of discriminating and deciding. And you will be better positioned to get that distinguishing guidance firmly into your written procedures so that others can follow the rule without ambiguity and uncertainty.

Offer a grace period when change is difficult

In a formal, complex, or protracted change, you may wish to maintain the status quo but notify analysts/operators of the “washout” period after which you expect full adherence to the new or existing standard. Do this only after fully educating and training personnel on the requirement.

From an auditor’s perspective, you could notify personnel (informally or formally) that the gap will be written up in audits once the washout period is done. Until then, you will note the gap in your observations but not as an audit finding.

Again, make sure personnel are educated and trained on the requirement. If needed, explain why it was not sufficiently followed in the past, how the requirement was “rediscovered,” and why it is important.

Address the root cause that led to the problem

Push yourself to identify and address the root cause.

Explore the rich, exhaustive root cause analysis resources from FDA, ASQ and elsewhere. I will publish an article detailing root cause analysis and my personal experience with these powerful tools.

Last word

Uphold exacting standards while thinking flexibly. This will foster continuous improvement.

Do you have an example of compromising? Of taking a wider perspective and letting something go? Let me know in the comments.

Further reading

A technical discussion from the National Institute of Standards and Technology on rounding

Another resource on the difference between rounding (for a final result) and truncating (for reporting an intermediate value)

An Excel resource on the two types of standard deviation formulas discussed above

One definition of dialectical thinking

The relevant FDA regulation on investigating the cause of quality problems

A useful outline of root cause analysis

About the photo

Oswald West State Park is a fantastic natural area on the upper Oregon coast. On a recent weekend I enjoyed hiking trails, a beach and incredible ocean vistas with two friends and a three-month old puppy. The puppy got tired and needed frequent carrying on a doggy backpack during her first trip to the Pacific coast (how adorable!).

Quality lapses at the CDC delayed coronavirus testing

In science, the need for quality systems is everywhere. Every institution, including the Centers for Disease Control and Prevention, the premier public health agency in the US, can produce seriously flawed tests and results when the pillars of a quality system are absent.

This New York Times article from April describes some fascinating and troubling quality problems at the CDC labs that developed the first covid-19 test kits.

Calling the CDC’s lab practices “sloppy,” officials from the FDA outlined lapses in sound laboratory and production practices:

  • A basic separation of functions was missing, leading to contamination and unreliable results.
  • There was a lack of expertise in commercial manufacturing.
  • No one was in charge of the entire process.

It was public health laboratories (the CDC’s “customers”), that alerted the CDC to these problems almost immediately. The CDC failed to detect the unreliable tests on their own before distributing the kits.

A commercial producer took over production and these issues then went away.

FDA regulations provide a framework for getting the right systems into place. For example, the Good Laboratory Practice regulations clearly outline separation of functions, designation of roles (management, study director, quality assurance unit, etc.).

This story of failure, beyond the delays to epidemiologists and grieving families, highlights the need for quality systems, not a reliance on individual heroes.

Even the most highly trained and resourced scientists will suffer quality lapses if they do not follow certain procedures and practices. If they find themselves operating with a flawed system, they may realize they were set up to fail.

It was the FDA, a regulator highly competent in inspection of quality systems and testing, that cited these gaps during an inspection.

A larger investigation into the CDC’s response to the coronavirus is pending. This may be the tip of the iceberg. I shared this article to once again demonstrate the need for the quality function in labs of even the highest levels of specialization and expertise.

About the photo: I hiked up Mt Defiance on Friday. It was difficult but not grueling. Next time I will visit Warren Lake on the way down for a swim. The view is of Mt Hood. You could see as far as John Day from the summit.

How to address fear and anxiety in your auditees

Fear and anxiety are everywhere, including in the typical biotech workplace. Quality assurance professionals must help to drive out this fear.

This article will present practical advice on how to do this with individuals and groups you interface with as a QA auditor or reviewer, including technical staff, department management, and suppliers.

Anxiety in the world and in the workplace

The global coronavirus pandemic has spread fear across the globe, including offices and labs. Basic acts of human connection such as hugging and shaking hands are now fraught. On top of this, the workplace is inherently a swirl of anxiety. Biotech companies deal with high-stakes production and testing where individuals can expect to be held accountable for everything they write or produce.

Then enters the QA auditor. Seeing this person show up (scheduled or unscheduled) for an audit with a binder in hand and a probing manner, scientists and technicians will sometimes wonder if harsh consequences are coming down on their heads. They know they do good work and they stand by it. But they might feel they are being unfairly questioned for technical challenges they are working hard to overcome, or judged against a standard they were not familiarized with up front.

Even people who appreciate the value of a thorough, independent review can feel a bit of dread when gaps and mistakes are pointed out and enumerated. That’s perfectly natural!

People who are not familiar with auditing, failure investigations and inspection readiness activities may jokingly call QA “the dark side” and fear being exposed or discredited in a place where their livelihood is on the line.

On top of these natural tendencies, consider the finding that anxiety disorders affect 18% of the US adult population. It is highly likely that you work with someone with anxiety disorder or another mood disorder.

As we move as a society from fear and isolation back to connection, hope and rebuilding, QA professionals must help this process along. We must actively allay fears and foster an organizational culture of openness, collaboration, and a unified problem-solving approach.

Recognize the signs of anxiety

Learn to recognize the following signs in coworkers:

  • Restlessness and fidgeting
  • Irritability and tenseness
  • Cracking of the voice or “clamming up” and not speaking
  • Sweating
  • Being tight-lipped in response to your questions
  • Appearing flustered in a task where they are known to be proficient
  • Aloofness
  • Arriving to work poorly rested and tired
  • Catastrophizing (overreacting, feeling hopeless, and thinking of the worst case scenario) in response to a fixable problem that is limited in scope
  • Having bathroom emergencies, a racing heart, dizziness and lightheadedness, headaches, and needing to leave early during stressful times
  • Asking for reassurance excessively
  • Perfectionism to the point of wasting time for diminishing returns on effort
  • Distractedness and lack of focus
  • Finally (and this is a big one), avoidance.

Practice openness

Internal auditing

Over the years, internal auditing has largely abandoned the practice of “surprise audits.” Rather, auditors now practice openness. This allows colleagues to put their best foot forward, to learn and become better versed in their standards and procedures, and it helps to set expectations up front.

This means establishing and sharing the audit plan in advance and making clear the standards and written procedures you will be comparing the department’s records and work practices to. If there are to be any interviews of staff, you will want to share this plan with management as well so that you do not put anyone on the spot and cause them embarrassment or difficulty.

Staff should know the general time when you expect to arrive in the lab or department.

If you ask to examine original training binders, curriculum vitaes or resumes, you should return them promptly to the individual.

At the end of an internal audit, and before finalizing the audit report, meet with department management to discuss any audit findings. Share what you plan to put in the audit report and give them a chance to respond. This will help allay anxiety because they will immediately know of any problems instead of waiting for the report.

Lastly, standards should be controlled by QA but shared openly and widely. For example, the ISO 13485 standard that sets forth medical device quality management practices should not be secret. Ask yourself, do staff have to come to you to ask for you to ask for quality system information, or can they readily access it on their own? There is a difference between “authorized to access” and accessible. Everyone should be able to access the information they need to do their jobs. Even the smallest hurdle or friction can cause busy technical staff to make shortcuts that are ultimately to the detriment of the product or the process.

QA needs to step up and exercise their responsibility and authority as bearers of the standards. Take inspiration from the word itself (standard-bearer). Let staff know that you are always available to share and educate about these standards, and to learn alongside them.

In-process audits

When observing technical procedures, share your audit checklist up front. It is not a secret. Staff, including those outside QA, should be able to view it and your inspection procedures in your repository of controlled documents.

If you are watching manual work such as a dosing of cells with a test article and controls, indicate the various reagents, equipment, materials, worksheets and records you will be examining, if appropriate. Doing this up front will give the technician time to prepare and do it right.

I once noticed a technician’s hands shaking during the dosing of an animal. Since the procedure involved a needle, a syringe, and live animals, I asked if she would like a few minutes break. She did want that. I busied myself with examining the study records so far, stood a little farther back from her, and made small talk with the group. The technician proceeded like the skilled pro that she was with minimal discomfort for the animal. I learned two things: 1) That she occasionally had a perfectly understandable case of nerves, and 2) I should stand a little farther back and not loom over anyone!

Correct any misperceptions about the role of QA. A technical staff member once introduced me and another auditor to a new staff member as “the police” of the organization. He was half-joking, but I made sure to correct that impression for the new person. Policing of the organization’s activities is at the lowest rung of a company’s quality development. This is because it connotes crime and punishment and the “catching” of errors. It is in fact counterproductive in many cases. In a mature quality system everyone internalizes quality practices, errors are prevented in the first place, and no one goes to jail!

If you are comparing the activities to a written procedure, ask the technician whether they are following (e.g.) SOP-123, revision 03. Do this instead of asking them “What SOP are you following?”

