8.2.3 Monitoring and measurement of processes - What is "Where applicable"

[EasyEd77]

[FONT=&quot]The standard reads:

The organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action shall be taken, as appropriate.

My question is, what determines when a measurement of the quality system is applicable? Does each process need a goal that is measured with a metric?
[/FONT]

 

[AndyN]

Re: 8.2.3 Monitoring and measurement of processes

EasyEd - Welcome

Management decide. Simples! If you have any processes without a goal, no-one is in control and if there's no metric, doubly so...

The "where applicable" helps, because - as an example - you may not wish to "measure" the document control process. It's not interesting to your customers, you probably don't make money on it and it's a very low priority when it comes to the business. So, you can make the decision: It's NOT applicable!

 

[EasyEd77]

Re: 8.2.3 Monitoring and measurement of processes

Thank you for the advice. I got dinged on my last audit because of this so I will be sure on each process to indicate if there is a measurable goal. If there is not one applicable I will state that too. My plan is to keep all measurable goals on one spreadsheet.

 

[Candi1024]

Re: 8.2.3 Monitoring and measurement of processes

The definition of "where appropriate" (which is close to "where applicable", right?) according to 21 CFR Part 820 is: it is deemed to be appropriate unless the manufacturer can document justification otherwise. A requirement is appropriate if nonimplementation could reasonably be expected to result in the product not meeting its specified requirements or the manufacturer not being able to carry out any necessary corrective action.

 

[J0anne]

Re: 8.2.3 Monitoring and measurement of processes

'A requirement is considered "appropriate" if it is necessary in order for

the product to meet specified requirements, and/or
the organization to carry out corrective action.'

AND it is deemed to be appropriate unless the organisation documents a justification otherwise. 1.2 Application

 

[EasyEd77]

Re: 8.2.3 Monitoring and measurement of processes

Ok so I just presented my argument against the write up to my auditor and his response was that the Rules 4 requires that [FONT=&quot]"there needs to be a performance indicator for all QMS processes." [/FONT]

 

[EasyEd77]

Re: 8.2.3 Monitoring and measurement of processes

He is looking for an objective for each process and a number that indicates performance and if the objective was met.

 

[AndyN]

Re: 8.2.3 Monitoring and measurement of processes

Have them tell you the PRECISE requirement, in the TS rules - by paragraph #

 

[EasyEd77]

Re: 8.2.3 Monitoring and measurement of processes

I just did that. I said "I am not trying to have a standoff, but where in the 4th edition rules does it state that there needs to be a performance indicator for all QMS processes? I want to be sure that I am doing the necessary changes correctly."

I will keep you posted.

 

[AndyN]

Re: 8.2.3 Monitoring and measurement of processes

Tell your auditor it's NOT in the rules and there's a note in the ISO 9K standard which defines the processes as certain sections of the standard:

"NOTE Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement."