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.

For more information go to www.rosehillsystems.com

On Inspection

ISO 9001 section 8.2.4 states “The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met.”   The standard goes on to say “Evidence of conformity with the acceptance criteria shall be maintained.”  It fails to point out though that quality cannot be inspected into the product.

Many organizations fail to achieve high quality, because they rely on inspection in the belief that they can inspect quality into the product.  Point 3 of Edward Deming’s 14 points states “Cease dependence on inspection to achieve quality.  Eliminate the need for inspection on a mass basis by building quality into the product in the first place.”  Phillip Crosby’s second absolute of quality says it differently: “The way to cause quality is through prevention not appraisal [inspection]”.

For a good example of what can happen when inspection is used as the only means of assuring quality read Austin, A L (2013) “Failure of Inspection The consequences of layering on quality checks” Quality Progress, January 2013.

In an audit I performed recently, the customer was inspecting welds using dye penetrant testing.  I issued a corrective action because no evidence that the tests had been performed was available.  The test reports didn’t include a place for the technician to indicate that the testing had been performed.  When inspection is performed assure that the results of inspection are recorded. 

Keep in mind that even 100% inspection is not 100% effective.  Inspectors make mistakes too.  Focus on mistake proofing production processes and designing quality into the product, not inspecting quality into the product.  Inspect when you must.  Select inspection points to occur just before high cost processes occur.  This assures that the product conforms to requirements before high cost is added to the product.  When you inspect assure that the results of inspection are recorded.

For more information go to www.rosehillsystems.com