General Document or OQE Comments SAT UNSAT

Transcription

1 4 Quality Management System Quality Manual (A) Has a Quality Manual been developed that includes the scope of the QMS, the documented procedures established for Section 2 #1 the QMS, and a description of the interaction between the processes of the QMS? Control of Documents Section 8 #1 - #6 (A) Are system documents reviewed and approved for adequacy Section 8 #3 by authorized personnel prior to issue? (B) Is the organization s approved document control procedure Section 8 #1 being followed as written? (C) Are pertinent issues of appropriate documents available at locations essential to the effectiveness of the QMS? (D) Are obsolete documents prevented from unintended use Section 8 #4 IAW the approved procedure? (E) Are obsolete documents suitably identified? Section 8 4 (F) Are changes to system documents reviewed and approved by the same function that performed the original review & Section 8 #3 approval and submitted to the government IAW NSI ? (7 days of approval) (G) Are changes and the current revision status of documents Section 8 #3 identified? Control of Records (A) Are records legible, readily identifiable, and retrievable? (B) Are records controlled IAW the CONTRACTOR s approved Section 8 #6 procedures? 5 Management Responsibility 5.1 Management Commitment SAMPLE OQE Section 5 Section 2 #7 & #9 (A) Show evidence of a documented procedure on Management Responsibility that addresses all areas of Paragraphs 5.1 through 5.6.3, 6.1, 6.2.1, 6.2.2, and of the ISO 9001:2008 Standard (IAW NSI Paragraph 3.1.2) Make sure that each of the paragraphs listed is covered in a procedure. They do not all have to be in the same procedure. They just need to be covered at the procedure level (not merely at the Quality Manual level) Customer Focus Section 2 #4

2 (A) Does top management ensure that customer needs and expectations are determined and converted into requirements? Section covered by and Section 2 # Quality Policy Section 2 #5 (A) Is the quality policy communicated and understood throughout the organization? Look for evidence that a quality policy exists. Make sure it includes a reference to complying with customer requirements and continual improvement. Look for evidence of communication of policy. Ask random employees to describe the quality policy in their own words. Section 2 # Quality Objectives Section 2 #6 The company decides what are the "relevant functions and levels". It (A) Are QMS objectives established at relevant functions and could be just one. It could be multiple, levels within the organization? but must be at least one set of QMS Section 2 #6 objectives. (B) Are established objectives measurable? The company must be able to demonstrate whether the objectives are being measured and met or not. Show evidence of current status or past status. Section 2 #6 (C) Are the quality objectives consistent with the quality policy and product requirements? QMS Planning (A) Is the QMS planned and structured to fulfill the quality policy and quality objectives by top management? (B) Does planning ensure that change is conducted in a controlled manner? (C) Does quality planning include required resources? (D) Does quality planning include opportunities for continual improvement of system processes? Responsibility and Authority Compare the objectives with the quality policy. They need to line up. Sections are covered as follows: (A) 5.1; (B) 5.1; 5.3 and (D) 8.5 Section 2 #6

3 (A) Are responsibilities and authorities clearly defined? Management Representative (A) Has top management appointed a member of management who has responsibility for the QMS? Look for an organizational chart, or position descriptions, or some other evidence. Show documentation on who that person is. Find that person ask him/her to describe their role. Look for "ensuring that QMS processes are established," "Reporting to top management on th eperformance of the QMS," and "promotion of awareness of customer requirements throughout the organization." Internal Communication Section 2 #8 (A) Is there communication between various levels and Look for evidence such as newsletters, functions with respect to the QMS processes? s, postings. Section 2 # Management Review Section 2 #7 & #9 (A) Are management reviews conducted at planned intervals? (B) Do reviews consider the system s continuing suitability, adequacy and effectiveness? (C) Are records of management reviews maintained? The company decides what "planned intervals" is and provide evidence of the "planned interval". Then ask for evidence that it is occurring. Request documentation on implementation proof. Need to see two consecutive sets of meeting notes, because in the next section you are l ooking for evidence of follow-up actions from previous management reviews. Section 2 #7 & #9 Section 2 #7 & #9 Section 2 #7 & #9

