Quality Management Systems
Companies that seek continuous improvements and remain sensitive about productivity, efficiency and customer satisfaction are likely to implement Quality Management Systems (QMS). The need for QMS arises from the most common errors that include a poor product or service design, unsuitable materials, poor physical conditions, lack of proper skill or training, and issues related to machine or equipment.
All the aforementioned factors are known for having a direct impact on the quality of the final product delivered. And it was an American by the name Joseph M Juran who was responsible for devising a comprehensive systemized approach towards the quality for the entire product lifecycle, starting from design to the end consumer.
The belief that by dissecting each part and process for quality, companies improved the chances of creating a reliable & long-lasting product. What started as a manufacturing approach by an American quality controller in Japan in the 1950s got transplanted into America reshaping businesses around the world.
What is the Quality Management System (QMS)?
A QMS is defined as a standardized and documented system that includes processes, procedures and responsibilities that aims at fulfilling defined quality objectives and policies. By implementing QMS, a company can fulfil its regulatory and customer-related obligations to improve effectiveness and efficiency across the organization. The foremost focus of the system is to accurately and precisely define procedures that will lead to the creation of quality products and services.
Although QMS does not emphasize improving the bottom line. It has been noticed that companies incorporating CMS are known to improve their earnings by a good margin through hidden or indirect benefits of the system. Now let’s look at other visible benefits of QMS, one by one:
- Customer Satisfaction: A company implementing QMS meets customer requirements by default improving the level of trust a customer has on the company.
- Operational Consistency: QMS can help achieve consistency in approach towards operational activities by improving resource utilization and timelines.
- Process Improvement: An organization can improve processes to influence consistency in product output, this is closely followed by reduced expenditures and completion of production within scheduled baselines.
- Increases Production: Improvement in production is directly correlated to reimagining established techniques and better training of employees. The entire production process becomes streamlined due to the renewed confidence in employees to troubleshoot problems.
- Reduces Rework: QMS ensures that quality is monitored continuously and immediate corrective actions are carried out on the occurrence of defects. This ensures the production of quality products that do not require rework arising out of warranty claims.
- Improves Internal Communication: QMS is known to emphasize issues about operations management. This prompts higher interaction between different department and groups within the organization ensuring seamless communication flow.
- Enhances Market Share: By implementing QMS successfully, a company stands to gain in authority and reputation, which naturally translates to healthy customer confidence and an enhanced market share.
7-Core Principles of Quality Management System (QMS)
ISO 9001:2015 is the international standard specifying requirements for Quality Management Systems for major industries. However, there are separate quality standards for different industries namely Automotive (IATF 16949), Services (ISO 200000), Medical devices (ISO 13485), Food (ISO 22000), Information technology (ISO 27001) and Aerospace (AS 9100D).
7 core principles govern all QMS systems, let’s look at each of them one by one:
- Customer Focus: The principle emphasizes the fact that a company must understand its customers in terms of what they need and when. The way of doing it is by addressing customer needs and providing exemplary customer service. While doing so a company can spot new customer opportunities and can deliver to the customer’s satisfaction. In the long term, it improves brand loyalty and revenues.
- Leadership: This provides an organisation with the direction to proceed through clear objectives involving the top leadership. It is proven that when employees are communicated about the vision of the organisation, they start showing more engagement to their work with improved productivity. This principle mainly addresses complaints from employees about ‘gaps in communication’.
- People Involvement: It spells out responsibilities clearly for optimum use of resources to produce higher efficiency and effectiveness in relevant processes. Well managed processes are known to improve consistency, reduce waste and delivers on the ideal for continuous improvement. Overall an efficient organization helps in building confidence among stakeholders.
- Process Approach: It is stated that consistent results are obtained when business activities are understood and managed as inter-related process that functions as a coherent system. The stress here is to understand results produced by the system by taking into consideration – processes, controls, resources and relevant interactions. By doing this an organization can optimize performance to the optimum.
- Continued Improvement: All organizations are expected to maintain a steady degree of improvement to raise existing levels of performance. This is done as adjustments to changes in the internal and external conditions thereby creating new opportunities. Here known benefits become obvious with improved organizational flexibility, ability to embrace new opportunities and improved performance.
- Evidence-Based Decision Making: This principle states that all decision-making in the business would be done through analysis of available data and information. This paves the way for more clarity in decision-making without any element of rashness and guesswork. Informed decision through analysis of data enhances the understanding of the marketplace and puts the leadership in a better position to defend past decisions.
