PATH & WHO & UNFPA Workshop 9 - Quality Management and Prequalification

Publication date: 2008

Session 9: Quality Management and Prequalification Session Objectives • Place international standards within quality management context • Discuss intent and scope of key quality management standards • Link quality management with prequalification requirements Quality Management • Includes all elements of organizational management that affect product quality • Does not include activities that have no effect on product quality Brainstorm • Identify at least five components of a quality management system Essential Components of a Quality Management System • A well-established quality management system will have documented: – Quality objectives – Management responsibilities – Training procedures – Process and quality assurance procedures – Record-keeping – Remedial action in case of quality problems ISO 9000 and 13485 • ISO 9000: Quality management systems • ISO 13485: • Specifically for medical devices • More prescriptive than ISO 9001 • More emphasis on risk assessment Quality Management and Prequalification • Prequalification involves examination of documentary evidence to verify the integrity of the product manufactured and compliance with ISO 13485 - Through review of the Site Master File Summary - Through review of the Product Dossier - Through on-site inspection • WHO specification 3.3: Pre-qualification “verifies that the manufacturer has the quality assurance and management system” The ISO 9000 Series • Getting a certificate is one thing • Getting the benefit in terms of operation is another ISO 9000 Fundamental Principles – Customer focus – Leadership – Involvement of people – Process approach – System approach to management – Continual improvement – Factual approach to decision making – Mutually beneficial supplier relationships 8 quality management principles: ISO 13485 • Clause 4: The quality management system • Clause 5: Management responsibility • Clause 6: Resource management • Clause 7: Product realization • Clause 8: Measurement, analysis, and improvement Making ISO 9000 Work for You • Be committed to the principles of ISO 9000 • Document your operation as it exists • Be prepared to justify your decisions Small Group Discussion • Discuss how your factory applies specified clauses of ISO 13485 Session 9 Handout 1 WARNING: This material is only a summary of the standard; do not use this material as a substitute for the complete official standard document. Summary of ISO 13485: Quality Management Standard for Medical Devices Clause 4: Systemic Requirements Summary • You must have a system of documentation that covers your policy, procedures, and product specifications. • You must keep records of production and testing. • You must keep the system up-to-date and usable. Details • 4.1: Must work out what is needed for the system, how to operate and control it, and make sure that it can work. • 4.2: Must have documents about the system (including policy and objectives, quality manual, procedures, records, legally required documents, etc.). • Documents must be controlled. • Must have file that fully defines each product (product dossier). Clause 5: Management Requirements Summary • Top management is responsible for ensuring that the system is created, operated, and developed. Details • 5.1: Management must provide evidence of commitment to quality system. • 5.2: Must ensure that customer requirements are determined and met. • 5.3: Must ensure appropriate quality policy which maintains the quality system and reviews quality objectives and policy. • 5.4: Management responsible for planning any changes. • 5.5: Management must define, document, and communicate responsibilities. There must be internal communication systems. • 5.6: There must be management reviews. Clause 6: Resource Requirements Summary • The organization must provide the necessary buildings, staff, and other resources to allow the quality system to develop and function. Details • 6.1: Organization must provide resources needed to effectively run the quality system and meet regulatory and customer requirements • 6.2: Must have competent, trained, and experienced staff. Must evaluate and maintain records of training. • 6.3: Must provide necessary buildings, utilities, equipment, and support. Must document the requirements for and record the implementation of maintenance. • 6.4: Must pay attention to work environment if it could affect quality. The WHO Prequalification Programme for Condoms: A Workshop for Male Latex Condom Manufacturers 1 Session 9 Handout 1 WARNING: This material is only a summary of the standard; do not use this material as a substitute for the complete official standard document. Clause 7: Realization Requirements Summary • Manufacturing must be planned to meet specifications, customer, and regulatory requirements. • Processes must be validated to show they do that. • Must maintain full documentation. • Product must be traceable through factory. Manufacture: General • Product realization (manufacture) procedures and facilities to be planned, including validation, tests, and appropriate records. • Must establish requirements for risk management and perform risk assessments. • Must determine and review customer and statutory requirements, and keep records of the requirements. • Must have effective ways of communicating with clients. Design • Must