AS9100:C PEARs (Process Effectiveness Assessment Report)

[howste]

If (external) auditors had been auditing the requirements of 8.2.3 appropriately, the PEAR would not have been conceived. I don't believe that internal auditors are auditing 8.2.3 any better than external auditors. It's certainly not required for internal auditors to use the PEAR, but we should at least understand its intent and ensure that our audits have an appropriate focus - and audit the requirements of 8.2.3.

[Sidney Vianna]

In Reply to Parent Post by Big Jim

Allow me to clarify myself. Isn't the the results of internal audits ONE of the ways that can be used to assess the effectiveness of a QMS?

Jim, a good auditor needs to be able to communicate effectively and ask precise questions. There is a huge difference between saying one of the ways and a component of.

Assessing solely the results of internal audits will NEVER give me a TRUE idea of the effectiveness of a QMS. But I should use the internal audit results as A COMPONENT of my QMS effectiveness assessment exercise.

Furthermore, let's not confuse assessment of process effectiveness and QMS effectiveness. 8.2.3 CLEARLY focus on PROCESS monitoring.

If 8.2.2 were the answer for process effectiveness monitoring, then 8.2.3 would be redundant.

[wooden nickle]

Does every process (procedure) associated with Product Realization require a PEAR?

[howste]

In Reply to Parent Post by wooden nickle

Does every process (procedure) associated with Product Realization require a PEAR?

Every product realization process requires a PEAR, but every procedure does not. Process ≠ Procedure.

[wooden nickle]

Howste, thanks for the reply. Our QMS is procedure based (old school), will I need to convert our procedures to processes?

[Big Jim]

In Reply to Parent Post by wooden nickle

Howste, thanks for the reply. Our QMS is procedure based (old school), will I need to convert our procedures to processes?

You need both processes and procedures. They are different. May I suggest you start with the definition of each.

From ISO 9000:2005

process -- set of interacting activities which transforms inputs into outputs

procedure -- specified way to carry out an activity or a process

Part of the possible reason for confusing the two is that when you look up process in a dictionary, one of the definitions given matches what ISO has chosen to define as a procedure.

Staying with ISO's definitions, think that processes in a company often fall out along departmental lines. Think of procedures as being more like a work instruction.

[Joy]

In Reply to Parent Post by wooden nickle

Howste, thanks for the reply. Our QMS is procedure based (old school), will I need to convert our procedures to processes?

The question was asked to Howste and he would not mind if I put my points here.He is a good friend

What you meant by "convert our procedures to process"?Hope you have your processes already if you are in business.To carry out your processes you have your procedures in place,some may be documented.

Just check following for your processes, if available
Sequence and interaction, determined and implemented
Process controls determined and implemented
Resources (including competence and information) determined and being provided
Process monitoring criteria determined and processes are being monitored

Process effectiveness and efficiency measurement criteria are determined and processes are being measured against these crieteria

Are you recording the measurement results to know how your processes are performing ( also to demonstrate to auditor).You need to keep it for your benefit and auditor will just check it and prepare his records.You need this data for analysis to initiate preventive actions (sometimes CA also)

Do you have (contnual) improvement plan for your processes?


If your answers are yes,you can boldly go for audit and I would be honoured to be the auditor

[wooden nickle]

In Reply to Parent Post by Joy

The question was asked to Howste and he would not mind if I put my points here.He is a good friend

What you meant by "convert our procedures to process"?Hope you have your processes already if you are in business.To carry out your processes you have your procedures in place,some may be documented.

Just check following for your processes, if available
Sequence and interaction, determined and implemented
Process controls determined and implemented
Resources (including competence and information) determined and being provided
Process monitoring criteria determined and processes are being monitored

Process effectiveness and efficiency measurement criteria are determined and processes are being measured against these crieteria

Are you recording the measurement results to know how your processes are performing ( also to demonstrate to auditor).You need to keep it for your benefit and auditor will just check it and prepare his records.You need this data for analysis to initiate preventive actions (sometimes CA also)

Do you have (contnual) improvement plan for your processes?


If your answers are yes,you can boldly go for audit and I would be honoured to be the auditor

Thanks to all this has been a real eye opener. Would it be possible to get an example of a process with an associated procedure for me to use as a guide.