Processes sharing the same nonconformance during an audit

[Gman2]

How do you advise handling the scenerio below:

Processes audited:

Saw Cutting
Welding
Stamping
Receiving
Machining

All of the above processes were audited on the same day and ALL of them had measuring equipment that was not calibrated. Would you write each process up for calibration or just write one NC against the standard for calibration?

This is where IMO the whole process vs standard thing gets a little convoluted.

And just for fun lets say out of the 5 processes audited that 4 of them had no training records and none of them knew the quality policy or any quality goals for the company.

Would each process get 3 NC's totalling 14 NC's total for the audit day(minus the one for having training records) or would you just write three total (1. Calibrations 2. Training 3. Communication) and just list the processe in each.

Thoughts?

 

[Golfman25]

It would be three total - calibration, training, communication - with a lot of evidence.

 

[Gman2]

Thanks a lot.
Stress is sinking in, audit is sneaking up like a freight train

 

[Ninja]

I would second Golfman25,

There is a systemic issue (issues, really).

Calibration is not being kept current. One cause, many affected areas...one solution (assuming centralized calibration).

Training system or recording is not effective. One cause, many affected areas.

Communication of quality goals is ineffective or missing...

Why solve it once and do the paperwork three to five times? Solve it, document it, move on...

 

[ScottK]

I'll also echo Golfman25 with the addition of: one NC per violation of the standard, so 3 NC's....
if you have "levels" of NCs then the more of each violation the more serious (minor, major, etc) the NC.
As Ninja says - it becomes a systemic issue.

 

[QAengineer13]

To add to the discussion, my , in your audit recommendation mention about a re-audit session in the same area and/or different area looking at the same audit scope as earlier,upon completion of the investigation for the current NC's and CAPA , later use the re-audit report if successful to close your CAPA effectivity due to the previous audit NC's.

 

[John Broomfield]

Whatever happened to process monitoring and correction per clause 8.2.3?

...this used to be what craftspeople and supervisors did.

Waiting for the auditor makes no sense.

 

[QAengineer13]

Whatever happened to process monitoring and correction per clause 8.2.3?

...this used to be what craftspeople and supervisors did.

Waiting for the auditor makes no sense.

John,

Please give some clarity as to what needs to be done? I agree waiting for auditor does not make sense, but potentially they can use re-audit is what I meant to see if the system works, if that's not considered as one possible solution please share your thoughts ...Thanks!

 

[John Broomfield]

John,

Please give some clarity as to what needs to be done? I agree waiting for auditor does not make sense, but potentially they can use re-audit is what I meant to see if the system works, if that's not considered as one possible solution please share your thoughts ...Thanks!

QAengineer,

Sorry. As others have said you have a systemic problem that impacts several processes.

Hence my recommended line of inquiry:

Are the people doing the work and supervising the work - monitoring their work against the requirements? The requirements include knowing the calibration status of the measuring equipment that is available for use.

To me the workers and supervisors seem prepared to start work without ensuring they have measuring equipment they can use. Process monitoring starts with being familiar with the requirements and having the necessary information and equipment.

This is an important line of inquiry not yet mentioned. You seem to have evidence of a failure to monitor and correct the processes against the requirements.

Also, are the people responsible for doing the work and for supervising the work authorized to refuse to start work until the necessary equipment is available and suitable for use?

The system is meant to be helping the employees to understand and fulfill requirements. Right now it seems to depend too much on its auditors.

John

 

[Bev D]

How do you advise handling the scenerio below:

Processes audited:

Saw Cutting
Welding
Stamping
Receiving
Machining

All of the above processes were audited on the same day and ALL of them had measuring equipment that was not calibrated...
Thoughts?

Not to add to your stress, but in many industries the widespread use of gages that are not calibrated could lead to major NC AND the suspension of your certification...as others have said these are serious gaps in your system and reqquire serious corrective action.