4 (D) Are all the required inputs and outputs being addressed? Inputs need to include 7 items (see ISO (a-g)). (a)results of audits; (b)customer feedback; (c)process performance and product conformity; (d)status of preventive and corrective actions; (e)follow-up actions from previous management reviews; (f)changes that could affect the QMS; and (g) recommendations for improvement. Outputs need to include 3 items (see ISO (a-c)). (a) improvement of the effectiveness of the QMS; (b) improvement of product related to customer requirements; and (c) resource needs. 6 Resource Management Section 3 #1 - # Provision of Resources Section 3 #1 - #4 (A) Does the CONTRACTOR determine resources required to implement the processes and to address customer satisfaction Section 3 #1 - #4 by meeting customer requirements? General Section 3 #1 - #4 (A) Are required competencies identified? Section 3 #1 - #4 (B) Are records of competencies maintained, as required? Section 3 #1 -# Competence, Awareness/Training Section 3 #1 -#4 (A) Are procedures in place to ensure that personnel are competent based on education, training, skills and experience? (B) Are appropriate records of required testing & education maintained? (C) Has the organization evaluated the effectiveness of training? (D) Does the CONTRACTOR have documentation of their Competent Persons Training Program IAW NSI ? (National Fire Protection Association Training IAW Section of 29 CFR Part 1915) Section 3 #1 -#4 Section 4 #1 - #3 Section 3 #1 -#4 Section 4 #1 - #3 Section 3 #1 -#4 Section 4 #1 - #3 Appendix 4 #2

5 (E) Has training been conducted and recorded for Competent Persons as required by NSI ? (Initial training 24 hrs., annual update 8 hrs.) Appendix 4 #2 (F) Does the CONTRACTOR have a Fire-watch Training program that provides theory and practical experience as required by NSI ? (G) Is training provided to all new Fire-watches and annual updates thereafter? Appendix 4 #4A Appendix 4 #4A (H) What visible means is used to identify the Fire-watch on board the ship IAW NSI ? (Badge, sticker, vest, etc ) (I) Has the CONTRACTOR documented TUM Training for individuals working aboard ship as required by NSI ? (Procedure and records) (J) Does the CONTRACTOR have a documented procedure for WAF & TUM Training as required by NSI , Paragraph 3.4.3? (Procedure, list of personnel, records of training) (K) Does the CONTRACTOR have a training program for tank cleaning personnel as required by paragraph of NSI ? (List of personnel and documentation of annual training) (L) Does the CONTRACTOR have a written training plan for accomplishing non-nuclear work on nuclear vessels IAW NSI ?(Procedure, list of personnel, records of training) Appendix 4 #4A Appendix 7 #1 -#4 Appendix 7 #1 -#4 Appendix 4 #3 6.3 Infrastructure Section 3 #5 (A) Does the organization identify needs and maintain the plant, workspace, hardware, software, tools, equipment, support services, communication, transportation, and facilities? Section 3 #5 7 Product Realization Determination of Product Requirements

6 (A) Show evidence of a documented procedure on Customer Related Processes that addresses all areas of Paragraphs through in the ISO 9001:2008 Standard IAW NSI Paragraph 3.1.3) (B) Does the organization determine customer requirements and delivery requirements? Review of Product Requirements (A) Is the review conducted prior to commitment to supply the product? (B) Does the review determine that the organization has the capability to meet defined requirements? (C) Are review results and subsequent actions recorded? (D) When customer requirements change, are changes to relevant documentation implemented? (E) Are requirement changes communicated to relevant personnel? Customer Communication (A) Does the organization identify and implement arrangements for communicating product information to customers? (B) Does the organization identify and implement arrangements for communicating with customers regarding enquiries, orders, and contracts? (C) Does the organization identify and implement arrangements for obtaining customer feedback and customer complaints? 7.3 Design & Development (A) Does the contractor perform design functions for customer contracts? If No, skip to Section (B) Are proper processes in place to control the design process if Purchasing Process Section 5 #1 - #3 design functions are accomplished? (C) Are records being maintained for the design process as required? (A) Show evidence of a documented procedure on Purchasing that addresses all areas of Paragraphs through in the ISO 9001:2008 Standard IAW NSI Paragraph Section 5 #1

