2. NQA-1 and The Quality Pyramid NQA-1 is how you conduct and document your business. Thinking of NQA-1 as a business operating model as opposed to a regulation that we must follow, converts the paradigm of high cost of operating to a paradigm of cost control. It may be the least expensive QA Program any firm can implement – The governing document is free, 10 CFR 50, Appendix B.
16. The short answer – EVERYBODY NQA-1 (The QA Program) is a team approach Each activity of an organization supports the next A contract is not full-filled by QA The organization is a machine that produces a product How the machine operates is dictated by the QA Program Who’s Responsibility?
17. Manual Written based on ASME NQA-1 It does not have to be complicated Written in support of the activities you perform The manual becomes your statement that you will operate to the applicable requirements of NQA-1 The Components QA Manual
18. Procedures The Manual specifies the required procedures How an activity will be performed and who is responsible Acceptance criteria is specified Which records are required The Components Procedures
19. Activities Every thing going on in the organization – Again a Procedure outlines how A Procedure will outline how to develop work instructions (Shop Traveler/Work Plan) Example – Concrete Placement Concrete Placement Procedure Prerequisites Records and when QC sign off is required Authorized Signatures, Etc. Instructions Procedure (Criterion 5) Work Plan outlining sequential steps in the placement of the concrete May contain QC sign offs Procurement Procedure (Criterion 4 and 7) How the concrete is procured Procurement of Testing agencies The Components Instructions, Material Control, Lay-down Yards, Inspections, Document Control, Procurement, Welding, Wiring, Concrete Placement etc.
20. Document Control Procedure (Criterion 6) The control of the work plan Control of the procedures themselves Control of drawings Control of the procurement records, etc. Material ID and Storage (Criterion 8 and 13) Staging of reinforcing steel Staging of concrete mix materials This is only a partial list The point is this Quality is introduced and built into the product by the control of the processes required to take an idea and transform it into reality Nothing is taken to chance – Hence SAFETY The Components Activities Continued Instructions, Material Control, Lay-down Yards, Inspections, Document Control, Procurement, Welding, Wiring, Concrete Placement etc.
21. Records The Objective Evidence Documents authorized personnel (Criterion 1) Documents Training (Criterion 2) Documents Acceptance Criteria Inspection Records Testing Results Record Storage (Criterion 17) Records must be protected, why would you not? Foundation of the Pyramid If not documented the activity never happened Records become the narrative of your product The Who, What, When, Where, and How, also Why The Components Records and Documentation
22. Define What you are going to be A dude with a broke down pickup truck and a jack-hammer OR A quality organization with Integrity Develop a Plan The Who, What, When, Where, and How, also Why Establish timelines Who is going to do what, based on the Procedures Commit to the Plan Assign responsibility and accountability Must have sound Leadership Management and Leadership are not the same thing Fund the Plan if really needed The Plan
23. NQA-1 is not asking you to do anything that you should not already be doing IF you call yourself a QUALITY ORGANIZATION. Nothing on this pyramid states NQA-1 NQA-1 only adds structure, the basis of what the Program is compliant to. That being said NQA-1 does have teeth Linked to 10 CFR 50, Appendix B CFR – Code of Federal Regulation That means it is Law if providing services to Nuclear Facilities 10 CFR Part 21 Civil and Criminal Penalties Implementation
28. Dan Murphy NQA-1 Lead Auditor American Society for Quality Certified Quality Auditor Masters Degree in Quality Assurance Experience 10 Years Business Operations Management Quality Implementation and Management Available for Speaking Engagements Expenses only Local engagements no fee Please email comments to dmurphyd@verizon.net The End