BME407 Ethics, Regulations and Standards in Biomedical Engineering (Week 2) PDF

BME407 Ethics, Regulations and Standards in Biomedical Engineering Week 2  Quality Management System Requirements What is a quality management system? In the most simple terms, a quality management system is a clearly defined set of processes and responsibilities that makes your business...

BME407 Ethics, Regulations and Standards in Biomedical Engineering Week 2  Quality Management System Requirements What is a quality management system? In the most simple terms, a quality management system is a clearly defined set of processes and responsibilities that makes your business run how it’s supposed to. Each organization tailors its own QMS, comprising a formal set of policies, processes and procedures established to elevate consumer satisfaction. A QMS guides organizations as they standardize and enhance quality controls across manufacturing, service delivery and other key business processes. The core benefits of a QMS include: Elevated consistency and standardization of processes and outputs Reduced errors and increased operational efficiency Improved customer satisfaction through the delivery of quality products and services Continuous evaluation and improvement of organizational operations What is process? TS EN ISO 9001:2015 4 Process flow – Example (Surgical suture manufacturing process) Finished Sterilizatio Packagin product n g (Surgical suture) Threa d Needle Windin Needle, Sizing attachme g packagi nt ng materia ls, reels 5 Why is a quality management system important? Every organization wants to strive for excellence. Because, ultimately, the quality of a product or service is what the customer gets out of it and is willing to pay for. Quality management plays a crucial role in delivering a superior experience, which in turn influences a company’s growth and performance. Here are six good reasons to consider investing in a quality management system: Brand reputation: This is priceless, of course. A brand is more likely to gain international recognition when an organization surpasses established quality benchmarks. Customer retention: Consistently meeting, or exceeding, customer needs and expectations fosters loyalty. When high standards are met or surpassed, why would customers go anywhere else? Business sustainability: Consistently delivering excellence ensures and maintains a steady supply of customers. Doing business sustainably, and producing minimal waste, is the best way to grow and future-proof an organization. Compliance: Meeting regulatory, safety and quality standards is a must and a QMS seamlessly facilitates this process. Competitive edge: Higher-quality products and services give businesses a competitive advantage in complex times. Staff engagement: Employees who feel they are involved in quality improvements tend to experience higher engagement and productivity. Benefits of using a quality management system There are numerous reasons to establish a QMS. Standardized processes improve efficiency and enhance productivity through the reduction, or even elimination, of redundancies and waste. Defect prevention reduces costs associated with reworking or scrapping. QMS audits excel at recognizing potential problems before they occur, thereby significantly reducing risk. What’s more, a QMS streamlines the record-keeping process, with improved documentation facilitating traceability and accountability – and aiding in regulatory compliance. A QMS also functions as a troubleshooting process, providing performance metrics and built- in audits to uncover weaknesses, establishing a solid foundation for improvement.  TS EN ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes This standard, which covers QMS requirements for medical devices, expects the organization to define the task(s) of the organization within the scope of applicable legal requirements, to define the legal requirements to which the Organization is subject within the scope of these duties, and to include these applicable legal requirements in the quality management system. 4 Quality Management System 4.1 General Requirements 4.1 General Requirements 4.1.1 Determining the scope of QMS / Documentation 4.1.2 Process Application 4.1.3 Monitoring and Measurement of Processes 4.1.4 Continuity of Processes / Changes 4.1.5 Outsourced Processes 4.1.6 Software 4.1.1. Determining the scope of QMS / Documentation - A Quality Management System shall be documented - QMS shall be aligned with EN ISO 13485 and applicable regulatory requirements. - Organization shall establish, implement and maintain any requirement, procedure, activity or arrangement required to be documented - The organization shall document the role(s) (Manufacturer, authorized representative, distributor, importer, etc.) undertaken by the organization under the applicable regulatory requirements 4.1.2 Process Application The organization shall: -determine the processes needed for QMS -apply a risk based approach to the control of processes -determine the sequence and interaction of these processes.  