7.5.2 Validation of processes

• Free PDCA Guidance
• PLAN your quality system
• DO day-to-day tasks
• CHECK the results
• ACT to improve

• ISO 9000:2005 Principles
• Process approach
• Leadership and people
• Customer focus

• ISO 9001:2008 Base Clauses
• 4.1a - 4.1d Process planning
• 5.1 Management commitment
• 5.3 Quality policy
• 5.2 Customer focus

• ISO 9001:2008 Requirements
• 7.5 Documented Information
• 7.1 Process planning
• 6 Resource management
• 5.3
• 6.2 Human resources
• 8.2 Determination Of Requirements For Products And Services
• Customer satisfaction

Process validation demonstrates the ability of the processes to achieve planned results.

• Define what controls are required (e.g. time, temperature, pressure)
• Define the level of training and competence required
• Approve equipment
• Use detailed work instructions
• Periodically re-validating the process

Validate production and services by:

• Proving that special processes have achieved planned outputs
• Proving that process owners are capable of achieving planned results
• Proving that process equipment is capable of achieving planned results
• Maintaining records

Your organization should define arrangements for validation that include the following:

• Qualification of processes
• Qualification of equipment and personnel
• Use of defined methodologies and procedures
• Requirements for records
• Revalidation

Should I document our production and service validation process?

It is not a mandatory requirement to document your service and production validation processes. However, you should always look to adequately define and control any operational processes that directly impact upon product quality. Therefore, the implementation of a service and production validation procedure will be appropriate to most businesses where such activities are undertaken.

How's best to document the process?

Develop and implement a procedure that defines:

• The criteria for review and approval of processes
• The level of approval for appropriate equipment
• The level of competence required for staff to validate the process
• Any particular methods and procedures that may be required

Looking for help documenting your process?

We provide a Process Validation Procedure template to help you manage this process in many of our ISO Templates.

Measuring production and service validation effectiveness

The effectiveness of the production and service validation may be evaluated by reviewing all elements of process and by looking for evidence that all activities are planned and conducted under controlled conditions.