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

Will an effective audit of records show if the QMS is effective

  • YES

    Votes: 6 27.3%

  • NO, post why you think not

    Votes: 16 72.7%
  • Total voters
    22
M

Mike S.

Happy to be Alive
Trusted Information Resource
#21
#21
db,

If you get your wife's name wrong from time to time it amazes me that you're still alive to tell about it! I guess it matters somewhat WHEN you get her name wrong, too! ;)
 
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C

Chris May

#22
#22
Meanwhile back at the original question............

The original post asked if an audit of records would INDICATE that a system was compliant (or not I presume).

Getting a bit "wordy" here, I think that, yes, it would INDICATE the general state of a QMS.

In my opinion, the completion and filing of the various 21+ records is the "hard work" of a QMS and if the company culture is such, that this is completed satisfactorily, then it would be a good INDICATION that the QMS is in order.

However, as stated previously by DB, on its own, it would not be objective enough to demonstrate compliance.

When I conduct an audit on a supplier, I can get a feel for their QMS by starting with Document/Record control and Training, but it is an Indication only.................

Best Regards,

Chris
 
D

db

#23
#23
Good point

When I conduct an audit on a supplier, I can get a feel for their QMS by starting with Document/Record control and Training, but it is an Indication only
Click to expand...
This is good advice Chris. I would expand it to include intenal audits as well. Although records only give a partial picture, that picture is relatively easy to view and if you have a problem there, you are sure to find problems elsewhere.
 
R

Randy Stewart

#24
#24
I think that the records will give an idea of the functionality of the system but not the effectivity of it.

If you standardize a subpar process - we just all make junk the same.

If you automate a subpar process - we just all make junk faster.
 
K

km2red

#25
#25
I think an audit of the records will give you just that: a picture of how well the records portion of the QMS is running.

We caputre a whole crap load of info around here. We even distribute it and put most of it into the right files, but if people aren't using it, or improving the system based upon it, it doesn't do the system any good.
 
C

Craig H.

#26
#26
If I may add 2 cents to this interesting discussion...

From a theoretical standpoint, I guess a records audit, especially with management review, etc., could suffice. I sure learned a lot from this perspective.

But, in real life, it sure would make me uncomfortable. Too often, there are records filled out day in and day out. Sometimes checking a group of boxes in a checklist becomes the primary task, not fulfilling the task denoted by the box.
 
H

Helmut Jilling

Auditor / Consultant
#27
#27
Absolutely NOT. It misses the whole point of a process approach. It would be like reading meeting minutes instead of particpating in the plannin meeting.

Auditing records will provide objective evidence that a system is NOT effective, because it will show evidence of failures in clear black and white. However, absence of evidence of failures does not guarantee absence of problems. It may just be that the failures were not adequately recorded... (Gee, I can't imagine anyone doing that...)

Further, a quality system, or business management system, is a complex organism and series of processes. A good audit has to evaluate effectiveness of skills, knowledge, interrelationships, process handoffs, etc. etc.

To determine effectiveness is much more complicated than to determine failure. That is why so many auditors can write up so negligible findings, but few auditors really get to the heart of the system. It takes someone with a management perspective, or someone who can see the big picture, to sysnthesize the effectiveness of a whole system.
 
H

Helmut Jilling

Auditor / Consultant
#28
#28
Randy Stewart said:
I think that the records will give an idea of the functionality of the system but not the effectivity of it.

If you standardize a subpar process - we just all make junk the same.

If you automate a subpar process - we just all make junk faster.
Click to expand...

I agree. Now, if we all make the same junk the same way (standardize), and we all make it faster (productivity), would that then qualify as Continual Improvement...? :lol:
 
A

AndyN

Moved On
#29
#29
Totally correct IMHO

hjilling said:
Absolutely NOT. It misses the whole point of a process approach. It would be like reading meeting minutes instead of particpating in the plannin meeting.

Auditing records will provide objective evidence that a system is NOT effective, because it will show evidence of failures in clear black and white. However, absence of evidence of failures does not guarantee absence of problems. It may just be that the failures were not adequately recorded... (Gee, I can't imagine anyone doing that...)

Further, a quality system, or business management system, is a complex organism and series of processes. A good audit has to evaluate effectiveness of skills, knowledge, interrelationships, process handoffs, etc. etc.

To determine effectiveness is much more complicated than to determine failure. That is why so many auditors can write up so negligible findings, but few auditors really get to the heart of the system. It takes someone with a management perspective, or someone who can see the big picture, to sysnthesize the effectiveness of a whole system.
Click to expand...
Couldn't have said anything better or different - you're on a roll 'H':applause:

Andy
 
R

Ragnar

Involved In Discussions
#30
#30
I apologize for my ignorance, could some one please provide me with a list of these "21 Required" records.
Thank You:
Respectfully:
Ragnar.
:thanx:
 
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