Production Control

ISO 9001 section 7.5.1 states:  “The organization shall plan and carry out production and service provision under controlled conditions.”  It goes on to state that controlled conditions means availability of product specifications, work instructions, equipment, and test equipment etc.

In an audit I was conducting recently, I came across a work instruction that instructed the technician to ‘use the custom jig.’  This raises the question:  Does ‘controlled conditions’ mean that jigs and fixtures should be identified and controlled?  It’s an important question from the auditor’s point of view.  If the fixtures are not controlled, should I write a corrective action?

To me, control means the same thing for a tool that it means for a document or  inspection equipment.   It should be identified, it should have a revision, changes to it should be approved prior to issue, and it should be inspected periodically to assure it is viable for use.

I raised the question of controlled tools with other quality professionals, and they all seemed to think the standard is moot on this point.  They all agreed that it makes prudent sense though.  Other standards such as AS9100 (the aerospace equivalent of ISO 9001) clearly state the requirement for tool and jig control.

Consider the potential problems:

·         A fixture used in production wears out over time and must be replaced.  Without a drawing, how do we make a new one that works the same as the last one?

·       The fabricator of the fixture leaves the company, or worse, we need to use the tribal knowledge of the person who made it to make another (assuming he or she remembers how).

·         A technician trainee doesn’t know what ‘use the custom jig’ means and doesn’t use the one we’ve fabricated for the purpose.

The standard leaves many things to interpretation by the external auditor.  Regardless of what the standard says, or how it is interpreted, be sure to document all production tooling with a tool number or other identifier, revision level, and a controlled drawing.  Inspect the tooling periodically to assure it has not worn to the point where it should be replaced.  It may make your ISO 9001 implementation a little easier.

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