Should the required production controls and control results be documented ?

[Libnani]

I am facing as ISO 9001 external auditor during audit on production process
the following issue : should the required control be documented ? or
it is sufficient that the operator or inspector put his signature on the production sheet to assure that the required control was done and the results are ok ?

As I Know, ISO9001 requires :
"Evidence that the realization processes and resulting product fulfil requirements"

for me the required controls (for ex. thickness , diam.,...)
and the test (control results) should be documented .

Please advise.

 

[atitheya]

.....

for me the required controls (for ex. thickness , diam.,...)
and the test (control results) should be documented .

Please advise.

Yes.

Mentioning the criteria, and the inspection results not only gives the evidence of conformity, it also helps during the inspection process, particularly where these matters are of critical importance to your operations and organisation, and minimises the chances of 'inadvertent non-conformance'.

 

[Stijloor]

I am facing as ISO 9001 external auditor during audit on production process
the following issue : should the required control be documented ? or
it is sufficient that the operator or inspector put his signature on the production sheet to assure that the required control was done and the results are ok ?

As I Know, ISO9001 requires :
"Evidence that the realization processes and resulting product fulfil requirements"

for me the required controls (for ex. thickness , diam.,...)
and the test (control results) should be documented .

Please advise.

Both methods are fine and meet the intent of the Standard. However, if it's important to record the actual inspection and test results for further analysis, then it's good practice to record the results. Think for a moment about what's important for your company, not necessarily the external auditor.

Stijloor.

 

[AndyN]

I am facing as ISO 9001 external auditor during audit on production process
the following issue : should the required control be documented ? or
it is sufficient that the operator or inspector put his signature on the production sheet to assure that the required control was done and the results are ok ?

As I Know, ISO9001 requires :
"Evidence that the realization processes and resulting product fulfil requirements"

for me the required controls (for ex. thickness , diam.,...)
and the test (control results) should be documented .

Please advise.

A signature doesn't show that 'results are O.K'! If an operator is making variables measurements, they should record the data. If they are making attribute measurements they should record the 'Go' or 'not go' and the gauge used. Without this analysis is not possible and it's impossible to detect trends. Signatures are meaningless........

 

[Libnani]

A signature doesn't show that 'results are O.K'! If an operator is making variables measurements, they should record the data. If they are making attribute measurements they should record the 'Go' or 'not go' and the gauge used. Without this analysis is not possible and it's impossible to detect trends. Signatures are meaningless........

"The signed work order is a record that the product meets requirements"
according to Cliff (thread of 30 April 2007 for a similar subject)

who is right ?

 

[AndyN]

"The signed work order is a record that the product meets requirements"
according to Cliff (thread of 30 April 2007 for a similar subject)

who is right ?

Both of us can be! If someone signs off having reviewed the recorded results, then it can indicate that the process is complete and the results indicate the product is satisfactory!

But just a signature without data is bogus.....

 

[Libnani]

Both of us can be! If someone signs off having reviewed the recorded results, then it can indicate that the process is complete and the results indicate the product is satisfactory!

But just a signature without data is bogus.....

I am an external auditor , i should take a decision . if i see only a signature on the production sheet . is it a non-conformity or not ?

 

[AndyN]

As an enternal auditor you have to decide - that's your job. It's impractical for us to tell you, we haven't seen what the QMS 'says' about this nor any evidence of implementation etc.

You are not really able to provide us with this information and as an auditor, it's your reposibility to evaluate what you see and come to a decision, based on facts - not what we tell you...........