Process Interaction Scheme Sales & CUSTOMER SATISFACTION Marketin MANUFACTURING Shipme CUSTOMER NEEDS g nt Maintenanc QC e Purchasing Managemen QMS R&D t 13 Interaction Table of Processes with Each Other  Document No : Release Date : …………. PROCESS CARD Revision Date : Revision No : PROCESS TYPE :  Main Process  Support Process  Subprocess PROCESS NAME PROCESS OWNER/RESPONSIBLE PURPOSE OF THE PROCESS PROCESS OBJECTIVE AFFECTING PROCESSES AFFECTED PROCESSES PROCESS INPUTS PROCESS ACTIVITIES PROCESS OUTPUTS CONTROL CRITERIA PERFORMANCE CRITERIA SOURCES (HUMAN RESOURCES, INFRASTRUCTURE, WORKING ENVIRONMENT) REFERENCE DOCUMENTS PREPARED BY APPROVED BY 15 Process based QMS Model 16 4.1.3 Monitoring and Measurement of Processes Determining criteria and methods for the operation and control of processes, Ensuring the availability of resources and information necessary for the operation and monitoring of processes, Monitoring, measuring and analyzing processes, Continuous improvement of processes and implementation of necessary activities to achieve planned results Process Approach 17  The Importance of the Process Approach a)Understanding and fulfilling the terms, b) Evaluating processes in terms of added value, c) Obtaining the results of process performance and effectiveness, d) continuous improvement of processes based on objective measurement 18 4.1.4 Continuity of Processes / Changes Changes to be made to these processes shall be: - evaluated for their impact on the quality management system; - evaluated for their impact on the medical devices produced under this quality management system; - controlled in accordance with the requirements of EN ISO 13485 and applicable Regulatory requirements. 19 4.1.5 Outsourced Processes - Define outsourced processes - monitor and ensure control over such processes (supplier/subcontractor evaluation, audit, etc. ) - quality agreements 20 4.1.6 Software The organization shall document procedures for the validation of the application of computer software used in the quality management system. Such software applications shall be validated prior to initial use and, as appropriate, after changes to such software or its application. The specific approach and activities associated with software validation and revalidation shall be proportionate to the risk associated with the use of the software. 21 4 Quality Management System 4.2 Documentation requirements 22 4.2 Documentation requirements 4.2.1 General 4.2.2 Quality manual 4.2.3 Medical device file 4.2.4 Control of documents 4.2.5 Control of records 23  Procedures that need to be documented 1. Software validation– 4.1.6 2. Control of documents– 4.2.4 3. Control of records– 4.2.5 4. Management review– 5.6.1 5. Work environment– 6.4.1 6. Design and development– 7.3.1 7. Design and development transfer– 7.3.8 8. Control of design and development changes– 7.3.9 9. Purchasing process– 7.4.1 10. Purchasing information– 7.4.2 11. Control of production and service provision– 7.5.1 12. Servicing activities– 7.5.4 13. Validation of processes for production and service provision– 7.5.6 14. Validation of processes for sterilization and sterile barrier systems– 7.5.7 15. Identification – 7.5.8 24  Procedures that need to be documented 16.Traceability – 7.5.9.1 17.Preservation of product– 7.5.11 18.Control of monitoring and measuring equipment– 7.6 19.Feedback– 8.2.1 20.Complaint handling– 8.2.2 21.Reporting to regulatory authorities– 8.2.3 22.Internal audit– 8.2.4 23.Monitoring and measurement of product– 8.2.6 24.Control of nonconforming product– 8.3.1 25.Advisory notices– 8.3.3 26.Rework– 8.3.4 27.Analysis of data– 8.4 28.Corrective action– 8.5.2 29.Preventive action– 8.5.3 25 4.2.1. General As defined in 4.1.1; QMS shall be documented. QMS documentation shall include: documented statements of a quality policy and quality objectives a quality manual documented procedures and records required by EN ISO 13485 documents, including records, to ensure the effective planning, operation, and control of its processes; other documentation specified by applicable regulatory requirements 26 4.2.2 Quality manual - the scope of the quality management system, including details of and justification for any exclusion or non- application; - the documented procedures for the quality management system, or reference to them; - a description of the interaction between the processes of the quality management system. The quality manual shall outline the structure of the documentation used in the quality management system. 