In response to frequent inquiries about the control of documented information in a quality management system, today I will explain the correct and efficient way to manage it in your organization.
It is important to note that all companies, regardless of their size or whether they have a functioning management system, must properly maintain and manage documented information as a support for their operation. Therefore, the content of this article is relevant to all companies, whether they have a quality management system, food safety, information security, or any other management system.
1. What is the Importance of Control of Documented Information?
The control of documented information is key to your company's success because it facilitates standardization. By documenting processes and establishing how activities should be carried out, you ensure that they are repeatable, regardless of who performs them. Of course, it is essential that the individuals responsible for executing these activities are adequately trained.
2. Recommendations for the Control of Documented Information
Here are three recommendations that will help you achieve efficient management of documented information, adding value to your organization:
2.1 Process Mapping for Initial Documentation:
It is crucial to follow a methodology when documenting your company's processes. This will help you identify the different processes within your organization and understand their interaction. By doing so, you can assign clear objectives to each process, considering the available resources. It also allows you to assess whether it is necessary to acquire new resources to achieve the desired results.
2.2 Keep the Methodology for the Control of Documented Information Simple:
Managing documents in your organization doesn't have to unnecessarily complicate things. I've seen companies add complexity to the management of documented information without reason. For example, they use hierarchical systems to classify documents as management, operational, or administrative procedures, which implies different management methods for each. Another example is the use of excessively complex coding systems (e.g., BC-CAL-PO-08). Often, these companies are not large enough to justify such complexity in document coding. A coding system that only indicates the document type and a consecutive number (e.g., PRO-08) is sufficient to ensure unique codes for each type of document.
2.3 Use Only Documents That Make Sense for Your Company:
It is essential for any company to use a document structure and types that add value to the organization's operation. Documents should be dynamic and provide value to those who consult them. For example, I have seen procedures that could have been clear and efficient if they had been documented in just two pages. However, endless sections are added, turning procedures into ten or fifteen-page documents, which become tedious to read. Follow these recommendations, and you will see how document management becomes truly efficient, without representing an additional burden for your company. If you realize that document management is adding more complexity or problems to your processes than the actual operation, it's time to change the way you control documented information.
3. Types of Documents for the Control of Documented Information
Each type of document has different objectives and purposes. To avoid indiscriminate use, it is essential to understand the existing documents and their correct use.
3.1 Procedures
Procedures are at the top of the document structure. They describe the specific steps to convert inputs from a process into the corresponding outputs. They are detailed and execution-oriented. Therefore, in an organization, there should be as many procedures as there are processes.
3.2 Policies
To ensure the proper execution of activities defined in processes, many of them will require specific rules known as policies. These policies allow us to clearly establish the rules of the game, indicating how activities should be carried out and what aspects must be respected. Their purpose is to prevent decisions or actions that are not allowed during the execution of any activity.
3.3 Work Instructions
Some activities, due to their nature or complexity level, require detailed instructions on how to carry them out. This may include the use of specific equipment, machinery, or software. For this purpose, work instructions are used, which describe step by step how to perform a particular activity. The existence of work instructions as a document type may vary depending on the complexity of the activities carried out in your company.
3.4 Specifications
During the execution of certain activities, it is common to refer to products, raw materials, or services provided by the company. Specifications are used for this purpose, which are documents that allow us to define the parameters and characteristics of these elements.
3.5 Records
Some activities described in procedures require evidence of their execution. For this purpose, formats or records are used, designed to keep a record that an activity or a series of activities were carried out properly. Records provide tangible evidence that the established procedures were followed and allow tracking relevant information about the activity performed.
4. Where to Obtain Documented Information for My Company?
There are three main sources from which all documented information is derived:
4.1 Organization Processes:
Processes are the basis of activities carried out in an organization. Documentation arises from these processes, as procedures, instructions, and records are created to describe and support the specific activities and tasks carried out in each process.
4.2 Standard Requirements:
Standards and guidelines, such as ISO standards, establish requirements for document and process management in an organization. These requirements act as a source of information for documentation since certain specific criteria and guidelines set by the standards must be met.
4.3 Organization Policies:
The organization's internal policies also play a significant role in documentation. These policies define the rules, guidelines, and principles that guide activities and decisions within the organization.
I hope this content has provided clear guidance on the goals of maintaining document management and has given you some basic guidelines to achieve efficient management without adding unnecessary complexity to your organization.
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