- Relationship Management: An organisation is expected to maintain healthy business relationships with relevant stakeholders like suppliers. Success is achieved when an organisation can manage relationships with interested parties on a sustained basis. A business is expected to do well when it acknowledges the interdependent nature of the relationship and the bearing it has on the performance of the organization.
Structure of Quality Management System Documentation
Irrespective of the industry you are in, there is a certain structure to the Quality Management System that is common to all. Here is a list enlisting them:
- Organizational Quality Policy: This is a declarative statement spelt out by the organization, outlining the commitment to quality and continuous improvement.
- Quality Management System Manual: Every organization would have a customized quality manual. The length and content of the manual vary with the size and complexity of operation along with the competence of the personnel involved. The manual specifies the scope of QMS, exclusions from the standard, references to relevant documents and business process model.
- Quality Procedure: This comes in different formats; some are descriptive while others are illustrative with charts and tables. It consists of the following elements – title, purpose, scope, responsibilities, definitions, description of activities, and appendices (if needed).
- Work Instructions: It is a part of the quality procedure but these include details of activities that need to be realized with a sequence of steps and methods to be used with an expected level of accuracy.
- Records & Forms: Records are evidence demonstrating whether the processes are meeting the requisite guidelines & specifications. It is the documentation depicting adherence of processes to prescribed procedures and work instructions. And forms, on the other hand, are blank templates that need to be filled with information to be added to the existing records.
Each of these elements contributes to creating a comprehensive QMS, allowing companies to design, update and improve the levels of quality.
Components for the Implementation of a Cohesive Quality Management System
A company is expected to have a system in place for coordinating, managing and implementing all the above-mentioned elements. In certain companies, the implementation would be put down on paper. Alternatively, there would be companies who follow QMS in a digitized format, which makes it altogether easy to meet the specifications and guidelines stipulated by QMS.
- Document Control: This consists of all quality based documents, procedures and policies that are required to record, organize and track actual actions on the ground periodically.
- Equipment & Asset Management: In most companies equipment and machinery are tightly connected to quality and these play an integral role in producing goods and offering services to the customer. Any major breakdown handicaps the organization.
- CAPA Management: This refers to ‘Corrective and Preventive Action’ and outlines how a company deals with the correction of existing and potential non-conformities in its process and end products. And, what steps it would take to prevent these from recurring in the future. Tracking and implementing CAPA is aligned with the notion of continuous improvement.
- Internal Audits: Quality and safety aspects of a business are constantly under scrutiny and can be audited at any time. A standard quality system will have version control and audit trails of all documents, allowing auditors to see exactly what has been followed in adherence to the QMS in place regularly.
- Integrated Dashboard: Tracking quality can be a daunting undertaking. But IT-based quality systems allow the data to be aggregated into one place. This is unlike a paper-based system, where it is difficult to reconcile different data sets. In IT-based systems, it is easier for data to be compiled and displayed to allow easy tracking and an unmatched level of predictability over time.
How SOPs can help implement QMS?
One of the elements that make up QMS documentation is ‘Quality Procedure’ and this is where SOPs play a crucial role in QMS implementation. Let’s look at how they help in QMS implementation:
- Crucial Element: An SOP (Standard Operating Procedure) is a crucial element that upholds the entire QMS framework together by defining responsibilities, methods, tools and metrics for each step in the product development process.
- Adherence to Regulations: It is written following the general and specific regulations & standards governing industries. Hence, it improves adherence to the desired level of compliance.
- Detailed Procedures: It includes all the processes of an organization with a high degree of detail and specificity, it helps an organization to save costs on product redesign and reformulation.
- Comprehensive Information Resource: An SOP is not written unless all the pertinent information is available to the author and because quality procedures are cross-functional by design, all departments need to work together in the formulation of an SOP. The final output is a comprehensive document that outlines all processes from start to finish.
Why should BPX be chosen for QMS development?
We at Business Process Xperts (BPX) are the leading process consultants in India, providing QMS solutions to both large and mid-size businesses. We offer consultancy services for SOP documentation, audit, training and implementation. Our consultancy offers services for all the major management system standards accepted across the world. We are known for implementing – international high-quality management systems, strategic quality management and integrated quality management system. Our strength lies in implementing QMS in a time-bound and easy to implement manner. Overall, our approach is strictly based on developing and implementing QMS to enable the organization to get ISO certification in the first attempt.