27 4.2.3 Medical device file The content of the file(s) shall include, but is not limited to: a) general description of the medical device, intended use/purpose, and labelling, including any instructions for use; b) specifications for product; c) specifications or procedures for manufacturing, packaging, storage, handling and distribution; d) procedures for measuring and monitoring; e) as appropriate, requirements for installation; f) as appropriate, procedures for servicing. 28 4.2.4 Control of documents During an internal audit, auditor must check the procedure for control of the documents whether the responsibles are defined for: - review, approve, update and re-approve the documents -Whether the current revision status of and changes to documents are identified -relevant versions of applicable documents are available -external documents identified and their distribution are controlled -system to prevent deterioration or loss of documents and prevent the unintended use of obsolete documents and apply suitable identification to them 29 4.2.4 Control of documents -check whether retention period of the documents are specified by applicable regulatory requirements. 10 years for non-implantable devices 15 years for implantable devices -it should be also defined for obsolete documents 30 4.2.5 Control of records Auditor should check the following in the procedure: -procedures to define the controls needed for the identification, storage, security and integrity, retrieval, retention time and disposition of records -methods for protecting confidential health information contained in records -are the records legible, readily identifiable and retrievable? Changes to a record shall are identifiable? -retention time of the records should be at least the lifetime of the medical device (not less than 2 years), or as specified by applicable regulatory requirements. 31 5 Management responsibility 32 5.1 Management commitment Does the management commitment include the following: -communicating to the organization the importance of meeting customer as well as applicable regulatory requirements; -establishing the quality policy; -ensuring that quality objectives are established; -conducting management reviews; -ensuring the availability of resources 33 5.2 Customer focus Top management shall ensure that customer requirements and applicable regulatory requirements are determined and met. 5.3 Quality policy What is the purpose of the organization? Comply with requirements and to maintain the effectiveness of the quality management system In line with quality objectives Communicated and understood within the organization Reviewed for continuing suitability 34  Issues That Can Be Evaluated in Quality Policy Quality level of products Product reliability Relations with customers Relations with personnel Resource improvement Environment Commitments to comply with the requirements of the QMS and to continuously improve the QMS 35 5.4 Planning 5.4.1 Quality objectives It is one of the items where non-conformity is most frequently detected for organizations! It is created when the job is completed, not at the beginning not enough care is taken often not integrated with the system and only updated before the audit 36 Quality Objectives Specific Measurable Achievable Relevant Time-Bound 37 5.4.2 QMS Planning Is top management aware of the establishment of quality objectives and the need to meet general requirements? When a change occurs in the QMS, is top management aware that this change has been planned and implemented? 38 5.5 Responsibility, authority and communication 5.5.1 Responsibility and authority Responsible Job s descriptions Organisation Scheme 39 5.5.2 QMR Must report to top management on the organizational scheme but be independent from other departments ! Duties: reporting to top management document the processes of QMS promotion of awareness of the requirements 40  Article 15 Person responsible for regulatory compliance (PRRC) Manufacturers must include at least one person within their organization who has the necessary expertise in the field of medical devices and is responsible for regulatory compliance. 41  Competency of PRRC Educational Background Professional experience 1 A diploma, certificate or Minimum one year of professional experience in other official evidence of medical devices, regulatory qualification awarded upon affairs or quality completion of a higher management systems education program in the field of law, medicine, dentistry, pharmacy or engineering or other relevant scientific discipline, or its equivalence 2 - Four years of professional experience in regulatory affairs or quality management systems related to medical devices 42 5.5.3 Internal communication Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system. 