Common Nonconformities in Quality System Audits

1. Quality Management System

1. Quality Manual

 

(1) The documents and manual requirements executed by various departments are inconsistent.

(2) The quality manual does not include or reference the procedures for document formation.

(3) The tailoring of the standard is unreasonable.

(4) The quality manual is not issued by the top management.

(5) The quality manual cannot fully reflect the nature and characteristics of the organization.

(6) The control and operation methods specified in the procedure documents are inconsistent with current practices.

(7) The procedure documents are not coordinated and consistent with the quality manual.

(8) The release, modification, and management of the quality manual are chaotic and cannot ensure that the latest valid version is used on site.

 

2. Document Control

 

(1) The procedure does not cover the control of obsolete documents.

(2) External documents and outsourced documents are not included in the control scope.

(3) Electronic media and other forms of documents are uncontrolled.

(4) Released documents have no approver.

(5) The revision status of documents cannot be identified.

(6) Obsolete documents kept are not marked.

(7) External documents have not undergone identification procedures.

(8) Documents are not reviewed regularly.

(9) The distribution of documents is uncontrolled, with random copying.

(10) Poor storage, unable to quickly present documents.

(11) Document change records are missing or inappropriate.

(12) Documents are copied or altered by unauthorized personnel.

(13) The documents used on site are not valid versions, or valid and obsolete versions coexist.

 

3. Record Control

 

(1) Supplier quality records are not included in the control scope.

(2) Control methods for quality records in electronic media form are not specified.

(3) The storage environment for quality records does not meet requirements.

(4) Methods for identification, storage, protection, retention period, and disposal of quality records are not specified.

(5) Quality records are incomplete, and there is no signature of the recorder on the quality records.

 

2. Management Responsibility

 

1. Management Commitment

 

(1) Top management does not know what evidence should be provided for management commitment.

(2) Organization members have different understandings of the quality policy and quality objectives.

(3) Insufficient resource allocation, poor quality of inspectors, internal auditors untrained.

 

2. Customer Focus

 

Unable to provide documents proving that customer requirements have been determined.

 

3. Quality Policy

 

(1) The quality policy is hollow, does not reflect the company's characteristics, and the relationship with quality objectives is unclear.

(2) Subordinate personnel are unclear about the quality policy.

(3) Unable to provide evidence of review of the quality policy.

(4) Some departments have also formulated quality policies.

 

4. Quality Objectives

 

(1) The content of quality objectives is incomplete and does not include the content required by product requirements.

(2) Quality objectives are inconsistent with the framework given by the quality policy.

(3) Quality objectives are not measurable.

(4) Evidence of achievement of quality objectives cannot be provided.

 

5. Quality Management System Planning

 

(1) The allowed tailoring in the quality management system is not explained in detail.

(2) The integrity of the quality management system is not maintained during changes.

 

6. Responsibilities and Authorities

 

(1) Interface relationships between personnel are unclear, and blame-shifting often occurs when specific problems arise.

(2) It is unclear who decides or handles certain matters (e.g., how to deal with nonconforming products).

(3) The organizational chart cannot clearly reflect mutual relationships, hierarchical relationships, etc.

 

7. Management Representative

 

(1) The responsibilities of the management representative are not clearly defined in document form.

(2) The responsibilities of the management representative are incomplete.

 

8. Internal Communication

 

(1) The purpose of communication is unclear.

(2) The communication tools are unclear.

 

9. Management Review

 

(1) Management review records are not kept.

(2) The content of management review does not meet requirements.

(3) Management review is not conducted by top management.

 

3. Resource Management

 

1. Provision of Resources

 

(1) The way resources are provided is unclear.

(2) Resource allocation is insufficient.

 

2. Human Resources

 

(1) Competency requirements are not determined.

(2) Records of education, training, skills, and experience are not kept.

(3) No assessment is conducted after training.

(4) No training on quality awareness was conducted.

(5) Inspectors, internal auditors, and metrology personnel have not obtained training qualifications.

(6) Using academic qualifications instead of work permits.

(7) Using training to replace work qualification recognition.

 

3. Infrastructure

 

(1) Facilities and equipment are insufficient.

(2) Equipment maintenance records are not kept as required.

 

4. Work Environment

 

(1) The work environment does not meet regulations.

 

4. Product Realization

 

1. Planning of Product Realization

 

(1) No quality plan was prepared for specific new products, projects, processes, and contracts.

(2) When establishing and implementing quality plans, the allocation of necessary personnel and resources was neglected.

