QA Manual Check List Q Class

(If necessary, Please refer ASME NQA-1(1994))

○ Name of Company :

○ QA Manual approved date :             ○ Rev.No. :         ○ Document No. :

No.	Quality Assurance Requirement	Related Contents in the Quality Assurance Manual	Remarks
1	Organization
2	Quality Assurance Program
3	Design Control
4	Procurement Document Control
5	Instruction, Procedure, Drawing
6	Document Control
7	Control of Purchased Items and Services
8	Identification and Control of Items
9	Control of Processes
10	Inspection
11	Test Control
12	Control of Measuring & Test Equipment
13	Handling, Storage and Shipping
14	Inspection, Test and Operating Status
15	Control of Nonconforming Items
16	Corrective Action
17	Quality Assurance Records
18	Audits

Note. In the Remarks column, explain the reason why if you have not applied to requirement.

QA Manual Check List Q Class (Detail)

Quality Assurance Requirement(Detail)	Related Contents in the QA Manual	Remarks
1. Organization
1) Responsibility for establishing, implementing and verifying of QA program
2) Organizational structure, functional responsibilities and authorities
3) Responsibility for audit, inspection
4) Organizational freedom for quality organization (person)
5) Report to a management level for activities affecting quality
6) The external and internal interfaces between organizational units
2. Quality Assurance Program
1) Establishing and maintaining QA Program
2) Scope of application
3) Relationship between QA program and procedure
4) Personal indoctrination and training
5) Personal qualification for quality verification and special process
6) Regular assessment for the adequacy of QA Program
3. Design Control
1) Identifying, approval and documentation for design input
2) Design Process
3) Design verification
4) Change Control
5) Interface control
6) Documentation and records
4. Procurement Document Control
1) Content of the procurement documents (Scope of Work, Technical Requirements, QA Program Requirements, Right of Access, Documentation Requirements, Nonconformances, Spare and Replacement Parts)
2) Procurement document review
3) Procurement document changes
5. Instruction, Procedure, Drawing
1) Prescription of the activities affecting quality
2) Quantitative or qualitative acceptance criteria

Quality Assurance Requirement(Detail)	Related Contents in the QA Manual	Remarks
6. Document Control
1) Preparation, review, approval, and issuance
2) Documented control system
3) Document Change(major/minor)
7. Control of Purchased Items and Services
1) Procurement planning
2) Supplier selection
3) Bid evaluation
4) Supplier performance evaluation
5) Control of supplier generated documents
6) Control of changes in items or services
7) Acceptance of item or service
8) Control of supplier nonconformances
9) CGI Dedication
8. Identification and Control of Items
1) Identification methods
2) Identification and traceability of items
3) Limited life items
4) Maintaining identification of stored items
9. Control of Processes
1) Process control
2) Special processes - Qualification of personnel, procedures and equipment
10. Inspection
1) Inspection requirements
2) Personnel(reporting independence, qualification)
3) Inspection hold points
4) Inspection planning
5) In-process, final Inspection
6) Inspection records
11. Test Control
1) Test requirements
2) Test procedures
3) Documentation and evaluation of test results
4) Test records
5) Test Facilities
6) Computer program testing
12. Control of Measuring & Test Equipment
1) Selection of measuring and test equipment
2) Calibration and control
3) Handling and storage
4) Records and marking

Quality Assurance Requirement(Detail)	Related Contents in the QA Manual	Remarks
13. Handling, Storage and Shipping
1) work and inspection instructions
2) Tools and equipment
3) Experienced or trained operators
4) Marking and labeling for packaging, shipment, handling, and storage
14. Inspection, Test and Operating Status
1) Status of inspection and test activities
2) Measurement for inadvertent use of items which were not passed inspection, test
3) Status identification for the traceabilities of items and documents
15. Control of Nonconforming Items
1) Identification
2) Segregation
3) Disposition; - control(in accordance with documented procedure) - Responsibility and authority for the evaluation and approval of disposition - Disposition(Technical justification for nonconforming item, dispositioned repair, or use-as-is) - Reexamination for repaired or reworked Items in accordance with the original acceptance criteria
16. Corrective Action
1) Prompt identification and corrective action for the conditions adverse to quality
2) Analysis of the cause, corrective action taken to preclude recurrence in the case of a significant condition adverse to quality
3) Documentation for the identification, cause, and corrective action for significant conditions adverse to quality and reporting to appropriate levels of management
4) Follow-up action to verify implementation of the corrective action
17. Quality Assurance Records
1) Establishing QA records system
2) Records validation, index, distribution, identification, classification, retention and correction
3) Storage, preservation, and safekeeping
18. Audits
1) Scheduling
2) Preparation(Personnel and Selection of Audit Team)
3) Performance
4) Reporting/ response
5) Follow-up action
6) Audit records