With colleagues in your own company, do not employ the tactic of the “pregnant pause.” Regulatory auditors will sometimes ask a question and then listen to your answer. Instead of responding with “I see,” or “Thanks for explaining that,” they will then be silent. This delay is a little unnatural and can cause you to second-guess your answer and provide more information than is appropriate.

Although the pregnant pause is used by regulators, do not employ it yourself. They are in a position of enforcing regulations. Regulations are standards with the power of the law behind them. You are a resource within your company and should not use anxiety-provoking techniques such as this.

Instead, offer correction when technical staff responds incorrectly. If this is outside of your scope of practice as an auditor, document the incorrect answer and route it to the appropriate scientific or management staff. It is very important to follow up on any observed deficiencies in training or proficiency. Just do so through the established channels.

Supplier audits

Send the audit plan to a supplier before doing an audit there. Bring a copy of your quality agreement and confirm with them that you are both following the same version of this important document. List the records you would like to look at and ask for specific processes you would like to observe. Treat them warmly, like your own colleagues.

Of course, if you uncover problems, you may request more records and dig deeper until your concerns are addressed. But do be upfront about your plan and your expectations.

Handoffs of records, reports and other documents

Always smile and greet your colleagues at handoffs.

This is self-explanatory.

Always build rapport first. Make sure your first interactions are to introduce yourself and learn about the other person. Your first meeting should not be an inspection where you are checking their work (this may not be possible in a supplier audit). Make a personal connection and share a bit about you.

A senior scientist (a man in his 50s and with a long, successful scientific career) once confided in me that he was nervous to get back my review and findings of a lengthy study of his. My mistake was in not chatting with him beforehand. He and I later became collaborators and improved the communication between our teams.

Promote inspection readiness

Promote the idea that it is better to root out problems in-house rather than through costly third-party auditors, or worse, letting the problems get discovered by clients or regulators. 

Implement procedures that make inspections routine so that no one will break a sweat when they find themselves being observed and their work checked.

Educate staff on inspection readiness, so that you can handle an unannounced FDA visit without a scramble and without delaying the inspector. Staff will be so accustomed to your thorough and open audits that they will not freeze when they find a regulator is watching them.

Cast yourself and your colleague as problem solvers

Fundamentally, all jobs are about problem identification, resolution, and prevention. Make it clear that your inspection is part of an ongoing effort to root out errors as a team and prevent future ones.

When writing up an audit finding, use objective language and evidence and state the finding in three terms:

  • The condition (the error or current state)
  • The standard that is not being met
  • The consequences of not meeting the standard

Make a careful distinction between the facts uncovered during the audit and your own judgements and recommendations. This will help avoid the appearance and the dread of personal judgement.

To be really helpful (and to allay anxiety), provide a recommendation for the auditee for how to rectify this finding. Don’t just leave it up to them to figure out. Don’t leave them with the impression that you “can’t describe what you want, but you’ll know it when you see it.” This is a much-lamented saying in the creative fields and it has no place in technical disciplines such as biotech.

Practice unified detachment

When you practice unified detachment, you frame yourself and the auditee as two people who are united against the problem, rather than casting the other person as the problem.

Hopefully your organization is a decent place, full of fair minded people. But some of your staff may have come from a dysfunctional company where a single mistake was grounds for dismissal. They may have a fearful response and try to paper over errors or pretend they did not notice. You need to recognize that and explain that your organization is a different kind of place, where we practice “unified detachment,” and view ourselves as partnering together to address what went wrong in the spirit of continuous improvement.

Without minimizing mistakes (people should be held accountable and in fact they often crave this accountability), show how you can give people the tools they need to do their job. Identify pain points. Make their job easier for them so that they are not pressured to cut corners.

Model yourself after a leader who has a warm, inclusive and compassionate approach

Is there a manager, director or executive in your company who you look up to? Someone with a charismatic, easygoing style, who always has a warm word and a handshake (or elbow bump) for you? This is a great person to model yourself after.

When you walk into a room for an inspection or an audit closing summary, remind yourself of this leader’s interpersonal style. Address your own discomfort, if any, before entering. Be present, warm and focused. Make it clear that there is no troubling subtext to the audit findings and that no one present is incompetent or unworthy. Rather, they are tractable problems that you are going to sort out as a team.

Practice confidentiality. Without taking on the role of therapist, be positive and accepting when people confide their mental health challenges in you. Never breach the trust they have lent you. View their anxiety as one aspect of a complex, multifaceted individual.

Their anxiety may in fact fuel positive traits such as their attentive and detailed work, their warmth and agreeableness, and their deep thinking on the far-flung repercussions of certain work problems. And do not judge their work based on what you know about their mental health. Instead judge the work according to the objective, well-documented, and openly disseminated standards you as a QA professional are responsible for upholding.

Share quality guru Deming’s advice to drive out fear

Statistician and quality expert W. Edwards Deming wrote extensively on the importance of driving fear out of the workplace.

Not only is this important psychologically, it also advances quality goals. outlines three methods for removing fear:

  • Don’t reprimand people if they make mistakes. Instead teach them to learn from the mistakes.
  • Encourage employees’ feedback from all levels. Use the Pareto principle to focus on the most important problems.
  • Involve the employees in solving problems. They are the experts at their station. Use their knowledge to implement sound change. When you involve employees, this naturally reduces fear.

I would add to this that QA people can channel complaints and suggestions productively. Suppose a technician complains about all the manual transcription they do. Their worksheet or batch record may be structured such that they fill out the same reagent, material and equipment information on dozens of consecutive pages. If this is a pain for them, it’s also a pain from a quality perspective! It is unlikely they are copying that info straight from the label. Instead, they have the equipment numbers memorized and they copy from one page to the next, which is totally reasonable and expedient but defeats the goal of concurrent documentation.

Help them out by flagging these issues in a recommendation section of your inspection report. Identify it as an area that has not yet caused a problem, but could lead to one in the future. In this way you help to drive improvement and you ally yourself with the technical staff who do the important work of science, engineering and production.

An example where I screwed up but ultimately fixed a much larger issue

I once made a mistake that resulted in repeating a short (three-day) scientific study and a delay to the client. Basically I failed in a logistical, paper-based handoff. The error was mine and I felt totally answerable for it.

But when we looked into it as a team involving my manager and my peers, we began to question the system we had been following of handing off sticky notes with handwritten study identifiers in a chain of transcription that started with technical staff and then was passed to us. Basically, we were passing sticky notes with handwritten (but critical) information.

We immediately started rethinking this process. The final result was a redesigned system that we linked to an even larger lean operations project. This amounted to a breakthrough change in the efficiency of our audit scheduling system, its incorporation into the master study schedule (a GLP requirement), the assignment of a dedicated staff person to do this scheduling, better defined responsibilities in this process, a greater ability to identify missed audits, and smoother handoffs.

It all began with a screw-up that I answered for (with a brief spike in anxiety and guilt). But by the end we had united as a team to do away with a laborious and error-prone process.

My message of hope and acceptance

Encourage everyone to bring their whole selves to work. Take to your role with professionalism, but also with gentleness and compassion. Recruit others in practicing discrimination (sorting out the good from the bad) and not recrimination (blaming individuals).

Drive out fear from your biotech organization to make it a place where people are accepted even as we continually strive for better.


Managing anxiety and stress in the workplace by the Anxiety and Depression Association of America

Facts & Statistics about anxiety

The Subtle Signs That Someone Might Be Struggling With Anxiety

Difficult Conversations: How to Discuss What Matters Most (this book is excellent and goes into detail about unified detachment)

The Anxious Achiever Podcast: Rethink mental health and work, with candid stories from leaders who’ve been there.

About the photo

The photo is from the Columbia Slough Trail in North Portland in May 2020. In my regular visits I see belted kingfishers, bald eagles, cedar waxwings, swallows, wood ducks and cormorants.

Roaches, Zika virus, and vaping-addicted kids: FDA warning letters are back!

Yesterday US Food and Drug Administration (FDA) warning letters came back, and they indicate the agency’s actions on novel and critical public health risks. The recent federal government shutdown appeared to slow the weekly issuance of FDA warning letters. I am glad these inspections and enforcement actions have recommenced. Read below for a few highlights.


A reproductive health clinic (i.e. fertility clinic) in Miami received a warning for failures in screening for Zika virus and other infectious diseases. Inspectors noted inadequate labeling of specimens (including semen). In addition, the clinic gave some donors an “eligible” approval before receiving the results of infectious disease testing.

There is also a worrying observation about issues at the clinic that go back four years, to 2015:

In response to Observations 3 and 4, you stated that your corrective action was to review and sign the appropriate forms in a timely manner based on the results of donor screening and testing. However, we note that these two observations were also cited during the previous inspection of your establishment conducted from November 19, 2015 to December 2, 2015. Your corrective actions, if any, after the previous inspection were not adequate to prevent recurrence of the same violations, as they were cited again during the current inspection.