 

2. Customer-Related Processes

 

(1) Product requirements are unclear and not documented.

(2) Product requirements are not specified, and there is a deviation in understanding the content of product requirement reviews.

(3) Contracts are not checked based on the tender documents.

(4) The results of reviews and follow-up measures are not recorded or are recorded ambiguously.

(5) Verbal or sporadic customer requirements (expressed as verbal orders or contracts) are not reviewed.

(6) At delivery, it was found that the organization lacked the capability to fulfill the contract.

(7) When product requirements change, relevant personnel are not notified in time.

(8) Communication with customers during contract and order processing is insufficient.

(9) There are no records of handling customer complaints.

 

3. Design and Development

 

(1) Interfaces between different groups involved in design (between design departments and between design and other departments) are not specified.

(2) Design inputs are not documented or reviewed. Applicable laws and regulations are not included in the design inputs.

(3) No design and development plan (result of planning) is prepared, and the plan is not updated timely with design progress.

(4) Responsibilities of personnel and phase divisions for each design are unclear.

(5) Design output documents are incomplete, do not meet input requirements, do not include or reference product acceptance criteria, and important product characteristics are not specified.

(6) Design output documents are not approved before release.

(7) Design is not reviewed/verified/validated, or production proceeds despite failed reviews.

(8) Follow-up measures after review, verification, and validation are not recorded.

(9) Design changes are not identified and not documented.

(10) Change approval personnel lack authorization basis.

 

4. Procurement

 

(1) Evaluation results of suppliers, especially follow-up measures, are not recorded. Suppliers on purchase orders are unapproved.

(2) Procurement documents and purchase orders are not approved before issuance.

(3) Customer-designated suppliers are neither reviewed nor verified by the organization.

(4) There are no criteria for selecting and evaluating suppliers.

(5) Procurement documents do not clearly specify the requirements for ordered products (such as quality and acceptance requirements).

(6) No corrective actions and follow-up verifications are taken for poor-quality suppliers.

(7) Approved suppliers are not re-evaluated within the specified time.

(8) There are no management regulations for modifications to purchase orders.

(9) Verification methods for purchased products are unclear or, although clear, are not implemented.

(10) When the organization or customer performs verification at the supplier's site, the procurement documents do not specify arrangements for verification and product release methods.

(11) No review or control activities are conducted for service suppliers (such as metrology instrument calibration suppliers, entrusted inspection agencies, transportation companies, etc.).

 

5. Control of Production and Service Provision

 

(1) Information for controlling production and service processes is incomplete; work instructions are lacking or insufficiently detailed and accurate, affecting product quality.

(2) Operators do not follow work instructions.

(3) Equipment is not properly maintained.

(4) The work environment is not effectively controlled.

(5) No monitoring measures for special processes, key processes, and quality control points.

(6) Operators are untrained or training records are missing.

(7) Production processes lack planned control (such as daily control of inputs, work-in-progress, and outputs).

(8) Obsolete drawings, specifications, etc., are still in use.

(9) Received raw materials lack specified identification or inspection status.

(10) Conditions for product release are not specified.

(11) Incorrect model products are found.

(12) Trucking or shipping companies are not reviewed.

(13) No corrective actions are taken for cargo loss during transportation.

(14) Goods are not properly identified, and accompanying documents are incomplete.

(15) No management measures for post-delivery (after-sales service) are specified, or specified but not implemented or ineffective.

(16) Contractual after-sales services are not performed or no records exist after execution.

 

6. Confirmation of Production and Service Provision Process

 

(1) Special processes were not confirmed.

(2) The confirmed processes and methods were not specified.

(3) Necessary reconfirmation was not conducted after process changes.

 

7. Identification and Traceability

 

(1) Products in production lack appropriate identification proving their identity (process cards, traveler sheets, route cards, etc.). Similar items are difficult to distinguish.

(2) In traceability situations, product identification is not unique and cannot be traced.

(3) Breaks occur in traceability implementation, making traceability impossible.

(4) The product identification system is either too simple or too complicated, failing to identify products in an "appropriate manner" and lacking operability.

(5) Product identification disappears during use and is not re-applied as required.

(6) When products are divided or repackaged, the marks are not transferred to each part as required.

(7) When products have expiration limits, no expiration date identification is made on the products.

(8) Packaging identification does not meet requirements.

(9) Nonconforming products are not marked.

(10) Identification disappearance and alteration occur frequently.

(11) When inspection status changes, its identification does not change.

