Example of documentation template for Process of Validation of Process

The following document templates (tool kits) are provided totally complimentary, free of charge to use as a starting point for Process of Validation of Process in IATF. As each business is different, additional documents or revisions would be required to meet your organization’s specific needs, requirements, context, risk profile, etc. ​​If after reading through all of these documents, you feel like you still need a consulting partner to help you develop your new documents – Contact Us. We’re always looking for interesting new clients and projects.

1.0 Process Approach of Process of Validation of Process.

2.0 Turtle Diagram of of Process of Validation of Process.

3.0 Annual Plan for Process Validation

  Company Name          YEAR
S.No.Process NameDept.Planned vs. ActualApr-10May-10Jun-10Jul-10Aug-10Sep-10Oct-10Nov-10#####Jan-11Feb-11Mar-11
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Approved BY :
 

4.0 MANUFACTURING PROCESS VALIDATION /REVALIDATION /CRITERIA

    Validation/Revalidation Criteria 
  S. No.  Process Name    Dept. NameName of Instrument (If Any)  New Equipment  in Use / Major Maintenance Carried out in the existing Equipment  Modifications in Tooling / Major Maintenance Carried out      Process Parameters Changed        New Operator      Change in Process Method      Frequency for Normal RevalidationPlan for Validation/R evalidation Schedule
           
           
           
           
           
           
           
           
           
           

5.0 Process Validation Report

Part No:Part
Name
 Machine No.Date:
Current Parameter Target:
  Process Name  No. Of Trials  Parameter to be ValidateProcess Parameters to be kept mean valuesTrial Observations 
  A  B  C  E  FVisualProductivity (Qty. in 8 hrs)Dimensional  Remarks
        SpecifiedObservationSpecifiedObservationSpecifiedObservationGood/Not Good
               
               
               
               
               
               
               
               
               
               
               
               
               
               
               
  Result 
    Team Members  :            Name                                                             Signature   Validated by:                                                                                                                                                                                                                                                                                                                                         Approved by:

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