The statement, “no job is complete without the proper documentation” holds true for many industries, as well as the organization overseeing them. The higher the operational standards, the more critical it is to document that procedures have been performed to meet or exceed those standards.
Most bio-pharma, food and beverage, cosmetics, and medical device manufacturers companies work closely with the FDA and USDA to develop procedures that ensure compliance with Current Good Manufacturing Practice (CGMP) regulations. When these procedures become a part of manufacturing practice, each step must be recorded and approved in real-time. If a facility is unable to “show its work” in a particular process, it’s very likely that the process will need to be performed again. This obviously costs time and money.
Consider this hypothetical example, where insufficient process documentation can lead to lost production time and reduced profits.
‘Henry receives a phone call from a customer who needs some parts electropolished. Unsure what electropolihing is, he looks online and finds a service provider that specializes in electropolishing. He receives a reasonable quote and sends out the parts to be processed. While waiting for the job to be completed, Henry researches electropolishing and develops certain expectations of what he can expect when his parts return. The parts are completed and returned on time. Henry inspects them and is pleased with results. He sends them on to his customer and, within a few days, receives an unexpected phone call in return. Unfortunately, his customer is not very happy and requests documentation detailing how these parts were processed. Henry is at a bit of a loss. He doesn’t have what his customer is asking for. He soon learns that without proper certification, the parts can’t be used and the process must be performed over again.’
Don’t be like Henry.
Quality documentation is too-often overlooked and missing, incomplete, inaccurate, or poorly-detailed certifications can lead to delays in product shipment or worse, products that must be reprocessed in order to fulfill a customer’s requirements.
The most reliable way to prevent such an unfortunate occurrence is to always request a sample of the certification provided for any requested process. A quality certification should be included with all processed parts with the following details:
|description of component(s)|
|identification of the electropolishing procedure used|
|final surface finish report (Ra if required by the owner/user)|
|description of system or component(s)|
|service provider’s company name|
|qualified passivation method used|
|documentation of passivation process, as follows:
(1) written qualified procedure
(2) documentation of process control of essential variables
(3) instrument calibration records
(4) certificates of analysis of all chemicals used
(5) process testing and verification
|postpassivation verification method(s) used|
|for material manufacturers/suppliers of components whose surfaces have been electropolished and/or passivated, a Certificate of Compliance for Passivation and/or Electropolishing stating that standard industry practices, such as ASTM A967 or ASTM B912, as applicable, have been used. If required to demonstrate the effectiveness of their procedure by a method mutually agreed upon.|
When the metal finishing services you trust meet ASME BPE standards, you can be confident that they implement best practices to increase the safety and reliability of your parts.
By choosing an electropolisher that meets or exceeds these standards, you can increase your parts’ safety, reliability and service life. Allegheny Surface Technology has experience providing metal finishing services for a variety of bioprocessing industries, and always adheres to ASME BPE specifications.
Allegheny Surface Technology is your trusted provider of high-performance, ASTM and BPE compliant electropolishing, pickling, mechanical polishing, and passivation services. Specializing in both in-house and on-site stainless steel surface refinishing/refurbishment services, AST assures both the quality and reliability of our services through multi-step Quality Assurance and inspection protocols.