All About QMS Processes: Their Sequence and Interactions in the Business
All About QMS Processes: Their Sequence and Interactions in the Business
A ‘process’ is a set of activities that uses resources available in the business to achieve a certain output (products). The ISO 9001 standard, which is an internationally acclaimed standard for a Quality Management System (QMS), calls for the implementation of a process approach in the organization. Not only this standard, but almost all ISO management standards, work on the principle of a process approach under which businesses are required to establish efficient processes that would be consistently executed and improved upon to derive the desired output. Therefore, understanding the sequence and interaction of a QMS processes is vital for your businesses. This article helps you to understand them. But first, you should know how to define the processes of your QMS.
Every business is unique and hence so are its processes. You need to define your business’s specific processes by determining objectives, resources and inputs to be used, and the desired outputs. In short, you need to precisely describe the following key elements to define your process:
• Resources and inputs: What do you need, how much to begin the process, and from where will it be sourced?
• Activities: What are the interrelated activities in the processes, what resources are used in the activities, and who carries out the activities to get the specific output?
• Outputs: Who is at the receiving end of the output, who benefits the most if the output is delivered as expected, and how do you determine if the output is delivered correctly?
While these are the key elements required to clearly define the processes of your QMS, the next section provides you with a closer look at the processes.
4 Crucial Processes of a QMS and Relations between Them
Regardless of the size of the organization, type of business, or quality objectives, these four processes must be dominant in the QMS to help them achieve quality compliance.
Quality Control Planning
The first process of any management system is always planning. Hence, to operate your QMS, you need to plan and set up its functions. You need to invest time, do some research, or engage quality assurance experts to determine the goals that your QMS should aim to achieve. In other words, you need to determine the baseline of the QMS so that the members (especially employees) understand what is to be achieved by working with it. During planning, you also should consider the requirements of the quality standard and decide which specific procedures are needed in the QMS to meet them.
Overall, in the planning process, you should fully underline the framework of the QMS by considering:
• Objectives of your business which include stakeholders’ expectations
• Roles/responsibilities of the employees in various functions of the QMS
• Requirements of the legal as well as regulatory standards
• How the processes of the QMS will be evaluated and how often
Quality Control
Once the functions and entire scope of the QMS are determined, the quality control process commences. In this process, everything is physically thoroughly examined to ensure whatever is specified in the earlier planning process is actually obtainable. You need to appoint teams that would inspect the production activities, raw materials, equipment used, packaging materials, delivery methods, and final products, in their respective manner. The teams should work to identify errors, inconsistencies, and mishaps anywhere in the business. The faster they are identified, the better it is. You can take corrective actions to prevent them from impacting the quality of final products or services.
Another vital part of this process is the collection of data. The different teams should collect data and maintain documents of their respective procedures. The management of your organization needs to review them for important decision-making.
Quality Assurance
While the quality control process is all about inspecting the production procedures, intermediate materials, and final products or services, the next process is quality assurance which is about affirming that the inspection is done properly. The quality assurance process is carried out just after the finished products/services leave the source and before they reach the customers.
Quality assurance is required for two purposes: to prevent any defects or mistakes in the end products/services that are overlooked in the quality control procedures, and secondly, to determine any improvements that can be made in them to further optimize the quality of products or services.
Also, importantly, the quality assurance process is necessary for evaluating how well your quality management procedures comply with the requirements of the proposed quality standard. For this, regular audits are made an important part of the quality assurance process. The audits help in identifying the noncompliant areas so that you can correct them as soon as possible.
Quality Improvement
Both quality control and quality assurance processes are linked to the process of quality improvement. Basically, this stage is about implementing changes and fine-tuning products/services to address the issues identified in the control and assurance stages. This is the most integral process without which the QMS is fruitless. To successfully execute this stage, you need to be competent at the earlier stages and gather as much data as possible. The management team should evaluate and re-evaluate the quality control and assurance processes by studying the data. Based on the evaluation and keeping compliance in mind, they can decide changes or additions in the QMS to produce better products/services than before.
Bottom Line
With all these processes properly included, you can develop the most efficient QMS that helps you to achieve your quality objectives successfully. The most important thing that businesses need to comprehend is the sequence and interaction of the QMS processes. If they are followed in the given sequence, you can have a foolproof quality management approach that helps you to control all issues and provide superior quality products/services to the customers.
If you want to streamline your business’s quality management with a QMS but do not know where to start, we at Compliancehelp Consulting LLC can help! We are a team of dedicated QMS experts and can guide you at implementing all its processes and gaining success. To know more about our expertise or hire us, visit our contact page.