Reading this letter I get the impression that basic laboratory controls are missing. This is unfortunate especially since the clinic is affiliated with a university. The letter mentioned Zika virus, west Nile virus, and a prion disorder called Creutzfeldt-Jakob disease. I sometimes wonder if we are failing to learn the required lessons from these emerging diseases. A few years on from the worst of the Zika outbreak, we still have inadequate screening and testing, even in a high-risk region such as south Florida.

Underage vaping

The FDA warned an online store for vaping juice and devices after the store sold these nicotine products to a minor.

If you are curious about vaping and teenagers, check out this recent New York Times article that paints a sad portrait of addicted kids. It also cites a statistic that “3.6 million middle and high school students are now vaping regularly.” I happen to believe that a teenager is better off vaping than smoking. However the addictive potential and long-term health risks of vaping are unknown. In addition the kids can vape anywhere, they can easily conceal these small devices, and they have no clear path to quitting.

It is in this context that the FDA has warned this and other companies that sell electronic nicotine delivery system (ENDS) products. Get used to that ENDS acronym because vaping is an issue that will not go away any time soon.

Also, I have to point out the cake, candy and fruit-flavored nicotine e-juice this company is selling. Some of them are even in a fruit juice box-style packaging! It’s hard to deny that they are marketing to kids:

Imported over-the-counter drugs

A manufacturer in China was cited for producing over-the-counter drugs (which are sold in the US) in the same equipment as non-drug products. This practice is unacceptable under the Good Manufacturing Practice (GMP) regulations.

The inspector cited other ongoing violations, including inadequate stability-indicating methods on the drugs and distributing drug batches without the quality unit’s review of failing test results. Interestingly, the company’s previous response was deemed inadequate because it did not include a root cause analysis. To me this shows the importance of thorough investigations when a failure occurs.

Pest-ridden food distributors

This one is gross. At a food storage and distribution facility in Florida, an inspector observed:

· One live cockroach on the wall along the east side of your freezer, under racking storing various food products.

· Three dead cockroaches in between packages of “United Sugars, Extra Fine Granulated, Pure Sugar Cane” packaged in 5lb paper bags. These packages were on a pallet along the wall on the west storage area, near the north end of the facility.

· An apparent birds’ nest along the ceiling in a center aisle, in the east storage area, across from the freezer and cooler.

· Apparent bird excreta on several boxes of “Loty Chicken Flavor Bouillon,” which were stored on a pallet near the wall shared with the south end of the freezer.

· Five dead cockroaches in Cooler #1 along the wall on both sides of the door. This cooler is used to store rice and other products which require a cool environment.

· Apparent cockroach parts (e.g., wings and exoskeleton parts) too numerous to count throughout your facility, along the east and center aisles in between racking systems, and along the walls.

· A powder, identified by your firm as a mix of corn flour and ground-up rodent bait blocks, throughout your entire facility along the walls, and in between racking systems of stored packaged food products. The bait was identified to be “Bell Contrac All Weather Blox” used to kill rats, mice and meadow voles.

· Your three dock doors used for shipping and receiving along the north end of the facility are open during business hours and are not screened to exclude any type of rodent or pest from entering the facility.

I appreciate the inspector’s thoroughness! They counted the roaches, poop and other animal signs, and noted their location. An audit finding should always be specific so that a follow-up inspection can verify whether corrective actions were effective.

Another food processing facility in Florida was warned over a repeated failure to follow a specific pathogen reduction process in their fruit juices. Because of the repeated nature of the violations, the letter included an interesting note about how the FDA is authorized “to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs.”

If they have to keep coming back to help you get your act together, you might have to pay!

Final comments

FDA warning letters are a treasure trove of information to help you understand the agency’s enforcement priorities on a wide array of medical and consumer products. I think it’s just a coincidence that three of the five entities cited here are in Florida.

The FDA website noted early on in the shutdown that “agency operations continue to the extent permitted by law, such as activities necessary to address imminent threats to the safety of human life and activities funded by carryover user fee funds.” I am not sure if this included the inspections referenced in this letter. However, I wouldn’t be surprised if there is a gap in warning letter postings three to six months from now.

The letter to the fertility clinic highlights a real risk: what if you or your fetus contracted the Zika virus from an anonymous sperm donor? For its part the underage vaping issue is big and it will only get bigger. The only apparent requirement for getting this nicotine vape juice from the site above is a credit card and a mailing address. The over-the-counter drugs could be part of a recall if the company’s response is deemed inadequate. This means American consumers could have to search their medicine cabinets for the bad pills. Finally, the pest issues at the food facilities are just gross.


Centers for Disease Control and Prevention:

“No instances of Zika virus transmission during fertility treatment have been documented, but transmission through donated gametes or embryos is theoretically possible.”


Recently Posted Warning Letters

New York Times:

“Addicted to Vaped Nicotine, Teenagers Have No Clear Path to Quitting”

Nexus Vapour:

Check out these kid-friendly nicotine vaping juices

Business book review: “Essentialism: The Disciplined Pursuit of Less” by Greg McKeown

Essentialism: The Disciplined Pursuit of Less is a business bestseller from 2014. This slim paperback is lively and readable in describing the principles of separating the essential from the nonessential in work and life. The author provides the briefest possible guidance on how to hone your skills of judgement and discrimination in order to focus on doing what is essential, and eliminating the rest.

I picked up the Kindle version of Essentialism after a webinar host recommended it. In addition, Tim Ferriss read some passages from it on his podcast that resonated with me. Lastly, I was attracted to the message of decluttering and simplifying in general, and this book promised another writer’s perspective on this issue. Essentialism is not specific to any particular industry or profession.

In this review I will explain why Quality professionals should consider picking up this book. If you don’t have time to read it, I hope this review will give you a couple of key takeaways and quotes. I will also direct you to some good YouTube summaries, because that is an excellent way to absorb quick messages from the huge yearly tide of business books.

McKeown argues that hardworking, smart people are overextended and distracted by many projects and tasks, and that many of these tasks are unimportant. Part of what drives this may be technology. But there are other factors, including the pattern of success distracting a person from what made them successful in the first place (such as a technically skilled engineer who becomes a manager and finds himself doing less and less of the skilled work). Another pattern is the many unimportant choices that a person faces in the typical day.

By applying a few simple methods of sorting the essential from the nonessential, one can eliminate many unimportant tasks and focus on what truly matters. Part of this means getting better at saying no (though this is not at all the bulk of the book).

A simple tactic for how to say no is the following:

Use the words “You are welcome to X. I am willing to Y.” For example, “You are welcome to borrow my car. I am willing to make sure the keys are here for you.” By this you are also saying, “I won’t be able to drive you.” You are saying what you will not do, but you are couching it in terms of what you are willing to do. This is a particularly good way to navigate a request you would like to support somewhat but cannot throw your full weight behind.

Another chapter goes into greater detail about the Pareto Principle, which suggests that in any given problem, 80 percent of consequences come from 20 percent of the causes. McKeown often restates this to say that 90 percent of the causes come from 10 percent of the causes. I like this latter, starker ratio because it encourages you to be even more ruthless in eliminating the nonessential and focusing on that essential 10 percent.

For the most part the author accomplishes the stated purpose of the book: defining essentialism and providing some tactics for getting there. In addition, he does not overstate the advantages of this approach. Since it is an all-encompassing outlook on life and business, essentialism requires constant discipline, as stated in the book’s title.

A strength of the book is the short examples of how to make a small essentialist win (such as the story of saying no above). Techniques and methods that bridge the gap between a proposed way of thinking and the day-to-day workplace tasks is helpful. Another thing I like is the numerous small tables that highlight the differences between an essentialist and non-essentialist with respect to the chapter’s topic.

I also like the simple black-and-white art. One illustration in particular from early in the book asks the reader: Do you want to make a millimeter of progress in all directions or a mile of progress in one direction? Accompanying this challenge is a diagram to keep in mind when you are considering what you want to “go big on.”

One weakness of the book (as with much business literature) is the anecdotes. As a business consultant the author has a wealth of illustrative stories to draw on and most of them are memorable. However, some do not support the underlying arguments of essentialism in the way the author intends.

For example, a highly practical part of the book provides hints on how to avoid lengthy, pointless meetings and do the work via an email instead. But a later chapter opens with a Silicon Valley CEO who insists on a 3-hour, unskippable meeting every Monday of every week that includes every executive in the global company. In fact they are required to schedule their travel to never conflict with this meeting.

This example is meant to illustrate how a firm routine can “eliminate the mental costs involved in planning the meeting or thinking about who will or won’t be there.” However, in my view it was another example of a large chunk of time that each meeting participant will subtract from the finite number of productive hours in his or her workweek.

A second criticism is the book’s short length. I wish it was longer! This makes it an ambivalent criticism because it shows that the author managed to light a fire with readers like me. I want more examples, more diagrams, more how-to’s. I want a book on essentialism in daily life. I want a book on essentialism in relationships. I want a book on essentialism in higher education and job training.

