NQA-1 Graded Approach, 55-Gallon Drum Summary

Transcription

1 1, Organization 2, Quality Assurance program 3, Design 4, Procurement Document 5, Instructions, procedures, and Drawings 100 Basic 200 Structure and Responsibility 201 General 202 Delegation of Work 300 Interface 100 Basic 200 Indoctrination and Training 201 Indoctrination Not 202 Training 300 Qualification s (auditors Not and Lead Auditors only) 301 Non-destructive Not Examination (NDE) 302 Inspection and Test 303 Lead Auditor Not 304 Auditors Not 305 Technical Specialist Not 400 and Qualification Basic 200 Content of the Procurement Document 201 Scope of Document 202 Technical requirements 203 Quality Assurance Program s 204 Right of Access 205 Documentation s 206 Non-Conformances 207 Spare and Replacement Parts 300 Procurement Document Review 400 Procurement Document Changes 100 Basic Drum manufacturers state up front they do not implement requirement 3, Design. Therefore using 5, Instructions, Procedures, and Drawings the DOE Contractor requires the Supplier to develop fabrications Drawing developed from the Technical s provided in the purchase order. Even though 3 is not implemented the DOE Contractor will require the Supplier to implement portions of Design, i.e. 100, 200, 300(c), 400 (excluding 401 and 402), 501.

2 6, Document 7, of Purchased and Services 8, Identification and of 9, of Special Processes 100 Basic 200 Document 300 Document Changes 301 Major Changes 302 Minor Changes 100 Basic 200 Supplier Evaluation and Selection 300 Bid Evaluation Not 400 of Supplier- Generated Documents 500 Acceptance of Item Not and Service 501 General 502 Methods of Acceptance 503 Certificate of Conformance 504 Source Verification 505 Receiving Inspection 506 Post-Installation Testing 507 Acceptance of Services Only 600 of Supplier Non-Conformances Not 700 Commercial Grade Not and Services Basic 200 Identification Methods 201 Item Identification Not 202 Physical Identification Not 300 Specific s Not 301 Identification and Not Traceability of 302 Limited Life Not 303 Maintaining Not Identification of Stored 100 Basic 200 process 201 Special Processes 202 Acceptance Criteria 203 Special requirements 300 Responsibility is implemented only when a standard is implemented that requires an individual is qualified to a recognized standard, i.e. AWS, SNT-TC-1A, 2006.

3 10, Inspection 11, Test 12, of Measuring and Test Equipment 100 Basic 200 inspection s 300 Inspection Hold Points Not 400 Inspection Planning Not 401 Planning Not 402 Sampling Not 500 In-Process inspection 600 Final Inspection 601 Resolution of Non- Conformances 602 Inspection s 603 Modifications, Repairs, or Replacements 604 Acceptance 700 Inspections during Not Operations Basic 200 Test s 300 Test Procedures (Other Than For Computer Programs) 400 Computer Program Not Test Procedures 500 Test Results 600 Test 601 Test 602 Computer Program Not Test 100 Basic 200 Selection 300 Calibration and 301 Calibration 302 Reference Standards Application Corrective Action Handling and Storage Environmental s Pre-calibration Checks Status indication 304 Commercial Devices General 402 Reports and Certificates

4 13, Handling, Storage, and Shipping 14, Inspection, Test, and Operating Status 15, of Non- Conforming 16, Corrective Action 17, 100 Basic 200 Special s Not 300 Procedures Not 400 Tools and Equipment Not 500 Operators Not 600 Marking and Labeling 100 Basic 100 Basic 200 Identification 300 Segregation 400 Disposition Responsibility and Authority 403 Personnel 404 Disposition 405 Re-examination 100 Basic 100 Basic 200 Generation of 300 Authentication of 400 Classification Not 401 Lifetime Not 402 Non-permanent Not records 500 Receipt of Not 600 Storage Not 601 General Not 602 Facility Type Not 603 Temporary Storage Not 700 Retention Not 800 Maintenance of Drums are manufactured in a continuous process. There are two test that are performed during production That if failed would require the drum be pulled from Production and not allowed to proceed. Corrective action will be implemented when systemic issue arise through supplier performance and nonconformances. Only A E are required

5 Section Description Applicability Comment The purpose of this requirement is to ensure that the 18, Audits 100 Basic definition of Quality Assurance as documented in 49 CFR is met. 200 Scheduling 300 Preparation 301 Audit Plan 302 Personnel 303 Selection of Audit Team 400 Performance 500 Reporting 600 Response 700 Follow-Up Action CFR Parts 49 CFR (Type A Packaging s) 49 CFR 178 Subpart M 49 CFR 178 Subpart L 49 CFR 172 Subpart H