Key Points for Writing Quality Management System Documents and Implementation Practices

The quality management system documents compiled by the CDC trace back to international advanced quality management standards/guidelines as their basis. These standards/guidelines summarize and refine the essence of quality management theories and practical experiences from countries around the world (including China), possessing advancement and scientific nature.

Quality management system documents usually include four levels, namely the "Quality Manual," "Procedure Documents," "Work Instructions," and "Record Forms." Establishing quality management system documents and conducting promotion and training before implementation are prerequisites for promoting quality management work.

This article discusses how to improve operability from details when writing quality management system documents, and also shares useful attempts on how to establish a long-term mechanism for promotion and training.

1. Points to note when writing quality management system documents

Pay attention to converting the terminology in standards/guidelines into plain language

After reading original texts such as ISO 9001 "Quality Management Systems — Requirements" and RBT/T-214 "General Requirements for Competence Evaluation of Inspection and Testing Institutions," one may feel that the terminology in these standards/guidelines is highly condensed. However, since they are translations from foreign languages, there are some specialized terms like "input" and "output." If these are directly quoted when writing quality management system documents, many people may find them obscure or say "I don't understand." Therefore, this issue must be taken seriously, and the terminology of standards/guidelines should be expressed in plain language to make it immediately clear to everyone. For example, the term "product" mentioned in ISO 9001, for the CDC, refers to "inspection and testing reports" or results generated after a service is completed and the evaluation by the service recipient. Therefore, when drafting quality management system documents, the term "product" should not be used.

Avoid rigidly copying the relevant requirements of standards/guidelines and their interpretations

The "interpretation" section of the guidelines, when explaining a particular clause, may require "establishing corresponding procedures." Some people believe this means an independent, standalone procedure document must be created. However, years of practice have shown that the "procedure" referred to here does not necessarily have to be a "procedure document"; it can also be represented by a "work instruction" level document. It does not have to exist independently and can be integrated with other procedure documents. If the content is extensive, the clause's content can be divided into two or more documents. Additionally, the understanding of certain terms in the guidelines should not be rigid or one-sided. For example, the term "sampling" in the guidelines is still referred to as "采样" (sampling) in some inspection and testing technical standards. Therefore, in our system documentation, we use the term "采抽样" (sampling). Another example is the term "complaint." The original obsolete version of the accreditation guideline was called "appeal and complaint," which required distinguishing between the concepts and meanings of appeal and complaint, often causing confusion. Fortunately, the current RBT/T-214 version has removed the term "appeal" and now uses "complaint" as a general term.

Ensure that the requirements proposed when compiling system documents are specific, clear, and operable

First, pay attention to the clarity of time limit descriptions. Initially, when compiling system documents, words like "timely" and "immediately" were often used to express the completion time requirements for a task. However, it was soon found that these words seemed to impose urgent requirements but actually did not. Executing parties often argued, "I started three days later, which I consider timely." After improvement, such words are now banned in all system documents, and specific requirements like "the same day" or "within 2 working days" are directly stated. This makes the requirements quantifiable, operable, and significantly enhances implementability.
Second, do not generalize or directly quote words like "should" or "may" from the original standards/guidelines. Instead, clearly state the requirements without ambiguous expressions of negotiation or suggestion.
Third, pay attention to detailed descriptions, such as the handover details when a task is transferred from one department to another, to avoid disputes caused by unclear responsibilities.

Make full use of the "Record Forms" level of documents

The fourth-level document of the quality management system, "Record Forms," records the processes and results of management system activities. It objectively and directly expresses the implementation status of the process node requirements proposed by procedure documents and work instructions. Some quality record forms have certain requirements for filling frequency and standards. In practice, departments often miss filling according to the required frequency. To help everyone correctly understand and use the forms, since 2010, we have tried to add and continuously improve operational content in the forms as "remarks." The remarks include who fills it, filling time and frequency, next flow node, etc., effectively improving the correct usage rate of the forms. This has become the simplest version of system documents and a good opportunity for their promotion.

Ensure there is sufficient time gap between the publication date and the effective date

If the publication date and effective date of a system document are the same, it is scientifically unreasonable. It is equivalent to suddenly imposing unfamiliar requirements without prior notice, causing confusion. Therefore, there must be a buffer period between the publication date and the effective date. This gap is reserved for promoting the document and preparing relevant personnel for its implementation. This gap also serves as a trial operation period for the document. For units implementing a quality management system for the first time, this period should be six months. For revised system documents, it can be one to three months depending on the situation. During this period, if it is a revision, all records that need to be archived should be from the previous version.

Pay attention to collecting employees' opinions and suggestions

The purpose of implementing a quality management system is to use advanced management methods to provide rules, guidelines, and compliance for various activities. However, the premise is to follow the standards/guidelines while finding a path suitable for oneself. The users have the most say in whether it is suitable and applicable. Therefore, we always value listening to employees' opinions and suggestions and actively collect them every year.
In the 14 years since the CDC was established, the system documents have been revised nine times, averaging a revision every two years. Many of these revisions were prompted by employees' opinions and suggestions. Based on practice, the documents were revised accordingly to improve flexibility and applicability, effectively linking the system documents with actual work and better fitting the unit's reality, thus achieving a high consistency between "writing and doing."

2. Promotion and implementation methods

We have always attached great importance to promotion and training, adopting a combination of centralized and decentralized, self-study and teaching, regular and irregular training methods, continuously exploring and improving.

Conduct promotion for all staff

Mainly used for promotion after system document revisions, organizing all staff for centralized lectures, using half a day to one day to inform everyone of the main revised content, then requiring departments to organize their own training.
This large-class method has a big scene and strong atmosphere, enabling all staff to quickly know about the formal operation after revision. We often used this method before 2014.
The drawback is that the training process lacks interactivity, the content is not rich, and training evaluation is difficult, with the overall form outweighing the content.

Carry out competition activities

This method is also one we frequently used in the early stages, with various forms: first, a closed-book exam for all staff, with center leadership participating and ranking departments and individuals based on scores; second, on-site competitions grouped by departments under the supervision of respective leaders, with preliminary rounds followed by finals, using rounds such as mandatory answers, quick responses, and timed questions to determine winners; third, on-site Q&A for middle management, where under effective isolation conditions, middle managers are questioned and scored on the spot one by one; fourth, on-site quiz for all staff, with participants randomly selected by department under the supervision of leaders, scores recorded and announced on site.

This method allows participants to conduct systematic and concentrated intensive study of the system documents and master the relevant content. The atmosphere of on-site competitions is tense and lively, which can stimulate departmental participation.
The drawback is that since it is a short-term intensive study, the learning behavior ends once the activity is over.

Carry out leadership team-led system explanation activities

We have used this method many times. Members of the leadership team divide and prepare important procedural documents for teaching. The unit's top leader also actively participates, personally lecturing all staff or middle-level managers and above. This reflects the leadership's emphasis, improves their mastery of system documents, and stimulates the initiative of middle managers with management potential.
The drawback is that this method basically belongs to all-staff promotional training.

Carry out self-study within departments

This method has always been required and written into procedural documents. The concept is very good; some departments adhere to it well, and the overall management level of the department has continuously improved accordingly.
The drawback is that execution quality varies; some departments do not genuinely engage in it, and without doing it, there will be no effect.

Carry out "Weekly Lecture" to form a long-term mechanism

The first three methods above are short-term, one-time training methods; if not maintained long-term, the effect will be impacted. The fourth method, "self-study within departments," is a better long-term behavior, but we found many departments execute it poorly. Therefore, in 2017, we proposed the requirement of "Weekly Lecture" for department management system documents. The department head leads the lectures, everyone must lecture, with regulations on frequency (once per week during department meetings), content (each department makes an annual plan ensuring comprehensive study), method (three-step approach: first state requirements, then check execution deficiencies, finally set corrective measures), and records (recorded in department meeting minutes and personal notes for review). The office is designated to conduct monthly in-depth assessments of departments (the unit's top leader has also led teams to inspect departments multiple times). Assessment methods include checking study records and randomly questioning department staff on site, forming a long-term mechanism for system document study, greatly improving all staff's mastery of system documents.

The drawback is that if assessments are not consistently maintained, some departments may not persist.

3. Discussion

Regarding the writing of quality management system documents

1. Operability is the vitality of quality management system documents

All quality management system documents should be written so that after reading, employees know what to do, how to do it, and to what extent it is considered qualified. Such system documents are operable. Highly operable system documents are practical and effective, bringing rigorous, standardized, and efficient management. Over time, employees realize that the various provisions in the system documents are not artificially increasing workload but, once familiar, actually reduce workload and become beneficial activities, thus encouraging proactive execution. If the documents are unclear in path, responsibilities are vague or insufficient, and filled with correct but meaningless statements, employees will inevitably lose interest and the documents will lose vitality.

2. Broadly soliciting and adopting employee suggestions will inevitably improve the applicability of quality management system documents

Employees are the main users of quality management system documents. "Only the foot knows if the shoe fits." It is necessary to widely listen to employee suggestions and be good at adopting those that are both compliant and reasonable. Under the premise of scientific and standardized management, minimize steps as much as possible and plug loopholes to improve execution efficiency. On the other hand, when employee suggestions are adopted, it increases their sense of ownership and pride, further motivating active participation.

Regarding promotion and training

1. Using multiple forms of promotion and training is very necessary to create atmosphere and stimulate employee participation

Although short-term promotion and training methods represented by one-time competitions cannot achieve long-term "freshness" effects, they are still very necessary and meaningful. They allow employees to feel a strong atmosphere of emphasis from top to bottom. Moreover, the intense, lively, and interactive style of competitions has a strong immersive effect and is especially popular among young people.
In summary, diverse and varied forms can increase novelty and stimulate interest, and should be included in the management's perspective.

2. Establishing a long-term mechanism of regular lectures is the fundamental way for system documents to be deeply rooted and subtly influence

Short-term, one-time promotion and training methods have some drawbacks, such as: participation without engagement (e.g., all-staff large lectures); initial emphasis but later neglect (e.g., closed-book exams); limited participation without full coverage (e.g., competitions where only selected participants fully engage).

By establishing and implementing the long-term mechanism of "Weekly Lecture," system document study is incorporated into "business learning". Everyone must lecture, year after year, repeatedly, with 100% participation. After years of continuous learning and training, employees' mastery and execution of system documents have greatly improved. Fabrication of records has basically been eliminated, and backdated records have been effectively curbed.