Tue. Aug 9th, 2022
    Quality Management and its System QMS - Total quality and compliance control

    Quality Management

    Quality Management (QM) describes a function (management) in the economy and all organizational measures that serve to improve process quality, work quality and thus product and service quality. Quality Management makes it possible to sustainably reduce costs and to develop top quality products.

    The term services in QM includes services, but goes beyond the usual term and primarily relates to internal organizational services. Quality management is a core task of management. In industries like the air and space travel, automotive, medical, parts of the health care, the medical rehabilitation or drug and food production one is quality management system prescribed.

    Various models for standardizing quality management have been developed since around 1900.

    Why is a quality management system essential for international companies?

    Virtually all of my production businesses are global, even if you only sell in your own country.

    Somewhere in the supply chain, disparate and siled management systems can mask sourcing methods and production patterns that do not match your values ​​or the demands of your customers. Therefore, even domestic companies that are dependent on materials sourced from abroad must behave like global companies. This is why forward-thinking companies have come to rely on integrated platforms and digital transformation technology for quality management systems.

    Improving a QMS should be viewed as an ongoing process, requiring decisions to be made long before potentially debilitating production issues arise.

    Decision-making should also be a flexible process, taken at specific times based on emerging data, not once a month, once a year, or even once a day.

    Benefits of improving a quality management system
    When companies can successfully achieve their QMS goals, they can:

    ● Ensuring a constant quality of production
    ● Comply with all applicable regulatory specifications
    ● Make partners responsible for respecting ethical standards
    ● Ensuring the transparency of the supply chain for their customers

    Up to this last point, here is a situation where you may already be in quality and regulatory compliance; however, it is too late to discover that a supplier has harvested raw materials unethically, ignoring ethical work practices or harming the environment.

    A quality management system designed to shed light on unethical behavior can bring accountability to the fore (situated or placed in front).

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    Models and standards Quality Management

    There are a number of quality management standards that are used as a framework or as a mandatory specification for the establishment of a quality management system. The use of the various quality standards shows strong regional and industry-specific differences. Above all, Asian and Anglo-Saxon manufacturers, especially in industry , have introduced quality management methods (see also Donabedian’s quality model ).

    EFQM and ISO 9001

    The best-known quality management models are the EFQM model ( European Foundation for Quality Management model) and ISO 9001 , both of which intersect in terms of process orientation.

    The EFQM model has a European orientation and also enables a certificate from an auditor – like that of EN ISO 9001. In contrast to ISO 9001: 2015, it is a competitive model that does not focus on the fulfillment of specifications but on personal responsibility in the assessment aims. The central concern of the EFQM model is continuous improvement through innovation and learning in all parts of the company and in cooperation with other EFQM users. It is constantly based on the world’s best implementations, so that it is never possible for a company to achieve the maximum number of points. Compared to ISO 9001: 2008, there is therefore greater motivation for further improvements. EFQM can be applied not only to commercial enterprises, but also to service and social institutions. The ISO 9001 revision:

    Special models

    Newer quality standards such as IATF 16949 : 2016 are more closely based on the well-known and well-founded methods of the founders of the industrial quality concept ( W. Edwards Deming , Walter A. Shewhart ).
    The CAF ( Common Assessment Framework ) model based on EFQM was developed for the public sector in Europe .
    For organizations with development tasks (internal IT departments, car development, machine development) there is the Capability Maturity Model Integration (CMMI) as a specialized process model. Due to the specific focus on development organizations, CMMI can go into more detail on individual process aspects.
    Statistical means are used in production to monitor the manufacturing process. Six Sigma is one of the quality strategies based on this.

    In project management own quality management procedures are also used, see quality management in project management.

    The QualityCertificate for Planners in Construction (“QZ Planners in Construction” is a registered word mark at the German Patent and Trademark Office) was developed especially for architecture and engineering offices in cooperation with TÜV Rheinland in 2007.
    The strictest certifications are those of the automotive industry, such as IATF16949: 2016 or its predecessor QS-9000 and VDA 6.1.

    Separate standards are provided in medicine and medical technology, as described under Quality Management in Medicine, as well:

    • in the area of ​​further education,
    • in aerospace and
    • in nuclear power plants.

    Rating

    Many quality management models attempt to make the processes objectively assessable. A distinction must be made between two fundamentally different approaches:

    a) Certifiable standards with defined minimum requirements for an effective quality management system , for example EN ISO 9001, which are assessed by audits.

    b) Self-assessment of your own quality management system and benchmarking between competitors for a quality award , for example the EFQM Excellence Award from the European Foundation for Quality Management (economy), the Speyer quality competition (for the public sector) or the Ludwig Erhard Award , the German award the rules of the EFQM with a high political reputation, within which the effectiveness of the competitive quality management systems are compared with each other.

    Criticism

    It is often criticized that only externally audited and certified quality management models can withstand objective criteria, as self-assessment is often assessed in favor of one’s own situation. Certificates issued by auditors, for example the three possible EFQM certificates, therefore focus on external audits instead of self-assessments.

    See also : Evaluation and Quality Management
    The social scientist Bettina Warzecha takes the position that complex work processes cannot be represented by key figures: It is a myth that industrial processes can be controlled by means of quality management. [1] [2]

    The social and economic scientist Paul Reinbacher qualifies quality management as kitsch , as it creates comfort zones in which expectations are met but no new impulses are generated. In this sense, quality management tends to be conservative rather than innovative. Even a functioning QM system does not provide any information about whether the products or services correspond to the general understanding of quality and are therefore of high quality.

    Structure

    Quality management is a self-referential process, which means that the procedures for improving the respective object can also be applied to the quality management process itself.

