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.

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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.

Quality documents like inspection instructions, inspection tools, applicable test procedure.

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