ISO 9001 Clause 7.5.2 Validation of Processes - How to comply?

[Paul Simpson]

Re: 7.5.2 Validation of Processes - How to do this?

Late to this particular discussion and there are plenty of posts I could pick up on to respond to but will confine my answer to this one and add some general comments.

I understand what you're saying Jim. It just seems to defeat the whole purpose of them holding any sort of Quality accreditation if you have to vet their processes anyway. Isn't API or a similar body carrying out annual audits on their systems to ensure they are doing everything right, including complying with clause 5.7.1.5 - Validation of Processes for Production and Servicing?

Now this is where I have to disagree with Jim and others. Firstly I presume you are carrying out the welding processes and have at least one of these controls in place:

• Coded (or otherwise approved) welders
• Weld procedures
• Controlled or calibrated equipment

As part of your weld procedures you go on to visually inspect the welds and then you are looking to bring in your (specialist) sub contractor to carry out NDT.

API make a big song and dance about what it means to be Q1 accredited, and so do a lot of the bigger oil and gas companies like Shell, Conoco, Haliburton etc.
However, it seems kind of pointless if that accreditation cant be taken as evidence that your processes are being controlled in such a way to conform to the customer, industry and statutory requirements.

So to continue. If your sub contractor has accredited certification or any of the other approvals Harry mentioned for inspection then you have done enough to satisfy any certification requirement and, more to the point, your own concerns. If they don't hold the necessary certification then you have to do your own checks on personnel competence / equipment suitability.

In an attempt to sabotage my own argument here, I have to say that a lot of the bigger companies we deal with who have Q1 or ISO 9001 accreditation, display the worst behaviours with conforming to the Quality requirements. But that's another story for a separate thread.

Thanks for your input Jim.

Now that will be an interesting thread. Unfortunately certification doesn't give the confidence it should but as the customer here you can impose your own expectation of what the supplier does. Unfortunately playing the ISO 9001 / API card up the supply chain doesn't work as well!

 

[Big Jim]

Re: 7.5.2 Validation of Processes - How to do this?

Process validation is also good for when you do not want waste money verifying its products.

John,

I have heard the point of view that validation is appropriate when the verification cannot be performed in an economically viable manner.

I can't find that justification in the standard though. Perhaps you can enlighten me.

What I see in the standard is "where the resulting output cannot be verified by subsequent monitoring and measurement . . . "

 

[John Broomfield]

Re: 7.5.2 Validation of Processes - How to do this?

John,

I have heard the point of view that validation is appropriate when the verification cannot be performed in an economically viable manner.

I can't find that justification in the standard though. Perhaps you can enlighten me.

What I see in the standard is "where the resulting output cannot be verified by subsequent monitoring and measurement . . . "

Jim,

Agreed, but our readers should not be limited by the standard if they want their management systems to add value faster and prevent loss sooner.

After all, the primary purpose of the management system should be to fulfill the organization's objectives not to pass a certification audit.

To this end we see organizations using TS 16949 even though they are not part of the automotive industry. They design their production processes to result in more right first time products.

John

 

[John Broomfield]

Jim,

On rereading your post I realize that I may not have done justice to your question.

I do not interpret this requirement ("where the resulting output cannot be verified by subsequent monitoring and measurement...") as ISO 9001 saying you must inspect or test to verify the product unless it is impossible to do so.

If a quality objective is to invest in prevention to reduce appraisal costs then designing and validating production processes to avoid having to sort good products from bad makes sense to me.

We know that ISO 9001 favors prevention over failure, and appraisal over failure; but I've never viewed ISO 9001 as favoring appraisal over prevention.

John

 

[Big Jim]

Jim,

On rereading your post I realize that I may not have done justice to your question.

I do not interpret this requirement ("where the resulting output cannot be verified by subsequent monitoring and measurement...") as ISO 9001 saying you must inspect or test to verify the product unless it is impossible to do so.

If a quality objective is to invest in prevention to reduce appraisal costs then designing and validating production processes to avoid having to sort good products from bad makes sense to me.

We know that ISO 9001 favors prevention over failure, and appraisal over failure; but I've never viewed ISO 9001 as favoring appraisal over prevention.

John

John,

Do you have any ISO provided guidance on your perspective? This looks like an end run around a very solid requirement. Basically you are saying I won't answer to this requirement because it isn't convenient.

 

[John Broomfield]

John,

Do you have any ISO provided guidance on your perspective? This looks like an end run around a very solid requirement. Basically you are saying I won't answer to this requirement because it isn't convenient.

Jim,

It is not a matter of convenience. It is a matter of planning the processes necessary for product acceptance per clause 7.1. Product verification per 8.2.4 then conforms to this plan.

The plans I am referring to require the use of verified, validated, monitored and measured realization processes to result in products that fulfill the criteria for product acceptance.

And the records provide evidence that the realization processes and resulting product meet requirements.

These clients have applied the requirements of clause 7.3 to the design of their product realization processes.

The minimum amount of product inspection and testing is not specified by ISO 9001 although TS does require dock audits.

John

 

[Big Jim]

Jim,

It is not a matter of convenience. It is a matter of planning the processes necessary for product acceptance per clause 7.1. Product verification per 8.2.4 then conforms to this plan.

The plans I am referring to require the use of verified, validated, monitored and measured realization processes to result in products that fulfill the criteria for product acceptance.

And the records provide evidence that the realization processes and resulting product meet requirements.

These clients have applied the requirements of clause 7.3 to the design of their product realization processes.

The minimum amount of product inspection and testing is not specified by ISO 9001 although TS does require dock audits.

John

Why would you equate this to 7.5.2?

 

[John Broomfield]

Why would you equate this to 7.5.2?

Jim,

I'm not equating anything to 7.5.2. You asked me for an ISO source for interpreting 7.5.2 to validate the process instead of verifying its products.

Clause 7.1 allows planning for this interpretation of 7.5.2 and 8.2.4 specifies no minimum amount of product verification beyond the quality plan.

John

 

[Big Jim]

Re: 7.5.2 Validation of Processes - How to do this?

Process validation is also good for when you do not want waste money verifying its products.

I think the confusion started here. This is a thread about 7.5.2, evidently your response went beyond 7.5.2 from a desire to add further illumination to validation in general, not just validation of special processes.

I think we understand each other now.

 

[Aussie99]

Re: 7.5.2 Validation of Processes - How to do this?

Now this is where I have to disagree with Jim and others. Firstly I presume you are carrying out the welding processes and have at least one of these controls in place:

• Coded (or otherwise approved) welders
• Weld procedures
• Controlled or calibrated equipment

As part of your weld procedures you go on to visually inspect the welds and then you are looking to bring in your (specialist) sub contractor to carry out NDT.

So to continue. If your sub contractor has accredited certification or any of the other approvals Harry mentioned for inspection then you have done enough to satisfy any certification requirement and, more to the point, your own concerns. If they don't hold the necessary certification then you have to do your own checks on personnel competence / equipment suitability.

Thanks for your input Paul. I was asking more as a generalisation, but your assumptions regarding controls would be correct if we were talking about a welding process.
I believe the big key is the difference between "certification" and "accreditation".
If my subcontractor has been "accreditated" by a recognised body for the task he is asked to complete, then I believe my validation process ends there for any works carried out by the subcontractor so long as they are within the bounds of the accreditation.
Just because his QMS is "certified" by API to Q1, doesn't mean I can accept the validation of his processes if no accreditation is in place.

Thoughts!