Interpretation of the "several issues" encountered in quality management work?

The author has worked in quality management for more than thirty years and has encountered many quality issues. To solve these problems, continuous learning, understanding, and implementation of standards are required. By formulating procedural documents, a work process can be standardized and normalized. However, in actual work, we often encounter employees and managers who raise various questions that cannot be answered by the standards and procedural documents, as well as viewpoints they believe to be correct. These questions and viewpoints affect the normal operation of the quality management system and bring some resistance to quality management work. Today, several questions and viewpoints are listed here to explain my own views or "answers" in order to clarify these issues and ensure the normal operation and effectiveness of the quality management system.

1. The company has passed quality system certification, so why are there still product quality problems?

Quality management system certification is a management certification, not a product quality certification. More simply put, it is a promotion of management philosophy and methods. The ISO9001 standard clearly states that implementing this standard is to "confirm the ability to consistently provide products that meet customer requirements and applicable legal and regulatory requirements." The term "ability" is emphasized here; having "ability" is a guarantee but does not ensure that the produced products will definitely have no problems. When assigning a task or job in daily work, it is always assigned to capable people; in project bidding, projects are awarded to qualified and capable engineering units. But even so, some problems are inevitable. Obviously, having "ability" can only reduce risk, not eliminate problems.

Objectively speaking, companies that have passed quality system certification have their quality management work continuously standardized, and their product quality is "guaranteed," with a relatively low risk of quality problems.

2. If a product has quality problems, it means the quality department did not do its job well.

Many people hold this view, and it also exists among some senior managers in enterprises. Take a close look: the production process of a product includes multiple stages, and if there is a problem in any stage of the product formation process, it will affect the physical quality of the product. In the early 1980s, China learned from Japan and promoted total quality management, which essentially aimed to solve this problem. Therefore, we often see or hear phrases like "the quality of people determines product quality" and "quality is character."

The quality management department is a functional department responsible mainly for implementing quality management standards, promoting quality management methods, and supervising the operation of the quality management system. The implementation of quality control depends on each process to carry it out and ensure it. If an enterprise holds the view that "if a product has quality problems, it means the quality department did not do its job well," it indicates that our quality management work is still at a primary stage and there are major issues in understanding, requiring continuous learning and improvement.

3. Internal quality audits are conducted every year, so why are there still so many problems every year despite annual audits?

Conducting internal quality audits is a means to maintain the effective operation of the quality management system. Enterprises use this regular audit to discover problems in the quality management system and correct them promptly. There are five reasons why problems persist despite annual audits: first, enterprises consist of multiple units and a certain number of employees, so violations of procedures are inevitable during execution, only differing in quantity; second, problems found in previous audits were not properly rectified and lessons were not learned; third, the quality management department does not closely manage the internal audit work, the audit depth is insufficient, and supervision and assessment of rectification and effectiveness are lacking; fourth, employees and department leaders change and are unfamiliar with procedures, making problems likely; fifth, internal audits are supervisory inspections using sampling methods, so it is impossible to audit all processes, which carries some risk.

For a specific enterprise, the reasons are diverse. Based on the above situations, annual internal audits will definitely find problems, but it is necessary to control the occurrence of basic and repetitive quality issues.

4. The "Quality Manual" and "Procedural Documents" have passed audits during certification, so why must they be audited and have modification suggestions during supervision and inspection?

We did not understand this question before and even questioned it. After multiple communications with certification bodies and years of practice and experience, we understood. The reasons are as follows: first, auditors have different understandings of the standards; each auditor has their own views on the standards, so when one auditor audits a company's "Quality Manual" and "Procedural Documents," there are inevitably imperfections; second, over time, everyone's understanding of the standards has deepened, some previously unclear points have become clear, and some past understandings may need correction; third, the audit process is a continuous improvement process, and re-auditing the documents ensures dynamic management and improves document quality. In fact, this is the same principle as enterprises making appropriate modifications to the "Quality Manual" and "Procedural Documents" in daily practice.

