Thursday, 27 May 2010 16:56

Corrective Action vs. Preventive Action

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There is a lot of confusion within the quality industry, and especially new companies about these two actions.  Part of the reason is that ISO 9001:2008 (and its predecessor 9001:2000) describe their associated activities in a similar structure, with a couple of key wording differences... We'll discuss the specific actions in a later blog.  For now lets clear the confusion of terms.
Over the last 10 years I have audited many small companies that hired consultants to perform their internal audits for them, so that they could meet their ISO 9001 audit requirements. Using an external consultant to reboot a failing system can be highly beneficial to overwhelmed staff. However, while auditor objectivity is indeed enhanced by using external auditors, someone internal must be responsible for ensuring complete follow through of any findings. The level of longterm effectiveness is dependent on company culture and management commitment to improve the QMS. I have rarely seen it work for small companies over the long term, for a couple of reasons:
Friday, 02 July 2010 16:51

Nonconformities vs. Corrective Actions

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"It's just a rework - don't make me do a Corrective Action form - the paperwork will take longer than the fix"....  Ever heard that??? There's a huge difference between NonConformities and Corrective Actions, but if you are the type of company who gets a customer return, and they demand a corrective action every time, you've probably come to dread these concepts.  Lets step back from the viceral "I hate paperwork" reaction that we all have for just a minute, and discuss the uses and purposes for nonconformities and corrective actions. There are many things that could potentiall fall into the NonConformity  (NC)category -especially since ISO defines a NC as "non-fulfillment of a requirement" - but for most of us, it breaks down to:
Wednesday, 07 July 2010 16:49

Making audits useful and not just a compliance tool

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Maintaining employee involvement in continuous improvement is all about corporate culture. If top management, managers, and supervisors are not routinely involved in addressing audit findings and driving improvement projects, it is all too easy for the QMS to have insufficient support to be more than compliance busy work.  ISO 9001:2008 says in the section for internal audits (8.2.2) that “management responsible for the area being audited shall ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes”.  This sentence emphasizes several  potential weaknesses to the effectiveness of any audit program:
    • Management attention to audit findings  --  see earlier blog
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