7 (B) Are there documented processes defining how suppliers are evaluated and selected on their ability to meet contract requirements? (If no documented process exists, how are Section 5 #1 - #3 subs/vendors evaluated?) Are purchase orders provided to subs? (Explain in remarks Critical) (C) Are quality records of subcontractors maintained? Section 5 #1 - #3 (D) Do purchasing documents contain data clearly describing the Section 5 #1 - #3 product ordered? (E) Are all quality requirements listed on the purchase order? Section 5 #1 - #3 (F) Are correct material specifications listed on the purchase Section 5 #1 - #3 order? (G) Is receipt inspection being performed IAW documented Section 5 #1 - #3 procedures? (H) Are purchase orders reviewed and approved prior to Section 5 #1 - #3 commitment to order? 7.5 Control of Production and Service Provision Section 6 #1 - #5 (A) Show evidence of a documented procedure on Production and Service Provisions that addresses all areas of Paragraphs through in the ISO 9001:2008 Standard IAW NSI Paragraph Validation of processes for production and service provisions (A) Are all processes validated to demonstrate their ability to Section 5 #1 - #3 achieve planned results? Identification and Traceability Section 7 #5 (A) Is identification maintained throughout the production and service operations? NOTE: Do identification tags utilized by the contractor contain the required information IAW NAVSEA Std. Item (company name, ship's name, hull number, system, location, and Work Item number) Customer Property and/or Government Furnished Property QA COMMITTEE REVIEW (A) Does the organization have processes in place to ensure the identification of customer property? (B) Are there processes in place to protect customer property from theft, damage, and/or loss of intended use? Section 7 #5

8 (C) Are processes in place to ensure that any customer property, which is damaged or otherwise unsuitable for use, is recorded and reported to the customer? (D) Is customer intellectual property treated in the same manner as materiel property? Preservation of Product Section 6 #6 (A) Does the organization operate processes which preserve conformity of product with customer requirements during internal processing? (C) Do these processes include delivery of product, identification, handling instructions, packaging instructions, storage instructions, warning notices e.g.: HAZMAT, and protection of product including constituent parts? (D) Does the CONTRACTOR maintain a Blank/Plug Log IAW NSI ? 7.6. Monitoring & Measuring Devices QA COMMITTEE REVIEW (A) Are calibrated instruments used? If No skip to Section 8. Section 6 #6 Section 6 #6 Appendix 3 (B) Show evidence of a documented procedure on Monitoring and Measuring Devices that addresses all areas of Paragraph 7.6 in the ISO 9001:2008 Standard IAW NSI Paragraph (C) If you perform instrument calibrations, are you accredited to either ANSI/NCSL Z540 (current version) or ISO/IEC by a Commercial Accreditation Activity, or certified by a Navy Certification Activity to NAVSEA ? (D) Is monitoring and measuring equipment calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards? (E) Is monitoring and measuring adjusted or re-adjusted as necessary? (F) Does monitoring and measuring equipment have identification in order to determine calibration status? (G) Is monitoring and measuring safeguarded from adjustments that would invalidate the measurement result? Appendix 3 #1 Appendix 3 #2 Appendix 3 #2 Appendix 3 #8

9 (H) Is monitoring and measuring equipment protected from damage and deterioration during handling, maintenance and storage? (I) If equipment is found to be nonconforming, are appropriate actions taken? (J) Are records of the results of calibration and verification maintained? 8 Measurement, Analysis and Improvement Customer Satisfaction (A) Show evidence of a documented procedure on Measurement Analysis and Improvement that addresses all areas of Paragraphs 8.2.1, 8.4, and in the ISO 9001:2008 Standard IAW NSI Paragraph (B) Does the organization monitor information regarding customer satisfaction and dissatisfaction? Internal Audits (A) Is there a documented procedure on Internal Audits? (B) Are internal quality audits being performed at planned intervals? (C) Are records of internal audits being maintained? (D) Are internal audit results being provided as input for management review? Monitoring & Measurement of Processes (A) Does the organization apply suitable methods for measurement and monitoring of the realization processes necessary to meet customer requirements? (B) Are T&I Plans being generated and updated in accordance with IAW NSI or is the Prime Contractor s T&I Plan used? (C) Is the CONTRACTOR maintaining a current list of (I) Qualified Inspectors as required by NSI ? (D) Does the organization have a process for handling inspections in accordance with NSI ? Monitoring and Measurement of Product (A) Show evidence of a documented procedure on Monitoring and Measurement of Product that addresses all areas of Paragraphs in the ISO 9001:2008 Standard IAW NSI Paragraph Appendix 3 #11 Appendix 3 #12 Section 1 #5 Section 1 #4

10 8.3. Control of Nonconforming Product (A) Is there a documented procedure on Control of Nonconforming Product? (B) Are nonconforming materials marked/tagged? (C) Are nonconforming materials segregated? Section 7 #1 Section 7 #1-2 Section 7 # Analysis of Data (A) Does data analysis provide information regarding customer satisfaction/dissatisfaction (See 8.2.1); conformance to requirements (See 8.2.4); characteristics of processes, products, and trends thereof (See 8.2.3), and supplier performance (See 7.4)? Continual Improvement Section 7 #1 - #4 (A) Does the organization facilitate the continual improvement of the QMS through the use of the quality policy, quality objectives, audit results, analysis of data, corrective action, preventive action, and management review? Section 7 #1 - # Corrective Action Section 7 #3 (A) Is there a documented procedure on Corrective Action? Section 7 #3 (B) Are in-house corrective actions documented? Section 7 #3 (C) Do issued s indicate corrective action performed by the contractor? Section 7 3 (D) Do corrective action requests list the contractor s plan to prevent a re-occurrence of the nonconformance? Section Preventive Action Section 7 #4 (A) Is there a documented procedure on Preventive Action? Section 7 #4 (B) Does the organization use appropriate data to identify opportunities for preventive action? (C) Is the preventive action process followed through to proper closure and reported to the Management Review Process? Section 7 #4 Section 7 #4 WELDING DESCRIPTION REQ. / REF. SAT UNSAT MAJOR MINO R

11 WELDER QUALIFICATION TEST RECORDS SHALL HAVE THE INFORMATION REQUIRED BY PARA REF. (A) para. 1. Welder identification to include name and ID# and Figure Date of test 3. Qualification test number, process, base material type, filler material type and size 4. Results of qualification test 5. Record of omission of space restriction when test is performed on pipe 6. Certifying signature by fabricator Review a random selection of welder performance records. Verify all records contain evidence of annual eye tests, welder workmanship REF. (A) section 5. training (WWT) each 3 years, score of 75% or greater on written Transferals of welder qualifications are authorized only under the MOA REF. (A) para. agreement between VSRA, AMMA and NSSA. Verify that transfers are , MOA between NSSA, VSRA and recorded per this MOA. AMMA Verify that welders (select at random) have completed quarterly maintenance of process for the current and previous quarter. Ref (A) para Verify that the following documents and designations are in place: Ref. (A) section 5 1. Welding Workmanship Training (WWT) lesson plan Ref (B) Section 4 2. Welder training program process instruction 3. Welder workmanship test bank 4. Designation of qualified technicians to perform eye tests, of evidence eye tests are given by optometrists 5. Method for recording maintenance of processes on a quarterly basis 6. Electrode control procedure 7. Welder Workmanship Inspector (WWI) process 8. Welding surveillance process Review random welding procedures (WPS), compare to welder Ref (A), section 4 & 5 performance records. Review recent welding program audits. Verify corrective and preventive actions recommended by these audits have been acted Ref. (B) section 6 upon and documented per company policy. Verify these audits have been performed by a Level III NDT Examiner at 2 year intervals. Verify a process is in force to verify subcontractor weld procedures are approved and welders are qualified in the process being performed. Ref. (A) para

