Key points in the operation of laboratory CNAS and CMA certification and accreditation system

Date：2022-12-16 14:38:26Views：406

Internal audit is a systematic and regular audit of the compliance, suitability and effectiveness of the system operation to ensure the self improvement and continuous improvement of the management system. The management review is the formal evaluation of the current situation and adaptability of the quality system by the top management of the laboratory on the quality policy and objectives. This paper collects and sorts out some materials, hoping to be of great reference value to all readers.

Part I Problems in the Internal Audit of the Laboratory

The key for the laboratory to do well in the internal audit of the management system lies in the leaders' attention to the internal audit and their quality awareness. The person in charge of quality shall personally take charge of the internal audit, especially the important management means and improvement mechanism of internal audit, so as to maintain and improve the system. Based on years of experience in quality management, the common problems in the internal audit of the laboratory are analyzed as follows:

1. No plan:

The typical performance is that the annual plan or specific internal audit work plan is not formulated according to the requirements of the procedure documents.

2. Inadequate understanding of internal audit by leaders:

Internal audit was not used as an important channel for each department and staff of the laboratory to reflect their opinions on quality management issues to the management, resulting in the internal audit becoming a mere formality.

3. Unclear purpose:

It is manifested in the weak quality awareness of some laboratory staff. On the one hand, they think that internal audit is to find faults, so they do not cooperate with the work; On the other hand, he thinks that the internal audit work is unnecessary, irrelevant to himself, and is the responsibility of the quality management department, so he has to deal with it, which greatly reduces the effectiveness of the implementation of the internal audit work.

4. Inconsistency with internal audit procedure:

The quality manual and procedure documents stipulate that the person in charge of quality shall be responsible for internal audit and approve the internal audit plan and internal audit report. However, in actual operation, the top management shall be responsible for and approve the internal audit plan and internal audit report, and the implementation is inconsistent.

5. The internal audit checklist is not prepared, or different inspection teams use the same checklist at the same inspection time and sign:

There is no record of the internal audit work, or the records generated by different internal auditors at different times and in different departments are filled in the same record, which is illogical and is suspected of being tracked down after the event.

6. The internal audit did not conform to the facts, was improperly described, and could not be traced:

This is a problem in many laboratories. For example, a non conformance item is described as "the record has been altered", which cannot be verified.

7. Failure to cover the whole system (such as management) or failure to cover all elements within one year:

Many laboratories mistakenly believe that only the testing department and support department are audited, and the top management, technical director and quality director do not need to be audited. Or only part of the elements were reviewed within one year, which failed to cover all the elements of the management system.

8. Corrective measures for some nonconformities remain on the surface of error correction:

If the report numbering is not carried out according to the numbering rules, during the rectification, only the wrong numbered report is simply corrected without organizing relevant personnel to study the document and strengthen supervision.

9. When analyzing the causes of non conformities, only objective causes should be found, not subjective causes:

For example, the reason for "the method and standard used are not updated" is analyzed as "too busy", rather than finding subjective reasons, not paying attention to the idea, and not working according to the document requirements.

10. The internal audit report does not evaluate the rectification effect of the last internal audit, nor does it evaluate whether this time has made progress.

11. The nonconformities found in each internal audit are the same or similar:

Some laboratories do not attach importance to the internal audit work at ordinary times. When encountering external audit, they hurriedly supplement relevant internal audit materials and use the internal audit information of previous years. They do not know that this will lead to more serious nonconformities, that is, the corrective measures taken for the rectification of previous nonconformities are invalid.

12. The office automation system is not used, but it is printed from beginning to end, which is illogical.

For the nonconformities found in the internal audit on March 1, the cause analysis was carried out on March 3, the corrective measures were taken on March 10, and the rectification was completed on March 30. However, all the records were printed on the form and signed manually, which was obviously illogical.

13. Inconsistency between internal audit basis (such as relevant criteria) and document provisions

The preparation of the internal audit form, the audit basis in the internal audit plan and the preparation basis of the system documents are inconsistent.

Part II Problems in Laboratory Management Review

The management review is to determine whether the laboratory management system and all the processes and results of the testing activities covered by it meet the continuous suitability, sufficiency and effectiveness specified in the quality policy. The laboratory uses the quality policy, quality objectives, audit results, data analysis, corrective and preventive measures and management review to continuously improve the effectiveness of the management system. Generally, the management shall organize a management review once a year, and additional management reviews can be conducted when there are changes in the positions of important personnel, institutional adjustments, etc. Based on years of experience in quality management, the author now analyzes the common problems in the laboratory management review as follows:

1. No plan; Typical situation:

The annual plan or specific work plan for laboratory management review was not formulated according to the provisions of the management system documents.

2. Management review without written materials:

According to the input requirements of management review and the requirements of relevant procedure documents, functional departments shall submit written materials as the basis for management review, but the laboratory only has the final report of management review.

3. The quality objectives are unrealistic and the short-term objectives cannot be achieved.

For example, one of the goals is that all testers will evaluate and analyze the uncertainty, but in fact, only a few testers may evaluate the measurement uncertainty in a short term. During the management review, the completion of quality objectives was not analyzed: if the objectives were feasible, why could they not be achieved? If the goal is unrealistic in the short term, should it be feasible?

4. Incomplete input (if quality supervision is not considered):

If some laboratories only consider the internal audit work, quality policies and objectives, it is not consistent with the implementation.

5. No description (or report) of various management information

The laboratory did not consider the records of relevant management work, such as subcontracting, suppliers, training, etc., and did not evaluate or report.

6. The improvement suggestions put forward in the last management review were not considered, so that the improvement situation and effect could not be known.

7. The conclusions are all valid and need no improvement:

It does not rule out the possibility that the management's quality awareness is weak, resulting in the laboratory's failure to truly use management review as an effective quality means to improve quality.

8. There are improvement requirements, but no one follows up:

It is manifested as non conformance of implementation, that is, it is not tracked according to the requirements of the procedure documents and closed loop management is implemented.

The above contents are related to the CNAS and CMA certification and accreditation of the laboratory organized by the Core Trauma Testing Department. I hope they can help you. Our company has a team of professional engineers and industry elites, and has built three standardized laboratories with an area of more than 1800 square meters, which can undertake a variety of test projects such as electronic component test verification, IC authenticity identification, product design material selection, failure analysis, functional testing, factory incoming material inspection and tape weaving.