have written procedures for design and development, including reviews and validation. • Must determine design requirements. • Design outputs must meet requirements and provide information for production. • Must have acceptance criteria. • Must have design reviews. Quality Control • Must have criteria for purchasing. • Must ensure that purchased product conforms to requirements. • Production to be done under suitable conditions with suitable monitoring and record-keeping. • Keep records of product cleaning, if appropriate. • Must determine and establish the monitoring and measurements needed to demonstrate conformity. • Must calibrate as needed and identify to show status if calibration. • Prevent damage to calibration. • Assess validity of previous results if calibration found faulty. Process Set Up • Production processes to be validated (unless output can be verified by monitoring). • Software used in production to be validated before initial use. • Must preserve product as required during production. Traceability • Product to be identified during production. • Must have procedures for traceability of product, and identify product status (pass/fail). The WHO Prequalification Programme for Condoms: A Workshop for Male Latex Condom Manufacturers 2 Session 9 Handout 1 WARNING: This material is only a summary of the standard; do not use this material as a substitute for the complete official standard document. The WHO Prequalification Programme for Condoms: A Workshop for Male Latex Condom Manufacturers 3 Clause 8: Remedial Requirements Summary • Process product quality and quality system and must be monitored. • Data collected must be analyzed. • Opportunities for corrective action must be identified. • Must have procedures for corrective and preventative actions and implement them when necessary. • Must review corrective and preventative actions. Monitoring • Must monitor whether or not customer requirements are met. • Must conduct internal audits of quality management system. • Must monitor quality management system. • Must monitor quality of product during production and keep appropriate records. • Nonconforming products must be controlled to prevent unintended delivery or use. Analysis • Must collect and analyze appropriate data for: – Feedback from clients (including complaints) – Conformity to requirements – Trends in production – Opportunities for corrective action – Suppliers Corrective and Preventive Actions • Must have procedure and take action to eliminate nonconformities and prevent recurrence. • Review corrective actions. • Determine and implement preventive actions to eliminate nonconformities. • Review preventive actions. Session 9 Handout 2 WARNING: This material is only a summary of the standard; do not use this material as a substitute for the complete official standard document. The ISO 9000 Series Fundamental Principles • Customer focus • Leadership • Involvement of people • Process approach • System approach to management • Continual improvement • Factual approach to decision making • Mutually beneficial supplier relationships 1. Customer Focus Organizations depend on their customers and should: –Understand current and future customer needs –Meet customer requirements –Strive to exceed customer expectations 2. Leadership Leaders: –Establish unity of purpose –Provide organizational direction –Create and maintain environments that support employee involvement in achieving organizational objectives 3. Involvement of People People at all levels are the essence of an organization—their full involvement enables their abilities to benefit the organization as a whole. 4. Process Approach Managing activities as a process produces a desired result more efficiently. 5. System Approach to Management Identifying, understanding, and managing interrelated processes as a system contributes to the organization's effectiveness and efficiency in achieving its objectives. 6. Continual Improvement Continual improvement of the organization's overall performance should be a permanent organizational objective. 7. Factual Approach to Decision Making Effective decisions are based on the analysis of data and information. 8. Mutually Beneficial Supplier Relationships An organization and its suppliers are interdependent, and a mutually beneficial relationship enhances the ability of both to create value. The WHO Prequalification Programme for Condoms: A Workshop for Male Latex Condom Manufacturers 9a - PPT - Qual Mgmt and PQ Session 9:��Quality Management and Prequalification� Session Objectives Quality Management Brainstorm Essential Components of a Quality Management System ISO 9000 and 13485 Quality Management and Prequalification The ISO 9000 Series ISO 9000�Fundamental Principles ISO 13485 Making ISO 9000 �Work for You Small Group Discussion 9b - H1 - Summary of ISO 13485 9c - H2 - ISO 9000 Series << /ASCII85EncodePages false /AllowTransparency false /AutoPositionEPSFiles true /AutoRotatePages /None /Binding /Left /CalGrayProfile (Dot Gain 20%) /CalRGBProfile (sRGB IEC61966-2.1) /CalCMYKProfile (U.S. Web Coated \050SWOP\051 v2) /sRGBProfile (sRGB IEC61966-2.1) /CannotEmbedFontPolicy /Error /CompatibilityLevel 1.4 /CompressObjects /Tags /CompressPages true /ConvertImagesToIndexed true /PassThroughJPEGImages true /CreateJobTicket false /DefaultRenderingIntent /Default /DetectBlends 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