ISO13485+CFR820+CTK QM.pptx

ISO 13485:2016 21 CFR 820 Regulation CTK QM Understanding Nov, 2022,QA What is Quality Management System A quality management system (QMS) is defined as a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. A QMS helps coordi...

ISO 13485:2016 21 CFR 820 Regulation CTK QM Understanding Nov, 2022,QA What is Quality Management System A quality management system (QMS) is defined as a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. A QMS helps coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis. ELEMENTS AND REQUIREMENTS OF A QMS Types of QMS Each element of a quality management system helps achieve the overall goals of meeting the customers’ and organization’s requirements. Quality management systems should address an organization’s unique needs; however, the elements all systems have in common include: ISO 9001 ISO 13485 ISO 17025 FDA 21 CFR 820 Regulation 1. Quality policy and objectives 2. Quality manual 3. Organizational structure and responsibilities 4. Data management 5. Processes – including purchasing 6. Product quality leading to customer satisfaction 7. Continuous improvement including corrective and preventive action 8. Quality instrument 9. Document control 10.Employee training and engagement 11.Supplier quality management www.ctkbiotech.com AS 9100, Six Sigma CMMI Why should we care about Quality? • Good quality management can enhance your organization’s brand and reputation, protect it against risks, increase its efficiency, boost its profits and position it to keep on growing. All while making staff and customer’s happier. • Quality is not just a box to be ticked or something you pay lip service to. Failure resulting from poor governance, ineffective assurance and resistance to change can, and do, have dire consequences for businesses, individuals and society as a whole. -IRCA www.ctkbiotech.com ISO 13485 :2016 QMS loop www.ctkbiotech.com CODE OF FEDERAL REGULATIONS – 50 TITLES CODES Title 1 General Provisions Title 17 Commodity and Securities Exchanges Title 33 Navigation and Navigable Waters Title 2 Grants and Agreements Title 18 Conservation of Power and Water Resources Title 34 Education Title 3 The President Title 19 Customs Duties Title 35 Panama Canal Title 4 Accounts Title 20 Employees’ Benefits Title 36 Parks, Forests, and Public Property Title 5 Administrative Personnel Title 21 Food and Drugs Title 37 Patents, Trademarks, and Copyrights Title 6 Domestic Security Title 22 Foreign Relations Title 38 Pensions, Bonuses, and Veteran’s Relief Title 7 Agriculture Title 23 Highways Title 39 Postal Service Title 8 Aliens and Nationality Title 24 Housing and Urban Development Title 40 Protection of Environment Title 9 Animals and Animal Products Title 25 Indians Title 41 Public Contracts and Property Mgmt Title 10 Energy Title 26 Internal Revenue Title 42 Public Health Title 11 Federal Elections Title 27 Alcohol, Tobacco Products and Firearms Title 43 Public Lands; Interior Title 12 Banks and Banking Title 28 Judicial Administration Title 44 Emergency Mgmt and Assistance Title 13 Business Credit and Assistance Title 29 Labor Title 45 Public Welfare Title 14 Aeronautics and Space Title 30 Mineral Resources Title 46 Shipping Title 15 Commerce and Foreign Trade Title 31 Money and Finance: Treasury Title 47 Telecommunication Title 16 Commercial Practices Title 32 National Defense Title 48 Federal Acquisition Regulations System Title 49 Transportation Title 50 Wildlife and Fisheries www.ctkbiotech.com 21 CFR 820 Regulation The FDA has identified in the QS regulation the 7 essential subsystems of a quality system. • Management controls; • Design controls; • Production and process controls • Corrective and preventative actions • Material controls • Records, documents, and change controls • Facilities and equipment controls all overseen by management and quality audits. www.ctkbiotech.com CTK QMS Over View www.ctkbiotech.com Quality System is established at CTK Documentation: in hard copy or in electronic Say what we want to do An organization: Human, facility, IT, equipment, environment Implementation: Feedback loop: www.ctkbiotech.com Resource Do what we say Monitor and correction How are CTK’s QMS documents established ISO 13465 21 CFR 820 Quality Policy Quality Manual 32 SOPs www.ctkbiotech.com Level 1 Level 2 100+ Work Instructions Level 3 100+ Quality Form Level 4 Quality Policy www.ctkbiotech.com www.ctkbiotech.com MANAGEMENT RESPONSIBILITY • Develop a quality policy and objectives for that policy – make sure it is understood and implemented • Establish an adequate organizational structure • Establish the appropriate responsibility, authority…and provide the independence and authority necessary to perform these tasks. • …Provide adequate resources, including the management of trained personnel, for management, performance of work, and assessment