• Charles

How to Build An Effective Quality Management System?

Updated: Apr 8, 2019

A quality management system is an efficient way in which people work so that success of an organisation is sustained. The process involves one being vision-oriented; learning enabled, analysis based, customer focused, quality controlled, a process managed, results oriented and team facilitated and value driven.

The quality management system process consists of the behavioural skills which are of utmost vitality. This is because these skills encourage a set of actions for creating successful outcomes even when the situations are much quality-deficient. However, it’s a widely known fact that managing is more about sociology than it is about technology. This is because managing takes into consideration, attitudes that are defined by values, behaviours that are influenced by attitudes, cultures that are created by behaviours, values that are reinforced by cultures.

Thus, some benefits that the quality management system offers are as follows:

  • It aims at delivering customer satisfaction.

  • The foundation of the system is the built on the quality reputation of a company or firm.

  • The system aims at providing structure to the company or an organization.

  • It drives the process of improvement in a systematic manner.

  • It aims at providing only good business.

  • It aims at yielding the company or firm only money through quality.

Some other specific benefits that the quality management system offers are as follows:

  • It aims at providing a QMS which fits with the operations of a firm.

  • It helps in the identification of potential opportunities for improvement.

  • It aims at ensuring management involvement at various levels.

  • It helps in aiding in the identification of quality and priority objectives.

  • It ensures that people have a clear understanding on how quality does affect them.

  • It also provides for effective and efficient measuring and monitoring processes.

  • It helps in the ready adaptation to altering situations and conditions.

Basic Elements of Effective Quality Management System Some essential elements of an effective and efficient quality management system are as follows:

  • Standard Operating Procedures: One should be prepared with SOPs, manuals, forms and templates. All of which can be used immediately as the system runs. Templates and forms should be used for the purposes of record keeping which the staff can routinely follow.

  • Documentations: This involves classifying, defining and approving of several kinds of documents. Master or technical and quality file documents which are needed to create for building up an effective quality management system for the manufacturing sites. The process starts with defining different types of documents before their classification and needs to be required for approvals. Last but not the least; one needs to retain the documents to understand them.

  • Documentation of Quality Management and Altering Control: Procedures are to be created for the generation of new quality documents or to alter control of the existing documents and reviewing of quality documents as well as satellite file management. One also needs to take care of the role of document author and approver along with document control officer and the satellite file administrator. In the aforementioned procedures, one will also define the numbering systems of different quality documents like audit files, forms, SOPs, templates, training files, manuals, project files and QA agreements along with their effective archiving system.

  • Preparing, Maintaining and Altering Control of Master Documents: Procedures are to be created that will give undivided focus on the management of master file documents such as control methods, specifications, finished goods, raw materials and packaging specification as well as formulation, test reports and stability files  are required to be generated during the product registration in the market.

  • Deviation Report System: It is nothing but a regulatory requirement for capturing all the deviations that evolve in the systems for maintaining the constant improvement of the processes and systems. Procedures are created that describes the categorisation of the deviations between production, quality improvements, audit, customer complaints, technical deviations and environmental, health and safety deviations. The procedures should even describe the management responsibilities of initiating deviation, analysis, capturing data and determination of assignable cause/s, investigation, generating of management reports as well as initiatives to be taken for the corrective and preventative actions.

  • Selection and Evaluation of Vendors: The aforementioned procedure ensures the description of the process by which a vendor might be certified to supply materials or services. The procedure applies to those vendors that supply a material or service that is to be used at any stage of manufacture by operations. One will describe the roles of each and every department in the process for certifying an approved vendor.

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