7.5.2 Validation of Processes for Production and Service Provision

[sgbhat]

Can we know the meaning & scope of service provision in this clause 7.5.2 & ISO /TS - 7.5.2.1(which says all process to be validated / revalidated) ?.

Do we need to consider following processes of a Production (part/assy. manufacturing) organisation as Service (provision) and to Validate them even ?
Eg.;-
Marketing ,
Purchase ,
Inspection,
(Machine/tool) maintenance,
Calibration/MSA,
100 % segregation ,
dock audit etc

Admin Note: There were 3 identical posts which the poster used 3 old threads to resurrect, so I have merged them into 1 and deleted the duplicate text in the resulting post (this post) and the posts in the other 2 threads.

 

[JoeDM]

I have smoke coming out of my ears trying to understand the "special processes" portion of this 7.5.2.

For the past three years, we have passed AS9100 audits with an exclusion to 7.5.2., since this states: "the organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement, and as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered"... "often referred to as special processes". Ok, check, got that part... Any work that we do with an outside service supplier comes back to our shop, goes through a thorough QA review prior to being sent to the customer. We make PWB's, no assembly, that's it, copper, laminate, holes and traces. So for us, we do not do any special processes that cannot be validated in house... any OSS processes take place PRIOR to final QA testing procedures, therefore the process IS validated in house, before delivery, our failures don't make it out the door. Any failure that takes place outside of our company after delivery would realistically be due to components and/or assembly, which we do not have any control over or responsibiltiy to. Anyway...

I have had an auditor recently tell me regarding our exclusion and I quote "Bull---t! If your telling me you don't have special processes you're lying", my explainations falling on deaf ears . I don't feel like changing my entire quailty system for a client auditor, but at the same time I'm not sure how to address the validity of this claim, successfully. Any feedback from anyone out there?

A sincere advance thank you to anyone who can help me wrap my brain around this finding.

I think it comes down to: can the quality of the laminated product be determined by subsequent inspection or measurement? If it can, maybe you need a new auditor. If you think you are correct call the certifying agency and have a discussion. I've found most auditors to be good, but they're not perfect.

What are your outside suppliers doing? Maybe that's where the auditor's concern lies.

 

[somashekar]

Just to keep an alert here that the quoted post of Shredder is from 2 Aug, 2011, and I guess by now he is a master on Validation.

 

[John Broomfield]

Can we know the meaning & scope of service provision in this clause 7.5.2 & ISO /TS - 7.5.2.1(which says all process to be validated / revalidated) ?.

Do we need to consider following processes of a Production (part/assy. manufacturing) organisation as Service (provision) and to Validate them even ?
Eg.;-
Marketing ,
Purchase ,
Inspection,
(Machine/tool) maintenance,
Calibration/MSA,
100 % segregation ,
dock audit etc

sgbhat,

TS requires design (and validation) of manufacturing processes. Where did you read "all processes"?

John

 

[sgbhat]

Thanks , I read "all processes " in 7.5.2.1 and that is ;- The requirements of 7.5.2 shall apply to all processes of production and service provision.

 

[Big Jim]

Thanks , I read "all processes " in 7.5.2.1 and that is ;- The requirements of 7.5.2 shall apply to all processes of production and service provision.

There is a huge lack of clarity here on the part of the standard based on the fact that TC176 has never provided a clear definition of what is a process.

There seems to be processes that pertain to production such as inputs to assembly, assembly, and the results of assembly (or plating, or welding, or soldering etc).

There seems to be management processes or business processes, such as declared in 4.1, where a company needs to determine their processes, how they relate to each other, and the need to monitor and measure them (some common business processes may be sales, purchasing, engineering, manufacturing, shipping, etc.).

7.5.2 seems to be mainly that any production processes that cannot be verified need to be monitored.

7.5.2.1 seems to indicate that 7.5.2.1 would apply to your business processes too.

All this is as clear as mud. No wonder there is a lot of confusion.

 

[John Broomfield]

Thanks , I read "all processes " in 7.5.2.1 and that is ;- The requirements of 7.5.2 shall apply to all processes of production and service provision.

sgbhat,

I read this as design (and validate) all processes that fulfill the requirements of clause 7.5 (production and service provision).

From 4.1 you will have determined the processes needed for your organizational management system (or QMS) to be effective.

Regarding which of these processes must be designed you can exclude the support processes such as purchasing, recruiting and training.

As your system matures, repeated cycles of improvement may prompt design of the other processes in the core process (from needs to cash) and those processes that sustain and direct the core process.

John