Shades of Gray

Know the importance of analyzing everyone’s bottom line        

by Denise Wrestler

"You can do whatever you want as long as it’s documented and justified—and legal." I live by this phrase, mostly because it’s my stock response to the age-old question, "Are we allowed to do 'such and such'?" But also because I truly believe in what it stands for.

As quality assurance (QA) professionals, we spend a lot of time making critical decisions that are black or white, yes or no, true or false, and pass or fail. But sometimes we’re confronted with decisions that fall somewhere in the gray area between the right and wrong answer.

In most situations, answering a question is as simple as finding the answer in a procedure or guidance document. For some of the more particular situations, however, interpreting vaguely worded regulations may be required.

No matter how a situation or question is handled, it is the responsibility of every QA professional to analyze the risk in the decision that is made, ensure that stakeholders involved are considered in the decision, and ensure that the decision is followed through.

So many parts, so many tools

No matter how large or small the decision, risk analysis always should be involved. For small, quick decisions, the possible effects of each decision should be considered.

Take, for example, a typographical error on a lot-release record. Your procedure clearly states that a technician's signature and date verifying final lot release testing must be documented before a lot may be shipped. But on Friday evening at 6 p.m., when everyone has left for the day, you find yourself standing in front of an impatient UPS employee with a pallet of product ready to be shipped and a lot release record missing a date next to the technician's signature.

Per your organization’s procedure, this shipment should not leave your facility. Per your own common sense, it seems ridiculous to send the UPS employee away empty-handed and let the product sit in the warehouse until Monday morning when the technician is back in the office to correct his or her error.

On the one hand, model QA employees should follow the rules 100% of the time. After all, it’s not your fault the technician forgot to write the date. On the other hand, this shipment may be what saves your organization from losing an account because of another late delivery.

How hard would it be to document a minor deviation to your procedure? How upset would the sales team be to learn something as minor as a missing date was the reason the product wasn’t shipped on time? What are the repercussions of your decision either way?

For larger, complex projects with many moving parts, risk analysis tools, which could require substantial time and resources, may be used. Failure mode and effects analysis (FMEA) is common in most industries and forces an organization to look at failure modes and their causes and effects, and to rank each failure based on its severity, likelihood of occurrence and likelihood of detection. FMEA is a great tool; however, this type of risk analysis might seem to be a bit overkill for the situation described earlier. Sometimes the best tool is simply old-fashioned common sense.

Although there are many ways to evaluate risk, ensuring that a thorough analysis is performed before a decision is made often is the best choice to ensure your decision is sound.

Walk in their shoes

As part of assessing risk in any decision, it’s critical to step into the shoes of those who may be affected by your decision. I have found that most stakeholders involved in most gray decisions fall in one of the following categories of people:

  1. Those who profit only when the product is sold. This includes stockholders, shareholders, owners, directors and individuals who have a direct stake in product being sold. Although you easily could argue that everyone in an organization makes money when product is sold, only those who make money off the immediate sale fall into this category.
  2. Those who profit from making the product. This includes an organization’s employees—from manufacturing, QA and R&D to HR and office administration. All employees share in the successful completion of a product from start to finish. Each department plays its role, and it’s the harmony in which these departments operate that determines how efficiently the product is made and how quickly the organization can make money.
  3. Those who don’t profit financially but benefit from the product’s use. This includes the end user, customers and distributors, for example. For medical device manufacturers, these are the patients who use the product or the health care providers who rely on the product to work every time.

It often is best to ask yourself how your decision will affect each stakeholder involved. In the earlier example, how would the owner of your organization feel about you holding back product for the sake of good documentation practices? Would the head of manufacturing respect the fact that by keeping product behind due to a documentation error, you’re ultimately paving the way for other future documentation errors? How critical is it that the product reaches the end user as soon as possible? Would your product save his or her life? Whatever your questions and answers may be, it’s always best to put yourself in the end users' shoes when making a critical decision.

Don’t back down

It’s important not only to stand behind your decision and defend it, if necessary, but also to follow through and ensure that any action items from your decision are completed. QA professionals often are tasked with the unpleasant job of saying "No" when the rest of the organization is saying "Yes," or they say "Yes," but only under certain conditions.

If you had released the product that Friday night, what would you have done first thing Monday morning? Would you have issued a corrective and preventive action? What would you suggest the organization do differently so that you’re not faced with a similar situation in the future? If you had decided instead to wait until Monday to ship the product, how would your follow-up actions on Monday morning have been different?

Always ensure that what you decide to do-—based on your own analysis of the risk and stakeholder involvement—is followed up from initiation all the way through completion. Making a decision and not ensuring that actions are in place to make your decision a reality can lead to confusion and finger- pointing down the road.

Denise Wrestler is an independent quality assurance/regulatory assurance consultant for CYA Medical Device Consulting in Dallas. She holds a bachelor’s degree in chemical and biomedical engineering from the University of California, Irvine. An ASQ member, Wrestler is an ASQ-certified quality auditor and engineer.

Good article! I like the real life, relatable example and thoughts on what to consider when operating in the gray area. It is really important in our organzations to be seen as a partner and not a cop (hard to avoid sometimes) - these are situations where we can explain processes/approaches and how we think about managing risk to achieve objectives. Thank you, Denise!
--Shelly Wearn, 01-24-2018

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