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What is the difference between validation, verification, revision & calibration?

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Question added by Abdelghany Abdelsalam , Plant Manager , Doctor Nutrition
Date Posted: 2014/08/27
Muhammad Saif ud-din Qureshi
by Muhammad Saif ud-din Qureshi , Freelance QHSE & other Management Systems Auditing, Compliance, Development, Training & Maintenance , Working as a Free Lancer

Following are the difference as per my limited knowledge, all of these processes can be called as monitoring processes, however  :

VALIDATION is a process, which is performed by the company on the processes, for which results can not be verified by subsequent monitoring processes by the company. To overcome, this short -coming in the process, the company sets criteria, by approving processes which are involved, approving Machines to be used, using qualified personnel and using internationally approved industry procedures. Two of the industries where validation is being used in many processes are Medicine Production, Essential Oil/Specialty Perfumes and Microbiology and Microchemistry, where use of ingredients is usually in PPM (Parts Per Million).

Verification can be either for the processes, documents or equipment (Internal Calibration), normally is done for activities, where results are evident after performing the monitoring activity, and based on results, either changes are made in process or process may be repeated or future processes can be changed, to rectify the problem. As oppose to Validation where actual results are not evident unless products used. Verification is an important part of the Quality Assurance and control activities. 

Revision in case of processes can be performed as a result of verification, hence may not be performed until required or otherwise a company if adopts a new technology, it can also cause revision in processes to refine the process and have better results in-turn of the same.

Calibration is an activity, which is performed to have confidence in the efficiency of the monitoring equipment being used by a company and give confidence to customer in the company's processes and products. The calibration is performed both internally and externally as required.

Shyam K Singh
by Shyam K Singh , Head - QA/QC , L&T

             Verification

             Validation

1. Verification is a static practice of verifying documents, design, code and program.

1. Validation is a dynamic mechanism of validating and testing the actual product.

2. It does not involve executing the code.

2. It always involves executing the code.

3. It is human based checking of documents and files.

3. It is computer based execution of program.

6. It can catch errors that validation cannot catch. It is low level exercise.

6. It can catch errors that verification cannot catch. It is High Level Exercise.

9. It generally comes first-done before validation.

9. It generally follows afterverification.

·         Calibration provides corrections required to make the logger accurate. Calibration is a comparison with a standard or reference resulting in determined corrections and uncertainties [pretty much a characterization of the instrument] and the results of the calibration may or may not be used to adjust the instrument.

 

·         Review is a tool of verification

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