Validation of production and service provision

Last century, this was called ‘special processes’.  How unscientific is that?  Well  good old ISO thought so too and now it has the fancy title.  The standard says; 7.5.2 Validation of processes for production and service provision.  Company Name validates any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement.  This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered.  Validation demonstrates the ability of these processes to achieve planned results.  Company Name has established arrangements for these processes including, as applicable; a) defined criteria for review and approval of the processes, b) approval of equipment and qualification of personnel, c) use of specific methods and procedures, d) requirements for records, and e) re-validation.

My head hurts.  The intent is that If you make stuff and the only way of testing it or ensuring that it meets specification is to do destructive testing, then put in the above requirements.  I don’t think I have ever typed this but ‘DER’ and I capitalised.  I don’t mean to trivialise this.  It is a fundamental set of criteria for any manufacturer or service delivery.  In my twenty plus years of consulting, even when I have come across a potential client who doesn’t even know how to spell quality, have these measures in place.  No really.  There are not too many businesses in existence that want to make bad product or deliver bad service.  So they don’t.  They may not know the quality speak behind the above requirements but they sure know how and why.

So when you get to this part of your quality management system development, use the requirements as a guideline, identify how you already do these things, document them if it is of benefit, point to records that demonstrate your process and move on to the next clause.

OK, OK.  I can hear the moans.  Here is a simple example.  Your company supplies two pieces of steel welded together in a bracket.  No protective coating.  Weld strength of 150 kpa.  There are approximately 1,097, 123 ways of describing this process to ensure the specification is met.  Here are just a few.  Bill of Material, drawing, sample plan for destructive testing for weld failure, purchase orders, material specifications for metal and welding rods, non-destructive testing of all welds, prototype evaluations, test jigs for squareness, thickness, width, standard operating procedure for assembly and welding, welding ticket of operator, quarantine area, retesting procedures, concessions processes and so on.

Try a little risk management analysis.  Try communication with your suppliers and customers.  Have pride in your workmanship and get on with it.