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Product quality should be monitored and analyzed to detect any tendencies toward error before the error becomes sign cant. Product failures come from either process or design issues. A consistent process will generate consistent failures if the design is flawed. A perfect design will generate random failures if the process is inconsistent. Therefore both areas must be addressed.

Design Flaws
When analyzing product failure data, systematic failures of one component or subassembly can be either design or process flaws. It typically takes only a brief investigation to target the failure as design or process based. The quality manager should summarize failures and present conclusions to executive management at the route management meetings. Design failures should be assigned to personnel who are qualified to make design changes.

Process Flaws
Process flaws may be random (due to human or equipment failures) or they may be systematic (due to a consistent but flawed process). Any investigation should begin with reviewing the standard operating procedure (SOP) with the operator to determine if the procedure is being followed. My experience is that at during an investigation, the operator will (now) have feedback about any possible issues with the procedures. Process problems can usually be resolved by developing a better setup or more detailed SOP.

Regardless of the cause of the failures, it is critical that an engineering change order be initiated and closed as quickly as possible to eliminate any more failures from. Really high-quality companies will put a "stop ship" order in place until the problem is solved.