12 Review the surveillance program records. Verify the minimum number of surveillances documented Ref. (B) para BRAZING DESCRIPTION Defition Needed etc. Verify that a brazer training and qualification program approved by a Level III Examiner is in place Verify that the brazing procedure has been approved by a NDT Level III Examiner and NAVSEA Representative. Ensure the procedure has the non-destructive and destructive test records. Review random brazer qualification records, must include: 1. Brazer name and ID# 2. Date of test 3. Process, position, base material types, pi[pe wall thickness, brazing alloy type 4. Results of qualification tests 5. Record space restrictions, if applicable. 6. Certifying signature by authorized company representative, normally a NDT Level III Verify a quarterly maintenance of process is documented for the present and preceding quarter for a random sampling of brazer records Verify a PCP is developed for P3-A piping (if applicable) Review the audit and sampling procedures, including the following attributes: 1. Lot or sample definition 2. Sampling plan including audit frequency 3. Attributes to be audited 4. Records and reports of audits to include ship number and system identification 5. Performance evaluation 6. Corrective actions for discrepancies found Ref. (B) para Ref. (B) para , Ref. (B) para Ref. (B) para Ref. (A) and Ref. (B) para and Table 3-1 Ref. (B) para NDT DESCRIPTION Defition Needed etc.

13 Does the contractor have a NDT Level III Examiner to supply the required certification of welders, NDT Level II Inspectors and procedure Ref. (A) para. 1.7 effecting welding, NDT and brazing? May be outsourced or supplied by an employee. Has a NDT Written Practice procedure been developed, approved by a Ref. (A) para. 1.6 Level III and NAVSEA Representative? Review random Level II inspector records. Records shall include: 1. Formal training and experience in NDT 2. Results of current examination(s) Ref. (A) para Record of eye tests 4. Completion of Written Practice requirements and certification signed by a NDT Level III Examiner Verify each NDT Level II inspector recertifies each 3 years, and Level III Ref. (A) para each 5 years. List the NDT method procedures and if approved by a Level III and a NAVSEA representative. 1. Visual 2. Liquid Dye Penetrant 3. Magnetic Particle 4. Ultrasonic Thickness 5. Ultrasonic Shear Wave 6. Radiography 7. Others Ref. (A) para Review the Technical Performance Evaluations for a random sample of Level II inspectors. Ensure these are in accordance with the company Ref. (B) Written Practice Procedure Verify practical examinations are performed on samples with known Ref. (B) defects Verify each Level II inspector has documented use of each method Ref. (A) para qualified each 9 month period. ENVIRONMENTAL PROCESS AUDIT DESCRIPTION KTR has NO enforcement/citations/penalties from any Env. Reg. Body in the past 5 years. (ex. USCG Oil Spill, DEQ Consent order, EPA violations)? If NO Skip to 2.

14 If NO, Describe: Does KTR s work involve any hazardous material or generate waste? If NO Skip to 3. If yes does KTR have a written plan to manage these materials. Are MSDS and/or other documents available at the worksite? If hazardous wastes are generated does KTR have the appropriate EPA Generator ID number for disposal? Does KTR have a plan to minimize pollution (paint, trash etc)? KTR storage containers will be properly placarded/labeled as to their contents. Does KTR perform coatings application work? If no Skip to 4. Does KTR comply with 40 CFR Part 63 including a written plan Is KTR aware that spills of paint/thinner are reportable to the National Response Center (NRC) and that KTR is responsible to report spills to NRC and the facility immediately? Does KTR perform abrasive blasting operations? If no Skip to 5. Does KTR have in place a method to record and report all abrasive blast usage? Does KTR perform containment operations for coatings applications and/or abrasive blast operations? If no Skip to 6.

15 Is KTR aware that discharges are not permitted and that KTR is responsible to report discharges to the facility immediately? Does the contractor perform welding operations? If no Skip to 7. Does KTR have in place a method to record and report all weld consumables? Does KTR perform transfers of oil/slops/hazardous materials over water? If no Skip to 8. Does KTR have a USCG approved Response Plan? Is KTR aware that spills are reportable to the National Response Center (NRC) and that KTR is responsible to report spills to NRC and the facility immediately? Does KTR have a current agreement with a USCG approved OSRO for spill response? Does KTR have a plan or procedures when an incident occurs to protect contamination of storm drains, sewer systems etc.? KTR will NOT use portable fuel driven equipment (i.e. Air compressor, Generator, Manlift, Pressure Washer, Hydroblaster ) Does KTR have in place a method to record and report all fuels consumed? KTR has secondary containment for all equipment meeting SPCC requirements? KTR will utilize portable fuel tanks to refuel equipment. KTR will only use approved properly labeled containers.