प्रभावी प्रक्रिया योग्यता, सत्यापन और सत्यापन का संचालन
Before discussing the concept of process qualification and validation, it is good to note that adequately assuring quality merely by in-process and/or finished-product inspection or testing is practically unrealistic.
Adequate quality assurance is best ensured by designing or building quality into the product. This can be done through the concepts of process qualification, validation and verification.
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Qualification
Qualification refers to a documented process of assuring that a specific system or equipment are able to achieve an acceptable criteria already predetermined to confirm that such an equipment is fit for intended use. Qualification focuses on equipment, systems, facilities and other tangibles. During the stage of process qualification, the process design is confirmed as being capable of reproducible commercial manufacturing. Process qualification covers the following:
- Design of the facility and qualification of equipment
- Performance qualification
- Process performance qualification procedures.
To ensure the effectiveness of your process qualification, you need to determine if you
- Have enough confidence in your manufacturing process.
- Have scientific evidence that assures that your process is capable of consistently delivering quality product.
- Are able to demonstrate that the process performs as intended.
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Validation
And, validation is simply establishing documented evidence through collection and evaluation of data, from the process design stage throughout production with the goal of providing a high level of assurance that such a system, or process will consistently produce a product that meets a predetermined specifications and quality attributes.
Validation focuses of processes or procedures that results in a service rendered or a product or a tangible item produced. Before validating a process, you need to be sure that the equipment has passed qualification. In the context of process validation, high quality product indicates consistency in product performance from component-to-component, batch-to-batch and unit-to-unit.
Overall validation is an on-going process assuring that routine production process remains in a state of control assessed by collecting and monitoring information during commercialisation, and incorporating risk management, with a view of the fact that more knowledge will be gained during batch production. This process necessitates proper process understanding and comprehensive process design to understand sources of variability.
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Process Verification
Formerly called re-qualification or revalidation, it has the primary goal of this stage is to assure that the process remain in a commercial state of control during batch manufacture, through an on-going program of collecting and analysing product and process data. Information collected during this stage should be such that are able to verify that the critical quality attributes are being controlled throughout the process operation. As initially stated that validation is an on-going process, hence once established, the equipment status must be maintained through:
- Routine inspection
- Maintenance
- Calibration procedures
- Periodic data assessment to determine if there is need for re-qualification.
Continuous feedback about product performance is a key to ensuring of process verification for effectiveness. To ensure the effectiveness of your verification exercise, you need to determine
- If your process remains in control.
- The type of data being collected.
- How often the data are reviewed.
- How to react to trends in the data.
- Type of sample plan in use.
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About the Author
Adebayo is a thought leader in continuous process improvement and manufacturing excellence. He is a Certified Six Sigma Master Black Belt (CSSMBB) Professional and Management Systems Lead Auditor (ISO 9001, 45001, ISO 22000/FSSC 22000 etc.) with strong experience leading various continuous improvement initiatives in top manufacturing organizations.
You can reach him here.
