Special Process validation Criteria Plan

Special Process validation Criteria Plan

What is Special Process?

Special Process is process which output of the process can not be definite.

What is Special Process Validation?

Special Process Validation is the method through ensure this process output fulfill application requirements 

Special Process validation Criteria Plan

Special Process that used as support of manufacturing process that special process need to validation for the ensure the output results positive, all the special processes required validation as per international standard requirements as same validated process is gives a surety to concern product quality as processes are validated.

For the better understanding, here  the examples of the process validation requirements and same will be formatted to command easier on process validation recording. As below you can see example & sample data for the one of the important process in steel industry are used for detect faults or leakage in steel materials, the sample data as are under:

Required Fields

A. Specification of Process

B. Process

C. Equipment

D. Personnel

Above all the necessary fields are used to confirm the validation process of special process, for the descriptions of the each validation fields are as below with sample data:

A. Specification of Process:

Eddy Current Testing ( ECT – ECT is the non destructive testing for the material for checking of critical or defects through pass from the machine, This testing is used in various steel industries, welders and fabricators, heat exchanger manufacturers, boiler manufacturers etc..)

B. Process:

Eddy current testing reference pieces shall be prepared as requirements of the standards materials are in used for testing and its specifications requirements, for examples of process is conduct as standardized instruments with reference standard pieces at least three times and second term being conduct 5 to 06 hours as confirm instrument standardization prior to turning the unit off at the end of the inspection cycle.

C. Equipment:

Instruments shall be calibrated at every year or as per defined by company or as per requirements given in instruments standards, calibration process should be conducted by ISO 17025 certified laboratory only, validation process requirement is concern standardization, in case of wrong measurement reflects equipment’s measurement.

D. Personnel

ECT Engineers should be qualified for ASNT / ISNT Level I or Level II in Eddy current testing level I / II Inspector for the non destructive inspection.

Format of Special Process validation Criteria Plan are available for the download, after download Edit, remove, add, and modify any fields as requirement of your company.

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