Knowledge of CAR/PAR Procedures - Should the entire organization know/understand?

[jackweed13]

Quick question for the Cove: Should the entire organization know/understand the 6 required procedures? CAR, PAR, Control of Doc/Rec, Internal Audit and MGMT Review? Our guys can find the procedure without issues but I am less than confident they understand them. Your thoughts please

[qusys]

The fact to know the 6 mandatory procedures can mirror in how the personnel of the organization carry out the process that are regulated by them.
If the processes work well, produce set results and have no shortfall, this could be a direct measure that personnel know and apply correctly the procedures.

I also undestand the rational of your question: there are many occasion that processes are managed in tribal fashion for some aspet and not all details are covered by the 6 procedures.
However these procedure as well as Quality manual remains documents of highe level in the documental pyramid , for the details there are work instructions or operative procedures.

Finally, my question to you is this: why do you that they do not undestand them? Are there any issues in the related process? Do they fill them only as a paper more than a living document to guide tkeir processes and activities?

Originally Posted by jackweed13

Quick question for the Cove: Should the entire organization know/understand the 6 required procedures? CAR, PAR, Control of Doc/Rec, Internal Audit and MGMT Review? Our guys can find the procedure without issues but I am less than confident they understand them. Your thoughts please

[sitapaty]

Originally Posted by jackweed13

Quick question for the Cove: Should the entire organization know/understand the 6 required procedures? CAR, PAR, Control of Doc/Rec, Internal Audit and MGMT Review? Our guys can find the procedure without issues but I am less than confident they understand them. Your thoughts please

All personnel engaged in quality related work should be aware of the existense of the procedures.But those persons who directly deal in recording CAR/PAR should know the details of the procedures.Besides both CAR & PAR procedures can be included in one single procedure.
-Sitapaty

[qusys]

To add some another thing, Mgmt review does not require a written procedure, but Control of non conforming material.

It is clear as the previous post said that all personnel involved directly in the above QMS system shall be competent and aware of the procedures that are aimed to manage QMS processes.

QM is the document that could easily transfer this type of knowledge together a training process.

Originally Posted by jackweed13

Quick question for the Cove: Should the entire organization know/understand the 6 required procedures? CAR, PAR, Control of Doc/Rec, Internal Audit and MGMT Review? Our guys can find the procedure without issues but I am less than confident they understand them. Your thoughts please

[somashekar]

I believe that the QMS broadly has two sectors. The structural sector which binds all the processes and the procedures of these are mandatory and must be known, understood, digested and well implemented by ALL in the organization, and any amendment to these procedures must be done with good amount of thought over it. The other is the functional sector which are owned and managed by the functional departments

[Sidney Vianna]

Originally Posted by jackweed13

Quick question for the Cove: Should the entire organization know/understand the 6 required procedures?

Not necessarily the procedures, but the CONCEPTS. Successful organizations are those that learn from mistakes and are genuinely interested in continual improvement. To that end, don't you think that EVERYONE in the company needs to understand the CONCEPT of corrective and preventive actions? Most people (if not all) should understand that they should be able to trigger a CAR/PAR request. Certainly, you don't want people misusing CAR/PAR's such as triggering a CAR to improve the quality of the food in the cafeteria...
Similarly, you want all affected people to understand the concept of documentation control and the need to use the appropriate version of the document when performing their tasks. Other aspects of the QMS, such as control of non-conforming products and internal audits are more "localized" and, frankly, it would be a waste of time to make everyone aware of those concepts when, for the most part, they would not be directly involved with it.

[Marc]

To make this applicable to every procedure in the company:

Each employee must know what documentation (including procedures, work instructions, etc.) they have a responsibility for compliance with (participate in/work with). Each employee should be able to explain their specific responsibilities and *how* related documentation affects them. Each employee should also know and be able to explain what they do when an event occurs which is not covered by a procedure they are responsible for.

[jackweed13]

Many thanks for all the thoughts. Its very helpful.