Document management, process documentation and QM documentation
Careful process documentation and a quality management system that is lived and breathed, support the creation and maintenance of the quality standards that you want to have within your company . Aside from any ISO certification as proof of implemented quality standards, a sophisticated quality management system helps you to structure the processes in your company in such a way that the requirements of customer satisfaction and formal concerns (proof and documentation obligations) are met.
Requirements for careful process documentation
Within the framework of a functioning QM system, many requirements needs to be met when it comes to documentation. Various minimum requirements for process documentation should arise not only out of the stipulations of the ISO 9001:2015 standard – but also out of a company's own best interests. It is in the company’s interest that even in the event of an employee’s absence, the valuable knowledge regarding process structure and process organization remains with the company or can at least be easily and quickly taken up by another employee.
The documentation required to ensure a functioning QM system, is based on the following generalized requirements.
Central documentation location with easy retrievability
ISO 9001:2015 no longer requires the implementation of a QM guide. However, it is not only the newly introduced term “Documented Information”, as a new category heading within the ISO standard, that has created the need for a central place of documentation. This should be kept up to date and contain approved and binding regulations for the company. In addition to the quality policy and the defined quality objectives, a description of workflows or process descriptions are required, and following from these, the corresponding procedural instructions - in particular with which process steps the necessary documentation must be prepared.
Structured document management as part of process documentation
The requirements for effective and efficient document management and process documentation are not limited to the one-time creation of binding content. Different process phases and revision processes are just as much a matter of course for the control of documents as they are for other process sequences. Three content areas can, however, be summarized specifically for document management:
- The initial creation, approval, release and subsequent evaluation of documents
- The revision of documents and the subsequent, repeated approval, release and evaluation process
- Maintaining clarity and traceability by archiving revised or outdated documents as well as the document creation and document management process
What all the phases have in common is that, in addition to standardized identification and structure, there must be clear guidelines for access, archiving and retention periods, data protection and data security, and binding regulations governing the powers of decision and disposition.
Documentation implemented to meet these requirements serves, in particular, as proof of compliance with the company’s internal guidelines, for subsequent verification of whether the requirements have been met within the process and also for the verification of the QM system as part of a possible certification.
To summarize: documentation is a must! It doesn't however have to be a burden – you can make sure that your documentation easy to create and use - and as a positive side effect, that it is better and more up-to-date than ever before.
Our Solutions with Atlassian Confluence
Our solution for implementing these documentation requirements has nothing to do with obsolete, manually-printed paper management in folders or even a supposedly more modern implementation using a network folder structure, with the storage of countless Word or PDF documents. We provide you with process documentation and document management as part of a real digital transformation, meaning that your documentation is accessible and available to all employees at any time, and system independently.
Accessible and usable – always! Everywhere! From any system!
You don’t need to pay for Microsoft Word, a PDF program or an internal network access to certain drives. Our solution is accessible from anywhere and does not require any additional programs on the end or client devices – and this includes content editing! You only need a browser and internet access. Access to an internal company network is, of course, also possible.
Role assignment: Distribution of tasks and rights
Do you already have a division of tasks and roles in your company? Do you use an LDAP structure or AD? We can build on this, define a clear distinction to new tasks within the context of process documentation and document management or implement a task-based new role assignment within our solution. The structured role assignment enables you to determine who is responsible for which tasks within the workflow. Your employees who are actively involved in the editing and design of document management and process documentation receive different access and editing rights (within the draft area) than your control and decision level, which is responsible for review processes and binding approvals. Depending on content and task, it is also possible to define whether these editing and role allocations carry over to all areas of the documentation or only to the specific relevant processes. Access to the released documentation (public area) is available to all assigned employees.
Workflows and process flow according to specific requirements
The simplest workflow consists of a few manageable steps: design, testing and approval as well as review of the valid and binding documentation. Our solution is as flexible as your company requires. If you want to request the decision of another (higher level) during the check and release process, or if you want to request processing by another department, you can create any desired and adaptable workflow variants.
