Three words to summarize the quality management system – brilliant!

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Three words to summarize the quality management system – brilliant! 2016-12-04 Quality and Certification If you were to use a few keywords to summarize the quality management system, what would come to mind? A colleague with 13 years of experience in quality management has identified three key principles: \"retreat,\" \"practicality,\" and \"detail,\" which is truly impressive. Counting the rings, I have been working in quality-related fields for 13 years, during which it was inevitable to encounter some conflicts related to quality system management. At first, quality management systems were very popular, and I wanted to become an auditor as well, so I started learning*. At that time, our quality department manager told us that to understand things, we first needed to memorize the system requirements! From then on, I spent day and night going through the clauses, memorizing 20 of them thoroughly (they were from ISO9001 version 94). In the end, it was given up for other reasons, which is certainly a pity. In 2005, when I became the manager of the quality department, I was responsible for organizing internal audits and dealing with external audits, which led me to truly understand the specific requirements of the quality management system. It was then that things became clear to me; I seemed to really grasp the requirements and methods of quality management. But the good times didn’t last long; the circumstances around me once again left me confused. During those years, private enterprises grew rapidly, with little accumulated management experience; their understanding of systems consisted of documents, records, and certificates. Moreover, many auditing agencies abandon their auditing principles for the sake of securing business deals; a factory with over a hundred employees can be fully audited in just two hours – a single photo is taken in the workshop, and the audit fee is collected along with the certificate. Some even try to please the companies in order to get business... It’s increasingly hard to understand what’s going on with quality management systems In 2007, I joined a pharmaceutical packaging company in Shenzhen. Since the company adopted management systems typical of pharmaceutical enterprises, and it dealt with companies that also followed strict management standards, quality system management received significant attention from the company’s top management. Almost all requirements related to improving system management were approved by the boss. As a result, within less than two years, an effective system framework was established. Although it wasn’t highly detailed, it functioned smoothly, and quality complaints also decreased significantly thereafter. This time, it really made me respect quality system management. Over the years, as the Quality Department manager, I have also served as the company’s management representative, responsible for the operation and maintenance of the system. But aside from that pharmaceutical packaging company of which I am proud, the systems in the other companies do not receive the respect they deserve; my role is merely to prepare some internal audit documents each year to deal with external audits. Out of helplessness, I suddenly realized one thing: why must system management be treated as a separate task? While it enables approval and the acquisition of certificates, it also serves as a management tool! It can be applied flexibly just like other management methods; there’s no need to follow them exactly as they are. After coming to that realization, I, who had been devoted to the study of management methods over the past few years, became motivated again; after some time, I was able to figure out some techniques. Three key principles—\"retreat,\" \"solidity,\" and \"detail\"—have been identified, which can be regarded as the basic concepts of the \"Li-style system management.\" 01 Progress through improvement is success. Nowadays, the system management in most companies focuses on preparing for audits in order to obtain a certificate that proves the company’s \"quality assurance capabilities,\" with little effort being put into proper implementation in daily operations. Moreover, system management does not yield immediate results like athletes using performance-enhancing drugs; it takes some time for its effects to become apparent, which is why so few people support it. Think about it – it’s far too difficult to change their views and work habits*. Therefore, by lowering the requirements, the system requirements are broken down into several smaller ones; some goals that are less difficult to achieve and will yield results more quickly are selected, allowing for implementation in stages from easier tasks to more complex ones, thereby increasing feasibility. Making progress is success! This is what is known as “retreating”. In this company today, the mixing process is a very crucial step. To strengthen and standardize the management of the mixing process, all factors that affect quality were analyzed, resulting in the identification of nearly 30 control points. Since it was difficult to make changes to all of them, priority was given to controlling a few key aspects, such as \"verification of the first batch of materials added, adding materials in sequence, and cleaning magnets.\" After adhering to these practices for 2 months, the employees gradually developed good habits, and the number of problems decreased by almost 30% – which is an excellent achievement. If one truly understands the system requirements as required by the system itself ； \"Execute everything as required and keep records of the operations.