2. 1 When auditing the key points of 4.2.4 quality record control, what relevant records can the auditor verify to prove their compliance (more than three)?
Looking at the standard text, there are many record requirements, such as management review records, training records, customer requirements review records (contract review), and planning requirements records in the process of product realization. Generally check the records in the realization process, such as the input, review and verification of development, the confirmation records of the process that needs to be confirmed, the verification records of solid and measuring equipment, and the control records of nonconforming products.
2.2 Please answer the common checkpoints when auditors review the key points of 8.2.2 quality system audit.
According to the standard terms, check the audit plan, audit plan, audit scope, auditor himself, audit record and audit conclusion, and track the rectification of nonconformities.
2.3 Please briefly answer the requirements of 4.2.3 Document and data management.
Press a)~f) of 4.2.3.
2.4 Please briefly explain the differences and connections between management audit and internal quality audit.
Difference:
Top management should organize management review to check the suitability, adequacy and effectiveness of the system;
The purpose of internal audit is to check the conformity and effectiveness of the system.
Contact person:
The result of internal audit is the input of management review.
2.5 Please briefly describe the difference and connection between nonconforming product management and corrective and preventive measures.
Difference:
The main purpose of nonconforming product control is to prevent misuse of nonconforming products.
The purpose of corrective and preventive measures is to prevent the recurrence of errors or potential errors.
Contact person:
The management of unqualified products provides opportunities for corrective and preventive measures.
Three. Case analysis: (7 points *5=35 points)
3. 1 The auditor randomly selected four employees in the design, quality control and production departments of the company. One of them answered that the company's quality policy was completely correct, the other was in the wrong order, and one answered the part correctly, and the other didn't know at all.
Please analyze:
4. 1. 1 does not meet the requirements, procedure 5.3 d)
Reason: 5.3 Quality policy d) requires communication and understanding within the organization;
4. When recording1.2, the auditor shall record the following contents:
According to the requirements of the checklist, record the time, place, personnel, facts (talks, observation and other means) and evaluation related to the inspection terms. ; Pay attention to the unique identification of traceability.
3.2 When the auditor checks a design surface, he finds that there is a change, but only when the change is made, the signature of the person in charge of the change is not. Excuse me:
4.2. 1 does not conform to Article 7.3.7 of this Regulation.
4.2.2 When recording, the auditor shall record the following contents:
Department, audit time,
When checking a design drawing (drawing number), it is found that there are changes, but only the time (year, month, etc.). ) signed by the person responsible for the change.
Does not meet the logo. wait for
3.3 The auditor found that an operator had a caliper at the job site without a label, but it had the company's property number. Please determine whether there are any nonconformities, such as
4.3. 1 If it does not meet the requirements, it will not meet Article 7.6 c) of the regulations.
4.3.2 Conformity and reason: 7.6 of a certain standard requires that the measuring equipment c) can identify to determine its calibration status;
4.3.3 It is impossible to judge, but it needs to be verified: if you are more careful,
Ask whether the calipers have measuring function in actual operation. If not, it is only used as a backing for drawing lines and can be ignored.
In addition, when asking about the marking method, is it stipulated that it is not suitable to mark the caliper, but to use other suitable methods?
3.4 The auditor requires the operators engaged in the test to demonstrate the monitor's work before taking up their posts and start the test. Are there any discrepancies, such as
4.4. 1 exists, which does not conform to the procedures and regulations.
4.4.2 does not exist, reason:
4.4.3 Unable to judge, but need to verify:
Inquire about the effectiveness of the test operation.
3.5 The auditor finds that nonconforming products are stored in the warehouse together with qualified products and products to be inspected, and the warehouse keeper replies that these products should be identified. There was no misuse, but the position was insufficient and the company's top management knew it, and it was not pointed out that it should be improved. Are there any discrepancies, such as
4.5. 1, exists, does not conform to the procedure, article 7.5.3.
The organization shall identify the state of the product according to the monitoring and measurement requirements of the whole process of product realization.
4.5.2 does not exist, reason:
4.5.3 Unable to judge, but need to verify: