Quality management, development of a quality manual - today these are the most important tasks in the quality management system of manufactured products or services. It is advisable to analyze this issue in more detail, to consider all its aspects separately.
Choosing an Approach to Developing a Document
One way or another, the development of quality guidelines for the organization is preceded by the choice of a specific approach. In other words, you need to find out which points are worth describing in the document and which are not. Employees of any company should use this "reference" in their professional activities, therefore, when creating it, this factor must be taken into account. How to organize the development of quality management guidelines so that it is effective and efficient?
In order to ensure the effectiveness of any document, it is necessary to understand that it must combine clarity and full coverage. It should be convenient to use. That is why, in the process of developing a quality manual, it is important to consider that it, as a rule, includes all the basic information about the structure’s quality management system. If necessary, links to additional documentation become relevant. The simplicity of presentation and comprehensibility make it possible to apply the manual to both specialists working in the field of quality and other employees of the company. Convenience of use, which is so important to take into account when developing a quality manual, ensures that employees will often turn to this particular document rather than seek solutions through colleagues or in an independent manner.
Completeness as a basic requirement for the development of guidelines
Among the recommendations for developing a quality manual for a laboratory, manufacturing enterprise or other company is the completeness of the material. It would seem that this requirement is one of the most difficult. But do not be scared. Fortunately, the thorny path has already been covered in our case, because at present there are standards for guidance on the quality of ISO. They are a clear regulation of what elements the enterprise quality management system should consist of. In addition, the standards allow you not to ask questions about how this system is created and how it should work.
When developing a quality management manual, you need to know that the key section of the document is the description of the objectives of the structure in the field of quality. In other words, we are talking about ideas that the company plans to implement over a specific period of time. Achievement of the goals mentioned by the developer is due to the competent fulfillment of quality requirements. So, when developing a quality manual for an enterprise, it is worth highlighting how each of these requirements is implemented separately in this structure. Usually the names of requirements are the headings of the sections of the document in question. It should be added that in the process of preparing the manual, one does not need to give free rein to one's own imagination regarding the numbering of sections. When developing a quality manual, it makes no sense to deviate from the numbering that is approved in the standard. Only then will the final document be understandable and recognizable both among the company employees and for external auditors.
It is important to keep in mind that, as a rule, certain people are responsible for fulfilling the requirements of the standard in the enterprise. Accordingly, these officials must be indicated when developing the quality manual, namely after describing individual requirements. Responsible can be the owners of the processes, as well as specific officials who manage the activities described in the documentation.
Clarity as a requirement for developing guidelines
When developing a quality manual for a laboratory, manufacturing facility, or other structure, it is important to consider a number of requirements. In addition to completeness, the comprehensibility of the material plays a significant role. One way or another, management should create an idea of the processes taking place in the company and their interaction. This is done to meet the requirements of the standard.
So, if there is a specific process, the implementation of which carries out a certain requirement of the standard, it is necessary to indicate in the document not only the process itself, but also its owner. If the requirement is met with respect to an activity not described as a process, a documented procedure should be indicated with instructions for the implementation of the activity with relevant comments that are causal in nature.
When forming a quality manual for new requirements, it should be borne in mind that in order to fulfill these requirements, as a rule, additional documentation is needed. These are, for example, process regulations that specify the composition of those responsible and the stages of the processes themselves. It is important to know that references to these documents are necessarily recorded in the manual. As a result of these operations, any employee should understand from the first reading what is expected of him in terms of implementing the requirements of the quality standard and related goals in this area. The employee must keep in mind what methods exist to achieve these goals at least at his workplace. The implementation of these recommendations on the development of a quality manual will allow for the involvement of all employees of the organization in the process of managing the quality parameters of products or services provided.
Usability Guide
Another important requirement for the development of a quality manual for a laboratory, production plant or other structure is the ease of use. It is impossible to argue with the fact that even on the most powerful car you can not go far, and indeed you can not leave if you install its steering wheel in the trunk. And overloading the instrument panel with all kinds of secondary sensors in one way or another will lead to the fact that the driver will begin to be distracted from the main process in his case to read interesting indicators.
ISO Quality Guide Example
It would be advisable to consider the manual and its standard sections with a specific example. For this we will take a testing laboratory. The first section of the document is an introduction. It provides:
- name of the structure in full and abbreviated form;
- regulation of the laboratory, where it is necessary to indicate the names of securities and their registration numbers;
- the location of the legal entity, where you need to specify both the postal and legal address;
- contact details (email, phone number);
- organizational structure of the company, which, as a rule, can be found in the annexes to the main document.
