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.

 

[Polly Pure Bread]

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

 

[brahmaiah]

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]

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.

 

[Polly Pure Bread]

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.

Why not define the key processes within the manufacturing process to be controlled and consistent with the quality objectives? What sequential activities are needed to be done to achieve one or more of the quality objectives? What inputs, activities and/or outputs in the key process need control in each of these processes? What aspects regarding quality of item to be controlled should be considered to achieve necessary product and/or process control? Who will be performing and what activities are to be done?

 

[Jason PCSwitches]

Thanks for the responses, let me provide more detail.

The NCR was issued specifically against the procedure, or lack there of. Here is the complete verbiage: Objective Evidence: Reference NCR-09 issued during this audit for in-process inspection and test activities not included in planning documentation. Review of Planning procedure M02-PRCI-041-06 Rev. 6, demonstrated it does not effectively define the process for planning manufacturing activities.

Requirement: ISO 9001:2000 / AS9100:2004 Rev. B, clause 7.1, “The organization shall plan and develop the processes needed for product realization (see 4.1). The planning of product realization shall be consistent with the requirements of the other processes of the quality management system.”



If you will notice this NCR was issued due to a finding (NCR9) that is related to planning. That finding was issued due to a lack of specific inspection sequences being outlined on the router. Mainly in-process inspection, once the operator inspects the part, it is noted next to the sequence, the auditor felt there should be a separate sequence for this and in tandem felt the planning procedure was inadequate. I can re-write the planning procedure, but I'm wanting to understand exactly what should be included in the procedure. I do not want to appeal the finding, I am looking for the most effective and efficient way to correct this.

 

[AndyN]

Thanks for the responses, let me provide more detail.

The NCR was issued specifically against the procedure, or lack there of. Here is the complete verbiage: Objective Evidence: Reference NCR-09 issued during this audit for in-process inspection and test activities not included in planning documentation. Review of Planning procedure M02-PRCI-041-06 Rev. 6, demonstrated it does not effectively define the process for planning manufacturing activities.

Requirement: ISO 9001:2000 / AS9100:2004 Rev. B, clause 7.1, “The organization shall plan and develop the processes needed for product realization (see 4.1). The planning of product realization shall be consistent with the requirements of the other processes of the quality management system.”



If you will notice this NCR was issued due to a finding (NCR9) that is related to planning. That finding was issued due to a lack of specific inspection sequences being outlined on the router. Mainly in-process inspection, once the operator inspects the part, it is noted next to the sequence, the auditor felt there should be a separate sequence for this and in tandem felt the planning procedure was inadequate. I can re-write the planning procedure, but I'm wanting to understand exactly what should be included in the procedure. I do not want to appeal the finding, I am looking for the most effective and efficient way to correct this.

I don't understand the problem here. I get that you feel the current system is weak, but the auditor telling you that they 'feel' that inspections should be a separate sequence is merely a bias.

Is there a problem with this process not being effective? Do you get good results? Do your operators all understand what they have to do?

I see no mention of this anywhere in the NC statement! Therefore, IMHO, you seem to be under a personal whim of the auditor. You should take it up with him or his management as to what's expected. By all means go ahead and rewrite a better system, but not based on what's reported by your CB, here.

 

[Randy]

On top of what Andy said, it's a pretty poor auditor that goes for 7.1 because that is some pretty low hanging fruit. Additionally a problem with 7.1 is indicative of serious or systemic failure and should result in high level nonconformity and be recorded as such. For fulfillment of 7.1 success has to be achieved in all of Section 7 that is not claimed for exclusion.

In many ways 7.1 is like 4.1 when it comes to fulfilling its requirements, conformence is achieved only when the subordinate requirements are met.

 

[alspread]

This does not sound like a time to go picking issues with the auditor. All of you guys are probably right that the auditor was incorrect. Or what did he mean by this or that. This guy has an immediate problem right now.

As stated in the original post you seem to have resigned yourself to "re-booting" you QMS to build it around the process model. Great idea.

Most quality managers in the business have enough to do day to day without having to chase after auditors and CB's after they're done. The time to do all of that was while the auditor was still in the plant. It seems that maybe JasonPCSwitches let this one get away with out fight during the audit and now is left having to clean up afterward.

I go along with Howste. If there is a real problem with manufacturing, then fix it, otherwise delete it and move on with your plan to rebuild the QMS.

Good Luck