Why not just audit the required 21 records - ISO 9001 Clause 4.2.4

[gpainter]

I heard an interesting comment. An audit of records would indicate a functional and effective QMS. So, why not just do that, audit the required 21 records. So, now a poll

 

[goose]

Recoords may be positive or negative. How they are analyzed and what happens as a result of this may determine system effectiveness; not records alone!

 

[M Greenaway]

Any assessment of the implementation and effectiveness of the QMS must be undertaken against objective evidence - remember the principle of factual based decision making.

Records are clearly good examples of objective evidence, however as Jim suggests I would not limit the audit to looking at what ISO or the company defines as 'quality records', but look at all the records.

 

[Anton Ovsianko]

Effective auditing of quality records is necessary but by far not enough to define effectiveness of a QAS.
It is especially so in countries like Russia, where non-verbal communication is more important than verbal. Records are only letters and figures put on paper (or on whatever). Believeing your eyes means much more.

Example:
A record states that a person has been trained and his competency has been checked to comply to existing requirements. Auditor comes to the workshop floor and sees that the same person cannot answer elementary questions concerning what he is doing.

Documented quality system to my mind implies that reality is reflected in documentation (records) and records are reflecting reality. (Sounds silly, but I hope you can feel what I meant).

However, some auditors I new over here are just satisfied with records looking accurate...

regards,

Anton

 

[M Greenaway]

Excellent point Anton.

When auditing the records do not just look to see that the right tick is in the right box and it is signed and dated - truth check what the record is purporting to prove.

 

[M Greenaway]

I would write you a finding against 8.2.2.

 

[gpainter]

Yes just an audit against all records required by your QMS would determine if the entire QMS is effective. Not just is the record there, but is it filled out properly, does it show what was done,does it relate to the QMS/Customer requirement, etc. Jim, I would like to see your list. We have a lot more than the required number. I will pose another question to you. The standard requires certain records, so if the standard is correct the records called for should show the proof of an effective QMS? This should be an interesting thread.

 

[Deb P]

4.2.4

The functioning of the record management system should be tested throughout the entire audit process. When accessing activities within the organization the auditor should ask for records of all activities related to the retrieval process. Auditors should pay attention to how long it takes to retrieve a records.

To properly audit 4.2.4 an auditor should assess all record control, retrievability and retention procedures with associated activities (departmental or divisional).

To audit records only without auditing the activities associated with the records does not provide enough evidence of the effective "operation" of the quality system.

 

[M Greenaway]

Well Carl think about this, if the question was 'does an audit of records adequately address an audit of clause 4.2.4' then the answer would be a bloody obvious yes.

The question did not ask that.

As per usual you see a very superficial view of the questions and answers in this forum, and of ISO9001 itself.

I suggest you take yourself back to kindergarten and try to learn something.

 

[M Greenaway]

Thanks Carl

Hopefully they will inspire you to learn.

Feel free to respond when you finally have something interesting and valid to add.

P.S. My name is Martin