Quality Assurance Audit Checklist

Date:                                   

Quality Assurance Audit Manufacturing    Audit #:                                              
                                         
Area Audited:                            Type Audit:                                          

Sr. Auditor:                             Dept. Mgr.:                                           



Master Production Records                             Response and Comments
                                                                           
 1)  Is there a Master Control File for each product?
 2)  Are Master Records signed and dated?
 3)  Are revisions updated and filed?
 4)  Are assembly and manufacturing steps fully described in master
     and working files?
 5)  Is there current documentation designating QC points for in process
     manufacturing?
 6)  Instruction for in process training?
 7)  Acceptable measurement standards?
 8)  Are acceptance and rejection limits observed?
     a)  Sample part tested:                                             
 9)  Are safe techniques used in assembly
Material & Components Control     
 1)  Are purchasing qualifications based on written specifications 
     and approval of vendor sources?
 2)  Are receiving/inspection areas neat and orderly?
 3)  Are inspection/testing procedures adequate and utilized?
 4)  Are rejected products clearly identified, segregated and held
     in quarantine pending final disposal?

Production Area

 1)  Are workers organized and scheduled?
 2)  Are sufficient working areas provided for task?

  
 3)  Access available to drawings and schematics?
 4)  Are instructions sufficient?
 5)  Are components and parts in accordance to master file?
 6)  Any disorganization visually present?
     a)  Tools randomly scattered about?
     b)  Parts on benches disorganized?
     c)  Components or parts for other assemblies present?
 7)  Cleanliness of working areas?
 8)  Organization of parts areas?
 9)  Organization of staging areas?
10)  Organization of labeling?
Production Equipment
 1)  Properly Stored?
 2)  Calibration records current?
Production Records
 1)  Are production records collected and filed?
 2)  Are order pending and in process posted?
Packing
 1)  Are finished products segregated?
 2)  Are packing and shipping instructions organized?
 3)  Is shipping material room supervised?
     a)  Are shipping materials adequate?
     b)  Are shipping containers and materials stored neatly?
Customer Complaints
 1)  Are complaint files completed adequately and organized?
 2)  Is there a periodic review of complaint files for trends?

Inspector Signature:                                Date:                               
Production Manager:                                                              
Name of Other Inspectors: