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Recently, I wrote several articles on the quality assurance systems for special equipment. I would like to state in advance that, due to my limited expertise, the views expressed in these articles represent only my own opinions; if there are any inaccuracies, I welcome feedback from those with more knowledge. Below, I would like to share some personal views on the ad hoc document. This text will be structured in accordance with the sequence of TSGZ0004; please let me know if there are any errors. (1) The system is a quality assurance system, not a quality management system. Generally, when special-purpose enterprises prepare such manuals, they call them quality management manuals or simply quality manuals; I believe this is not very accurate, as quality management is referred to as QM, while quality assurance is QA. Therefore, the correct term should be quality assurance manual, unless the enterprise follows the GB/T19001-2008 standard. Furthermore, Article 1 of TSGZ0004 (hereinafter referred to as 0004) makes it clear that it deals with a guarantee system, not a management system; quality assurance is merely one aspect of quality management. 2. According to the definition in GB/T19000-2008, 3.2.8 states that quality management includes quality assurance (check the standard yourself). 3. The 9000 series focuses on comprehensive management, while 0004 deals with process management. To put it simply, the 9000 series covers even operational aspects, whereas 0004 only concerns processes. As long as you meet these basic requirements, ensure that the quality is satisfactory and complies with regulatory standards, and no problems arise, that’s enough. As for whether the market will eliminate you or not, what does that have to do with the requirements? (Comments are welcome.) The 0004 system is an extension of process management in 9000 – do you agree? During the last review, I said this to the reviewer; he disagreed, but was unable to give any specific reasons. (II) It is clearly stated in Article 3 of 0004 as to what principles should be followed in establishing the system. There are eight principles in total. In previous articles, I have also analyzed the differences between ad-hoc systems and the 9000 system. The first of the eight principles of 9000 is to focus on the customer; ad-hoc systems, on the other hand, emphasize compliance with legal requirements. Thus, the first principle among these eight is to comply with laws, regulations, safety technical specifications, and relevant standards. It’s not true that the more system documents there are, the better – it’s not about simple copying either; what’s important is that these documents must suit the actual conditions of the organization. In fact, having participated in many audits, I know that the so-called system documents used by small companies are nothing but pretenses; they are not actually implemented at all, serving only as a formality (with the exception of large companies). Perhaps it’s because authorities are aware that 9000 standards are not being followed that they came up with standard 0004. One more thing to note: if the system functions properly, it can be quite useful. 2. The difference between a quality manual and procedure documents: The definition is clearly stated in GB/T19001-2008, so there’s no need to repeat it here. In simple terms, the manual tells you what needs to be done, while the procedures tell you how to do it. (3) How to prepare special documents: 1. Try to follow the sequence outlined in 0004. I’ve seen many manuals; the process of preparing them usually involves a manager assigning someone to take care of it. This person often doesn’t know where to start, so they look at how others have prepared such documents, downloading them from websites like Baidu Wenku, Daokebaba, Sina Ask, Docin, etc., changing the name slightly, and then completing the task. This approach is completely wrong, because the files you download from the Internet are mostly still in the 9000 range (or modified from that value). The special reviewers also tend to prefer values around 9000 (the reason isn’t explained; you need to figure it out yourself). So, there are serious problems with this approach. 2. Try to write according to the terminology of 0004. How should this be understood? There are many such examples; let’s mention a few briefly. (1) There is a cover and a manual titled \"Quality Manual\" – but when was the term \"Quality Manual\" mentioned in 0004? Look at 2.1, the Quality Assurance Manual. Where does the concept of a quality manual come from? Refer to GB/T19001-2008 4.2.2. Is there a difference? It’s already been explained above. Taking file and record control as an example, there are various terms used for this; some call it file and documentation control, others call it simply file control, etc. None of these are correct. Look at 0004, the third element. There’s no such thing as file and document control at all – who came up with this? File control is also incorrect; this concept comes from 4.2.3 of 19001. Some people ask whether this is important – of course it is. First, it allows one to immediately tell if something has been copied from 9000. Second, it helps prevent neglect of record control. What does this mean? Well, this third element involves two aspects: file control and record control. Some manuals and procedures do not even mention record control! I have seen it before. (3) Taking document and record control as another example, how is 0004 written? 14 aspects: preparation, joint review, approval, labeling, distribution, modification, retrieval, collection, purchase, receipt, storage methods (for external documents), storage facilities, retention period, and destruction. If it’s not written in your manual, then it must have been modified based on 9000. It is recommended to check each element to see if it is written according to the terms and order of 0004 3. How to distinguish between manuals and procedures ； A manual is a concise document that provides an overview; procedures, on the other hand, specify how things should be done and are documents that need to be written in detail. If the manual is written in excessive detail, how can the procedures be written? Is that the reasoning? Below is a summary of the elements that are easily overlooked in each category. 1.1 In terms of management responsibilities and 1.1 quality policies and objectives, such a quality policy should mention at least two points: safety and continuous improvement. Quality goals should be allocated to departments, with specific allocation documents and statistics on completion status. It would be best to have a specific explanation, such as what goals were set at 95%, what the numerator and denominator are, how the calculation is done, and which department is involved If it doesn’t meet the standards, it cannot be issued to anyone. There are also corrective and preventive actions to be taken. Regarding the 1.2 Quality Assurance System Organization, two diagrams are required: one is called the Quality Assurance System Diagram, and the other is called the Organizational Structure Diagram. These two are different from each other. It seems inappropriate and not good to combine these two diagrams into one in a manual. 1.3 Responsibilities and authorities: It should be specified that the legal representative is responsible for safety and quality – do not forget this. Regarding the appointment of persons in charge of various quality control systems, it is sufficient to follow the specific safety technical specifications, or you can also use the evaluation criteria provided by the evaluation team. Do not appoint people arbitrarily, nor omit such appointments. For example, some companies appoint designated persons for standardization and for measurement – is this appropriate? My opinion is to look at the standards; are the standards proposed by Timuti? Is Timuti mentioned in the evaluation criteria provided by the review panel? If it’s mentioned, then setting it up is necessary; otherwise, what’s the point of mentioning it? Why look for trouble for yourself? I believe that, under any circumstances, the evaluation guidelines should take precedence. Regarding quality assurance engineers and technical supervisors, does 0004 mention the technical supervisor? No, the concept of a technical supervisor originates from the relevant regulations for special mechanical and electrical equipment. It doesn’t matter if you set it up, but be sure to coordinate the responsibilities and authorities of those two people properly (since signatures are involved, they can’t be signed carelessly). 1.4 Management Review: Just follow your management review control procedures. The requirements outlined in 0004 are quite simple – it’s sufficient to focus on three aspects: suitability, effectiveness, and adequacy. If an error occurs, it’s likely that the three aspects were not mentioned. In the terms and abbreviations section of the quality assurance system documents, I noticed that many manuals refer to the concepts of 19000 when explaining things such as what quality is and what constitutes a product. Is this necessary? You had better not mention the term and abbreviation 19000 here; it isn’t included in the basis for compiling your manual. Is it appropriate to introduce this concept in your document? In the basic elements section, 0004 includes a total of 18 elements; four of these can be removed. These are non-destructive testing, physical and chemical tests, heat treatment, and other controls (whereas \"other controls\" is clearly defined). The quality plan section is often overlooked – people either fail to include it or do not understand it. 4. Contract control: The scope of the contract is very important; which contracts must be reviewed? There are many types of contracts, such as purchase contracts, sales contracts, installation, maintenance, and renovation contracts. Are all these contracts reviewed? During contract review, it is essential to specify the applicable laws and regulations, safety technical specifications, standards, and technical requirements. 5. Design control: Items (5) and (6) are prone to problems; one issue is the lack of regulations regarding the control of external design documents, and the other is the absence of provisions concerning product type testing. 6. Material and component control: For suppliers for whom regulatory and safety technical specifications require administrative approvals, it is essential to verify their eligibility for such approvals. There are two types of administrative licensing requirements here: one is a manufacturing license, and the other is a report on type testing. For mechanical and electrical products, a single type testing report is not sufficient; the components must also be registered as having undergone type testing. Some companies produce components that have only been tested but not registered, and this is not acceptable. Regarding the evaluation of sub-suppliers, there is a time limit involved; it means that an evaluation needs to be conducted again, as it’s not possible to use the same evaluation results for decades. I’m also a bit confused about terms such as subcontracting, outsourcing, external collaboration, and outsourced labor services; I’ll leave this section blank for now. Once I find clear definitions, I’ll add them here. I’d also appreciate it if experts could provide additional information on this topic, preferably including standards, references, and the sources from which they come. 7 Operation (process) control: Process discipline is emphasized here; it is necessary in the manufacturing process, as well as in the processes of installation, modification, and maintenance – this discipline must not be neglected. The main issue with tooling and molds is that the following aspects have not been addressed: documentation, labeling, storage, regular inspection, maintenance, and disposal of tools and molds. 8 Welding control: Here, several updates to the standards are proposed; with changes to the NB standards, the weld evaluation criteria also need to change. 9.10.11 is omitted, as subcontracting is generally used; if no subcontracting takes place, the procedures can be followed as usual. As for evaluating the subcontractors, there is a time limit – an evaluation must be conducted again, as it’s not possible to evaluate them once and then wait for decades. 12. Inspection and testing control: (4) Control of inspection and testing conditions, including the location for inspections and tests, the environment, temperature, media, equipment (devices), fixtures, test loads, safety measures, supervision of tests, and verification processes. Some companies do not include this item; it should be added if necessary. 13. Control of equipment and inspection/testing devices: It is important to mention equipment records here; some companies lose these records, and this issue is difficult to resolve – one can only ask the manufacturer to provide them. If that’s not possible, then it’s necessary to maintain proper records of the equipment. 14. Control of non-conforming products: A common problem is that only a determination of non-conformity is made, without any actions taken regarding corrective measures for those non-conformities, such as their formulation, review, approval, implementation, and follow-up verification. This is not acceptable. 15 Quality Improvement and Services: Issues related to quality raised by quality supervision departments and inspection agencies, as well as activities such as the collection, compilation, analysis, feedback, and handling of quality information – these are not covered here and need to be added. A full internal audit should be conducted at least once a year. This recommendation is based on the principles outlined in GB/T190011; it can be simplified, as standard 0004 deals with this matter rather briefly. (3) Regularly collect and analyze data on the first-pass yield and the rate of products that require rework, and identify specific preventive measures ； (4) User services, including service planning, implementation, verification, and reporting, as well as the responsibilities of relevant personnel. These two items are easy to be overlooked; just make up for them. 16 Personnel training, assessment, and management (3) Management of the personnel required for special equipment licensing, including recruitment, secondment, and transfer out. There are many companies that have fallen through this process; be sure to add them in. 17: Other controls – there’s a concept related to this; take a look to see if it applies. 18: Implementing the licensing system for special equipment – (5) Providing relevant information; this is something that’s easily forgotten