Ten Common Nonconformities in Quality Management System Audits

1. Design and Development

Customer special requirements were not identified or implemented
Special characteristics (including product and process) were not identified and controlled

DFMEA or PFMEA did not consider potential or occurred failures

Symbols for special characteristics were not identified in process documents

Lack of linkage between PFMEA and control plan

Unable to prove PFMEA and control plan are dynamic documents

Top management did not participate in stage reviews

Process capability was not evaluated for new processes

Incorrect scoring of "S", "O", and "D" in PFMEA

Some performance test conditions do not meet customer requirements

2. General Requirements for Quality Management System / Quality Manual

Processes in the quality management system were not identified

Sequence and interaction of processes were not specified in the quality manual

Performance indicators for identified processes were not specified

Process performance indicators were not monitored

Lack of linkage between process performance indicators and quality objectives

3. Management Review

Top management did not participate in management review

Processes within the organization were not identified

No process performance indicators were established or used as inputs for management review

Customer special requirements were not considered

Improvements to the system, products, and resources were not considered

Improvement measures were not monitored

Inputs did not cover the requirements of the standard

4. Purchasing / Product Approval Process

Special characteristics related to raw materials and parts were not communicated to suppliers

Requirements for supplier production approval process were not specified or implemented

Selected suppliers were not approved, or re-approval was not conducted after supplier changes such as relocation

Supplier quality system development was not conducted

Supplier delivery performance was not monitored, and extra freight was not monitored

Acceptance criteria for products were not agreed upon with suppliers

5. Control of Production and Service Provision

Operation preparation was not verified

Control methods specified in the control plan were inconsistent with those in the work instructions and were not implemented in actual production

Production planning was not order-driven and its completion was not monitored

Process parameters specified in work instructions were not monitored as required

Process capability monitoring for special characteristics indicated in process control documents was not conducted

Abnormal conditions in statistical control charts were not analyzed

Inspections of products during production processes did not meet product requirements

No measures were taken when production processes were unstable or process capability was insufficient

6. Identification and Traceability

Products stored within organizational processes were not identified

Inspection and test status were not included in identification

Traceability of produced products, especially safety-related, was not achievable

Time requirements were not identified during production cycles for products or raw materials with storage period requirements

Nonconforming or expired products were not identified in a timely manner

7. Control of Monitoring and Measuring Devices

Calibration records meeting requirements were not provided

Test software was not calibrated

Allowable criteria for monitoring and measuring equipment were not established based on product requirements

Calibration results could not be traced to international and national standards

No internal calibration records for internal calibration

Internal calibration specifications were not established, and standard instruments were not reflected in internal calibration records

Limit samples were not regularly verified

Measurement system analysis was not conducted for measurement systems specified in the control plan

External metrology organizations used were not accredited laboratories

8. Competence, Awareness, and Training

Job competency requirements were not determined

Training plans were not developed based on training needs

Personnel involved in product quality could not prove competence

Training plans did not consider all employees, including temporary and transferred employees

No methods were established to measure employee awareness

Employee safety and injury risks during production

9. Control of Nonconforming Products / Corrective / Preventive Actions

Nonconforming products were not isolated in a timely manner

Concession acceptance of nonconforming products was not approved by customers or internally

Priority reduction plans for nonconformities related to customer concerns or key organizational issues were not developed

Cause analysis was not conducted for corrective actions on nonconformities

Corrective actions were not feasible

Effectiveness of corrective actions was not verified

Causes of nonconformities and corrective actions were not fed back to FMEA, nor considered for similar products

Preventive and mistake-proofing methods were not considered

10. Continuous Improvement

Confusion with the concept of corrective actions

No analysis of the current situation, nor formulation of new objectives

No consideration of continuous improvement from the perspective of the organization's overall quality management system or manufacturing process