activities, including quality audits to meet the requirements of this part. • Review the suitability and effectiveness of the quality system…to ensure that the quality system satisfies the requirements of this part. www.ctkbiotech.com The QA Department Responsibilities • Assist Management in defining the company’s Quality Goals and translating them into action • Train and empower employees to keep the quality system on track • Ensure understanding and compliance of the law • Maintain the quality system in a compliant state – always ready for audit • Submit for product approvals Internationally and keep the company informed on regulatory status and regulatory changes Communicate with government authority Communicate with top management Communicate within organization: all departments and staff www.ctkbiotech.com INTRO Who is the Quality Department? Bill Roxanne Validation specialist QA/Doc Control Jerry – QA / RA Candace – QA Specialist Zhen Rheinhart QA Associate QA Associate Steven Song, Geetha QA-RA consultants INTRO Management Rep – A regulated job description 21 CFR Part 820.20 (3): “…a Member of Management who, irrespective of other responsibilities, shall have established authority over and responsibility for: (i) Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and (ii) Reporting on the performance of the quality system to management with executive responsibility for review.” 21CFR 820 regulation Slides onwards are section view of 21CFR 820 regulation www.ctkbiotech.com TRAINING MAY BE THE SINGLE MOST IMPORTANT ASPECT OF QUALITY’s JOB… If you have learned what is right…you know how to recognize what is wrong. www.ctkbiotech.com • What Does the FDA Require?      www.ctkbiotech.com Management Commitment – Management Review Personal Accountability Follow the recipe – or Change it! GDP – Good Documentation Practices – Evidence! Find and Fix your own problems! – CAPA, Internal Audits QUALITY DEFINED WHAT IS QUALITY? The simple definition: Conformance to requirements of a process or product Re-stated: A quality process – or a quality product – is one that conforms to requirements QUALITY DEFINED • In manufacturing, a measure of excellence or a state of being free from defects, deficiencies and significant variations. • The totality of features and characteristics of a product or service that bears its ability to satisfy stated or implied needs. • “The standards cannot create Quality…ISO (and FDA QSR’s) are just an empty bookshelf for you to design and build your processes on…Quality is achieved when you achieve the minimum requirement of a specified performance standard. Quality is a specified performance range…Toyota Corolla and a top of the line Mercedes Benz are “quality cars”. • Totality of characteristics which act to satisfy a need www.ctkbiotech.com What is Quality Management? • The act of overseeing all activities and tasks needed to maintain a desired level of excellence. This includes the determination of a quality policy, creating and implementing quality planning and assurance, and quality control and quality improvement. www.ctkbiotech.com FDA REGULATION…. WHY? The QS Regulation applies to finished device manufacturers who intend to commercially distribute medical devices.” 21 CFR Part 820 – General Provisions (a) (1) 3rd sentence…“The requirements in this part are intended to ensure that finished devices will be safe and effective…” (c) Authority…”The failure to comply with any applicable provision in this part renders a device adulterated under section 501(h) of the act. Such a device, as well as any person responsible for the failure to comply, is subject to regulatory action.” WHAT DOES FDA REGULATION REQUIRE? OVERVIEW OF 21 CFR Part 820 Quality System Regulation Management Responsibility QUALITY AUDIT • …Conduct audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system. • Conducted by those not having direct responsibility for the areas being audited. • Take Corrective Action • Re-audit if you need to • Management needs to review the results www.ctkbiotech.com Management Responsibility PERSONNEL • Shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed. • Identify training needs – Train all personnel • Workers must be aware of device defects that may occur if the job is not accomplished properly • Those who perform verification and validation activities need to be aware of defects and errors that they might encounter during those activities… www.ctkbiotech.com PERSONAL ACCOUNTABILITY …independence and authority…. • Take full responsibility for your position and duties • KNOW your job – do it correctly – be competent – continue to learn • The law says YOU have been empowered to do the best job you can for CTK – and – to do it the “right” way – YOU are obligated to follow the FDA regulations and all established processes and procedures. Empowered: to give power or authority to, to