The role of procedural instructions in quality management: A fundamental guide for structured processes
Reliable quality is based on various factors. A cornerstone for consistently high standards and efficient processes is the process instruction. It defines a binding framework for specific processes, taking into account relevant specifications – and thus ensures that quality targets are achieved.
But how do companies create comprehensive and compliant procedural instructions? When is such a guideline not only internally binding, but even a legal obligation? To what extent do the sector and company size determine the type and scope of a procedural instruction?
Whether you are an SME or a global corporation: with tepcon’s expertise and high-performance software support from the tepcon instructor, you can create such guideline documents transparently and efficiently.
How is the procedural instruction defined and differentiated?
Procedural instructions are binding documents that define procedures and processes in the company in detail and precisely. Quality objectives, defined results and the inclusion of any relevant standards specify the exact steps to be carried out in practice.
The process instruction is often considered equivalent or synonymous with other process documentation procedures such as standard operating procedures (SOP), work instructions or process instructions. However, it is important to differentiate between the terms.
Although SOPs are similar to procedural instructions, they usually go into more detail and focus on specific workflows within larger processes. In contrast, work instructions focus on specific activities of individual teams and employees. Process instructions , on the other hand, have a more documentary character and refer less to procedures.
Procedural instructions in the QM context
Quality management and procedural instructions go hand in hand. Certain standards such as ISO 9001, ISO 45001 and ISO 13485 specify a list of necessary process instructions. While highly regulated industries such as pharmaceuticals, chemicals or healthcare usually have mandatory requirements , structured process guidelines can be used effectively in almost all areas.
Procedural instructions are also often a prerequisite in safety-critical environments such as industry and manufacturing. It is not only large companies that benefit from consistent implementation. Small and medium-sized companies can also increase their transparency, efficiency, quality standards and therefore competitiveness.
Structure and content of a procedural instruction
Procedural instructions should be clearly structured and cover the following aspects of content.
Once the desired objective, the scope and the responsible persons or departments have been defined, the procedure and the necessary resources can be defined step by step in the actual process description.
- Aim and purpose
- Scope of application
- Responsibilities
- Process description
Furthermore, the procedural instruction should refer to relevant requirements, laws and guidelines and provide clear instructions on data storage and documentation.
- Norms and standards
- Documentation
- Test and release procedure
Last but not least, the document must be regularly reviewed, updated and optimized. This procedure should also be clearly set out in the procedural instructions.
Design instructions simply, professionally and effectively
Only rarely do existing specialists in the company have the necessary capacities and resources to develop guidelines and instructions to the required extent.
But: The effort is worth it! So what can companies do?
The specialists at tepcon offer a high level of consulting expertise in all matters relating to quality management and procedural instructions.
The tepcon instructor is a software multi-tool that offers a high level of relief in this area in particular and delivers qualified results. All aspects of a professional process instruction are covered intuitively and efficiently with the tepcon instructor: from the definition of the framework factors to the process description and continuous updating.
This enables companies in a wide range of industries to create greater security and quality in no time at all. They benefit from high added value without tying up too much capacity.