When Your Supplier Substitutes Cleanroom Products: Actions to Take

What if my cleanroom consumable supplier substitutes products?

Substitutions were commonplace during the early 2020s due to supply disruptions caused by the COVID-19 pandemic. While product names, descriptions, and part numbers might not have changed, there is a high likelihood that packaging, country of origin, and product material/formulations did change without approval.

[Part 3 - Business Continuity:  Secondary Manufacturer/Qualification Series]

A transparent cleanroom products manufacturer would provide advanced notice of any material changes before the product arrives at your facility. In the chaos of global supply chain disruptions, notification did not always occur and end-users received noncompliant products that failed to meet previous standards.

Do I need to qualify for the substituted product?

Yes. You should assess and complete the due diligence to requalify the product after any changes, whether the manufacturer published the changes or not. This includes testing the new product to see if it meets your original specifications and requesting the documentation needed to keep your process and controlled environment compliant with your standards and government regulations (if applicable).

What actions should I take?

Dig into the details. Do not accept substitution without prior notice, approval, and documentation.

Quarantine the new product received.  

If the first notification of substitution is the inventory arriving at your facility with different product information than previously approved, quarantine the new product.

• • • Inspect packaging.
      • Is it compliant with cleanroom standards?

What changed?  

• • • Is it a different country of origin? A change in the country of origin may also signal that the manufacturing process has changed. If the manufacturer has traceability of raw materials and robust quality control, they can supply you with supporting documentation about the changes.  
    • Is it a different product number? Ask for an explanation and documentation to demonstrate equivalency to the prior product. Does the new product meet your requirements for cleanliness and performance?
    • Is there full traceability of materials through the supply chain? How long have they been manufacturing the product? Can they provide lot-to-lot test data on the performance attributes to verify the product is within acceptable upper and lower limits on published specifications?

Check your contract or purchasing agreement for requirements around substitutions.  

Are they in violation of the agreement by substituting the product?

What is their obligation to you?

If you do not have a clause to address substitutions in your purchasing agreements, this could be an opportunity to reevaluate.

Test the product.

• • • Use a standardized testing methodology, specific to the product being tested, which is repeatable and based on IEST recommended practices, or choose an independent lab to conduct testing.
    • If it is a glove or garment, once you are satisfied the product meets your specification for cleanliness, you can run a trial with your operators.
      • Does the glove still provide the same comfort as the prior glove?
      • Is it compatible with your process?
      • Is the substituted garment comfortable for your operators to wear?

Get buy-in from your operators on any new product.

Reach out to your secondary supplier.

These qualification steps take time to execute. If the product substitution arrives at your controlled environment without prior notification, it could jeopardize your operation. Relying on a secondary supplier can help, assuming you have one prequalified. While you requalify the manufacturer, a secondary supplier can help you maintain business continuity. In our series on qualifying a secondary supplier, we discuss the reasons for having a deeper bench of suppliers and why single sourcing is no longer a viable strategy.  

If you are requalifying your cleanroom products supplier, put Valutek on your list as a potential new supplier. Our helpful customer service team can help answer questions, and provide Certificates of Compliance and Certificates of Analysis to demonstrate compliance to our published product specifications.

Explore More Resources:

Cleanroom Glove Selection Fundamentals Series

Cleanroom Wiper Selection Fundamentals Series