    Management

    In QM as a management task, the following are defined:

    Quality policy

    Aims and responsibilities are very important!

    It is in the interest of the management to put down clear descriptions, otherwise it can be held personally responsible for the damage caused by the product.

    DIN EN ISO 9001 : 2015 provides for an evaluation of the quality management system to be carried out at regular intervals by top management, i.e. the management. No individual persons are evaluated, only the system. Furthermore, it is not advisable to carry out the assessment of the QMS by your own quality management representative , because a self-assessment makes little sense.

    In the specifications of the standard, it is required that the assessment should take place at “regular intervals”; in practice, the assessment is carried out on an annual basis. The assessment of the quality management system examines whether the QMS meets current requirements in terms of performance and effectiveness, or whether an adaptation according to Section 9.3.2 of the ISO standard is recommended. In terms of content, it is important to draw conclusions about customer satisfaction, or whether changes in the internal and external stakeholder groups are required for the company, as well as a summary of the services of external providers and the results of monitoring and measurements. The results of the assessment flow into the current and subsequent audit reports.

    Read also: 3 Styles of Managements | The essential qualities of a good manager

    Quality management control loop

    Great emphasis is placed on the continuous improvement of processes. Experiences from this flow back into the planning, so that a control circuit (Deming circuit: Plan, Do, Check, Act) is created:

    • Quality planning – an actual state is determined and the framework conditions for quality management are determined. Then concepts and processes are developed.
    • Quality control – the results obtained in the planning phase are implemented (QFD: Quality Function Deployment, FMEA: Failure Mode and Effect Analysis).
    • Quality assurance – evaluation of qualitative and quantitative quality information (cost-benefit considerations, checking of assumptions made).
    • Quality gain – information obtained from the previous phase is used for structural improvement measures and process optimization. Successes and results are communicated.

    Best Quality Management Software

    MasterControl

    MasterControl is an Electronic Quality Management System (eQMS) that enables life science companies to eliminate paper-based quality processes and meet regulatory standards. With MasterControl, organizations can improve compliance with FDA regulations and ISO quality standards, while increasing manufacturing efficiency and product quality.

    The web-based solution helps organizations automate GxP processes and connect every stage of a product’s development cycle to every department. Automated routing and escalation ensure rapid responses to information provided by departments such as engineering, regulation, manufacturing, quality assurance, sales and marketing.

    Training management features include automating task assignment and monitoring, as well as the sequencing of training courses. MasterControl’s nonconformity features help identify, assess, review and manage nonconforming materials. Managing quality audits makes it easier to track basic audit information and results, and automates the planning of recurring audit-related activities. Users can streamline the complaints handling process using a multi-page form that customers can access from almost anywhere.

    Available in the following countries: Australia, Canada, China, Germany, United Kingdom, Japan, United States.

    Qualtrax

    Qualtrax is a cloud-based compliance management platform. It allows companies to manage employee credentials, documents, processes, training and exams. The software is designed for forensic laboratories, testing laboratories, forensic scientists, manufacturers, utility companies and any other industry that must comply with the following standards: ISO 17025, 17020, 13485 and 9001, GFSI (Global Food Safety Initiative), FDA (Food and Drug Administration), ASCLD (American Society of Crime Laboratory Directors) / LAB (Laboratory Accreditation Board), ACLASS (Assured Calibration and Laboratory Accreditation Select Services) and FQS (Forensic Quality Services).

    Qualtrax provides the tools necessary to manage external and internal audits. The software aims to simplify the quality management of heavily regulated industries and to ensure compliance with critical industry regulations. Users can refresh data for the entire organization and manage compliance with role-based actions that control viewing documents and changing permissions.

    Processes can be automated using workflows in Qualtrax, including corrective actions, incident management, accident reporting, etc. Deficiencies and process bottlenecks can be identified. Users can report on current or completed workflows. Users can also manage employee training through Qualtrax: role-based training, automated alerts, and document matching with trainings or assessments.

    Available in the following countries: Australia, Canada, United Kingdom, Mexico, United States.
    Languages: German, English, Korean, Spanish, French, Japanese, Dutch, Polish, Portuguese.

    Greenlight Guru Quality Management Software

    Greenlight Guru is the only quality management platform designed specifically for medical device companies. The platform helps companies get safer products to market faster, simplifies FDA and ISO regulatory compliance and provides a single source of truth by connecting the management of all quality processes like CAPA (Corrective Actions and Preventive Actions), risk, audits, document control, training, design control and more. Device makers across the globe are replacing their outdated paper-based and general purpose legacy quality systems with Greenlight Guru to push beyond baseline compliance and achieve True Quality. For more information or to request a demo.

    Administrators can also view, assign, escalate and track opinions and complaints and manage version history to perform external or internal audits and inspections using Greenlight Grow, the post-market QMS module.

    Process Street is checklist and standard operating procedures software for businesses. The platform allows them to create and automate workflows, checklists, forms and standard operating procedures. They can automate workflows and collaborate with their team.

    Process Street

    Process Street provides businesses with an easy way to manage their teams’ recurring processes and workflows. Users can create rich process documents including images, videos, email templates, subtasks, etc. Processes can be executed as checklists and collaborative workflows managed and stored securely with security and software permissions.

    Teams can collaborate on all processes from all devices, sharing templates privately with customers and guests or publicly with the world. Users can collect data, automate tasks with form fields, and push data to and from other applications with over 600 integrations offered by Process Street.

    Available in the following countries: Australia, Brazil, Canada, China, Germany, United Kingdom, India, Mexico, United States.
    Languages: English.

    Source: PinterPandai, QMS

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