This article considers teamwork principles in the projects of developing and implementing Quality Management Systems (QMS) by means of using a specialized Business Studio software.
Keywords: normative and reference information, Update the regulatory documentation, relevant regulatory documents, process descriptions, standard process descriptions, implementing Quality Management System, developing Quality Management System, QMS procedure diagrams,identify inconsistencies, identify deviations, analyze a nonconformity, nonconformity analys, documented procedures, develope QMS documentation, process documentation, gather values of process indicators, gather nonconformities, identify causes, knowledge base of nonconformities
Volumes of information that the qms team has to deal with
QMS development projects (and activities that need to be performed in order to maintain the implemented QMS in working order later) differ from many others in the large volume of information that should be analyzed and generated. This should be definitely considered when planning methodological and technical support for such projects. Let’s find out what kind of information the QMS team deal with and evaluate its volume.
First of all, this information includes business processes of the company. Let’s try to estimate the number of processes of an average company: there are about 10 top level processes in an average company, each process is decomposed into about 7 subprocesses and those in their turn into about 6 more subprocesses. The most important and critical subprocesses are described in the form of procedures A procedure is a flow of elementary activities (operations). There are about 15 steps in each procedure. Therefore, we get: 10*7*6 = 420 subprocesses described in 1+10+10*7 = 81 diagrams, and about 50 procedure diagrams, giving a total of 50*15 = 750 steps. Please consider that each process (or process step) has about 10 inputs and outputs as well as a set of properties describing the process: performers, the owner, deadline requirements, etc. It becomes obvious that the amount of information about the company activity described in the form of business processes is quite significant. Therefore, in case these processes need to be changed or optimized, the QMS team gets a lot of problems due to the huge number of relationships between these processes.
In addition, this large number of processes needs to be implemented efficiently. In order to measure this efficiency, the QMS team has to deal with a system of indicators. However, one of the most difficult tasks for the team is to collect and monitor values of these indicators.
Some indicators (most likely those to be monitored at a lower level of the organization and at individual stages of business process) should be monitored frequently, sometimes every shift or day. Others need to be collected and monitored at less frequent intervals, e. g. weekly or monthly. At the very top level of the company, indicators may be measured even less frequently. And the team will again have to deal with a large amount of information — indicator values that need to be analyzed in a reasonably short time and to identify emerging deviations and inconsistencies.
Moreover, it is not just about inconsistencies identified as a result of process monitoring. The team has to deal with internal audit findings, nonconformity messages received from customers and employees as well as any other source. The QMS teams should analyze this information and come up with the decision to correct the identified inconsistencies. In order to make the right decision, all the factors contributing to the nonconformity in question need to be considered, and again this is a large amount of data. Often when analyzing a nonconformity, it is helpful to refer to similar cases somehow resolved in the past. Thus, all the cases should be carefully gathered by the team, and this activity also takes time.
You see that the amount of information that the QMS team has to work with when developing and maintaining QMS, is very large and varied: it includes the processes, indicators, nonconformities, and information on nonconformity analyses as well as the list of causes that led to nonconformities.
It should not be forgotten that this list contains only the main types of information related to QMS, but there are also the quality objectives of the company, the organizational structure, the documents used and much more.
Problems encountered when developing a “paper” qms and how they are solved with business studio
When developing and implementing a QMS, the team faces an equally daunting challenge: all of the above information needs to be reflected in the QMS documentation. This may include documented procedures, various methodologies, quality records, and, of course, the Quality Manual. The large amount of information that QMS professionals have to work with, should be considered when organizing a teamwork or developing QMS documentation; otherwise, the project will be condemned into serious risks.
The traditional solution, which has been used before and is still used today, is to create the so-called paper-based QMS. In this case all the QMS documents are prepared with the help of the common text editor like Microsoft Word, and process diagrams, in the best-case scenario, are developed by using the Microsoft Visio business graphics editor. All received files are stored in more or less structured directories on a corporate server and are distributed to employees in the printed form.
Analysis of dozens of enterprises shows that the most critical problems each enterprise faces, concern:
- Document development;
- Providing access to documents;
- Document update;
- Storage of accumulated measurement data.
When the team works with a huge amount of information and needs to modify several business units constantly, there is a high probability of errors. Thus, the team needs a special software solution to cope with this problem. The Business Studio system is exactly what the QMS team needs. Thanks to its functionality, it makes a teamwork with a large volume of QMS information easy and convenient.
Let’s consider problems that usually arise when implementing a “paper” QMS and benefits of using Business Studio instead.
