My biggest frustration is being able to tell the difference between what a systems requirement is, and what a process requirement is. Does anyone have a document that breaks out system requirments versus process requirements. Moreover something that points out what every area should have versus what only specific areas would have? :thanx:

My biggest frustration is being able to tell the difference between what a systems requirement is, and what a process requirement is. Does anyone have a document that breaks out system requirments versus process requirements. Moreover something that points out what every area should have versus what only specific areas would have? :thanx:

A good way to differentiate is to remember that a system requirement will almost always govern more than one process. It's an overarching requirement that processes must abide by. Process requirements, on the other hand, might be applicable to more than one process, but not all processes.

Chaos,
I don't think that there is any shorcut to this. Sections of the standard like Competence, Awareness and Training apply to everyone that impacts product. Purchasing applies only to those dealing with suppliers. I wouldn't get too caught up in the sematics. Clauses are going to apply differently to different companies.

Create a matrix of the departments in your company vs. the clauses of the standard. Fill in the boxes wherever you can possibly imagine the clause creating a requirement for action in that department. You should be able to answer your own question this way.

To my knowledge process requirement is the one where we have to find & implement the things as per the process requirement and it is a constraint for the other process.

on the otherhand the system requirement is the one where it is the requirement of the organisation to implement the system .so it is nothing to do with the process requirement, it will cover all the processes fallowed by the organisation.

so the system requirement is more important than the process requirement.

Chaos,
Fill in the boxes wherever you can possibly imagine the clause creating a requirement for action in that department. You should be able to answer your own question this way.

The issue I am having is for say, 8.5.2 Corrective action. All processes should have some type of corrective action, or should they? Lets say I am auditing the request for quote process. Do they need to have a separate procedure for CAPA? Does every process? At what point does this become overkill? Is there some type of a "Test of Intent" to show whether or not you really should be asking the question according to the tier level of the process? :eek:

The issue I am having is for say, 8.5.2 Corrective action. All processes should have some type of corrective action, or should they? Lets say I am auditing the request for quote process. Do they need to have a separate procedure for CAPA? Does every process? At what point does this become overkill? Is there some type of a "Test of Intent" to show whether or not you really should be asking the question according to the tier level of the process? :eek:

I think you are trying too hard. In a process Approach, they would not "all have a procedure for CAPA." You would have one procedure for CAPA, and everyone would follow the same procedure, if and when they have a need for CA.

Also, I recommend you use the correlation matrix in TS Rules. Where there is a primary responsibility, put a 1. Where there is a secondary linkage, put a 2. Otherwise, leave it blank. Don't overdo it, but identify where the logical important linkages are, and it will tell you where to audit.