~William A. Foster
Implement A Quality Management System Effectively and Efficiently
Today’s fast changing business environment demands from a company increased flexibility, openness and security. Stakeholders expect transparency, highest quality and compliance ensuring product quality, patient safety and data integrity. In fact, companies operate in a highly competitive environment, which ruthlessly challenges their activities. Businesses need to stay ahead of the opposition. In order to achieve it, they must deliver products or/and services on time, maintaining the highest quality standards.
Pro-Active Quality Management Framework
Quality Management Framework is a powerful business improvement solution, which can notably decrease the cost and effort necessary to pro-actively handle risk, quality and sustainability challenges.
Furthermore, it assures that data quality and integrity is being attained, increasing confidence in the quality of records, service and products. Such a certainty builds a strong image and reputability among various stakeholders. It helps to define undetected needs for financial or human resources operations. Moreover an implementation of quality management framework is an appropriate way to maintain focused provision of good management practices.
Standards and Regulations
In fact, in many companies quality practices are divided and disconnected. Usually firms recognize the need of a binding system, when procedures and policies became too complex and too complicated to be effectively managed. They start looking for a concept, which combines quality realization processes and detects the gaps between quality planning and implementation. They start seeking for a tool, which measures and monitors product development Lifecycle.
Thus, to possess compliant and integrated system, businesses should develop and implement a managed quality framework encompassing procedures, practices, and resources needed to improve the efficiency and effectiveness of services. It is advocated that the quality framework is built on requirements of the appropriate Standard of the ISO 9000 Quality Management Standard series, or similar internationally accepted practices satisfying predominant global and local regulatory demands. The ISO 9001 defines international requirements for a quality management system that can be followed internally within the company and externally by involved parties, whereas ISO 9004 aims to ensure fulfillment of customers’ expectations. In fact, all controlling authorities highly recommend adopting such a system in order to ensure the best quality control.
Different quality management areas
Quality Management is a live system, which is shaped by acquisitions, portfolio changes, operational re-adjustment, manufacturing repositioning, facility rearrangements, restructuring, and workforce sizing. Dynamic regulatory environment demands flexibility and elasticity, thus all companies’ internal procedures must be easily adaptable and changeable. In fact, facilities repurposing, different production lines, procedures, role changes, responsibilities or even employees’ voluntary premature retirement programs have a great influence on company’s know-how, internal knowledge, expertise and general QMS success.
In order to manage all of those variations QMF must be implemented. In fact it is a fundamental groundwork for controlling and managing company’s procedures. It allows continuous performance improvement over the long term. It focuses on the clients while recognizing the needs of all other stakeholders. Furthermore, it defines roles and responsibilities of employees and points the accountable bodies. Quality Management Framework lets handle resources, recruitment and training helping to recognize individual enactment, and personnel welfare policies.
Qualification of internal and external vendors for service and technology
Furthermore QMF identifies what type of outsourcing is required (GP, specific equipment). It defines internal procedures to be respected when selecting a contract producer, department and functions involved. Additionally, it tells how a contract should be set up including all interfaces, responsibilities, information exchange processes, written quality/ service / confidentiality agreements and other activities accommodated with it.
The foundation of a Quality Management Framework
The most important document of QMF is a quality policy or equivalent. Even though a company itself decides how detailed it should be, the quality policy should provide comprehensive and reliable guidance of general procedures and their management. It should consist of at least five elements:
- – scope
- – quality commitment
- – explanation of the main processes
- – processes interactions
- – definition of major responsibilities
- – quality assurance processes
- – execution of available resources
A completion of all of those stages ensures mature and effective system in place. It improves procedures consistency and predictability of results. Additionally, it helps to prioritize improvement opportunities.
Even though the cost of quality is perceived as high, the price of lacking high quality procedures can be much higher. In fact, it prevents higher costs because of its capability to highlight unrecognized faults of processes, instruments or management. Undoubtedly, the price of doing something costly – right now, is causing a “pain” in regards to budget. Nevertheless, the long-term benefits and future paybacks are in fact much higher. It protects company’s good name, its prosperity and ensures effective management. Therefore each of business leaders should ensure possession of reliable and consistent quality management framework.
KVALITO AG, as a consulting group helps companies all over the world to build an excellent Quality Management Frameworks. Our experienced consultants show and teach how to ensure high performance, reduce risk and succeed sustainable growth based our clients needs. KVALITO AG is helping clients everywhere from high profile corporations to small, local companies. Our service assessments and trainings enable our clients to continually improve their products and services.
KVALITO ensures a greatly integrated risk management, document control, audit readiness and high compliance process. We will lead your processes ensuring continuous improvement across the whole organization.
We understand your needs and we will help you to comply with
quality management system standards beyond compliance.
Author: KVALITO Consulting Group
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