Management Review - Audit Nonconformance

[Raffy]

In my previous company, we integrate all the requirements as one Quality Manual. There are common requirements that can be put as one. But there is an example manual on this site: http://elsmar.com/pdf_files/Quality and Other Manuals/ - which is also part of this forum, there are several quality manuals you can use.
Hope this helps.
Best regards,
Raffy

 

[Joey Pan]

Hi,
I do not think checklist is a good action,because in clause 5.6.2&5.6.3, the standard is already list the inputs and outputs and the NCR is just because someone did not do it, in a word,lack of execution.so according to this problem,below two actions maybe can help:
1)train all the folks who involve in MR,let they know the inputs and outputs in MR;
2)set up a approver to check the MR report,such GM,Management Representative,in my orgnization,the MR report shoul be approved by GM;
BTW,you also can negotiate with auditor about the action because this type of issue is kind of common and the auditor know how to deal with it.
Due to i am chinese and my english is not very well so sorry in advance if you can get my point clearly.

 

[Mikishots]

Re: Management review - Nonconforming

Root cause, IMHO, means that u have to put question "Why?" until u get the very first answer - e.g.:"MR did not carry out the job" - why? - because he / she lacks the acknowledgement of ISO clause 5.6 / requirements of ur procedure describng this clause - why? - because he / she was not trained with this clause. So, training MR could be a good start for preventing future ncf.(followed by future verification of effectiveness of this measure, sure)!
Of course, u can continue with 'Why?", but I think enough is enough

Lack of training is also a "root cause" that is frowned upon by auditors. You may think enough is enough, but if you provide training as containment action, what's keeping it from happening again in the future?

One more WHY: WHY is the management rep and top management not being trained on the requirements of Clause 5.6? Fix this, and it won't occur again unless it's deliberately contradicted.

 

[bluepagen]

Re: Management review - Nonconforming

My company has experienced a nonconformance of this nature.

We use an audit agenda, with each requirement of the standard for inputs and outputs listed with an area to document the discussion and who presented the discussion.

During an API audit, we did not document enough detail during the discussion of regulations, specs, standards that would impact our business. We did revise the management review agenda to include this as a specific topic to be addressed and assigned a person to lead this dicsussion.

When doing our corrective action, we documented what was missing from the management review meeting agenda, and at the next availalbe managers meeting held this discussion. It was documented as all the meeting are.

We included this and the revised agenda in the supporting documentation when responding to the finding.

If there were specific areas or topics that were overlooked you might try this.

Good Luck.

 

[ssz102]

why the input and output should be showing in the meeting minutes?

the input of management review is a info that hold a management review, and the output as following improvement plan

meanwhile, you may be refer to the clause 5.6 ISO2008 standard

 

[Colin]

How about another angle on this? WHY are the organisation not addressing all the elements of 5.6.2/3? - perhaps they don't understand them. It is not always obvious what 'process performance and product conformity' and 'the status of preventive and corrective actions' mean to many people.

Try using language that they understand like 'performance against objectives' or 'number of nonconformances' or 'amount of scrap/wastage' and you may get a better response.

And/or try not having a specific meeting called 'management review' - many of the items discussed at management review are covered in daily/weekly/monthly management meetings anyway so why not summarise them at management review and point the auditor to where the details are elsewhere?

Nowhere does the standard say this has to be done all in 1 sitting and summarised in 1 report.