ISO 9001:2000 Paragraph 5.5.1 - Responsibility and Authority

[jim543]

Our Quality Manual states that all Management Team members have the authority and responsibility for identifying and recording noncompliance with quality processes and procedures and for developing and implementing corrective action.

Are we in compliance with what ISO 9001:2000 5.5.1 requires?

Why or why not?

Please give me any feedback you have, particularly regarding what the ISO 9004-2000 guidance document says 'should' take place. Thanks. Jim

[Kevin Mader]

Why limit it to the Management Team?

Who is responsible for Quality? Everyone. While management has the most authority and responsibility to improve quality, everyone has some input.

Regards,

Kevin

Kevin,

Great call! Everyone is responsible for quality and reporting if quality standards are not met. Different companies have various means to it but it all comes down to a team commitment.

Outstanding!

[gpainter]

I think you are ok for what 5.5.1 calls for on CA and nonconformities, but what about the other areas e.g. preventive,design,contract review, etc?

[ROMALLEY]

I have found that empowering the entire workforce with the ability/responsibility for identifying nonconformances and initiating C.A.P.A. s has helped to foster a positive outlook of our quality system. Give them a voice; you'll be amazed with what they come up with.

[jim543]

Thanks to all for your comments.

This question was raised by one of our Internal Auditors assigned to that Section of the ISO Standard, particularly concerned about Authority (since Responsibilities are defined in appropriate procedures). As the Author of that Section of the Quality Manual, I was forced to reflect on this compliance question and hence sought your wisdom.

What I DID NOT HEAR anyone say is “As policy and documented in Procedure XYZ, certain employees have the authority to STOP SHIPMENT of a scheduled delivery and/or to BLOCK PRODUCTION of suspected non-conforming product.”

What I DID HEAR is the spirit of the ISO 9004-2000 Guidance Document clause which says: “People throughout the organization SHOULD be given responsibilities and authority to enable them to contribute to the achievement of the quality objectives and to establish their involvement, motivation and commitment.”

My original concern then about compliance with the Standard remains open. As Company policy, we certainly try to encourage all those wonderful ideas of ‘team commitment’ and ‘input throughout all levels of the organization.’ Authority however deals with where the buck stops.

Please continue to offer your ideas on this subject.

Jim

[E Wall]

Originally posted by jim543
Our Quality Manual states that all Management Team members have the authority and responsibility for identifying and recording noncompliance with quality processes and procedures and for developing and implementing corrective action.

Are we in compliance with what ISO 9001:2000 5.5.1 requires?

Why or why not?

Please give me any feedback you have, particularly regarding what the ISO 9004-2000 guidance document says 'should' take place. Thanks. Jim

Just another viewpoint here. But I need some clarification.
Who are the Management Team?
Do they themselves identify, write-up, develop, implement, and follow-up on the CA's?
Or is the responsibility and authority actually assigned to Supervisors, QA Manager or Auditors, etc..but the mgmt team is responsible to oversee the effectiveness of the process?

Using a simple yes/no response basis: If they don't actually perform the function then no, it does not meet the requirement. Because you should be referring to who is actually performing these tasks outlining specifically who has responsibility/authority.

Example; Our procedure (which must by approved by management) explains that:
1. "All Company X employees are responsible for initiating corrective or preventive actions if cognizant of any situation that may adversly affect product quality." and,
2. "The Company X Management Team is responsible for periodic reviews of the system and enforcing this procedure in an effective manner."

Both statements detail specific responsiblities, and by doing so state the authority to take the necessary actions (which is appropriately detailed in the guts of the work instruction using if/then format).

Originally posted by jim543

What I DID NOT HEAR anyone say is “As policy and documented in Procedure XYZ, certain employees have the authority to STOP SHIPMENT of a scheduled delivery and/or to BLOCK PRODUCTION of suspected non-conforming product.”
Jim

Jim,
I believe what you have been seeing is the concept that all employees should be empowered to report anything that they feel requires CA's. Not just that certain employees have the authority to stop shipment/block production. Without getting into detail, or the Pros and Cons of our system (already did that in another thread), we allow all employees to report problems of any kind. A simple Problem Report form is available on computers and any of our employees can stop production until nonconformances are rectified. As for your focus on product being halted due to non-conformances, it's obvious that all your production, inspection and shipping personnel should be allowed to "hold" material until it has been properly dispositioned. I know that some companies do not want to stop a conveyor line over every little "thing" that someone thinks is a N/C. Nobody here can help you out with that scenario. However, when you write your procedure for 8.3 Control of Nonconforming Product and 8.5.2 Corrective Action, YOU address this. The climate in my company is that even if an employee does not complete a Problem Report at that very moment, production stops until the issue is resolved. Your answer is in your own hands. If you have to butt heads with Senior Management (that may not be your case) to empower your employees to stop work on an obvious non conforming product, you need more than advice. Otherwise, you make that call. Simple as that! If I misinterpreted your last post as to the advice you got to your original post, correct me. I've done that before!