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Mitigating Customer Risk With Process Validation

Navigating an increasing best practice for quality management service.

About 25 years ago, customers’ requirements for parts included wanting a good part, on time and at fair price.

But in today’s world, that just isn’t good enough anymore.

Increasingly, more companies are taking a risk-based approach to running their business — wanting to ensure a part process is in control, what the yields are and if the part will act the same way if different or other components are switched out of a system.

More and more, this type of risk mitigation as part of quality management services is taking the form of process validation, a method of best practice that has become critical in the delivery of quality parts.

Process validation is a collection and evaluation of data from the process design stage through the production stage, which provides evidence that a process is capable of consistently delivering quality parts.

For Fiberoptics Technology, this process validation includes how the company draws the fiber to the correct size, the assembly for specific products, how rod and tapers are drawn, how laser engraving is accomplished and many more validations depending on the parts.

This is important because internally Fiberoptics knows that its process yields good results every time — otherwise it is a waste of time, resources, material and human effort. If the company finds that the process is producing large amounts of scrap and waste, then the process is not validated for producing a good part every time.

Externally, this is important because companies see that Fiberoptics evaluates risk to reduce the risk they take in trusting the company to produce a quality product.

By providing further proof of the process and further risk mitigation that the parts are validated, this reduces the risk of making a bad part. And in the aerospace, medical and military markets, risk management and process validation are of paramount importance.

In fact, process validation is quickly becoming a standard in numerous industries including aerospace, military and medical even though regulatory requirements per standards don’t require it to a certain extent.

As recently as two years ago, Fiberoptics rarely heard the phrase process validation in any of its audits from medical and military customers. However, nowadays every audit has questions regarding the company’s process validation.

As a result, Fiberoptics Technology has taken this growing intensity for process validation and applied it to its best practices in order to ensure quality parts to customers and mitigate any risk concerns.

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