Creating documentation and a record control system is an important aspect of adopting an IATF 16949-based Quality Management System (QMS). You must ensure that your organization generates the most appropriate documentation since it will define how your QMS is maintained and enhanced, as well as how your documents and records must be developed, published, withdrawn, and used. It comes down to whether you want your documentation to be a formality, an inconvenience that renders your QMS useless. Or do you want your IATF 16949 documentation to make it simple to maintain your QMS, allowing your organization to reap the full benefits of IATF 16949 implementation?
Organising your QMS Documentation
Certain documents are required by IATF 16949 as part of the Quality Management System (for more information, see this List of necessary documents required by IATF 16949). There are several reasons for this documentation requirement:
- To provide a comprehensive picture of the company's operations
- Help increase understanding of the QMS
- To promote process uniformity
- To demonstrate achievement of objectives and targets
You must focus on what your firm needs to document when developing your QMS documents: What papers can assist in increasing efficiency? What documents are relevant to your company and the industry in which it operates? The last thing you want is a slew of superfluous documents that no one uses because they just aren't necessary.
To that end, before producing and implementing any document, determine its role and purpose. This is how you should organise your IAF 16949 Quality Management System documentation:
1) Quality Manual: The quality manual should be suited to your firm; its structure and content should be determined by the size of your organization, operational complexity, and employee competency. Smaller businesses will be able to fit their entire QMS into one manual, whereas larger businesses with multiple sites will most likely have multiple quality manuals. In general, the quality handbook will include the following basic elements:
- The title of the document
- Index of contents
- Exclusions and limitations of the QMS
- Version and approval information
- Quality Management System Description
- The business process model of the corporation
- Explanations of responsibilities of employees
2) Quality Policy: In general, "policy" refers to a declaration of assertion issued by an organization. A quality policy should indicate the company's commitment to quality and the continuous improvement of its operations. This policy should be succinct, concise, and to the point, as it is frequently utilised for promotional purposes, displayed on corporate premises, and posted on its website.
The quality policy's purpose is to set the company's structure for accomplishing quality objectives. In turn, the company's quality goals are defined by quantifying these quality targets.
3) Procedures: QMS procedures should include the document title, purpose and scope, responsibilities and authority, descriptions of all actions, and references to any applicable SOPs, work instructions, and records. It is up to you how you document this information: processes can be written in narrative style, illustrated with diagrams and flow charts, structured with tables, or a combination of these formats. If necessary, include appendices.
4) Work Instructions: Work instructions might be included in a method or merely referred to in it. Work instructions typically comprise the same parts as procedures and have a comparable structure. The difference is that the work instructions are more explicit, covering activities that must be completed, stages to be taken and in what order, tools and procedures to be utilised, and accuracy requirements.
5) Records and Forms: You will need evidence to do all your activities and procedures that are done that’s specified in the procedures and work suggestions. Records and documentation come into play here. The majority of these will be performed by employees, but a few will fall under the purview of top management (for example, Management Review Minutes). To keep records and forms practical (and staff using them), focus on generating brief, easy-to-complete documents and forms; use checkboxes rather than open-ended questions and empty rows.
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