When developing a process model and generating QMS documentation based on it, team members constantly have to develop the same process diagram or modify the same document even though they work on different parts of the process model. And it is very important to inform each team member about changes in a timely manner. Since there are lots of relationships between processes in one model, it is easy to make mistakes in documentation.
With Business Studio, the QMS team works in a single database: all the names are unique and the information is stored in one place. This prevents, for example, a situation when the same process is named differently in different documents or has different performers. The Business Studio system provides the QMS team with the collective parallel work — modifications of boundary inputs and outputs of the processes made by separate specialists working on different diagrams, will always be consistent with each other. Besides, Business Studio can limit access of employees to objects, for example, a certain specialist may work only with the processes of a certain group, look through the organizational structure and has no access to the company’s objectives and indicators.
Very often when developing a “paper” QMS, the quality team is assigned to develop the QMS documentation themselves so as not to distract process owners from their regular job. The approval of the document takes place, but the final process documentation turns out to be far from reality. In addition, a document approving process is significantly increased in time just because the paper document reaches each approver one by one.
With Business Studio, the approval of new or modified process models is facilitated by email notifications. An email is generated for each person responsible for approval. The email asks this person to review and approve the modified process model or submit the comments (Fig. 1). By allowing competent specialists to review and revise draft documents, the valuable time of the QMS team members is significantly saved.
Figure 1. Developing a process model in Business Studio
As we have already mentioned, documentation not only needs to be developed, but also be distributed. And any employee who needs to use this document to perform his/her job, should always have access to it. Usually, the team has to create several hard copies of one document and distribute them to all the interested employees.
Business Studio solves this problem by providing quick access from any workstation to a full set of up-to-date information. And you can generate either a specific document, such as a Process Description, or a full set of documents in the form of HTML Publication or Business Studio Portal.
When you have the “paper” QMS, a small change in one document may result in the need to change a bunch of related documents. The QMS team makes changes to its own copies of documents, and issues a change sheet for employees who use these documents to perform their work. These sheets are reprinted in the required number of copies and distributed to the employees concerned. In case a huge amount of changes should be applied to a document, the document should be reissued, all related employees receive a copy of a new document, the old copy is achieved. And the QMS team should save all the copies of all the documents throughout their lifecycles. If the company is large, there will be plenty of such documents with a long shelf life. And sometimes the QMS team has to look through this amount of documentation to find some particular information.
It is much easier to make changes in Business Studio because the processes are modeled in a single database. The input of one process and the output of another one is one and the same object in the system. If you rename an arrow on one diagram, the arrow is renamed on all the diagrams where it is present, automatically. This approach solves the problem of making changes to a large number of company processes. Any object in the database (process, position, indicator) has its own properties. The fact that the property gets a new value is automatically reflected in all the regulatory documentation where this information is used.
Business Studio also helps analysts to gather values of process indicators, nonconformities and their causes. These values can be imported from the Microsoft Excel files or entered by users at Business Studio Portal. There is a possibility to limit access of persons who are in charge of entering or controlling values of specific indicators to other indicators.
Figure 2. Monitoring indicator values
When using a “paper” QMS, the team may face the problem of accumulating knowledge on the ways of eliminating nonconformity causes. Business Studio makes it possible for the QMS team to create a knowledge base of nonconformities and reports on their analysis, identified causes and developed techniques for eliminating them.
Nonconformity messages can be entered into the database from any workstation (Figure 3).
Figure 3. Entering nonconformity messages
Such a knowledge base captures information about the staff involved in the analysis, all the necessary information about the results of the analysis (Figure 4). For any nonconformity, the team can always obtain a report that includes information on the analysis, identified causes and developed decisions.
Figure 4. Nonconformity analysis performed
This knowledge base allows the QMS team to reduce the time for operational decision-making by quickly and reliably analyzing similar situations, significantly improving corrective and preventive actions.
In summary, it is worth listing the main features that make Business Studio a very handy tool for the QMS team:
- A single database for storing information;
- Possibility of collaborative parallel work with database elements;
- Quick access to a full set of up-to-date information from any workplace;
- Publication of work results for joint access;
- Limitation of access rights to the information.
The teamwork will be effective if the actions of the team members are well coordinated. Business Studio brings an organizing and guiding component to the team’s work in developing, implementing and maintaining the QMS.
Teams that have worked with the “paper” QMS have already realized the disadvantages of working with it. Nowadays there are few people left who still prefer to work in the old format. Today the QMS managers have a real alternative — the Business Studio system. The QMS functionality of Business Studio has been developed under control of leading quality specialists and consultants and provides the most effective QMS development and support.
March 2023
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