Collier & Associates

TYPICAL AUDIT ISSUES

• Lack of Management Support
  -Executive/top Management doesn't attend opening meeting
  -Lack of allocating resources
  -Negative attitude, forced into certification...
  
  
• Management Representative or QA Position & Authority is too low
  -Supervisor or Manager Position vs VP or Director
  -Where Quality or Mgmt Rep is located on organizational chart
  -Working for Production/Operations
  -No direct access to top management
  
  
• Documented system does not reflect actual operations
  
  
• Documented system is not consistently implemented
  
  
• Quality Policy does not contain/reference direct measureables/objectives
  
  
• Management Review(s) are ineffective
  -Quality Policy & Objectives are not reviewed
  -Suitability of the Quality System is not included in the Review
  -Meeting minutes utilized in lieu of conclusions
  -Inadequate inputs into the Review (does not represent data from all "silos")
  -Really an operations meeting not a Management Review
  
  
• Contracts not effectively reviewed
  
  
• Specification call outs are unavailable or not the latest revisions
  
  
• Capabilities are not reviewed at time of order/contract acceptance
  
  
• Shipping on-time percentage is low = ineffective contract review/weak system
  
  
• Contract requirements not met
  
  
• Design Plans without Design Reviews included or not "Phased" per actual process
  
  
• Design Project records incomplete
  
  
• Design Inputs don't meet outputs, are not tested or did not meet acceptance criteria
  
  
• No evidence of appropriate design review/changes as a result of a negative test
  
  
• Documents of External Origin not effectively controlled
  
  
• Wrong revisions of drawings, specs, etc. utilized on floor
  
  
• Not all types of documents/data are controlled
  
  
• Materials not adequately controlled (ID, status, storage, etc.)
  
  
• Process or Work Instructions/Specifications not met
  
  
• Lack of 3rd level process work instructions
  
  
• Receiving Inspection without PO availability
  
  
• Final Inspection (paperwork is incomplete, outside of spec limits, etc.) & not captured
  
  
• Product nonconformities not linked with the Corrective Action system
  
  
• Root causes not consistently identified on Corrective Action Requests
  
  
• Limited awareness of the Corrective Action System
  
  
• Corrective Actions follow ups are inconsistent
  
  
• Preventive Action not employed
  
  
• Improper handling & storage
  
  
• Record Indexing/storage not specified (per type of record)
  
  
• Internal Audit Programs are ineffective
  -All quality elements/areas not reviewed
  -All aspects of processes or areas not reviewed
  -Negative responses without issue write-ups
  -Inadequate tracking/follow up
  
  
• Training needs not effectively identified
  
  
• No evidence of a plant wide statistical needs analysis
  
  
• Statistical techniques utilized without a procedure
  

  ---

  Services Available | Internal Auditor Training Synopsis | Management Review Training | Internal Auditor Training
  "Cafeteria" Plan Option | Types of Quality System | Biography | Company Assessed/Audited |
  Companies Trained | Code of Conduct | Prospect Questions | Advanced Internal Auditor
  Pricing | Specials | Recommended Consulting Plan |
  | Home |