TS16949 who has the monitoring and measuring program files for the production process? It's urgent!

* * * * * * * Manufacturing Co., Ltd.

Version: B/

Page number: 2/3

Monitoring and measuring equipment control program

Document number: lx-B-19

1 Purpose

Effectively control the monitoring and measuring equipment to ensure the effective measurement results.

2 Scope

This procedure is applicable to the control of all measuring tools, measuring and test equipment in this enterprise, including equipment owned by employees and customers.

3 responsibilities

3.1 the quality department is responsible for the management of monitoring and measuring equipment; Responsible for purchasing general measuring tools.

3.2 the technical research and development department is responsible for formulating calibration specifications; Responsible for the design of special measuring tools.

3.3 the manufacturing department is responsible for manufacturing and repairing special measuring tools.

4 working procedures

4.1 procurement of monitoring and measuring equipment.

4.1.1 the technical research and development department shall apply to the quality department according to the requirements planned by multi-party demonstration teams or the user department according to the requirements of process monitoring and measuring equipment.

4.1.2 the quality department conducts a feasibility review on it, determines the appropriate monitoring and measuring equipment, fills in the Measuring Tool Purchase Application Form, and submits it to the deputy general manager for approval. If necessary, after the approval of the general manager, it will be purchased by the Purchasing and Supply Department.

4.1.3 after the monitoring and measuring equipment of large-scale equipment is purchased, the manufacturing department shall conduct acceptance according to the Equipment Control Procedure and fill in the Equipment Unpacking Acceptance Record Sheet.

4.1.4 for the self-made special measuring tools, the technical research and development department will design the drawings and the manufacturing department will manufacture them.

4.1.5 for qualified monitoring and measuring equipment, the quality department shall establish the Monitoring and Measuring Equipment Account, classify and number the monitoring and measuring equipment, and number and identify the physical measuring tools.

4.2 calibration or verification of monitoring and measuring equipment.

4.2.1 all monitoring and measuring equipment should be calibrated or verified before initial use.

4.2.2 the quality department shall contact the metrological department qualified for calibration or verification to calibrate or verify the measuring equipment that can be traced back to international or national standards.

4.2.3 the quality department shall contact the original equipment manufacturer for calibration or verification of the measuring equipment that cannot be traced back to the international or national standards.

4.2.4 The technical R&D department shall formulate calibration or verification rules for the special measuring tools made by the enterprise, which shall be calibrated by the quality department and approved by the customers if necessary.

4.2.5 the quality department shall determine the verification period according to the usage frequency and regulations of measuring tools, and prepare the Measuring Tool Periodic Verification Plan, which shall be audited by the department manager and implemented after being approved by the general manager.

4.2.6 the quality department shall fill in the notice of measuring tool periodic verification for the expired measuring tools according to the arrangement of measuring tool periodic verification plan, and notify the measuring tool using department, and the quality department shall submit the inspection or self-inspection on time.

4.2.7 for the self-verification projects (internal laboratories) of our company, the verification personnel must be trained by the superior competent department to obtain the qualification certificates of the verification projects they are engaged in.

4.2.8 a copy of the qualification certificate of the verification unit (external laboratory) submitted for inspection, including its scope, shall be kept.

4.2.9 the quality department shall keep the calibration/verification records of the calibrated measuring tools, and the quality department shall mark the "certificate of conformity" of the measuring tools, which shall indicate the qualification period and the number of the original certificate on which it is based.

4.3 management of unqualified monitoring and measuring equipment

4.3.1 when the operator finds that the monitoring and measuring equipment is invalid under any circumstances, he should immediately stop using it and hand it over to the quality department for treatment, and can only use it after it is confirmed to be qualified.

1.1.1 For the unqualified measuring equipment, the Quality Department shall take the following measures and keep records:

a Mark the unqualified measuring equipment or leave the use site;

b evaluate the validity of the previous measurement results and take corresponding measures for the suspicious products measured in the past;

c inform customers of the suspicious products that have been shipped and take follow-up measures.

4.3.3 The self-made measuring tools that can be repaired by this enterprise shall be repaired by the Quality Department according to the Tooling Control Procedure, and the measuring tools that cannot be repaired by this enterprise shall be contacted by the Quality Department for external repair. The repaired measuring tools shall be verified according to the requirements of 4.2.

4.4 Use of monitoring and measuring equipment

4.4.1 Operators should use monitoring and measuring equipment correctly and calibrate it before each use.

4.4.2 when the operator finds that the measuring equipment has no serial number, no qualified mark, over-period and failure, he should report to the quality department in time.

4.4.3 The operator must regularly maintain the measuring equipment and prevent the adjustment that will invalidate the measurement results.

4.4.4 when the post personnel change, it is necessary to go to the quality department to handle the device handover formalities in time.

4.4.5 the quality department is responsible for taking back or sealing the idle equipment from the site, and it needs to be re-used.

4.4.6 For scrapped monitoring and measuring equipment, the Quality Department shall put forward the Equipment Scrap Sheet, which shall be scrapped after being reviewed by the Technology R&D Minister and approved by the Deputy General Manager, and the Quality Department shall be responsible for marking the scrapped equipment or evacuating it from the use site.

4.5 calibration/verification records

The quality department shall keep records of all measuring tools, measuring and test equipment according to the Record Control Procedure:

a Modification according to engineering changes (if applicable);

b any reading that deviates from the specification when receiving calibration;

c description of compliance with specifications after calibration;

d record of notifying customers if suspicious materials or products may have been shipped.

5 reference file

5.1 equipment control program

5.2 tooling control program

5.3 record control program

6 record

6.1 measuring tool purchase application form

6.2 equipment unpacking and acceptance record sheet

6.3 monitoring and measuring equipment account

6.4. Measuring tool periodic verification plan

6.5 Measuring tool periodic verification notice

6.6 Measuring tool scrap list