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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
V

vanputten

#31
#31
Process vs Product

IMHO, records are the product of a process. I thought the whole point of ISO 9001 and quality managements systems was to look at the process behind the product. If we get the process "right", then the product will be "right.' (I use the word "right" to mean conforming, correct, effective, efficient, etc.)

Look no further than the financial industry and the financial audit industry to see the effectiveness of auditing only records (the output of the process.) Sarbanes Oxely may be slowly chaninging this paradigm but I still see an emphasis on financial records in financial audits. Auditng only the records is not effective. It does not provide a snap shot the the entire business sytem that produces the product.

Regards, Dirk
 
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Q

qualityboi

#33
#33
Quality Records

vanputten said:
Process vs Product

Look no further than the financial industry and the financial audit industry to see the effectiveness of auditing only records (the output of the process.) Sarbanes Oxely may be slowly chaninging this paradigm but I still see an emphasis on financial records in financial audits. Auditng only the records is not effective. It does not provide a snap shot the the entire business sytem that produces the product.

Regards, Dirk
Click to expand...
I believe that Dirk is correct. The weakness of auditing only records is that there is a validation peice missing. SOX, sad to say, is an output of many things, one of them being doctored or creative record keeping.:magic:
 
B

BSpitler

#34
#34
As mentioned earlier, auditing only records violates the notion of a "process approach" to auditing. It is like your doctor diagnosing and treating you by looking at your past medical records. Audit results should indicate the "health" of the QMS.
An audit of records alone would be of very little value to an organization. Very few opportunities for improvement would be identified.
 
C

celso klitzke

#35
#35
ah the records...

1 - Records show the past. We should know how is the present too.
2 - We need more than the required twenty-like to demonstrate the health of the QMS.
 
Last edited by a moderator:
Jim Wynne

Jim Wynne

Staff member
Admin
#36
#36
celso klitzke said:
1 - Records show the past. We should know how is the present too.
Click to expand...
That's the answer in a nutshell, but it assumes that records accurately show the past. If an audit is to be based solely on records, then an assumption must be made that the records are accurate, comprehensive, and show a reliable picture of the system. That's an unwarranted assumption, hence the need to actually see the system at work.
 
L

ldllmd

#37
#37
Records are not enough to know if the organization works properly. It is important to search for evidence regarding the good practice in the organization. Records are evidence, but what happens at the workplace is of great importance too. To see if people are aware of what they do, if they know and respect the procedures is a must, not just to audit the 21 records required by ISO 9001
 
P

progressive post

#38
#38
genuinity of records have to be coroborated with the working in the department and units.objective evidence ,work practices and also level of awareness of the documented system will confirm that records are genuine and real.regards.progressive post.
 
E

Eric ng

Involved In Discussions
#39
#39
I voted "NO" because records are only one part of the many ISO requirements. Noncompliance can occur on ISO any iso clause or clauses that do not required records.

Eric
 
C

Caster

An Early Cover
Trusted Information Resource
#40
#40
Helmut Jilling said:
Absolutely NOT. It misses the whole point of a process approach. .
Click to expand...
Thanks, I was waiting for someone to say process approach.

Somewhere (likely here) I got the idea to also look at the interfaces between processes (Sales to Design to Manufacturing) to find real opportunities for improvement. It works!

As to the brief flame war earlier, my mouse has a great little scroll wheel to zip me by things like that. A few microseconds of scrolling moves me to endless learning opportunities. Unlike most other forums I visit, this one has a high value content for me.
 
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