Audit Schedule for Multi Site Certification

B

Boscoeee

#31
The way I've always looked at it is that the standard states that your program should be planned based on importance, risk and results of previous audits. If I have an area that had many finding during the past year chances are that I will audit them more frequently next year or if there were no findings for the past several audits than I might audit them less. If the schedule always stays the same then the registrar/auditor will say these are not being taken into consideration during planning.
I have to chime in on this one as I have struggled with a customer audit on this issue. Historically, when planning Internal Audits they are mapped to product and previous issues which does not drive me to do more audits necessarily. However, it does ensure that those areas are covered during the Internal Audit. One of my customer's auditor was very pointed in sharing a non conformance that my approach is not prudent or acceptable. In the spirit of ensuring that the Audit plan is more robust I am working through a planning process to replace the current annual plan that I use.

My thoughts today are to focus those areas that are the most important to our business.

1. Customer Escapes - Perform Product Audit on all customer escapes to ensure root cause and corrective action have been completed and validated.
2. Internal System Escapes - Audit the manufacturing and quality processes used to manufacture our parts when internal QPPM reaches trigger point.
3. QMS Audit - Continue to perform Internal Audits of the QMS on an annual basis.

Any comments about my approach would be helpful I am sure.

Thanks,
 
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Coury Ferguson

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#32
The way I've always looked at it is that the standard states that your program should be planned based on importance, risk and results of previous audits. If I have an area that had many finding during the past year chances are that I will audit them more frequently next year or if there were no findings for the past several audits than I might audit them less. If the schedule always stays the same then the registrar/auditor will say these are not being taken into consideration during planning.
I agree, that is the best approach. But, what is the (hypothetically) requirement that the Auditor is saying that you do not meet? You have planned intervals, based upon importance, and risk. Your auditors are competent, you have a defined procedure, so what am I missing here?
 

Sidney Vianna

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#33
The way I've always looked at it is that the standard states that your program should be planned based on importance, risk and results of previous audits.
Michelle, you are definitely on the right track, but one correction I would like to offer. The standard does not state should, but shall. It is a requirement, not a suggestion. Internal audit resources are limited. They should be used wisely. An internal audit program which contains a risk management approach to it is a much better approach.
 
U

Univrsl

#34
Michelle, you are definitely on the right track, but one correction I would like to offer. The standard does not state should, but shall. It is a requirement, not a suggestion. Internal audit resources are limited. They should be used wisely. An internal audit program which contains a risk management approach to it is a much better approach.
Further to Sid's point, the rationale for the schedule should be presented with the schedule for approval. Our schedule and rationale are approved annually (or more frequently if conditions/schedule changes dictate) by the appointed Management Rep.

Our rationale for this year's schedule included production schedule and projected inbounds, results of previous audits with focus on work instruction currentness and accuracy, new personnel with focus on Quality Policy and criteria for product acceptance, customer complaints with focus on corrective action verification, customer requests, registrar's observations/improvement opportunities, and new off-site locations.

When all of these variables are considered, it's impossible to have one audit schedule in a procedure that never changes.
You could have a schedule where you always audit Manufacturing processes in March and September for example... but the focus or process areas audited may change from audit to audit based on criteria similar to our rationale above.
 
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