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Denise Robitaille


Tackling the Tough Problems

Corrective action that corrects

Published: Tuesday, March 7, 2006 - 23:00

It’s the week after the huge annual trade show—the opportunity for you and the rest of your industry to showcase your companies and to rollout your latest, greatest blow-the-competition-out-of-the-water product offerings. Unfortunately, instead of having a working model to demonstrate—to wow the thousands of visitors—all your sales force had were a bunch of conceptual drawings, some high-gloss brochures and the ubiquitous key chains to hand out. The sales reps spent three exhausting days giving their spiel about this really cool gizmo that will be available in four weeks. Meanwhile, the competitors on all sides had every dancing, spinning, sparkling, oozing whirly-gig known to man chattering away in adjacent booths, making your company look like the sorriest entry at the local science fair. They were taking orders while you were collecting business cards. Adding to the pain is the fact that tens of thousands of dollars have been expended in travel, accommodations, fees, etc., and that has all gone for naught.

The original plan had been for the new device to be released at the annual trade show. That plan had been formulated ten months earlier at a high-profile meeting attended by senior managers representing various departments and divisions. The project may have even been plotted using Gantt charts or some other project-tracking software. There were defined requirements. There was a documented plan. There was a schedule.

Why is it that when it comes time to taking a look at what went wrong, we often don’t even think to funnel our analysis through the process that we have developed specifically to deal with this eventuality? Sub-clause 8.5.2 of ISO 9001:2000 directs organizations to: “eliminate the cause of nonconformances in order to prevent recurrence.” It further states that: “Corrective actions shall be appropriate to the effects of the nonconformities encountered.” What could be more appropriate than addressing the cause of a problem that involved the nonfulfillment of a documented plan that ended up costing the organization tens of thousands of dollars in wasted marketing dollars and probably thousands more in lost revenue? Would it not be worth investigating the root cause of this problem in order to make sure it never happens again?

Many organizations clog their corrective action system with dozens of corrective action requests relating to product defects, incorrect documentation and auditing findings. But when it comes to the really big problems–the ones rife with financial pain, oozing red ink–we abandon the process and revert to haphazard fire-fighter tactics and nonproductive finger-pointing. Why can’t we look upon this as a nonconformance to a specified requirement and, therefore, something that would warrant corrective action? What would happen if we applied some of our investigative quality tools to this situation?

Opening up our toolbox, let’s select a variation on the fishbone diagram. Utilizing the five “Ms” and the “E,” we can begin to look at all the factors that may have contributed to this breakdown.


  • Were there any issues relating to the materials for the product?
  • Were specifications adequately defined?
  • Did we allow enough time for the process of investigating reliable sources for the materials?


  • Were there enough engineers assigned to the project?
  • Did you have all the right people providing input into the development of the original project plan?
  • Did they have the necessary qualifications?
  • Were there changes in personnel during the project?
  • Did individuals have enough time?
  • How well controlled and defined were the communications between key people on the project? Were there any barriers in communicating with one another?
  • Were authorizations and responsibilities well-defined and communicated?
  • Were engineers trying to work on multiple projects?
  • Were manufacturing personnel trained on the new assembly procedures?


  • Did the designers have the appropriate software for the project?
  • Was production equipment scheduled and made available when needed to build prototype models?
  • Was an assessment done to determine new equipment and tooling needs?

Method (Into this category go all processes and plans.)

  • Was there a design plan?
  • If there was, how well developed was it?
  • Did it take into account all required interfaces?
  • Did it include reviews at identified milestones?
  • Was the design plan periodically checked or ever revised?
  • Did the plan include identification of risk factors and contingency plans?
  • How about plans for developing manufacturing documents?
  • When were those documents verified?What other processes are linked to design and development?


  • What metrics did you establish, if any, to periodically verify that the project was on track?
  • What metrics did you use to originally calculate how long the project would actually take?
  • Did you define the metrics to inspect, test and verify the product?
  • Did you assess current instrumentation to ensure it could perform the requisite verifications?


  • What is the environment in which the engineers work?
  • Is it chaotic? Is there limited space?
  • Did the design and development plan take into account the need to prep or re-organize the manufacturing area?

These are just a few of the questions that come out of this initial root cause analysis. You don’t have to guess or form elaborate conjectures. The answers to the questions will be found in records of the design process, revision histories for documents, purchase orders and training records. They’ll provide verifiable, objective evidence of what went wrong so that the organization can establish procedures and protocols to ensure the trade show fiasco is never repeated.

The payoff for the corrective action plan that ensues should ensure a better-controlled process that will be infinitely more productive and effective than sitting in a board room grumbling and rehashing the nightmare tradeshow. Use your corrective action process to make a difference.


About The Author

Denise Robitaille’s picture

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.