Procedure doesn't define the process - 7.1 Planning of Product Realization

[Jason PCSwitches]

Hello all, this is my first post but I have been browsing for some time now. It has been a big help thumbing through these threads.
A quick background: I inherited a limping QMS system about 6 months ago with no prior quality specific experience. I have a BS and over 10 years of upper management experience in several environments, but I had to teach myself as I went along (thanks again to the Cove). 2 weeks ago I got us through our recertification audit and all considered, it was a success. No majors and a few minors, re-cert will be no problem.

That being said, one of my NCRs was related to 7.1 planning;

Review of Planning procedure M02-PRCI—041-06 Rev. 6, demonstrated it does not effectively define the process for planning manufacturing activities."

Eventually I will need to totally re-boot the QMS and its procedures, the system was set-up around the elements and not the processes. Due to no requirement for a specific procedure in this clause, and ammiting the existing procedure is a joke, should I just delete the procedure all together? In order to satisfy the NCR I would need to overhaul the procedure and it is useless anyway.

Any thoughts or suggestions? Thanks again, I look forward to your replies.

[howste]

Hi Jason, welcome to the Cove!

Can you post the full text of the nonconformity? If what you posted is the full text, I see no reason to do anything other than to appeal it. As you said, there's no requirement for a documented procedure for this, unless your organization determines it needs one.

Was there some evidence of poor manufacturing results because of poor manufacturing planning? If yes, then update the procedure and process and make it more effective. If no, and the document adds no value, then delete it and be done with it.

[dQApprentice]

IMHO there should be a process or set of processes to support the achievement of the quality plans.

[brahmaiah - 2010]

In Reply to Parent Post by Jason PCSwitches

Hello all, this is my first post but I have been browsing for some time now. It has been a big help thumbing through these threads.
A quick background: I inherited a limping QMS system about 6 months ago with no prior quality specific experience. I have a BS and over 10 years of upper management experience in several environments, but I had to teach myself as I went along (thanks again to the Cove). 2 weeks ago I got us through our recertification audit and all considered, it was a success. No majors and a few minors, re-cert will be no problem.

That being said, one of my NCRs was related to 7.1 planning;


Eventually I will need to totally re-boot the QMS and its procedures, the system was set-up around the elements and not the processes. Due to no requirement for a specific procedure in this clause, and ammiting the existing procedure is a joke, should I just delete the procedure all together? In order to satisfy the NCR I would need to overhaul the procedure and it is useless anyway.

Any thoughts or suggestions? Thanks again, I look forward to your replies.

Deleting the procedure is not the correct solution.A good auditor can find the same NC by questioning concerned audittee.Now you have an NC in hand you have to go through routine CORRECTIVE ACTION PROCEDURE by a)Find Rout Cause for te NC
b)Decide an Action Plan
c)Execute the Action Plan effectively
d)Close the NC through reauditing by the same auditor/audit agency
You can omit the procedure for the next surveillance audit duely approved in an MRM.
V.J.Brahmaiah

[samsung]

In Reply to Parent Post by brahmaiah

Deleting the procedure is not the correct solution.A good auditor can find the same NC by questioning concerned audittee.Now you have an NC in hand you have to go through routine CORRECTIVE ACTION PROCEDURE by a)Find Rout Cause for te NC
b)Decide an Action Plan
c)Execute the Action Plan effectively
d)Close the NC through reauditing by the same auditor/audit agency
You can omit the procedure for the next surveillance audit duely approved in an MRM.
V.J.Brahmaiah

What is the need of an RCA and CA when there is no requirement stated or otherwise. Can you please explain the rationale for the proposed actions.

[brahmaiah - 2010]

In Reply to Parent Post by samsung

What is the need of an RCA and CA when there is no requirement stated or otherwise. Can you please explain the rationale for the proposed actions.

NC has to be closed by a root cause analysis and a corrective and preventinve action.Even for deleting the unnecessary procedure you need RCA and CA.
Identify the unnecessary procedure as root cause and deletion of procedure as CA.
You have to fill all colomns in the standard NC form.
V.J.Brahmaiah

[Stijloor]

In Reply to Parent Post by brahmaiah

NC has to be closed by a root cause analysis and a corrective and preventinve action.Even for deleting the unnecessary procedure you need RCA and CA.
Identify the unnecessary procedure as root cause and deletion of procedure as CA.
You have to fill all colomns in the standard NC form.
V.J.Brahmaiah

Deletion and removal of any document does not require "RCA and CA."

Stijloor.

[AndyN]

In Reply to Parent Post by brahmaiah

NC has to be closed by a root cause analysis and a corrective and preventinve action.Even for deleting the unnecessary procedure you need RCA and CA.
Identify the unnecessary procedure as root cause and deletion of procedure as CA.
You have to fill all colomns in the standard NC form.
V.J.Brahmaiah

I sincerely hope not........otherwise a total bureaucracy will reign.....