An Overview Of Process Validation In AS9100

An Overview Of Process Validation In AS9100As you implement your Quality Management System using ISO requirements for AS9100, you may be confused about the difference between design validation and design verification. Correctly understanding validation may be complicated, so what it is and how does it work?

ISO 9001:2015 standard Clause 8.5.1 on control of production and service provision has this to say: “the validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement.”

This means you need to validate processes where you are unable to effectively check a product or service’s compliance to standards without damaging the part. If you are building something to a certain standard of damage resistance, it is impractical to test each part to the point of breaking to verify that it was built correctly. Therefore, you must validate the production process to ensure the appropriate steps and measures were taken in production.

Process validation must represent how a process is occurring. If you try to validate in a manner different than how the process will be completed, you could run one order and find the results satisfactory while increasing the process to several hundred per day may not actually perform as expected.

A simple way for validation is to set up your production process in the manner you will normally use it and start an expected run of the production process. Use regular operators, standard tooling and equipment, typical environmental conditions and normal gauges. Now that you’ve shown a process can proceed under standard conditions and doesn’t require any special requirements or attention, you are able to determine that the process will do what you need it to do.

Additionally, this will identify if special skills or training is needed for a step in the process. Once identified, you will be able to create the necessary procedures for ensuring proper training is given to the operators and highlight any necessary certifications that are needed.

Process validation may seem complex, but proper use of it will save your company time and money. As your processes become more reliable, you will experience less emergencies and downtime due to broken equipment, improper builds or missing parts.

While AS9100 Rev D does not implicitly require every process to validated, it may be something your organization chooses to implement. Typically process validation is used in scenarios where the monitoring or measuring is not feasible or practical.

Proper, detailed documentation is required for your process validation protocol. While not specifically defined under AS9100 Rev D, you should refer to documentation standards as listed under Clause 4.4.2. Identify what documented information is needed to support your process validation and operations then ensure that it is written down and communicated to appropriate parties. You also need to create documentation standards for your validation results, to ensure confidence that the appropriate steps are being followed. You may also consider including the appropriate competency requirements and records to show that all appropriate actions were taken.

Using proper process validation procedures will not only benefit your organization, it will also give your customers confidence in your product, limiting the number of products that leave in nonconformance.