"Actual" Audit Results Required?

[AndyN]

Andy, Ajit, Samsung and JaneB,

Thanks for the replies.

We are not yet at a point in our quest to have any good metrics on our audits, but it seemed to me that there should at least be some documentation in the management review as oppossed to just "results were discussed". I know that in our walk throughs that a few items have popped up more than two or three times.

We have a management review meeting this week and I am going to bring up the subject. We'll see what the QA manager and upper management think.

I liked the point about too much jargon, detail, etc. Just the concise facts.

Thanks.

Bill

Bill:

There may be a clue to the frequency of audits or management reviews here. Often audits are done too infrequently or reviews too frequently to assist management getting a 30,000 ft look at the system and its effectiveness.

I'd suggest that if you can't 'tell' if the processes are performing as planned, and are in compliance to the defined system, then one (audits) or other (reviews) - or both - might need to be looked at before you go much further. There's a 'sweet spot' to be hit here...

 

[JaneB]

it seemed to me that there should at least be some documentation in the management review as oppossed to just "results were discussed". I know that in our walk throughs that a few items have popped up more than two or three times.

Sometimes it's quite enough to simply note that 'results were discussed' (assume results were good). Other times the 'documentation' may be quite clear in that an Action would (or should) be raised from the management review - delegated to someone to follow through, etc.

Audit trail.... if the meeting records make it clear which audits were discussed (name/number/whatever), and the audit reports themselves clearly report whether there were issues or not, then if there were any issues on those reports (internal or external audits) that need further action, I'd expect some kind of record of that in the MR minutes/actions/whatever. If the minutes just note 'discussed' without action for a problem, that's a symptom of ineffective review for a start.

And yes, if a few items have popped up a few times... that's a symptom of a recurring problem.

 

[JaneB]

I am sharing a template of MRM, which I had downloaded from the internet couple of months ago.

Ajit, I know some people like this kind of template. I loathe them, because they're structured and written around the exact clauses and terminology of the ISO 9001 Standard. I'd much, much rather see one that was clearly based on the client's own terminology, topics and order of business. And I argue you're much more likely to get really effective MR in such a case.

 

[Ajit Basrur]

Ajit, I know some people like this kind of template. I loathe them, because they're structured and written around the exact clauses and terminology of the ISO 9001 Standard. I'd much, much rather see one that was clearly based on the client's own terminology, topics and order of business. And I argue you're much more likely to get really effective MR in such a case.

Thats true Jane but in the absence of one, many MRMs go off tangent. This is identical to use of audit checklists

 

[winchm]

The Internal Audit Plan should include the elememts (or clauses) and processes on schedule to be included in the audit.

The internal auditor is responsible to execute the audit as assigned to her/him.

The internal auditor records the elements audited for the processes assigned and documents the non-conformances if required, reviews root cause analysis and CAPA submitted by auditee, verifies NC is closed within the specified time and does follow-up to confirm CAPA was effective.

There should be a matrix for the Internal Audit and record of the internal audit completion within the specified time in Audit Plan.

A summary report on the Status of the QMS should include any
1.) major deficiencies that may affect the System, Product or service.
2.) opportunities for improvement
3.) action items from audit reports
4.) status of Internal Audit completion as planned, the number of elements audited and a simple trend analysis of number of NCs per element and process (AKA Area)

The summary report is prepared by either the Internal Auditor, Lead Auditor, or ISO Management Rep. The ISO Management Rep should present the Summary report to top management at management review.

The summary report should be concise - if a registrar or customer audits Management Review process and has a question she/he can review the Internal Audit Process - or visa versa.

I have MS Office 2003 and prefer not to install software to open 2007 MS docx, pptx, etc. but I'm sure it reads like the standard. That's all folks,

 

[JaneB]

Winchm, where are you getting all these 'shoulds' from? And the detailed prescriptions for what 'should' be contained in an audit report? Because they most certainly are not written in the Standard itself.

