Process Validation Services
Precision polymer optics are often a critical enabling component of an optical system. In addition to design for manufacturing (DFM), it is often important during design and development to understand and characterize how the component would behave in large-scale manufacturing, before sourcing large volumes. One way to reduce risk after transferring from development to production is to conduct a process validation.
Process validation is often practiced in medical device manufacturing and other controlled industries, where the typical sequential activities are referred to as IQ, OQ, and PQ (Installation Qualification, Operational Qualification, and Performance Qualification). It is a method of collecting and evaluating data, using statistical methods, to demonstrate control and capability of a manufacturing process. Evidence of sufficient controls can be established as follows:
- Installation Qualification (IQ) of manufacturing equipment
- First Article Inspection (FAI) to verify tooling
- Operational Qualification (OQ) of process variables
- Calibration and gage capability studies (Gage R&R) for measurement instruments and techniques
- Performance Qualification (PQ) of the manufacturing system as a whole
Depending on the nature of the component and process flow, some or all of the above activities may be conducted. Considerations for the validation strategy may include:
- Are there any supplier control procedures in place which require these activities?
- Which features on the component are critical?
- What level of risk is associated with the critical features? In other words, what are the consequences of being outside the design tolerance?
- How tight are the tolerances relative to the precision of the measurement methods?
- What are the expected batch sizes?
Some industries require process validation for manufacturing finished products when the output of the process isn’t 100% verified. Suppliers of custom components may or may not utilize validation; they may use other methods of qualifying a process. It is important to understand the supplier’s typical process development activities and decide whether their existing controls are sufficient to ensure delivery of quality components.
Process validations can be costly or may fail if not planned for appropriately. Since the supplier is the subject matter expert on their manufacturing processes, it is important to work closely with them to agree upon, rather than prescribe, any validation requirements. This will maximize the chance of a timely transfer to production.