Re: ISO 9001 Clause 7.5.2 - Validation of Process for Production and Service Provisio
7.5.2 says, “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. ”
The idea is to detect and eliminate problems before the customer detects them. Not only are problem reports and warranty claims expensive for both parties, they can lead to reduced customer satisfaction and make it hard or impossible to win repeat business. Most organizations find it's cheaper to invest in avoiding problems than merely fixing them when they occur.
We use 7.5.2 when one of our manufacturing or service delivery processes produces results that are hard or impossible to check. All the examples above are good ones IMHO:
Welds are hard to check without destructive testing or (expensive?) x-ray equipment. The process is carefully controlled (under 7.5.2) with close attention to materials, equipment and – critically – operator skill, and in safety-critical applications the materials, tools and operators are constantly revalidated with periodic test welds (which are scrapped) to ensure they're working.
CD burning is a good example because the computer has to keep up with the spinning disk and cannot be distracted by other concurrent tasks. If it gets distracted and slows down momentarily it can inject errors into the burning process that are hard or impossible to find. So the whole CD-burning rig is validated with trial CDs prior to production, and revalidated as necessary.
I think the rice could be a good example because, although its quality can be verified when cooking is complete, if it's bad it has to be done again; the beef with oyster sauce, and the stir-fried vegetables will have to be kept warm and the guests will be kept waiting – not an issue if they're all drunk but certainly a problem in a busy restaurant. So a professional chef might well validate quality of raw materials, cooking equipment especially temperature gauges and timers, and the skills of assistant chefs. Breweries do something similar to ensure every batch of beer is good for delivery because although they can taste and destroy bad batches, that can lead to dry pubs, thirsty customers and total misery for all concerned!
“Cannot be verified” means, for me at least, “cannot” either due to physical impossibility, or due to lack of time, resources etc.
If the product (e.g. the elevator cars) cannot be completely verified without the customer's involvement, in my experience that's usually addressed with detailed specifications of the acceptance criteria that enable the product to be delivered to the customer. These are either sufficiently detailed to enable the supplier to conduct tests and inspections such that the customer does not have to verify every product as it is delivered, or acceptance tests and inspections are conducted with the customer's involvement. For example, when I take delivery of a new car (that'd be nice!) I can inspect its paint for scratches; but I have to take it on trust that the manufacturer has validated the processes for applying undercoat because any blemishes will have been rendered invisible to me by the final coat – which is why if I'm buying fleets, I like suppliers to be ISO 9001-certified with no exclusion to 7.5.2 in the paint shop.
Finally, I agree that the auditor should give a clear explanation as to why he or she expects a clause to be included in scope. While auditors are not to give advice or consult, they can give examples of how they would expect a clause to be used and its benefits. Simply treating the standard as a conformance check-list is a poor audit service that misses opportunities to deliver value through education.
Hope this helps,
Pat
Try specifying what particular paragraph(s), and/or sub-paragraph(s) out of ISO9001, Section 7 you are trying to exclude. Explain the organization's justification for the exclusion.