\" Those operators who haven’t even finished elementary school and are constantly busy either get extremely anxious or are unable to switch jobs right away; this is why stepping back is important. You can’t eat an elephant in one bite! “The concept of “retreat” is also reflected in the methods I use; I have always adhered to the “acute angle theory”. I’m not sure if anyone else has proposed it, and if not, then I am the founder of this theory. By applying the theory of acute angles, taking retreat as a means to move forward and achieving goals step by step is determined, on the one hand, by the actual situation of the enterprise; more importantly, it is due to my lack of a strong personality, and it may not be applicable to others. However, based on past experience, the results have been fairly good. 02 Solving Practical Problems: The principle of \"practicality\" means that the operation of a quality management system should be grounded in reality rather than being superficial, with solving actual problems as the starting point. This approach aims to change the perception that such systems are merely ornamental and superficial, thereby creating opportunities for the advancement of system management. In this regard, it is necessary to identify the problems that arise within enterprises or processes, determine their true causes, and the preventive measures for such causes are generally specified in the system. By analyzing these problems, one can explain the rationality and necessity of the system’s requirements, thereby helping people understand the significance of them. Since these requirements are directly related to their own interests, people are generally willing to accept them, and over time they become supporters of system management. In this company now, people were previously required to review orders in accordance with the established system in order to ensure quality and on-time delivery, but no one paid attention to it, thinking, \"Can signing a name on a piece of paper really solve the problem?\" ”It’s too pointless; no one wants to do it – at most they just sign their name, without even reading the content. Of course, the order review form at that time didn’t specify any detailed requirements either; it was just a form. Due to inaccurate evaluation information, the production plan became meaningless; adjustments had to be made continuously during implementation, preventing the capacity from being utilized, and even leading to delays in deliveries – no matter how much effort was put in, it was of no use. Last year, we organized a review to refine the order evaluation form – what aspects should be evaluated at each stage? How to deal with problems? It has been made clear that everyone is required to take responsibility for the signatures they put on. Such as, \"Are all the materials available? What is missing?\" When will it arrive? What quality issues were there to be aware of in the past? ......”After more than half a year of actual operation, although some aspects have not yet been fully implemented, the feasibility of the plan has improved significantly. With no changes in personnel or equipment, the production capacity has increased from around 80 tons per day to around 150 tons per day at present. Everyone’s output-based wages increased suddenly; at such a time, when discussing the necessity and importance of order evaluation, how many people would object? Solving practical problems and creating management opportunities are another powerful tool of system management. 03 Simplify complex things through attention to detail. “Attention to detail” refers to the need for thorough preparation in a quality management system in order to ensure that a requirement or regulation is fully implemented. Everyone has their own understanding of management, and most people agree that management entails \"organizing/planning, coordinating implementation, monitoring and supervision, and improvement.\" My understanding of management is to turn abstract concepts into something concrete ； Simplify complex things. To achieve this, being \"specific and detailed\" is particularly important. After all, everyone’s capacity to accept and understand things isn’t exactly the same; if we want everyone to agree on a particular direction, we can’t give them any chance for misunderstandings regarding the product. In the company’s “Change Management Procedure,” it was originally stipulated that “when there are significant changes in personnel, machinery, materials, methods, or the environment, relevant applications and approvals should be submitted through change orders...” So what constitutes a significant change? What if it’s not a major change? It is inevitable that different interpretations will arise, which can affect efficiency at the least, and lead to quality issues at the worst. Therefore, I prepared a \"Change Approval Checklist,\" gathered everyone together, listed all possible changes, defined each one individually, and specified the handling procedures for each. In this way, there are no more ambiguities; what remains is to carry it out. I believe that quality is achieved through control; we have strengthened quality inspections during the process, requiring that factors that affect quality be identified and corrected. Having all inspectors learn about * and understand the factors that affect quality may not be achievable even in half a year. All the possible influencing factors were listed – there were over 80 of them in total – and they were compiled into an inspection form. All they had to do was go through each step one by one, checking off “√” or “×” in the corresponding fields; everything could be completed within a week. We can be even more “detailed” in what we do! Here, I can only summarize my own limited experience. Of course, there are many more effective approaches to managing a quality system; as long as one delves into it thoroughly, insights will surely be gained. I believe a method that suits me better can be found. Under no circumstances should you be misled by the need to obtain certificates, conduct internal audits, or pass external audits; this is nothing more than a \"conspiracy\". Once you truly put the system into operation in conjunction with the actual business activities of the company, the company will soon reap the benefits. May those who are committed to system management continue to thrive!