Confusion remains there in the process validation when a company takes initiatives regarding the implementation of the ISO 9001 Quality Management System. Many businesses aren’t able to understand the difference between design validation and design verification, and both remain complicated for organizations, especially small and medium-sized.
What is validation? How does it work? These are a few questions that you must get answers to. Validation is something that can help you make sure that your work processes are working exactly as you intend to. In simple words, process validation is all about controlling a process while performing multiple necessary tests that can ensure that the process is being performed exactly it is designed to be.
The Clause 8.5.1 of ISO 9001:2015 standard states,
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.
It shows that any process should be validated in case you aren’t able to perform checking of a product or service whether it is complying with your input requirements or not. For example, you can’t check the strength of every weld in a welding or soldering process between your regular production until or unless you damage or destroy any parts.
It’s true that not every process is supposed to go through validation as per the requirements of ISO 9001:2015 standard. However, you can still choose to validate your work process to reduce costly or complex inspection of your product or service.
How to Validate a Process?
The best way is to hire a professional individual or company to do the job for you. If your business is in Dubai, you can easily find ISO 9001 consultants in Dubai online to perform the best process validation for you.
How actually is it performed? Well, the best way to validate a process is by simply performing it. First, you must go through a trial to ensure if the process parameters are being met. After that, you can go through a full check on your products or services to confirm that the process is being performed exactly as per the requirements.
There come many businesses where you can’t ensure validation without breaking or destroying parts. The best example is of welding-related work where you have to cut something apart to ensure welding is done correctly.
You can also use process validation to bring lots of improvements in your business. Validation, sometimes, becomes complex but it does give multiple benefits to your process. It makes your process more reliable, safe, error-free, and cost-effective. Moreover, it gives soothing feelings to a businessman when he finds that his work process is performing well.
Process validation can also make the audit process and reduction of nonconforming products better than ever for your business. Most importantly, it can help you bring consistency in your process and maintain a perfect environment of continual improvement within your organization!