Every enterprise should cherish the audit comments on the "Quality Manual" and "Procedural Documents" during supervision and inspection, as these comments are more targeted and closely aligned with the enterprise's actual situation. Implementing these comments is very important for improving document quality and maintaining the effective operation of the quality management system. It is also a process for our internal auditors to learn and improve.

5. For enterprises certified by the quality management system, why do different practices exist for the same clause of the standard?

There is a principle here: the quality management system standard specifies "requirements," not "practices." The standard does not require uniform practices; enterprises determine suitable practices based on their actual situations, as long as the "requirements" are met.

Some enterprises like to look at the practices of certified enterprises when undergoing quality management system certification. This idea and approach are understandable, but it must not be copied rigidly and must be combined with the actual situation of their own enterprise. The actual situation includes product industry, scale, production process, personnel quality, corporate culture, etc. Only quality documents formulated based on actual conditions are operable.

Some enterprises, when encountering problems in the operation of the quality management system, like to compare themselves with certified enterprises in the same industry to find justification or reasons. In fact, this is not comparable and not a basis. This phenomenon is especially obvious in the allocation of quality responsibilities. For example, one enterprise assigns the "management review" work to the quality management department, while another enterprise may assign it to the company office; one enterprise assigns supplier evaluation to the supply department, while another assigns it to the quality department, and so on.

6. For the same quality work, one auditor issues a nonconformity, but the next auditor says it is not a problem.

This phenomenon occurs during supervision audits, and sometimes enterprises are at a loss and cannot tell which statement is correct, sometimes revising a document back and forth. The reason still comes down to differences in auditors' understanding of the standards.

Currently, certification bodies continuously train auditors to improve the accuracy of their understanding of the standards. At the same time, for such issues, certification bodies have established a principle: do not classify issues still debated or discussed in academia as nonconformities. If a nonconformity issued is disputed by the enterprise, it should be further verified or canceled. One should not impose their own or their organization's practices on the audited entity.

7. If there are many problems in certification audits or failure to pass, the reason is that the auditors were not properly received.

This view generally does not exist in large enterprises but is common in some small enterprises. The reason for this misunderstanding is a lack of understanding of the certification process and nature. Certification audits are third-party audits; the enterprise and certification body have a contractual relationship (certification is charged). It is not a superior-subordinate relationship, nor an inspection team formed by a higher authority that passes the audit by listening to reports and inspecting the site. Whether certification is passed depends on the standards, factual evidence, issuance of "nonconformity reports," and preparation of "audit reports." It is not something determined by one person.

The National Certification and Accreditation Administration has clear disciplinary requirements for certification bodies and auditors. At each certification audit, the audit team leader must announce the audit discipline and the company's complaint channels. Companies provide a written evaluation of the auditors and submit it to the certification body. These measures are sufficient to ensure the fairness of the audit, and there is no situation where "there are many certification audit problems or failure to pass because the auditors were not properly received."

8. Why are there so many problems during mass production when product design finalization was said to be problem-free?

Under the current situation where product development and production run concurrently, this situation indeed exists, and many companies and users have experienced it. The main reasons for this situation are: first, the production quantity during the development process is small, so some problems may not have been exposed; second, products during development are generally assembled and debugged by technical personnel, who directly handle some issues themselves; third, the program execution during development is not thorough, and some testing and verification work is not fully completed; fourth, there are inherent problems at the design finalization stage, and in the rush to finalize, issues are left unresolved. These problems directly affect the physical quality and reliability of the product and cause considerable trouble for users. Strictly following procedures and fully exposing and resolving problems during small batch trial production is the fundamental way to avoid these issues.

Clarify and answer these questions so that we can correct our attitude towards quality management work, overcome previous incorrect views and ideas, smoothly carry out quality management work, ensure the effective operation of the quality management system, and ensure the improvement of the product's physical quality.