I hope this kind of guidance is forthcoming. It’s now 2019 so five years have passed since the book’s publication. To continue honing essentialist skills, one may have to look elsewhere. A few resources I have found in this strain of thought are Cal Newport’s book Deep Work, Tim Ferriss’s podcast (and his somewhat dated book The 4-Hour Workweek) and Marie Kondo’s rapidly expanding corpus of decluttering guidance.

Another book echoing this philosophy (in my opinion) is Your Money or Your Life by Vicki Robin and Joe Dominguez. Why? Because it addresses the concept of enough. In my opinion, enough is tied conceptually to essentialism. I would recommend this personal finance gem to anyone who felt a spark from Essentialism. I am always happy when I come across a book that helps tie together a few different authors in the same way of thinking.

At this point I would like to highlight two connections between essentialism and Quality.

First, Quality professionals will instantly recognize the Pareto principle. This principle is in the quality curriculum and it’s worth revisiting again and again. As much as I like essentialism, it may be no more than a sexy rebranding of the Pareto principle. By adhering to the view that a small number of causes are truly important, and disregarding or de-prioritizing the rest, one can make a lot of progress. This would conform to my view that all the winning principles of Quality are known, they just need to be implemented and maintained.

Second, Quality professionals need to be constantly vigilant about straying from their core role of checking. The purpose of a Quality group within a company boils down to checking the work of the operations/production part of the company. Too often, due to misunderstandings, mission creep, and the good nature of individuals, Quality professionals take on projects that belong to operations. Sure, they might do a good job. But the question is, who will check their work? The better arrangement is the traditional one: Quality, in the course of their work, identifies a gap. They recommend (or require) operations to fix it. Quality checks the fix and reports back, continuing the cycle.

Thus it is the checking that is essential. Quality professionals should keep that in mind. Reading Essentialism will help them maintain vigilance at the dividing line between the doing and the checking.

Quality professionals should read this book. I would also recommend it to technical people who feel they spend too much time on meetings, email and other ancillary projects (isn’t that everyone?).

The image is from Columbia Park in Portland, Oregon today (20 Jan 2019). The quote from Lao-tzu is from one of the chapter headings in Essentialism.

Lastly for a taste of the language of Essentialism and a few nuggets, see my Kindle highlights below.

“I have a vision of everyone – children, students, mothers, fathers, employees, managers, executives, world leaders – learning to better tap into more of their intelligence, capability, resourcefulness, and initiative to live more meaningful lives.”

“Essentialists see trade-offs as an inherent part of life, not as an inherently negative part of life. Instead of asking, “What do I have to give up?” they ask, “What do I want to go big on?” The cumulative impact of this small change in thinking can be profound.”

“Essentialists spend as much time as possible exploring, listening, debating, questioning, and thinking. But their exploration is not an end in itself. The purpose of the exploration is to discern the vital few from the trivial many.”

“Richard S. Westfall has written: “In the age of his celebrity, Newton was asked how he had discovered the law of universal gravitation. ‘By thinking on it continually’ was the reply.… What he thought on, he thought on continually, which is to say exclusively, or nearly exclusively.”3 In other words, Newton created space for intense concentration, and this uninterrupted space enabled him to explore the essential elements of the universe.”

“You can think of this as the 90 Percent Rule, and it’s one you can apply to just about every decision or dilemma. As you evaluate an option, think about the single most important criterion for that decision, and then simply give the option a score between 0 and 100. If you rate it any lower than 90 percent, then automatically change the rating to 0 and simply reject it. This way you avoid getting caught up in indecision, or worse, getting stuck with the 60s or 70s. Think about how you’d feel if you scored a 65 on some test. Why would you deliberately choose to feel that way about an important choice in your life?”

“In the first pattern, the team becomes overly focused on winning the attention of the manager. The problem is, when people don’t know what the end game is, they are unclear about how to win, and as a result they make up their own game and their own rules as they vie for the manager’s favor. Instead of focusing their time and energies on making a high level of contribution, they put all their effort into games like attempting to look better than their peers, demonstrating their self-importance, and echoing their manager’s every idea or sentiment. These kinds of activities are not only nonessential but damaging and counterproductive.”

“As Ralph Waldo Emerson said, “The crime which bankrupts men and states is that of job-work;—declining from your main design to serve a turn here or there.””

“Nonessentialists say yes because of feelings of social awkwardness and pressure. They say yes automatically, without thinking, often in pursuit of the rush one gets from having pleased someone. But Essentialists know that after the rush comes the pang of regret. They know they will soon feel bullied and resentful—both at the other person and at themselves. Eventually they will wake up to the unpleasant reality that something more important must now be sacrificed to accommodate this new commitment.”

“Use the words “You are welcome to X. I am willing to Y.” For example, “You are welcome to borrow my car. I am willing to make sure the keys are here for you.” By this you are also saying, “I won’t be able to drive you.” You are saying what you will not do, but you are couching it in terms of what you are willing to do. This is a particularly good way to navigate a request you would like to support somewhat but cannot throw your full weight behind.”

“In a reverse pilot you test whether removing an initiative or activity will have any negative consequences.”

“As Alan D. Williams observed in the essay “What Is an Editor?” there are “two basic questions the editor should be addressing to the author: Are you saying what you want to say? and, Are you saying it as clearly and concisely as possible?”7 Condensing means saying it as clearly and concisely as possible.”

“This may seem a little counterintuitive. But the best editors don’t feel the need to change everything. They know that sometimes having the discipline to leave certain things exactly as they are is the best use of their editorial judgment. It is just one more way in which being an editor is an invisible craft. The best surgeon is not the one who makes the most incisions; similarly, the best editors can sometimes be the least intrusive, the most restrained.”

“The way of the Essentialist is different. Instead of trying to accomplish it all—and all at once—and flaring out, the Essentialist starts small and celebrates progress. Instead of going for the big, flashy wins that don’t really matter, the Essentialist pursues small and simple wins in areas that are essential.”

“Research has shown that of all forms of human motivation the most effective one is progress. Why? Because a small, concrete win creates momentum and affirms our faith in our further success.”

“On the basis of these hundreds of thousands of reflections, Amabile and Kramer concluded that “everyday progress—even a small win” can make all the difference in how people feel and perform. “Of all the things that can boost emotions, motivation, and perceptions during a workday, the single most important is making progress in meaningful work,” they said.”

“My experience has taught me this about how people and organizations improve: the best place to look is for small changes we could make in the things we do often. There is power in steadiness and repetition.”

“Similarly, we can adopt a method of “minimal viable progress.” We can ask ourselves, “What is the smallest amount of progress that will be useful and valuable to the essential task we are trying to get done?” I used this practice in writing this book. For example, when I was still in the exploratory mode of the book, before I’d even begun to put pen to paper (or fingers to keyboard), I would share a short idea (my minimal viable product) on Twitter. If it seemed to resonate with people there, I would write a blog piece on Harvard Business Review. Through this iterative process, which required very little effort, I was able to find where there seemed to be a connection between what I was thinking and what seemed to have the highest relevancy in other people’s lives.”

“The way of the Nonessentialist is to think the essentials only get done when they are forced. That execution is a matter of raw effort alone. You labor to make it happen. You push through. The way of the Essentialist is different. The Essentialist designs a routine that makes achieving what you have identified as essential the default position. Yes, in some instances an Essentialist still has to work hard, but with the right routine in place each effort yields exponentially greater results.”

“And routines can indeed become this—the wrong routines. But the right routines can actually enhance innovation and creativity by giving us the equivalent of an energy rebate. Instead of spending our limited supply of discipline on making the same decisions again and again, embedding our decisions into our routine allows us to channel that discipline toward some other essential activity.”

“In an interview about his book The Power of Habit Charles Duhigg said “in the last 15 years, as we’ve learned how habits work and how they can be changed, scientists have explained that every habit is made up of a cue, a routine, and a reward.”

“The question is, “Which is your major and which is your minor?” Most of us have a little Essentialist and a little Nonessentialist in us, but the question is, Which are you at the core?”

“I still fight the urge to impulsively check my phone; on my worst days I have wondered if my tombstone will read, “He checked e-mail.” I’ll be the first to admit, the transition doesn’t happen overnight.”

“This story captures the two most personal learnings that have come to me on the long journey of writing this book. The first is the exquisitely important role of my family in my life. At the very, very end, everything else will fade into insignificance by comparison. The second is the pathetically tiny amount of time we have left of our lives. For me this is not a depressing thought but a thrilling one. It removes fear of choosing the wrong thing. It infuses courage into my bones. It challenges me to be even more unreasonably selective about how to use this precious—and precious is perhaps too insipid of a word—time. I know of someone who visits cemeteries around the world when he travels. I thought this was odd at first, but now I realize that this habit keeps his own mortality front and center.”

“If you take one thing away from this book, I hope you will remember this: whatever decision or challenge or crossroads you face in your life, simply ask yourself, “What is essential?” Eliminate everything else.”


Essentialism (Amazon)

Your Money or Your Life (Amazon)

The Life-Changing Magic of Tidying Up (Amazon)

Tim Ferriss Podcast episode with Essentialism quotes and reaction

How to Say “No” Gracefully and Uncommit (#328)

The 4-Hour Workweek (Amazon)

Deep Work (Amazon)

A couple of YouTube summaries of Essentialism:

Software Requirements Specification: How to contribute as a Quality representative

Every employee wants their teammates to value their contributions. This is a universal desire. In this article I will describe how to contribute effectively to a specific kind of project that I know: the software requirements specification.

Specifically I will describe how to help craft this document as a Quality representative on the project team. The Internet abounds with resources on everything software-related. So in this article I hope to convey my own unique experience and voice on this topic. If you have ever been the Quality representative on any kind of software team, I invite you to read on.

What is a software requirements specification?

The software requirements specification (SRS) is an important document in software development. It is crafted near the beginning of a software development project. Its structure includes:

  • A complete description of the software’s function
  • Defining, in advance, how users will use the software
  • Defining all quality and engineering requirements and applicable standards
  • And others

Here is a good definition from Wikipedia: “Software requirements specification is a rigorous assessment of requirements before the more specific system design stages, and its goal is to reduce later redesign.”

Its purpose is to:

  • Prevent failure
  • Reduce redesign
  • Meet and exceed requirements

The SRS is important because it helps prevent project failure. Simply put, it is useful. A well-crafted one will save time and money during development and serve as the basis for verification and validation later on.

Behind the SRS is a complex process of requirements elicitation, made possible through effective communication and documentation. The person who writes it is generally a business analyst. This individual is not a developer, not a user and not a manager, but someone trained in the software lifecycle and in technical writing.

Where Quality fits into this effort

The SRS is fundamentally a Quality process, even though it is not driven by the Quality unit of the company.

Note the terms requirements elicitation, verification, validation, redesign, standards, etc. The SRS is a quality planning document, with the intent of building quality into the software instead of reworking it toward the end of the project. It is a tool for establishing explicit, agreed-upon standards by which to judge the outcome (which parallels the Quality unit’s role of checking). It prevents redesign, which is analogous to scrap but is probably even more labor-intensive to address.

In addition, the Quality unit may be an internal customer that will use the software. As a representative on the team you thus help to provide user stories and convey what is important to you in using the planned software to do your job.

All engineering involves trade-offs. The information you provide, once it is explicitly documented in the SRS, helps the software engineers to prioritize wants and needs and incorporate them into the final product.

My own experience

I had a great opportunity to be on such a team. The goal was very worthy: to overhaul our clients’ ordering process.

Leaders within my company had heard client feedback about our ordering process and not all of it was positive. In addition they had their own experience to draw on: they compared our clunky, web-based form with the frictionless experience of ordering on or other e-commerce apps. They compared them and realized we could do better. If we redesigned our ordering system to be like Amazon’s, our clients would avoid the occasional frustrations, would be more likely to come back, and would be more likely to order the additional testing and manufacturing services that we recommend.

I joined this team after the initial project charter was created but before the SRS was created. The charter reflected these worthy goals and it had inspiring language created by the project manager. The charter also conveyed the full support of executives (including the “project champion” from the executive leadership).

Once my name was added to the charter and my responsibilities listed, I felt eager to contribute toward making the project a success. Helping with the SRS is one of the ways I did so.

Key components of an SRS and my own experience

In general an SRS will contain the following:

1. Purpose

2. Scope

3. System overview

4. References

5. Definitions

6. Use cases (user stories)

7. Functional requirements

8. Non-functional requirements

I won’t go into detail because you are quite capable of Googling this stuff. But I would like to highlight the Quality unit’s role in the SRS’s purpose, use cases (user stories), and functional and non-functional requirements sections.

The Purpose section of the SRS is worth your attention. You should scrutinize it (and the project charter) to understand the goals of the software and how you will use it.

In my case (the client ordering system I mentioned above), I would use the client information entered in this new ordering system during my reviews and audits. Therefore it was very important that the project team incorporated my Quality input on regulations regarding handling and reporting of client-provided information.

For instance, the proposed system needed to preserve client-provided sample names, lot numbers, surface areas, extraction ratios, preparation instructions, etc. with exact fidelity. In the event of a change to this client-provided information, Quality would need to review each change. Each change also needed to be attributable and time-stamped in order for the Quality unit to meet its Food and Drug Administration-mandated objective of reviewing these changes.

The Use cases (user stories) is where Quality (and other future users) convey to the team how they will interact with the software.

In my project, the most important user of the client ordering system is the client. The project team I worked with had extensive communication with several of our clients who had expressed willingness to “pilot” the new system once it was online. These were loyal clients who had mastered the old system and all its kinks, but were eager to use a new and improved one.

In addition to the client, Quality would interface with this system daily and hourly when reviewing reports, inspecting manufacturing processes, and inspecting in-process scientific studies. We would also pull up this client order record during audits, during failure investigations, and before approving reports and certificates. As Quality representative, I and another auditor collaborated and described to the team how we would use the new software. With the business analyst’s help, these user stories were formalized and refined and they became part of the SRS.

Lastly, the functional and non-functional requirements sections help project stakeholders understand and agree on what the software will do and how it will work. In software engineering there is a distinction between the two kinds of requirements. You don’t need to understand this distinction or separate your input into the two categories. More important as a Quality representative is to communicate on an ongoing basis with the team to convey your must-haves and your wants. You will commit to being a good-faith negotiator on needs versus wants. You will make a full effort to understand, and then you will be flexible on your wants but clear on your needs.

Here are some examples. In my project to create a new client ordering system, the following requirements surfaced:

  • The ordering system must communicate with full fidelity/exactitude with our Laboratory Information Management System (which is used in data capture and reporting).
  • The system must have full audit trails, allowing investigations to capture the who, what and when of every change to client-supplied information.
  • The system should flag any changes to client-supplied information made by company technicians and scientists after the sample submission with strikethrough text or an asterisk, to allow the Quality unit to review these changes.
  • The system should allow Quality to pull up a few useful reports, including a report for inspections of ongoing studies, and a report to pull up during client visits.
  • The system should be clear about where the definitive record is, so that there is no disagreement or confusion for a reviewer contemporaneously or months or years down the line.

The examples above are both functional requirements and non-functional requirements (in software engineering terms). They are also divided into wants and needs. In this project I was explicit with the team about the audit trail need because regulations require that the Quality unit review changes to critical study data. We needed to ensure that a sample submitted under one name would not be reported under another name, without the proper authorization and review.

When it came to “flagging” these changes, I considered such a feature a want because such system flags would help us zoom in more efficiently on changes, deletions and insertions that needed Quality review. In discussions with the team my Quality partner and I made it clear that this and the reporting features were a couple of “nice-to-haves” so that the team could prioritize while still understanding our desires.

The last bullet point is borderline between wants and needs. On one hand, computerized systems that talk to each other are bound to have redundant data. Written procedures can compensate for this by pointing to the most concise record. On the other hand, any hint of contradiction in two computerized systems could be problematic if regulators examine the record years later and cannot reconstruct what was actually done in the lab or manufacturing area.

There is one last SRS component I would like to highlight: diagrams and pictures.

Busy people (doesn’t that include all of us?) and adult learners in general will scan the document for images. If you can create a Microsoft Visio process chart that illustrates clearly and simply how Quality will use the software, then this image may feature prominently in the SRS, and it will help the team and others in your company to understand your role and build software that will fully equip and enable that function.

Microsoft Visio is a fantastic tool that warrants an article of its own. (Alexa: remind me in 3 months to write it!). If you use Visio to map out the Quality interface with the planned software, review this diagram with the technical writer and your unit, make it pretty and then finalize it in a way people can agree on, you will be a hero. And your work will feature prominently in the SRS.

How to contribute as Quality representative

Help the software team out at this crucial stage by being available, by reading the project updates thoroughly, by relaying needed info back to the Quality team (while cc’ing the project manager and observing any other project confidentiality ground rules), and by bringing questions you can’t answer to Quality management.

Below is a list of further tips:

  • As a Quality representative you can help the writer of the SRS to fully describe:
    • System Interfaces
    • User Interfaces
    • Hardware Interfaces
    • Software Interfaces
    • Communication Interfaces
    • User characteristics
    • Reliability
    • Availability

For instance, you will learn how the proposed software interfaces with your already-existing systems. You will convey to them how often and where you will log in (at your desk, in the labs, on the manufacturing floor, on a portable tablet, etc.). You will be able to request reviewer-only access, or superuser or Quality administrator privileges for your group.

You may convey to the writer of the SRS how the typical Quality employee goes about their job. Are they all tech-savvy? Will they know how to use a tablet or stylus? Are they accustomed to pulling up the proposed reports and queries?

You may need to convey how and where Quality auditors and specialists do their jobs. If the software needs to be accessed while in labs or on the manufacturing floor, it might require a tablet. Will the WiFi connection be fast enough? Will the tablet be durable? Will it be wheeled about on a cart, or carried by hand? Will it be navigable and reliable if a client wants to see the system? Or does it require an employee to print out a manual copy of a report for the client to review?