authorize, especially by legal or official means… to enable….to permit… www.ctkbiotech.com FOLLOW THE RECIPE – OR CHANGE IT! …all established processes or procedures…. • You are obligated to FOLLOW the procedure, work instruction, batch record - “recipe”…. but… WHAT IF IT IS WRONG? What if it doesn’t work for us? CHANGE IT – CORRECT IT MAKE IT RIGHT www.ctkbiotech.com …all established processes or procedures…. What if it is overly burdensome? What if it makes the job harder? What if it just doesn’t work for our department, our personnel, or our company? CHANGE IT IMPROVE YOUR PROCESS(ES) www.ctkbiotech.com CHALLENGE TO THOSE WHO ARE RESPONSIBLE TO DO THE WORK: LOOK AT THE FDA REG • Use your blue book – what is the requirement for your area of responsibility? • Look at your current procedure(s), process(es) • Compare – review – discuss improvement opportunity with your department and QA • Can improvements increase efficiency? … decrease time to market?... Save or better utilize resources?... While remaining compliant? www.ctkbiotech.com DESIGN Controls • PLANNING – the most important element of design controls • INPUT - Design Requirements are appropriate and address the intended use. Document and Review • OUTPUT – Define and document outputs to allow an adequate evaluation of conformance to design requirements. • DESIGN REVIEW – Formal reviews planned and conducted at appropriate stages • DESIGN VERIFICATION – Verify that the design outputs meet the design input requirements. • DESIGN VALIDATION – Perform validation under defined operating conditions on initial production lots. Must conform to user needs and intended uses. www.ctkbiotech.com Design Controls… • DESIGN TRANSFER – ensure the design is correctly translated into production specifications • Control your Design changes • DESIGN HISTORY FIILE – collect all the design documents for each type of device – whatever is necessary to demonstrate that the design was developed in accordance with the approved design plan. www.ctkbiotech.com DOCUMENT CONTROL • Documents needed to ensure compliance with the regulations must be approved • Must be available for use • Remove obsolete documents – so they can’t accidentally be used • Control your changes • Communicate changes to the people who need to know www.ctkbiotech.com Not part of the regulation but important for successful control of documentation and ability to provide evidence… GOOD DOCUMENTATION PRACTICES • No white out! • One line through a mistake, initial and date • NO BACK DATING – NO BOGUS DATA • No BLANKS! • Use N/A – only if N/A is an allowable answer! • Write legibly!! A reviewer and others need to read it – maybe years later! • Fill out batch records in REAL TIME!! • Do not re-copy data! www.ctkbiotech.com Purchasing Controls • All purchased or otherwise received products and services must conform to specified requirements. • Evaluate and select your suppliers, contractors, and consultants on their ability to meet specified requirements – including quality requirements. • CONTROL your suppliers – keep records of acceptable ones • Ensure your suppliers agree to notify you of changes in the product or service they are providing – so that you can figure out whether it will have any effect on your finished product. www.ctkbiotech.com Identification and Traceability • Product must be identified during all stages of receipt, production, distribution – to avoid mix-ups. • Label! Identify components and product, shelving, etc. – the stage of that product should be easy to see. • Use control numbers – lot numbers – make sure they are traceable TO FACILITATE CORRECTIVE ACTION. www.ctkbiotech.com Production and Process Controls • Control and monitor production processes (to be sure the device conforms to its specifications.) • Use process controls if deviations from specs could occur with work instructions, methods that control the manner of production - monitor and control the process parameters and component and device characteristics during production – comply with reference standards – approve processes and equipment, develop a criteria for workmanship. • Control production process changes – re-validate before implementation www.ctkbiotech.com Production and Process Controls • Control the environment when it could have an adverse effect on the product • Maintain requirements for personnel practices where it could effect the product • Prevent contamination of equipment or product • Maintain building of suitable design and space to prevent mix-ups • All equipment used in manufacturing must meet specified requirements and be maintained, inspected, adjust only as posted. • Remove manufacturing material that could have an adverse effect • Validate computer software when used as part of the production or the quality system www.ctkbiotech.com Inspection, measuring, and test equipment • Control the