Notes on the API inspection and follow-up review:
1. The follow-up review minutes are a factual record of the issues found on site. They were recorded jointly by General Manager Wang and the recorder, and were later organized into this document.
2. The follow-up review minutes have been issued to all functional departments. The nonconformities involved and the related responsible departments have been identified.
3. Some of the nonconformities were corrected during the inspection. Some can be strengthened and improved through future study and training. Some must be improved during future work, and others must be corrected within the specified time limit.
4. The issues were found through sampling. This does not mean that departments not involved in the sampling, or documents not checked, are free from similar issues. Each department should conduct self-inspection and correction according to the nonconformity content in the minutes.
Reason for the API inspection finding:
1. Cause Analysis
High-pressure fluid-control components, including valves, tees, crosses, threaded connections and other connections, were newly developed products for the company. During product development, metrology personnel did not fully understand the requirements of API Spec 6A. As a result, pressure transmitters were not calibrated according to the calibration interval and requirements specified by API Spec 6A.
2. Corrective Actions
1) Prepare a training outline focused on API Spec 6A, national metrology regulations and other API specifications.
2) Train metrology personnel.
3) Assess personnel who participate in the training according to the training requirements.
4) Revise the periodic calibration plan according to the calibration interval and requirements specified by API Spec 6A.
5) Send pressure transmitters that are approaching their calibration due date to the metrology department for calibration according to the revised periodic calibration plan.
6) Evaluate the competence of the metrology personnel who participate in the training.
3. Preventive Actions
1) Organize relevant personnel to study API Spec 6A, national metrology regulations and other API specifications.
2) Assess personnel who participate in the training according to the training requirements, in order to prevent similar events from recurring.
3) Evaluate the competence of relevant personnel.
API Follow-Up Review Minutes
1. Existing Issues and Suggestions
1) During on-site inspection, the pressure gauge accuracy class was +/-1.5%, while API requires +/-0.5%. Although it was explained that the pressure transmitter accuracy was better than +/-0.2%, the auditor considered that the pressure gauge should preferably be changed to +/-0.5% accuracy. Responsible department: Sijin workshop.
2) It is recommended that flowchart-style procedure documents and work standards be placed together for convenient reference. Responsible department: Quality Office.
3) In the quality objectives, the function of the Quality Office is not clear. Its main functions should include monitoring system operation, disposing of nonconforming products, proposing corrective and preventive actions, handling customer complaints, conducting quality statistics and proposing continuous-improvement opinions, arranging internal quality audits and preparing management review reports. Responsible department: Quality Office.
4) The decomposition of quality objectives in the Supply Department has problems. The objectives should be measurable and should focus on the direction of future effort.
Items 3 and 4 should be led by the Quality Office, and each department should prepare its own quality objectives according to its work plan.
5) For special-process equipment point records, the initially provided record covered five points and had no recording paper strip. After overnight corrective action, nine-point records and recording strips were provided. Responsible department: Equipment Department.
6) The design procedure should include design methods, design assumptions, design calculations and design requirements as design-input requirements. Responsible department: Quality Office.
7) In the witnessed load test for the plug valve, the test load for the valve-body strength test did not conform to the 6A specification, including the test outline and inspection procedure. Responsible department: Sijin workshop.
8) Magnetic-particle testing and ultrasonic testing numbers were identical and should be distinguished. Responsible department: Inspection Department.
9) Design-change documents lacked an evaluation of the impact on product components and delivered products. Procedure documents should also add this content. Responsible department: Technical Department.
10) For 6A products, contracts should include specification level, temperature, working pressure, material and related content. Responsible department: Sales Department.
11) Approved-supplier evaluation should include supervision of the supplier's ISO system, including certificate renewal. Responsible departments: Production Department and Supply Department.
12) For outsourced special processes, in addition to normal entrustment agreements, technical agreements should also be prepared. The content should include equipment qualification, personnel qualification and acceptance criteria. Responsible department: Production Department.
13) Nonconforming measuring instruments should be evaluated. If product dimensions may have been affected, traceability should be conducted, including all previous products. Responsible department: Inspection Department.
14) Management of external measuring instruments should be written into procedure documents. Responsible department: Inspection Department.
15) Statistics for product conformity and customer satisfaction should not only be accurate, but should also be evaluated. Responsible departments: Sales Department and Quality Office.
16) Statistical data did not correspond to quality objectives and requirements. The process may be inconsistent in method or data collection. Each department should provide true information and data. Responsible department: Quality Office.
17) System planning, including the effectiveness and suitability of policies and objectives, process control, monitoring, measurement and resource provision, should be reflected in the management review report. Responsible department: Quality Office.
18) Equipment had no maintenance plan. A procedural document should support equipment maintenance planning. Responsible department: Equipment Department.
19) In the design documents for the 500-ton single-arm elevator, drawings were not signed. Trial-manufactured products should also follow the procedure. Responsible department: Technical Department.
20) The elevator clearance was large. Although replacement was carried out, solutions for similar products used by other customers should be listed. Responsible department: Quality Office.
21) Corrective actions should have specific plans submitted to the Quality Office. The Quality Office should supervise and inspect implementation and evaluate effectiveness. Responsible departments: all functional departments.
22) The concept of preventive action was unclear. Responsible department: Quality Office.
23) System changes caused by organizational changes should be evaluated. Responsible department: Quality Office.
24) The education-level requirements for responsible personnel in the Production, Supply and Equipment departments should be written into job responsibilities. Responsible department: Education Department.
25) Training should include personnel skill assessment, and the responsibilities and authority requirements of all types of personnel should be summarized. Responsible department: Education Department.
26) The API Monogram management system should state that the scope of monogram use applies only to the company. Responsible departments: Quality Office and Inspection Department.
27) The internal-audit plan should include audit items related to previous nonconformities. The issues listed in this inspection should also be treated as major internal-audit objects. Responsible department: Quality Office.
28) Reminder: before inspection, inspectors should return measuring instruments to zero and confirm their accuracy. This requirement may be written into procedure documents. Responsible department: Quality Office.
29) Personnel did not understand the factory policy and objectives. Responsible departments: all functional departments.
30) It is recommended that the pressure-test device be monitored by camera for safety, reliability and continuity. Responsible department: Sijin workshop.
2. Nonconformity
The calibration interval for pressure transmitters was one year, which did not conform to API 6A. The specification requires pressure-measuring devices to be periodically recalibrated with a standard pressure-measuring device or deadweight tester at 25%, 50% and 75% of full scale. Before historical calibration records are established, the maximum calibration interval should be three months.