Creation process and binding nature of the publication
The structure of our solution is based on a two-level model. These levels behave separately from each other, but are nevertheless seamlessly interlinked. The creation and revision of your documentation, as well as all creation steps predefined in the workflow, including release, take place in the draft area. Once the workflow has been completed, the authorized and binding documentation in the public area is automatically made available to the employees in the company. This separation ensures that in the public domain, only verified binding versions are visible to employees.
Versioning in draft and public areas
Our system takes into account the need for versioning , as well as the traceability and comprehensibility of the various editing, modification and versioning steps. Within the draft area, the user, date and time as well as content changes and intermediate steps on the way to the final version of a document are recorded.
Version documentation also takes place in the public area. However, this does not include all the development information and intermediate steps shown in the draft area for the 'new' version of a document. The version comparison is limited to a clear representation of the changes between the different released binding versions.
Global template, area-specific templates and multilingualism
The use of templates is not only great for achieving a uniform presentation of the documentation, but also for simplifying the creation processes. Templates can be created globally, i.e. for the entire process documentation, or specifically for individual areas. Global templates or area-specific templates and their content can be created according to your company’s specifications and ideas. Different language versions are also possible.
Archiving, reminders and time control of availability
An expiration date can be added to each process or documentation. When this expiration date is reached, an automatic archiving or re-submission to an assigned person is initiated. In addition, we offer the option of automated usage monitoring of access to the documented content. If, for example, a document is no longer used or called up over a defined period of time, a revision is sent to the assigned person before it is archived. In this way, you receive and control a clear process documentation that only includes the contents that are actually used and needed.
Content presentation by means of process visualization
In addition to the native graphical workflow representation, it is also possible to visualize individual or comprehensive processes within the documentation. Even complex processes can be effectively visualized for your staff using clear graphics, sequence and structure displays or organizational charts. Helpful for this is the content link between the graphical representation of a process and the individual process steps, which are also linked to in the same system and therefore readily available. This form of user-friendliness increases your employees' acceptance when it comes to the application and use of process documentation.
Word and PDF-Export
Our solution is based on Atlassian Confluence and is therefore independent of third-party software such as Microsoft Word or Adobe Acrobat. All content can be exported from the process documentation with just one click if, for example, you want to send the documentation of individual process flows to external customers.
We support you during the migration of your existing process documentation to our solution. We also support your employees with detailed instructions, assistance or training if you want to migrate the content yourself. Carrying out the migration yourselves (or rather getting the responsible employees to carry out the migration) has the advantage that your assigned employee roles get to know the system from the very beginning and if necessary, company- specific requirements can still be implemented.
Search Engine and Notifications of Changes
Documentation can only be used in your company if it can be found. Our process documentation solution includes an optimized search engine. In addition to the possibility of making certain areas easily available by means of a quick-filter, a full-text search also allows you to find that needle in the haystack.
Automated notifications can be assigned to the various roles so that your employees are always up to date. Assigned members and specific-area assigned members receive a notification, if a new documentation relevant to them is released in the public area. Additionally, notifications are also available for employees in the draft area, ensuring prompt processing within the workflow.
Lessons-Learned - With a commentary on the living-instrument
If you implement your process documentation with our solution based on Atlassian Confluence, you will soon realize that your documentation is not a static collection of content. Involve your employees in the progress by integrating company-internal lessons-learned knowledge into your existing process documentation. This turns your QM-System into a real living-instrument, which always shows the latest secure state of knowledge. With the annotation function and inline comments, all your employees can notify your draft team of errors in existing documentation within the public area or mark suggestions for improvement immediately on the spot. This means that the draft-department always has new input aiding their continuous improvement. At the same time, the separation of the draft area and the specified creation, review and approval workflow as well as the subsequent release ensures that only those changes are included in the binding document, which have been accepted as binding by those responsible. The final binding documentation is therefore not edited by everyone, but only by the assigned persons.