Verification vs. Validation

You can verify and confirm, but that doesn’t mean it’s right.

As some of you know, quality “speak” and concepts have been known to bleed into my everyday life. This is not uncommon for quality professionals. The only difference between some of us and the rest of you is that many of you are still in denial. You won’t admit to the occasional slip of the quality tongue (e.g., “I need to see the objective evidence that you’ve done your homework.”)

Several years ago, a colleague from Central America asked if I had any good examples of the difference between verification and validation. This particular question has plagued many organizations for quite some time. How can something possibly be verified as meeting specification and still not be what the customer wants? It seems illogical, and yet the truth is that it can and does occur.

I told my friend that I did indeed have a good example and proceeded to tell him this true story:

I was helping my mother with some crafts for her church bazaar. My mother would crochet fancy attachments resembling a stylized pinafore that she would affix to kitchen towels. This not only made them very pretty, but served the practical function of creating a loop for hanging the towel.

My mother has a serious commitment to her church’s bazaar, and she’d committed to making several hundred of the towels. (My mother at the time was an octogenarian.) The crocheting could get tedious and the quantity grew daunting as the bazaar approached. I offered to help.

My mother had a pattern with very specific instructions that included the ply of the yarn and the gauge of the crochet hook. I gathered multiple skeins of yarn and headed home, where I spent much of my spare time during the next few weeks crocheting colorful mini-pinafores. I followed the instructions, using the specified hook and yarn. My little pinafores looked exactly like those that Mom made.

Unfortunately, when she attempted to sew my pinafores onto the towels, they were too small. The problem is that I crochet more tightly than my mom. An unanticipated and undefined process variation had resulted in a product that, although it met all the specifications in terms of number of stitches, number of rows, and gauge of tool, nevertheless was not fit for the intended use.

I thought to myself, “This is just like verification and validation.” (Yes, as nerdy as it sounds, I actually did say this to myself.) We had verified that the material, process, and tools were correct and that the output in terms of the defined instructions was also correct. I did exactly what my mother told me to do. However, when we moved on to validation, we found that despite verification of fulfillment of the defined requirements, the product still did not meet the intended need. They simply were not going to work.

In the same way, an organization can produce a product that is not what the customer intended or expected. This could be due to inadequate or ambiguous specifications. It could also result from variables in process or materials that have an adverse or unanticipated effect on the final output. Some of these might include:
• A field installation estimate that didn’t take into account the cure time for the epoxy, resulting in a late completion
• Shorter-than-expected shelf life of a product due to extreme temperatures
• Negligible traces of a substance that was presumed to be inert and benign to the raw material
• A software feature that functions properly but has a visual effect completely different than what the customer wanted

Some of these variables can probably be caught using several planning tools. Ensuring complete understanding of customer specifications, asking questions, and requiring more details can help mitigate these surprise outcomes. Processes like failure mode and effects analysis also serve to broaden individuals’ perspectives of potential problems.

However, even with robust processes in place and utilization of effective prevention tools, it’s still possible to have unanticipated consequences. That is what justifies the time spent on validation. It’s often the one last chance to catch a glitch that would otherwise get away from us.

In my mother’s case, she was able to alter the towels to fit the nonconforming pinafores. Your customers may not be quite so accommodating.

My friend thanked me for the story and asked permission to use it for training he was conducting in South America. I gladly granted consent and then let my mother know that there was a quality professional somewhere in Venezuela talking about her and her church bazaar towels.

About The Author

Denise Robitaille

Denise Robitaille is the author of thirteen books, including: ISO 9001:2015 Handbook for Small and Medium-Sized Businesses.

She is chair of PC302, the project committee responsible for the revision to ISO 19011, an active member of USTAG to ISO/TC 176 and technical expert on the working group that developed the current version of ISO 9004:2018. She has participated internationally in standards development for over 15 years. She is a globally recognized speaker and trainer. Denise is a Fellow of the American Society for Quality and an Exemplar Global certified lead assessor and an ASQ certified quality auditor.

As principal of Robitaille Associates, she has helped many companies achieve ISO 9001 registration and to improve their quality management systems. She has conducted training courses for thousands of individuals on such topics as auditing, corrective action, document control, root cause analysis, and implementing ISO 9001. Among Denise’s books are: 9 Keys to Successful Audits, The (Almost) Painless ISO 9001:2015 Transition and The Corrective Action Handbook. She is a frequent contributor to several quality periodicals.