By the way, it is best to display the organizational structure schematically.
Application area
After the introduction of a quality manual for the testing laboratory during the development process, it is important to indicate the area of application. This topic is placed in a separate section, usually the first in a row. For instance:
- This document presents the policy in the field of quality management, as well as key principles and methods that ensure the functioning of the quality system in the research laboratory.
- The manual is developed by one or another employee, signed by the director of the research center, and also approved by the organization’s management and secured through the press of the legal entity.
- In order to ensure constant maintenance of a high level and effectiveness of the quality system, timely implementation of corrective operations, the manual is reviewed and supplemented if the legal entity is replaced or reorganized, as well as in the case of a change in the scope of accreditation of the structure or improvement of the quality system.
- This document has been compiled in accordance with the requirements of certain laws and regulations of the country.
- The scope of use of the quality management system extends to all points of implementation of laboratory activities.
Normative references
The second section of this document, as a rule, contains normative references. It is important to note that all laws, regulations, guides and other sources that are used in the preparation of the quality manual should be clearly and thoroughly written and indicated. Next, it is advisable to move on to acquaintance with the third section of the manual, which describes all the terms and definitions used in the work.
Terms and Definitions
This section is large enough, so we will consider it with a specific example of our laboratory. The following terms and their definitions apply in this document:
- Accreditation is a confirmation of compliance of a legal entity or individual entrepreneur with certain criteria.
- An extract from the register (in other words, an accreditation certificate) is a document that is generated automatically by means of the state information system in the field of accreditation. It is a certificate, confirmation of the fact of accreditation in a specific field of activity.
- Quality is a collection of properties inherent in an object. As a rule, these characteristics relate to the ability of this facility to meet the needs that are initially set.
- KXA, or quantitative chemical analysis, is a quantitative determination formed experimentally and related to the content of one or more components of the sample composition by physical or chemical methods.
- The analysis technique is a complex of specifically characterized operations, the implementation of which leads to the obtaining of the results of the KHI with established accuracy indicators.
- An audit, or internal audit, is a documented, independent, systematic process of obtaining audit results and objectively evaluating these results in order to establish the degree to which previously agreed audit criteria are met.
- An audit program is a set of established audit criteria for one or a number of inspections, which are planned for a certain time period and are mainly aimed at achieving the goals.
- Audit criteria is a set of requirements, procedures, and policies that are used as references. It is important to note that audit criteria are used to match audit evidence with them.
- An auditor is a person who demonstrates his personal characteristics and is competent to conduct an audit.
- An audit team is one or more auditors who conduct an audit.
The list of terms and definitions can be continued, however, the main purpose of this article is to clarify the meaning and nature of the material published in each section of the manual, so it is advisable to proceed to the next paragraph.
Laboratory Quality Management Requirements
This paragraph is final in this document. Nevertheless, it is the most informative. To begin with, you must specify the name of the laboratory, as in the first section, and then give information about the leadership of the structure, namely, you need to describe the position of the head of the research center or quality manager and to whom they report. After that, it is advisable to characterize the organizational structure and senior staff with positions and relevant professional responsibilities. In addition, it is important to remember the ways of substitution, that is, deputy directors of different departments of the laboratory. The following should talk about:
- Responsible for the quality management system employee. It is necessary to indicate not only his position, but also the details of the relevant order for employment.
- Implementation of the QMS and the basics of its functioning.
- Responsibility and authority of the employees of the research center in the field of quality, including the distribution of duties, rights and responsibilities between the employees of the research center.
- Regulation of the structure.
- Human Rights Research Center.
- The rules for ensuring the confidentiality of information, even those that come from third parties.
- Management responsibility for activities organized in the laboratory.
- A set of regulatory and technical documentation, which in any case acts as the property of the customer. So, after conducting laboratory work, this documentation remains in the research center or is returned to the customer by prior agreement.
- The results of the work and paperwork, which act as the property of the customer only after the work is paid.
What else?
In addition to the points presented above, in the section “Requirements” regarding the laboratory center, it is necessary to indicate the following:
- Subcontracting for the implementation of measurements. It is necessary to add that the purpose of this procedure is to ensure high-quality test results if subcontracting structures are involved in their implementation. One way or another, the research laboratory is fully responsible for the work carried out by the subcontracting organization.
- Management of work related to tests that do not meet the approved requirements.
After describing all sections of the manual using the example of a research center and a detailed analysis of all the requirements for the document today, it is advisable to draw some conclusions.
The main point is the need to document the whole range of processes carried out in the field of ensuring and improving the quality of products or services. It is also important to have paper as part of documented processes governing issues of document management in general.