Exploring the Necessity of Requalifying Cleanroom Product Manufacturer

How often should you audit and requalify your current cleanroom consumable provider?

The frequency with which you should requalify your cleanroom consumable manufacturer depends on different factors. Cleanroom gloves, wipers, apparel, and other consumables are critical to reducing contamination and keeping your process compliant with standards and product specifications.

[Part 2 - Business Continuity:  Secondary Manufacturer/Qualification Series]

Depending on your application, you might need to requalify these products more frequently than others for compliance and consistency. Qualification of cleanroom products and the manufacturers that make the products should not be a one-and-done activity. All manufacturers make changes to product formulations as materials, technologies, and processes used in manufacturing evolve.

Does the current vendor meet quality and performance requirements?

Routine testing of products is the only way you can be sure the quality and performance characteristics of the product meet your requirement. A lack of consistency in product quality should trigger a requalification process. Investigate any quality issues before a regularly scheduled requalification process. Ask the manufacturer to provide their documented quality control procedures.

Can they trace the raw materials through the supply chain and manufacturing process?

Do they have transparent, documented preventative and corrective action reporting?

How fast do they respond when there is a potential quality concern?

Has there been product formulation, material, or manufacturing process changes?

You should always require your manufacturer to provide advanced notification of material changes. If product changes have occurred, hold incoming products for requalification and testing before use. Unapproved product substitutions and part number changes need to be investigated and could trigger an automatic requalification depending on the reason for the substitution and when you received the notification. Investigate product substitutions that arrive at your facility without notice before bringing the product into your controlled environment.

Meet annually or semi-annually with the manufacturer.

It is essential to work closely with your cleanroom consumable manufacturer to establish an appropriate schedule for product requalification based on any required changes. Conduct site visits and regularly meet with the manufacturer to review product performance and usage and forecast updates. Any reputable manufacturer will offer site visits and welcome the opportunity to highlight the quality of their products and processes.

Since 1988, Valutek has evolved into the trusted brand it is today because of our emphasis on customer service, industry experience, technical know-how, and accountability. Read about five reasons why customers trust Valutek to supply products that are mission-critical. 

Explore More Resources:

Cleanroom Glove Selection Fundamentals Series

Cleanroom Wiper Selection Fundamentals Series