ISO 9001:2008 (part 2)

ISO 9001:2008 is not that much different from ISO 9001:2000. There are clarifications, changes in terminology and greater emphasis on basic ISO tenets. A greater emphasis on basic ISO tenets is what we found to be the most important feature. These ISO components affected range from management review, internal audits, vendor audits, corrective actions request (CAR) and preventative actions request (PAR).

Corrective and preventative actions now incorporate a philosophy called the 5 whys. This is an important improvement to the system. Anyone that has answered a CAR or PAR in the past has at one time or another used the employee not trained response. Non-conformance: A production lot was scrapped out at XYZ department. Root Cause: Employee was not trained properly. Short term CA: Lot was remade. Long term CA: The employee was re-trained. A good CAR/PAR Coordinator would not accept that response. Employee not trained / employee re-trained is not a valid response. With the incorporation of the 5 why principal you are forced to dig deeper till you reach the root cause. Its actually very simple. Keep asking why till you can’t ask why anymore.

Q. Why was the employee not trained properly in the first place?

A. The employee was supposed to know how to use a micrometer but didn’t know how.

Q. Why did the trainer not realize the employee didn’t know how to use a micrometer.

A. Management assumed the employee knew how to use one.

Q. Is use of a micrometer specified in the training records?

A. No. The training record is only a sign off and does not reference required skill sets.

Q. Why does the training record not list required skill sets to be individually signed off by the employee?

A. Management didn’t think of it as being required.

To quote a former President of the United States, “The buck stops here!” Ninety percent of all non-conformance can be traced back to management action or in-action. We own it so get used to it. A good manager shall accept responsibility. A poor manager shall blame someone else. Simply emphasizing the 5 why philosophy helps ensure that the real root cause is identified and ultimately corrected. The ultimate goal is to prevent the non-conformance from re-occurring, not to place blame.

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One Response to “ISO 9001:2008 (part 2)”

  1. shred Says:


    This post solved my problem – keep up the good work!…

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