A special process in manufacturing according to the ISO 9001 standards is defined as any process that could change a part’s material elements or physical integrity. Many of these processes are necessary to complete the final product. Further, there is no way to verify the quality of the product after a special process has been applied without completing a destructive test.
A special process in manufacturing is a process that puts stress on the product or part of the product due to mechanical, chemical, or thermal operations. Most common special processes include welding, plating, painting, and heat treating.
What are the different types?
A special process can be anything from painting the product or welding to complete the product. Take painting a product, the paint is supposed to not fade for 15 years, and you do have a test to confirm that it will last for this period of time without fading. Unfortunately, you are unable to confirm the exact time frame. Similarly for a weld, the product you are selling has a 5-year guarantee that it will hold strong. Although the weld can be checked, there is no way to confirm that it will hold that long.
ISO 9001 Special Process and Validation:
- Special processes are those outputs that you cannot confirm or verify as functioning until their delivery.
- To confirm this type of process, you must prove the processes’ ability to achieve the desired results.
- Companies must establish criteria and arrangements for how they will validate and approve the process.
Common method for validating the process:
- A known good part is put through the special process
- A qualified operator performs the process
- A process work instruction is used to perform the process
- The equipment used has been maintained or calibrated
- To your best ability, the product quality is verified upon completion of the operation.
- A quality record is maintained with the contents of the above criteria
TQS Inc. is a consulting firm that has assisted clients over the past 30 years to implement quality, safety and environmental systems that comply with the ISO requirements. If you need help, contact Vincent Zottola at (412) 968-9101 or check out our website at tqsservices.com.