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  Auditing
  Corrective actions

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Author Topic:   Corrective actions
Mark Smith
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Posts: 32
From:
Registered: May 99

posted 20 February 2001 09:29 AM     Click Here to See the Profile for Mark Smith     Edit/Delete Message   Reply w/Quote
Last week we had our annual ISO surveillance audit and one of the non-conformances written up was the fact that our SOP for corrective actions states that " Data identifying needs for CA/PA may originate from one of the following sources:
Inspection and Test Records
MRB Reports
Audit Findings
Customer Complaints
Service Reports
Employee Feedback"

but the work instruction for Corrective actions states in the SCOPE section
"2.1. This procedure does not include corrective or preventive action systems covered by other procedures such as complaint handling, MRB, general inspection, internal audits, ECN's, field corrections or medical device reporting".

The auditor saw a conflict but I argued that corrective actions can exist but not be named as such. For instance, the act of having an MRB review and disposition non-conforming materials is in itself a corrective action for dealing with the presence of non-conforming material. In my opinion , there would be no added value in also assigning a corrective action request to this effort. comments?

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Dan Larsen
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Posts: 137
From:Sussex, WI
Registered: Feb 2001

posted 20 February 2001 05:24 PM     Click Here to See the Profile for Dan Larsen   Click Here to Email Dan Larsen     Edit/Delete Message   Reply w/Quote
I also see a conflict. CA involves a lot more steps than is typically applied to a quick response to a customer complaint or a single reject. Most often, these involve a "quick fix" to resolve the immediate issue.

I think your response to the finding should include a change in the wording for your instruction. The action taken on the individual issues in each of the items you're quoting is, to me, "containment" and not full CA (careful root cause analysis and long term action). The trend information from each of the systems you quoted can and should be used for corrective/preventive actions.

For example, you can respond to each individual customer complaint (containment) and your system could stop there. But if you get a lot of complaints of the same type (trend analysis), you may want to initiate a corrective/preventive action to reduce the total number of customer complaints.

I use this approach with most of my clients. I tend to keep the reject/complaint systems separate from CA to avoid the need for a full blown audit system. The info from these systems is then evaluated for trends that can be moved to the CA system.

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David Mullins
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Posts: 248
From:Adelaide, South Australia, Australia
Registered: Nov 1999

posted 20 February 2001 06:29 PM     Click Here to See the Profile for David Mullins   Click Here to Email David Mullins     Edit/Delete Message   Reply w/Quote
I don't know about conflict, I'd say more like contradiction. This looks pretty messy, so I'd say your auditor was quite correct to make mention of the contradictions contained in the documentation of this fundamental area.

The quote from the WI also suggests you are overdoing the number of procedures - can't you roll some together? I wouldn't recommend having disparate CA/PA guidelines.

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