I presume you are describing how you do it in your particular system/organisation. But much of what you say is not necessarily something that 'should' be done in every organisation.

Much, much better to stick strictly with what the Standard itself says shall be when we attempt to talk about what 'should' be done by everyone'!

 

[howste]

Winchm, where are you getting all these 'shoulds' from? And the detailed prescriptions for what 'should' be contained in an audit report? Because they most certainly are not written in the Standard itself.

I presume you are describing how you do it in your particular system/organisation. But much of what you say is not necessarily something that 'should' be done in every organisation.

Much, much better to stick strictly with what the Standard itself says shall be when we attempt to talk about what 'should' be done by everyone'!

I agree with Jane. What you're describing can be good practices, and may be very effective if implemented well. Rather than stating they "should" be done, you can state that you prefer to do it that way, and then describe the reasons (benefits) for doing it that way.

 

[winchm]

Whoa - I think the Post Title is misleading - it is about Management Review and recording of audit results for MR.

I was responding to Willyboy, a new Internal Auditor who was questioning whether the Management Review input by the current Quality Manager was sufficient. Willy wanted to know if the internal audit results maintained by the Quality Manager in his own files and office should be included in Management Review – I, like others suggested an internal audit summary.

Others attached presentations which I couldn’t open, but I suspect they gave an example of how the Audit results are summarized. The following is an example of a Management Review Agenda that I had on file but is not verbatim. Clauses 5.6 Management Review, 5.6.1, General, 5.6.2 (inputs) and 5.6.3 (outputs)

• Continuing suitability, adequacy & effectiveness of Quality System
• Audit results (internal, customer and third party)
• Customer feedback (c-sat & loyalty results)
• Process performance and product conformity (including CoPQ)
• Status of corrective and preventive actions
• Changes that could impact the quality management system
• Recommendations for improvement (collaborate for best practices)
• Progress toward quality objectives (improvement plans)
• Follow-up on any actions assigned during previous management review

I could not answer Willy directly other than to give advice as what to look for in both the management review process and the internal audit process. I use the word should as this is what I would look for in MR and IA processes. I do not use the word Shall as I am not quoting or writing the standard – merely answering a newbie’s query on what he should look for when auditing management review and performing an internal audit.

 

[JaneB]

Whoa - I think the Post Title is misleading - it is about Management Review and recording of audit results for MR.

This often happens (misleading titles) but then, I think it's to be expected a bit - it's often hard to think up the 'exact right' title when creating a new post.

Winchm, I think it's great that you're aiming to help and I encourage you to continue to get involved and do so!

And I'm not attacking you, but I am taking issue with perhaps the way you expressed what you said. I don't want to split hairs, but there's very little real difference in meaning between shall and should. And to me, when I see /hear someone saying 'this should happen and this should be like so' in a professional context, I think they're quoting some authority (standard, legislation, contractual, policy) etc that means 'it must be like this'. So to me, it didn't read so much as you offering advice 'here's how we do it, and this is why we do it', but just making blanket pronouncements 'it must be like this' without any reasoning given. I therefore return to the authority (the Standard), compare that with what you said, and disagreed.

You see, I know that lots of other people read along in threads - or may do so days, weeks, even months from now, so if I read something that I think is inaccurate or misleading, I query it or say a bit. (Sometimes more than a bit).

May I respectfully suggest, as Howste did, that it's much more helpful if you're offering advice / describing your own way of doing things to make that clearer, rather than using the 'it should be' form?

There's several good reasons for this. One is that if you keep saying 'should', you're very likely to encounter quite a few opinions to the contrary, such as mine for example

But far more importantly, by offering reasons for why, you help improve understanding by others, as well as foster a spirit of sharing and healthy, open, professional debate. Which is strongly encouraged in the Cove.
Hope this clarifies for you.
that it

... imerely answering a newbie’s query on what he should look for when auditing management review and performing an internal audit.

This wasn't my understanding of what was asked by the OP (original poster).