Audit Checklist and Guidelines | Audit Rating System

Professional auditors should preferably be knowledgeable in the following fields through one-on-one training, classroom training, videotapes, and reading.

Table of Contents

1. Product itselfProduct characteristicsProduct/process flowProcess documents and recordsIdentification and control of material, parts components.Products handling procedure and limitationsTest Control.Operating environmentFeedback system Record-keeping requirements.Corrective action.Personnel interface.
2. Checklist For Audits
   1. Audit Type .......
   2. 1. Equipment/tester/tools control  
   3. 2. Operator
   4. 3. Documentation 
   5. 4. Parts / Assembly
   6. 5. Process control status
   7. 6. Environment
   8. 7. Calibration/standards audits
   9. 8. Chemicals/materials control
   10. 9. Software system
   11. 10. Quality assurance self-audits
   12. 11. Production control crib
   13. 12. Rework
   14. 13. System audit
   15. 14. Audit
3. Audit Rating System

• Product itself

• Product characteristics

• Product/process flow

• Process documents and records

• Identification and control of material, parts components.

• Products handling procedure and limitations

• Test Control.

• Operating environment

• Feedback system 

• Record-keeping requirements.

• Corrective action.

• Personnel interface.

Checklist For Audits

Audit Type .......

1. Equipment/tester/tools control  

• Calibration control/schedule.
• Monitoring activity.
• Certification status.
• Maintenance status.
• Data integrity/verification.
• Standards check.
• Availability of tools.
• Startup/shutdown.
• Correlation verification.

2. Operator

• Qualification status.
• Compliance with the procedure.
• Output (quality) verification/operator capability.
• Data recording verification.
• Rework verification.
• Observation for conformance to procedures.
• Product handling.
• Workmanship.

3. Documentation 

• Line documents ( availability, readability, accessibility, document content, level).
• Document adherence.
• Quality documents like inspection instructions, inspection tools, and applicable test procedures.
• Routing/flow chart/traveler.
• Maintenance documents.
• Training documents.
• Experimental procedure.
• Records/log books.
• Off-specs.

4. Parts / Assembly

• Conformance to spec.
• EC level.
• Handling/packaging/storage/shipping.
• Data availability.
• Scrap/manufacturing engineering hold / material review board parts (non-conforming part).
• Traceability.
• In-process product.
• Finished product.
• Non-conforming product control and disposition.

5. Process control status

• Process control instructions/actions.
• Control Chart status.
• Check corrective actions.
• Verify manufacturing data.

6. Environment

• Cleanliness of the work area.
• Particle count verification.
• Humidity recording.
• Temperature recording.
• General housekeeping.

7. Calibration/standards audits

• Calibration evidence.
• Overdue for calibration. 
• Monitor standards.

8. Chemicals/materials control

• Shelf life labeling.
• Receiving inspection status.
• Handling/storage.
• Shelf life.
• Non-conforming chemicals/materials control and disposition.
• Relationship to work instructions, Manufacturing Engineering, and Material review board.

9. Software system

• Software control.
• Data integrity/verification.

10. Quality assurance self-audits

• Inspection data verification. 
• Housekeeping.
• Inspector training/qualification.

11. Production control crib

• Finished product control. 
• Storage/handling.
• Receiving inspection status.
• EC level.

12. Rework

• Procedures.
• Product Quality. 
• Product disposition. 

13. System audit

• General Administration.
• Product development. 
• Product Qualification.
• Functional testing.
• Field Performance.
• Personnel training.

14. Audit

• Material review board.

Audit Rating System

The audit rating system is designed to bring consistency to the evaluation of audit results across the business units. The operation of a rating system is as follows:

1. Each discrepancy will be classified as either major or minor. 

Major:- A deviation from a specification or from procedural requirements, which may cause major product malfunction or yield loss at higher level assembly, for example, components not meeting test criteria. 

Minor:- A deviation that could create some unwanted variability in the product or process or which presents a slight risk, for example, an unqualified operator working on a product or documents that have not been updated

2. All audit discrepancies will be scored in the following manner: 

Major: 04 Point

Minor: 01 Point  

Recurrence of major deviation: 8 Point

Recurrence of minor deviation (from last audit): 2 Points. Consecutive 3 items recurrence of minor deviation becomes major: 4 Point.

3. The overall audit rating is obtained by adding the points for observed discrepancies, dividing by the total number of audits, and subtracting from 100.

Rating = 100 - Total point ∕ Total number of audits

4. All major discrepancies require immediate corrective action with a written response.

5. Overall audit ratings are established for percentage(%) Range: 95 to 100% Excellent. 90 to 95% Satisfactory. Below 90% unsatisfactory, requiring immediate attention and corrective action response.                              

Types of inspection in quality control