(12) Inspection status requirements for location, stamps, signatures, and records are incomplete.

(13) On-site products have no inspection status identification or have incorrect identification.

 

8. Customer Property

 

(1) Customer products are not verified.

(2) Customer products are not clearly identified and not properly segregated.

(3) Damage, loss, or unsuitability of customer products is not recorded or reported to the customer.

(4) Customer-provided testing equipment and intangible products (software, etc.) are not included in control.

 

9. Product Protection

 

(1) Packaging and transportation marks and protective marks are not properly applied as required.

(2) Handling personnel have not received skills and safety knowledge training.

(3) Regular inspections of inventory are not conducted as required (by organization’s own rules). Inventory items show deterioration or damage.

(4) Packaging operations are performed without packaging work instructions.

(5) Warehouse inbound and outbound management is chaotic.

(6) Warehouse records do not match physical inventory; warehouse is disorganized; different products cannot be clearly distinguished.

(7) Warehouse rules (such as first-in-first-out, segregated storage) are not followed.

(8) Customer products are not stored separately, making traceability impossible.

(9) Special packaging requirements in contracts are not explained in detail to operators.

(10) Packaging material suppliers are unapproved. Packaging materials are unchecked.

(11) Accompanying documents are incomplete.

 

10. Control of Monitoring and Measuring Devices

 

(1) Calibration status identification of measuring equipment is not unique or missing.

(2) No calibration procedure exists for self-made measuring equipment.

(3) Measuring equipment is past calibration due date.

(4) Calibration results are not recorded or are recorded improperly.

(5) Equipment in use is not systematically managed (such as maintenance regulations).

(6) Measurement capability of equipment does not meet measurement requirements.

(7) Measurement software is not verified before use.

(8) Only instruments within the equipment are calibrated, not the measuring equipment itself.

(9) Measurement personnel do not adjust as required.

 

5. Measurement, Analysis, and Improvement

 

1. General

 

(1) Monitoring and measurement activities cannot ensure conformity or implement improvements.

(2) Requirements for using statistical techniques are not adopted.

(3) Errors occur in the use of statistical techniques, possibly due to lack of training or absence of relevant work instructions.

(4) Data collection is not standardized.

 

2. Customer Satisfaction

 

(1) No method is specified for collecting, analyzing, and using customer satisfaction information.

(2) No improvement measures are taken when customer satisfaction declines.

 

3. Internal Audit

 

(1) Audit planning is not conducted or the plan content is incomplete.

(2) Audit plans are not prepared for each audit.

(3) Internal auditors are untrained or lack qualification certification.

(4) Follow-up verification of corrective actions after internal audits lacks records, or verification records are not reported to relevant departments and personnel.

(5) Internal auditors have direct responsibility relationships with the audited departments.

(6) Audit content is insufficient and merely formal.

 

4. Process Monitoring and Measurement

 

(1) Processes requiring monitoring and measurement are not identified. Special and key processes are not monitored or measured.

(2) Process monitoring and measurement methods are inappropriate.

 

5. Product Monitoring and Measurement

 

(1) No acceptance criteria for the product.

(2) The stages of monitoring and measurement are unclear.

(3) All specified inspections were not completed, and release was made without approval from authorized personnel.

(4) Inspection records are incomplete or improperly maintained.

(5) Sampling inspection is not standardized.

(6) Inspectors are unqualified.

 

6. Control of Nonconforming Products

 

(1) No procedure or the procedure is not applicable.

(2) Nonconforming products are not identified.

(3) Nonconforming products are not handled, or the authority for handling is unclear.

(4) Reworked/repaired products are not re-verified.

(5) The distinction between rework and repair is unclear, and concession acceptance is made without customer or authorized personnel approval.

(6) The organization has no measures for handling nonconforming products after sale.

 

7. Data Analysis

 

(1) Data collection is not standardized.

(2) Data analysis does not provide the following information: customer satisfaction; conformity to product requirements;

process, product characteristics and their trends; suppliers.

(3) When problems are found in data analysis, improvement activities are not implemented.

 

8. Improvement

 

(1) No planning and management of continuous improvement process; unclear understanding of continuous improvement.

(2) This corrective and preventive action procedure is compiled.

(3) Customer complaints are not analyzed or handled.

(4) Improvements, corrections, and preventive actions are implemented but not recorded.

(5) The basis and reasons for taking preventive measures are unclear.

(6) Implementation of corrective and preventive actions is not reviewed.

(7) The status of corrective and preventive actions is not submitted for management review.