  • To continue in this vein, the Quality representative may contribute quality attribute general scenarios:
    • A modifiability general scenario
    • A performance general scenario
    • A availability general scenario
    • A security general scenario
    • A usability general scenario
    • A reliability general scenario

Don’t be intimidated by the term “quality attribute general scenarios.” You are not responsible for putting Quality requirements into engineering terms that will be used by developers. Rather what this means is that the Quality representatives will convey system-independent requirements, and the writer of the SRS will draft them into system requirements.

As an example, Quality may require that auditors have read-only access to the system, so that they fulfill their role of checking but not altering or “fixing” things themselves, which would muddy the waters of measurement and accountability. This is a system-independent requirement. The writer of the SRS will convey this requirement into technical terms and it will thereby become an architectural pattern and a set of measurable, specific quality attribute requirements. See the Carnegie Mellon University link below for an interesting discussion of these terms.

Five final tips

Consult with your team for additional perspectives. Explain the goal of the project, and then provide specifics. Give an open invitation to join for those who want a greater voice in a software project that will affect them.

Escalate to Quality management if you encounter a question that you don’t know the answer to. Consult Regulatory for requirements you may not be aware of that may need to be reflected in software requirements. Ask a manager to help you distinguish between wants and needs. Ask a manager to join you in project meetings if you need to press a certain point more finely.

Read the project charter in the beginning and re-read it occasionally or when it is amended. Share it with the Quality unit if it will help them understand the goals and benefits of the project.

There are development methodologies where an SRS is not central. Consider the following forum response (I edited for clarity) from The author is referencing the fact that you can’t know everything in advance, no matter how much you plan:

“Recently developers have articulated why Big Up-Front Design (BUFD) is the hallmark of failure. BUFD is typically an exercise in make-believe, where you pretend you fully understand the problem and how precise code will solve it before you even begin development. The design document is treated as a contract, and all kinds of pain ensues. Been there, done that.”

This means you should be open to other, novel means of capturing requirements. You should be as agile as the rest of the team!

Lastly, various companies will try to sell you software to create SRS’s. Some of these services may work great. However a vendor cannot do the hard work of talking to people, following through, clarifying, etc. A senior product manager at Cisco said, “Understanding what is actually required is both a science and an art.” (See the reference below). A piece of software on its own cannot achieve one of the main objectives of the SRS, which is to foster consensus. Do a CTRL+F on my article and note how many times I used the word “craft.” A skilled communicator often drives the SRS process and makes it so valuable to the software project. You can make this person’s job easier through your contributions.

Research further on your own with these resources

SRS templates:

Examples of actual or mock SRS’s:

YouTube videos:

  • Some YouTube videos on SRS’s are of poor quality or are simply incorrect. Some are from third-party companies that want to convince you that their software/outsourcing operation is the only way to do it correctly. I won’t provide a list of videos because the assortment is constantly evolving. Since you are a Quality professional, I trust you to use your well-practiced discernment!

Articles and papers:

Final thought

I see a bright future for individuals in Quality who are able to interface effectively with software teams. If you can communicate with business analysts and developers and bring that technology back to your Quality unit, you will benefit both groups and you will grow in credibility and prestige.

I hope you have felt a spark from reading this article. I enjoyed writing it. If you have a question or comment for me, let me know below!

p.s. The photo is from Saint Johns Bridge in Portland, Oregon. I took it on a fine sunny day in Cathedral Park.

How to use Microsoft Access for your company’s Quality needs

This year I had a great opportunity to learn Microsoft Access.

MS Access is a database software that comes with Microsoft Office (Word, PowerPoint, Excel, et cetera). To my surprise, I found it was packaged with my home edition of MS Office. If you are paying for a home edition of MS Office, you already have it for as long as you pay the monthly fee ($8).

In this article I will show you the basics of what I learned. I will describe how you can use this software to solve problems in your Quality unit or in the larger organization. I will show you how you can gain the highly advantageous moniker of “the software person” on your quality team within a short timeframe. And I will highlight some great opportunities to pursue once you get a handle on this powerful database tool.

What is MS Access?

You can easily read the Wikipedia page, visit the Microsoft tutorial site, or watch a couple of Youtube videos on what Access does, so I won’t restate all that information here. In a nutshell, an Access database helps you go beyond Excel spreadsheets in robustness and functionality.

Think of the biggest, oldest, most bloated spreadsheet you use at work. Perhaps it is a list of approved suppliers. Perhaps it is a team tracking spreadsheet. Perhaps it is a spreadsheet for tracking defects and corrective actions in outgoing products.

Now think of the problems involved: individuals are often locked out as another person edits the spreadsheet. Multiple versions are floating around, and there is confusion over which one is definitive. They constantly need to be reconciled. The spreadsheet is old, so it is opened in compatibility mode and some macros have broken down, resulting in extra clicks with every opening and closing of the file. The file is large and slow. Individuals can easily delete, replace, or fat-finger their entries without much traceability. When it comes to analyzing the data, you have to make extra sheets and you question whether you are drawing from the correct source cells. Redundant and ambiguous values proliferate.

A database helps you get around these problems. For instance, instead of navigating to the correct sheet and entering data in an individual row, the user can fill out an attractive, easy-to-use form. Instead of relying on finicky charts, you can export a standardized report with parameters you have specified. Finally, there is the extremely important advantage of unambiguous (unique) values. A properly designed Access database, unlike a spreadsheet, will not give you ambiguous answers when you ask, “What is client X’s current email address?”

The four main components of Access

Access has four pillars: tables, forms, queries and reports.


An Access table is basically a spreadsheet. In fact, you can enter data directly in each table just like you would with an Excel spreadsheet. Early on, however, you will assign a primary key to each table that ensures unique records. Access tables can also be linked in very versatile and customizable ways that allow you to answer tailored questions and perform trending and other analysis.


Access forms are exactly that: an organized way for the user to enter data. Instead of typing into a row on a spreadsheet, the user can follow the prompts in a pretty, organized form. The data goes precisely to the table or tables specified by the designer. Invalid data entries can be rejected.


A database can grow to huge proportions. A query allows a user to ask a simple question, filter data to answer a question, combine data from multiple tables, or add, alter or delete data from tables.


Reports are fun. They allow you to analyze and visualize vast amounts of database data based on your specific parameters. You can customize the report’s header and graphics.

Assistance for the learner

All of the above components are accompanied by a “wizard.” This is Microsoft’s module for helping you efficiently select the correct option when constructing your database.

In addition, you will not be writing code unless you want to. If you have a giant database that needs to do something highly specialized, you can learn macros and Visual Basic to solve the problem. But you don’t need to learn to write code, or google snippets of code, to get the job done. Instead, Access is populated with tools, drop-down lists, drag-and-drop functionality, and modules to help. Access also provides “views” such as Design View, Layout View, Datasheet View, Form View, et cetera that display essentially the same information, but in a different way. This allows you to get the job done in a very visual manner or in a spreadsheet-like way. And you can switch back and forth between views at any time to understand what you are looking at.

Three uses for Access in a Quality unit

Do you have an Approved Suppliers List? This important, often regulated document is sometimes nothing more than an Excel spreadsheet. Auditors may ask to see it and question whether it is locked down with the correct editing permissions. They may ask if it is the definitive record, or just a notation for the paper copies, which are definitive. An Access database can help you meet and surpass these expectations. Of course, you will have to validate the use of the database. But in the end it will be much less slippery than a spreadsheet (and less pricey than paying for supplier management software!)

Another use is for tracking your team’s work. Suppose you are trying to standardize the various tasks the typical Quality unit does. This often begins with timing studies. For a defined period, each Quality person can use the database to enter their daily tasks, along with the time it took to complete them. The form they use can even include a box for entering unexpected problems (Pareto events) that led to extra time beyond the standard/expected/takt time. When analyzing this timing data, management can pull up customized reports that zeroes in on outlier tasks and the corresponding problems. This allows management to focus on the 20% of the issues that are causing 80% of the problems.

Finally, if you are a preclinical testing laboratory, the GLP regulations require that QA maintain a Master Schedule of all studies. An Access database, validated of course, is a great place for this. QA can edit while still making it available on a view-only basis to anyone in the organization who needs to see it.

An example from my own life: a personal finance tool

Early on while learning Access I put one of my personal finance spreadsheets (my net worth tracker) into Access. I had been relying on a Google Drive spreadsheet for this task. However, as some accounts are opened and some are closed, it became more and more unwieldy. The auto-updating charts and tables I had created were becoming inaccurate and drawing from the wrong data sources.

So, I exported some of this data into Excel, and then into Access. After tweaking some of the reporting functions, I found this to be a more robust way of tracking my financial goals. I also created a better form for entering my biweekly update on payday. Currently my financial info is small enough to manage with spreadsheets. But over the course of decades, a database may be the way to go. If I ever start a business, I will be well-positioned to track this kind of info because of what I have learned to do with Access.