equipment, calibrate it per standards, keep good calibration records Process Validation • Establish procedures – monitor and control process parameters for validated processes – make sure specified requirements are met – and then continue to be met Receiving, in-process, and finished device acceptance • Inspections, testing – incoming product – in process – final acceptance www.ctkbiotech.com Labeling and Packaging Control • Must remain legible and affixed during processing, storage, handling, distribution • Don’t release labels till inspected • Store to provide proper identification and avoid mix-ups • Design and construct packaging and shipping containers to protect the device • Establish procedures for handling, storage, distribution (Control the devices) www.ctkbiotech.com Nonconforming product • Control product that does not conform to specifications • Identify it, document, evaluate, segregate, dispose of as appropriate • Maintain procedures that define responsibility for review and disposition • Justify when product is used after discovery of nonconformance • Have procedures for rework, retest, re-evaluation www.ctkbiotech.com Corrective and Preventive Action - CAPA ANALYZE: • Processes • Work operations • Concessions • Quality audit reports • Quality records • Complaints • Returned product • Other sources (QA Observation, Safety Issues, etc) www.ctkbiotech.com C A P A C A P A www.ctkbiotech.com • • • Investigate the causes of nonconformity GET TO THE ROOT CAUSE Identify the actions needed Verify or validate the corrective and preventive action FIX YOUR OWN PROBLEMS – KEEP THEM FROM HAPPENING AGAIN Records • Records need to be maintained so that they are reasonably accessible to responsible officials for review and copying. • Records stored in automated data processing systems shall be backed up. • Mark documents confidential when delivering to the FDA • Keep records for a period of time equivalent to the design and expected life of the device, but in no case less than 2 years from the date of release for commercial distribution • Do not have to show the FDA management review documentation, quality audits, or supplier audit reports. www.ctkbiotech.com • Device Master Record – for each device – includes specifications, composition, formulation, component specifications, software specifications, production product specifications, equipment specs, production methods, procedures, environment specs, QA procedures, acceptance criteria, packaging and labeling specs, installation, maintenance, service records. • Device History Record - DHR’s are maintained for each batch, lot, or unit… maintained to demonstrate the device is manufactured in accordance with the DMR, include the label, UDI, control numbers. www.ctkbiotech.com Quality System Record – Includes or refers to the location of, procedures, and the documentation of activities required by this part that are not specific to a particular type of device, including but not limited to, the records required by 820.20 (Management Responsibililty) i.e., www.ctkbiotech.com (Quality Manual) COMPLAINT FILES • Establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. Procedures are to ensure that: • All complaints are processed in a uniform and timely manner • Oral complaints are documented upon receipt, • Complaints are evaluated to determine whether an investigation is necessary. Must show reason if not investigated. • Complaints that represent an event which must be reported to the FDA must be promptly reviewed, evaluated, investigated, and maintained in a separate portion of the complaint files. www.ctkbiotech.com Statistical Techniques • Where appropriate, establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics • Sampling plans, when used, shall be written based on a valid statistical rationale. Must establish and maintain procedures to ensure that sampling methods are adequate for their intended use and to ensure that when changes occur, the sampling plans are reviewed. www.ctkbiotech.com WE MUST REMEMBER - • The law says to “establish and maintain procedures”… It does not dictate the how It only gives the Rule and the Intent • Once you create a procedure and put it into your quality system IT BECOMES LAW If you are not following your written procedure – you are out of complianceWE www.ctkbiotech.com WHAT IS HAPPENING IN EUROPE? • Due to a medical device scandal, patient deaths, public uproar – New regulations have now been implemented in Europe • Medical device rules are now EU LAWS not just directives to the Member States • Notified Bodies, responsible for certification of manufacturers, have been reviewed – and removed where necessary • IVD Manufacturers now must have MOST of their IVD products approved by a Notified Body. Self-Certification will no longer be acceptable. • PATIENT SAFETY IS THE GOAL !! THANK YOU! REMINDER – See QA with your questions!