Special Process in ISO 9001

Special Process in Manufacturing Defined

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.

Most of these processes are necessary for completion. Although there’s no way to verify the product after this type of process without proving its function through use or completing a destructive test.

A special process in manufacturing is a process that puts some kind of stress on the product or part of the product due to mechanical, chemical, or thermal operations.

Thus making the product unable to be measured, monitored, or verified until its sale and use by the purchaser. This requires special attention in the electronic inspection process (IPTs).

Who completes a special process?

Special processes are often extensive and need specialized equipment and qualified personnel to complete them. Due to this, many special processes are unable to be completed in-house or are too complicated to waste time trying to do yourself. Subcontracting special processes save you time and money. Also, further training for operators and costly additions to your process is not needed.

a special process can be performed in house or subcontracted.

What are the different types?

A special process can be anything from painting the product to a section of difficult 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 a number of years without fading. Unfortunately, you are unable to confirm the exact time frame. Thus, you know the paint won’t fade for some time, but the 15-year guarantee cannot be known unless you actually wait. 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. Further, the use of a product will have an impact on its lifespan so there can be a prediction of how long it will last, but no concrete calculations to prove it.

ISO 9001 Special Process: 3 parts

  1. Special processes are those outputs that you cannot confirm or verify as functioning until their delivery.
  2. To confirm this type of process, you must prove the process’s ability to achieve the desired results.
  3. Companies must establish criteria and arrangements for how they will validate and approve the process. They can ask things like if the equipment is sufficient and if the operators are qualified. What records are kept from production and what procedures have been followed? The final question is when each process will be revalidated. 

Simplifying Quality Inspection.

Inspection Test Plans, eITPs