Growth and value to your company

I would encourage you to learn Access and teach it to others in your group. Don’t just preach, though: actually solve a problem. If you identify one or more people struggling with a bloated spreadsheet or with aging tracking and trending reports that are becoming less relevant, create a user-friendly database for them with a beautiful splash page. Show them the possibilities and then once they get the hang of it, offer to go all the way and import the source data with the support of management.

You will benefit immensely from gaining a reputation as “the software person” in Quality. People who can solve software issues in their group without expensive in-house IT and vendor involvement are greatly valued.

Once you have gained proficiency in Access, consider moving on to more advanced database software such as SQL. In this program, also provided by Microsoft, you can create advanced databases that integrate with web-based apps that face customers or internal groups. The reporting functionality is correspondingly advanced.

Where you can go to learn the software

Start with the training at Microsoft Support. Watch Youtube videos for every level of expertise.

Visit for an excellent, comprehensive guide to getting proficient. This guide is by an Access expert named Adam Wilbert. The course is 5 hours total and has been viewed 330,000 times. It is an excellent resource. My only complaint is that the guy talks very fast. I got around this by playing the tutorial at 0.75x speed! The course is filed under Business > Databases > Access 2016. I am fortunate to have free access to this learning suite through my metropolitan library. Check whether you have such a perk. If not, the monthly fee may still be worth it. Consider it a career expense.

Lastly, take an in-person course. It’s hard to learn from a screen alone. Although community education systems (through public schools or libraries) may offer Excel classes, they are unlikely to offer Access classes. So, look to community colleges and universities. My manager and I took an 8-hour, one-day course at Normandale Community College in Bloomington, Minnesota. Since we had acquainted ourselves already with the basics, we skipped to the intermediate level course. It was the right choice! I would recommend this to save some money. Again, I am fortunate that my employer covered this excellent career development opportunity.

My challenge to you

I would like to challenge you to a short-term goal of learning the basics of Microsoft Access. Create several tables with data relating to something you are into, such as sports, personal finance info, or something from work. Create a form, a query, and a report. Identify a problem at work that you might be able to help with. Lastly, let me know how it goes. I would love to hear from someone who has used Access to make the job easier for themselves and their colleagues. I would also like to hear from those who progressed successfully from Access to SQL or another web-integrated database software.

This FDA warning letter is appalling

Thank goodness for diligent regulators. Read on, and be horrified.

The US Food and Drug Administration (FDA) recently inspected a testing facility outside Los Angeles and found serious concerns about the quality and integrity of the data produced there. In its warning letter, which is publicly posted online, the agency’s inspectors outlined the objectionable conditions they found.

Anyone interested in the role of this powerful agency in protecting the American public health should read this letter. Prepare for a glimpse into the “wild west” of preclinical research. Prepare to be appalled!


Drugs and medical devices undergo extensive testing before touching human beings in clinical trials. These studies are called non-clinical (or preclinical) research. In the United States these studies are regulated under the Good Laboratory Practice regulations. As part of its Bioresearch Monitoring Program, the FDA inspects testing facilities to ensure the data generated is scientifically accurate and valid.

These inspections can result in a range of actions. For a well-run facility, management actually benefits from such an inspection. They get feedback on weak areas and they better understand the agency’s thinking on certain scientific or organizational issues they face.

For a poorly run facility, the inspection could result in a warning letter at best or an immediate shutdown of the facility, followed by legal prosecution, at worst.

This letter indicates the facility is poorly run. Appallingly so. As such, all the scientific data it has generated on the investigational drug is in question.

Some choice passages from this warning letter

There were no records indicating the presence of a functional QAU, or records of any QA activities at the facility. In addition, you indicated during the FDA inspection that you were the study director as well as the head of the QAU. However, this practice undermines the QAU from performing its required functions separate from and independent of the personnel engaged in the conduct of nonclinical laboratory studies. You also indicated that a veterinarian for the study from (b)(4), was a member of the QAU; however, that veterinarian signed a statement denying that he was a QAU member.

It’s going to be hard to walk that one back!

Considering your test facility management’s overall lack of responsibility to implement basic essential elements of GLP compliance, the quality and integrity of the study data cannot be assured because there was no QAU oversight of the nonclinical laboratory studies conducted at your testing facility.

This is pretty bad. The QAU must monitor the conduct and reporting of the organization’s studies. When it comes to life-impacting drugs and devices, the integrity and acumen of the researcher alone is not enough.

Your testing facility failed to establish standard operating procedures (SOPs) in writing setting forth nonclinical laboratory study methods that are adequate to insure [sic] the quality and integrity of the data generated in the course of the studies, as well as to ensure appropriate handling and care of animals.

During the inspection, you indicated that as a surgeon, you knew all operation procedures, and therefore you did not agree that SOPs needed to be established.

Written SOPs, with appropriate approvals and control, are a bedrock of quality testing. It’s hard to overstate this.

For a reader who does not have a scientific background, let me make an analogy: Have you ever been in a court of law? What if you were on trial for a capital crime, and your lawyer showed up with no computer and no documents. You ask him, “What’s up, did you not prepare at all?” In response, he taps his temple and grins, saying, “Don’t worry, it’s all up here!”

I am impressed with the incredible capabilities of the scientists that I work with every day. But they and I know the importance of independent checks. The surgeon the FDA interviewed is saying his authority and expertise puts him above independent checks. He is saying we should trust his data because of his skill and expertise. Sorry, but this is not a medieval guild. Mastery is not a validated method, and modern drugs and devices require independent examination and comparison with a standard.

As the study director, you must ensure that all experimental data, including observations of unanticipated responses of the test system, are accurately recorded and verified.

You failed to ensure that all experimental data were accurately recorded and verified.

For the toxicity study in dogs, dose calculation worksheets for nine dogs show body weight measurements and test article administration in June and July 2016; however, purchase records indicate that eight of the nine dogs were purchased in August 2016, which makes the data entered before August 2016 invalid. In fact, during the FDA inspection, you acknowledged that the data entered before the dosing in August was inaccurate and did not reflect real-time data entry.

For all data changes, you failed to ensure: (1) that the original entries were not obscured; (2) that the reason for all changes was indicated; and (3) that all changes were dated and signed or identified at the time of the changes.

The study director’s role in a preclinical study is extremely important. He or she serves as the single point of control for the study. The passages above speak for themselves. They may even point to falsified data, though this is not explicitly suggested in the warning letter.

Basic data integrity principles and methods are taught to undergraduate science students within the first week of their laboratory courses. These include correcting handwritten entries without obscuring the original entry, signing and dating, documenting concurrently, et cetera. The warning letter shows these principles were not followed at this facility.

Because you failed to ensure that all experimental data were accurately recorded and verified, and that all entries and changes in entries were properly documented, FDA has concerns about the integrity of the data generated from the nonclinical toxicity studies conducted at your testing facility.

The investigators use professional-sounding understatement.

You failed to comply with the above requirements to retain and to provide archives for storage and retrieval of all raw data and specimens.

You were unable to provide all data requested during the inspection; you indicated that you were unsure where the data was, and that it might be at your home.

The absence of raw data and specimens collected during these nonclinical toxicity studies, and the absence of proper storage of raw data and specimens, raises significant concerns about the integrity of the study records and data.

Again, understatement. Archival procedures, controlled storage conditions, data completeness, and traceability are a bedrock of quality. These procedures would be in the SOPs, but as noted above, the facility’s SOPs were inadequate or absent.

Testing to determine the stability of the test and control articles in the mixture must be conducted, either before the study initiation or concomitantly, according to written SOPs that provide for periodic analysis of the test and control articles in the mixture. However, none of these analyses were done.

Does this sound a bit esoteric to you? It’s not. Before testing a compound in preclinical toxicity trials, the compound must be well-characterized. This ensures that the compound that eventually is dosed in humans matches the compound that was given to animals or to in vitro test systems. Without this characterization, you are putting humans in those safety trials at risk, or generating poor-quality data.

The protocols of nonclinical toxicity studies in mice, hamsters, rabbits, and dogs… did not have a date of approval by the sponsor and did not contain sufficient details, including but not limited to:

a. A statement of the purpose of the specific study

b. The name and address of the testing facility at which the study is being conducted

c. The procedure for identification of the test system

d. The methods for the control of bias

e. The frequency of tests, analyses, and measurements to be made

f. The records to be maintained

The study protocol is a central document. To name just two possible consequences of not having one: How do you identify a deviation from the study plan, if no plan was documented? How do you evaluate the outcome, if no predetermined endpoints were established? Not having an adequate protocol leads to weak scientific data and conclusions.

As evidenced by FDA’s inspection findings, your testing facility management failed to fulfill the primary responsibilities to establish appropriate policies and procedures intended to ensure the quality and integrity of nonclinical data for FDA submission. Furthermore, the deficiencies found in your oversight as the study director and the absence of an independent QAU indicate that your testing facility failed to fulfill the core responsibilities to remain GLP-compliant. As a result, FDA is concerned about the validity of nonclinical data generated by your testing facility.

Failure to address the violations noted above adequately and promptly may result in regulatory action without further notice.

