Root Cause Failure Analysis - Not following Customer packaging Specification


Hi All,

Recently we received a complaint from our medical device customer that product was not packaged per customer specification. Our experienced staff that usually work on this process were on annual leave this day so we trained additional staff on the day (Which was rushed due to meeting due dates) before packing the product. In addition the error in packaging was not picked up at final inspection. I am now completing the CAR Investigation, RCA but I am unsure how to go about completing my 5WHYS. It would be very helpful if someone could guide me on each step of the 5Whys for this type of investigation.

Your expertise would be greatly appreciated.


Super Moderator
You already have a good start!
Why was the training rushed?
Why was the training ineffective?
Why were the errors not picked up in final inspection?

There's no real secret formula with the 5-why approach. There's no rule for using exactly 5 whys - more or less may be needed. Keep asking why until something is revealed (root cause) that, if you fix that, the problem won't occur again. And remember there's no rule that only 1 root cause exists - may well be more. Your questioning may take you down multiple paths. Any of the above questions may result in unique causes.

Also, there are other problem solving tools (fishbone, FTA, etc.) that you may find are more intuitive to use.


Trusted Information Resource
I'd do something like:
  • Why customer received incorrectly packaged product?
    • Packaged incorrectly by staff
      • Why?
        • Staff didn't follow packaging procedure
          • Why?
            • Staff lacked experience
              • Why?
                • Training inadequate, etc.
            • Or...perhaps staff knew but ignored procedure
            • etc.
    • Incorrect packaging not detected in final inspection
      • Why?
        • .....

Edit: Also, I sometimes find that the question "why?" is implicitly taken as something like "why didn't this work as expected?", which can be unhelpful since a gazillion things might cause some process not work, so one's mind just gets lost in all the possibilities. Instead, sometimes I find it helpful to as ask instead "what had to happen for this occur exactly as it did?" That is, frame it in the positive instead of the negative. This way one's mind tends to hone in on just the things that made it exactly that way. I hope that makes sense.
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Change Agent and Data Storyteller
Super Moderator
I would also include a 'why' that looks at why the experienced staff were all off on annual leave at the same time...and, if this is a regular or accepted practice, why was effective and meaningful training not provided in time? Annual leave doesn't usually sneak up on an organization so, at first glance, I don't buy the "rushed due to due dates" answer.

Jim Wynne

There needs to be an effort to identify tribal knowledge and create contingency plans. I think I've told the story here before about a place where I worked that ran out of welding gas one day. It turned out that somehow, at some indefinite time in the past, a manufacturing engineer had taken over ordering the gas, and only a few people knew it. The gas was always there when needed. He abruptly left the company and orders weren't placed.


Looking for Reality
Trusted Information Resource
FWIW, if this investigation is to be shared with the customer...consider the last "Why", and the corrective action to be implemented in light of whether or not the customer will be pleased with it.

You know what went wrong and's in your post. This is all about preventing recurrence (internal) and assuring the customer (external). Pay attention to both in the single "5-why".


Always make sure that your root cause analysis lead you to a tangible corrective action.
I work in a company that its HQ is outside the US and hence we can't simply do every single logical CA that I used to do in other companies. HQ is chocking us when it comes to update corporate POS, for instance.


Forum Moderator
Remember to address the systemic cause, which may be the lack of cross-training for critical duties.


Super Moderator
If you end up pointing to people, re-visit your 5 why's. Asking the incorrect Why can make you at fault or even the Easter Bunny

Point to people you lay blame, point to process you find fault...Look for breakdown in process!


Quite Involved in Discussions
People need to use their training, so a good cross training program has the alternates doing the work periodically, such as once a week or once a month.
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