ISO 9001:2015 Insight: Process Validation

For certain processes, monitoring and measurement cannot be used to verify that the resulting output meets the input requirements. Any defects in the output will only become apparent after the product or service is in use. Consider the process for welding – it’s not feasible to test the strength of every weld as this requires destructive testing of every product. Therefore, any defects or weaknesses in the weld will only become evident after the product has been in use by the customer. When the output of a process cannot be verified, ISO 9001:2015 Clause 8.5.1, requires the process to be validated – validation is used to demonstrate the ability of a process to achieve its planned results.

Examples of processes that typically require validation can include:

• Welding
• Painting
• Sterilization
• Heat treatment
• Aseptic filling
• Soldering
• Sealing / Glueing
• Protective coating
• Software for performing calculations

To validate a process, a number of trials must be run with measurements throughout to confirm that the key process parameters can be met and that the final outputs meet the input requirements. Key process parameters can include: flow rates, humidity, time, temperature, pressure and cleanliness. Dependent on the nature of the outputs, destructive testing may also be required to confirm that the specified requirements are met.

When validating a process, it’s important that it is set up and operated in the manner that it will normally run: operators, work flow, materials, equipment, facility, environmental conditions, process parameters etc. This will allow the organization to determine if there are any specific competence requirements, equipment requirements, procedures or process parameters needed to operate the process effectively and efficiently.

The organization must retain records of all process validations. Records may be related to: determination of key process parameters, risk assessments, supplier qualification, equipment calibration and maintenance, competency of personnel, environmental conditions and process results.

Re-validation of the process will be required under the following conditions:

• Changes to requirements for products and services
• Changes in workflow
• Changes in key process parameters
• Changes in materials
• Changes to equipment