More understatement. I haven’t checked, but this facility may already have been shut down! The FDA has the power to walk in and immediately halt operations. Especially since this is not their first warning letter.

Some caveats

I don’t wish to pile on. I don’t want to be part of an Internet mob. And I always assume good intent instead of nefarious fabrication and fraud. But people should be aware of the risks to health out there. The FDA cannot inspect every facility all the time. They cannot catch all the shoddy science out there. They can’t prevent people from wasting money on ineffective treatments.

I also feel sorry for the animals in these studies, which include mice, hamsters, rabbits and dogs. The letter indicates there were no SOPs describing their care and handling. What if some of them suffered from poor treatment? What if their treatment was fine, but the data from their studies was completely invalidated? It’s as if they underwent testing for nothing. If an animal was used in research, something good should come out of it. This may not have happened here.

I will write an article about how to use FDA warning letters and other materials to be proactive in your organization

In a future article I will show you how to use the FDA’s warning letter database to your advantage. The point is not just to gawk at the egregious ones. You can use the warning letters to get an edge and understand the agency’s thinking on many biotech and pharmaceutical subjects.

What do I mean by “getting an edge?” Let me explain. Have you noticed how regulations change very slowly? The GLP regulations that we follow were finalized in the 1970s and 1980s! There is nothing in those regulations mentioning cloud-based data capture, gene editing, or artificial organs. The FDA occasionally releases non-binding guidance documents that help industry, with its cutting-edge techniques, from falling afoul of these older regulations. But even those guidelines quickly become dated and cumbersome.

FDA warning letters, on the other hand, reveal findings and enforcement actions from inspections that occurred only weeks or months previously. The letters also indicate the reasoning behind the actions. A useful FDA inspection finding includes three things: a detailed description of the circumstance, the applicable standard (usually a regulation), and the possible consequences of not meeting the standard.

Read closely and you will find all three components in the letter I linked above. In my upcoming article I will break down the warning letters in a way that will make you a better auditor who will be even more valued by your organization or auditee.

Final comments

Visit the FDA warning letter database regularly. Stay tuned to warning letter news. Read my upcoming article on warning letters. Let me know if this article benefited you. And let me know if your jaw dropped as much as mine did!

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How I boosted my knowledge and credibility with the Certified Quality Improvement Associate certification

This past Saturday I sat for the Certified Quality Improvement Associate (CQIA) exam. I passed and now I can draw on this body of knowledge and cite this certification for the rest of my career in quality.

In this article I will explain what this certification is. I will describe my experience in preparing for and taking the exam. I will share what I have learned about certification pathways in quality. Finally I will offer some advice on whether you should pursue the certification yourself.

The Certified Quality Improvement Associate

The American Society for Quality (ASQ) introduced the CQIA certification in 2000 as a way to introduce the basics of quality to individuals and organizations that are not already in traditional quality roles. Getting such employees certified is a way to integrate quality throughout the company. Those already in a quality role can obtain the certification as a first step toward more intensive certifications such as Certified Quality Engineer.

The body of knowledge covered in the materials and coursework touches all aspects of quality. Some examples of learning objectives follow:

“Define quality and use this term correctly in various circumstances.”

“Define and distinguish between common and special cause variation in relation to quality measures.”

“Identify supplier performance measures, including quality, price, delivery and level of service.”

Succeeding on the exam requires remembering, understanding, and applying your learning from the materials I reference below. The exam reflects the body of knowledge presented in the CQIA Primer. Everything you need to know is in this textbook. There are additional materials that will enhance your learning and give you an edge. Actively participating in a prep course, doing as many practice questions as possible, and connecting with your instructors will also boost your chances and make your investment of time worthwhile.

Preparing for the exam

To prepare, I attended four three-hour courses presented by subject matter experts in quality. Each of the instructors were Certified Quality Engineers. At each session we:

  • Did a practice quiz
  • Went over two or three chapters from the CQIA Primer
  • Did practice exam questions as a class
  • Addressed any questions from our readings and end-of-chapter exams

You could prepare for the exam without this kind of course but that would mean doing a lot more solo work. In the class was at least one person who had failed the first time around. So, do whatever you can to get an edge!

Outside of class I read the Primer, took the end-of-chapter exams, and drilled myself again and again with the practice exam software.

It’s this last part that was especially valuable. The software is simple but has two particularly useful functions: it allows you to select the length of your exam and it breaks down your scores by section. This means you can practice for the exact length of the CQIA exam (110 questions in 3.5 hours). Once you are done you can see what areas you are weak in and revisit the Primer.

I read the Primer, highlighted key definitions, charts, figures and tables, and went over them again and again. I did not read the full Certified Quality Improvement Associate Handbook, but I visited it for some longer exposition of a couple of topics from the Primer. It also came in handy during the exam (more on that later).

During my many practice exam drills, I kept aiming for the 80% correct rate needed to pass the exam. I did some drills open book (as the official exam is) and some without. Both ways are valuable because you want to know the information and you want to know where to find it.

I had one classmate who did not have a college degree and was unaccustomed to the test-taking environment. Note-taking, reviewing, and computer-based exams were all unfamiliar to her. She was very anxious about what the exam would be like and she felt she wasn’t retaining anything during the course. If this sounds like you, anything you can do to become accustomed to that environment will help. Tell the instructor about your background. Take the practice exams. Create flashcards or other learning tools that work for you. Set up a timer and get used to how it feels to be timed while answering questions.

The exam itself

My exam was administered by Prometric, a third-party testing company. My exam was on Saturday morning. I had a good experience and found it was the same as Pearson Vue, where I took my EMT-B exam several years ago.

Read all the exam rules in advance and arrive with what you need. Make sure you have removed the practice exam questions from your CQIA Primer and that all your materials are bound.

The exam was the exact level of difficulty as the practice exam questions. As I said above, that program was very, very helpful for focusing on areas where my recall was weak.

You will spend lots of time flipping through the book looking for key tables and definitions. If you can find an answer within two minutes using the index or your own sticky flags (which are permitted), you will succeed on the exam.

There is plenty of time to finish the exam. I left with an hour to spare even though I went back to look up many flagged questions.

I used the exam software features to my advantage: a strikethrough to eliminate distracter choices, a timer to keep an eye on my progress, and a flag function that lets you revisit the question. I did not use the physical dry-erase board or the calculator that Prometric provided.

I did not take a break, but this is an option if you want one.

There was no math. At all.

I used the glossary of the CQIA Handbook several times. It was faster and sometimes more detailed than the index of the Quality Council of Indiana book. When a question was difficult and the choice depended on wording, I consulted the relevant section of both the Primer and the handbook.

ASQ certification pathways

My aim is for further certification. This graphic is pretty ugly but it gives you an idea of how to build on previous certifications as you grow more advanced and more focused on your area of quality.

Don’t take this chart as the final word. If you have questions, attend a chapter meeting of ASQ and talk to the presenter or another quality person. They will have firsthand knowledge of certifications. Tell them your situation and goals and ask for suggestions. Bring the same information to your manager and get their opinion as well, before committing to a specific certification.

As you can see, the CQIA is an initial certification that can lead to several professional ones.

Should you get the certification?


Yes, you should. Even if you are not in a traditional quality role, you may benefit from the CQIA. It may open the door to Six Sigma, lean, team dynamics skills, statistical process control, etc. Each of these is just a small section of the Primer but a vast field of practice of their own.

I am fortunate to be in a company that paid for my materials and for the exam as part of their dollars-and-sense interest in furthering my development. I hope you are in the same situation. If not, perhaps you can convince your manager to come around. If they won’t cover the cost, just pay for it on your own. The total will run you about $300. That might hurt a bit, but it will strengthen in your future earnings potential and pay off in the end.

Once you have the certification, you have it for life. You can keep the materials at your desk and share your learnings with coworkers. And if you progress to further, more expensive or labor-intensive certifications, you will walk in with greater confidence.

CQIA Handbook

Final comments

What do I mean when I say I “boosted my credibility?” In quality we are not just people with sharp eyes or attention to detail. People who work in quality do not have a certain personality type. Rather we are following rigorous methods developed toward the end of the Industrial Revolution to ensure safe products, reliable service, unexpected delight and longer, healthier lives.

To study quality is to apply the scientific method in your day-to-day work. Getting a certification such as the CQIA helps you learn these methods and meet the experts who practice them. It thereby signals your credibility. It shows others in your organization that you are on the path toward expertise and that your work is based on the methods of a true profession.

As you consider the CQIA (or if you are preparing for the exam), feel free to reach out to me for more details. I have plenty of study tactics to share and some ideas about quality certifications that I didn’t cover in this article.

I wish you success!



Certified Quality Improvement Associate Primer

Certified Quality Improvement Associate Exam USB Flash

Find both at (

Get both of these! The Primer is absolutely required. The practice exam software is a near-necessity.


The Certified Quality Improvement Associate Handbook, Third Edition 3rd Edition

This is not a necessity, but I would recommend it. It is more attractive and better organized than the Primer, and it will be useful during the exam.


CQIA Primer