43 5.6 Management Review Has the procedure for MRM been published? Are reviews scheduled at regular intervals? Is the date of the last MRM stated? Has the necessary announcement been made before MRM? Is there an assessment of improvement opportunities and needs for changes to the quality management system, including the quality policy and quality objectives? Are records maintained? 44 5.6.2 MR Inputs a) feedback; b) complaint handling; c) reporting to regulatory authorities; d) audits; 5.6.3 MR Output a) improvement needed to maintain the e) monitoring and measurement of suitability, adequacy, and effectiveness processes; of the quality f) monitoring and measurement of management system and its processes; product; b) improvement of product related to g) corrective action; customer requirements; h) preventive action; c) changes needed to respond to i) follow-up actions from previous applicable new or revised regulatory management reviews; requirements; j) changes that could affect the d) resource needs. quality management system; k) recommendations for improvement; l) applicable new or revised regulatory requirements. 45 6 Resource management 46 6.1 Provision of resources meet applicable regulatory and customer requirements and QMS need Examples of sources: Qualified manpower Appropriate infrastructure, machinery-equipment Suitable working environment 47 6.2 Human Resources Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience. Proper education? Hiring Experience Orientation Continous improvement with Staff trainings 48 6.2 Human Resources Presentation-based trainings Paper-based trainings On-the-job trainings -Exams (Paper-based, online) -Exams (Oral) -Observation during on-the-job training 49 6.3 Infrastructure document the requirements for the infrastructure Infrastructure includes, as appropriate: a) buildings, workspace and associated utilities; b) process equipment (both hardware and software); c) supporting services (such as transport, communication, or information systems). 50 6.4 Work environment Maintenance plan Tracebility for the infrastructure Implementation of the plan Time intervals defined in the plan 51 6.4.1 Work environment The organization shall: a) document requirements for health, cleanliness and clothing of personnel if contact between such personnel and the product or work environment could affect medical device safety or performance; b) ensure that all personnel who are required to work temporarily under special environmental conditions within the work environment are competent or supervised by a competent person. 52 6.4.2 Contamination control Procedure regarding pest control Procedure for Microbiological Environmental Monitoring Cleaning Validation Procedure Pest control: -Service procurement must be carried out at certain periods. -There must be a contract with the company from which the service is received. -A post-service transaction report must be obtained and kept as a record. The person who performed the process, the material used, the station, etc. are included in the process report. It should be stated for which pest treatment is being carried out. The person performing the process must have a Biocidal Applicator Certificate. The station layout plan and activity report must be obtained from the company from which the service is procured. 53 7 Product realization 54 7 Product realization 7.1 Planning of product realization Are the processes defined for product realization? Is Risk analysis presented and appropriate? -quality objectives and requirements for the product; -documents -resources specific to the product, including infrastructure and work environment; -required verification, validation, monitoring, measurement, inspection and test, handling, storage, distribution and traceability activities specific to the product together with the criteria for product acceptance; -records 55 7.2.1 Determination of requirements related to product -requirements specified by the customer, including the requirements for delivery and post-delivery activities; -requirements not stated by the customer but necessary for specified or intended use, as known; -applicable regulatory requirements related to the product; Customer requirements cannot override Regulatory requirements! - any user training needed to ensure specified performance and safe use of the medical device; - any additional requirements determined by the organization 56 7.2.2 Review of requirements related to product Organisation shall review the requirement defined in 7.2.1 Are there any change? If there are, are they all implemented in QMS? 57 7.2.3 Communication The organization shall plan and document arrangements for communicating with customers in relation to: a) product information; b) enquiries, contracts or order handling, including amendments; c) customer feedback, including complaints; d) advisory notices. The organization shall communicate with regulatory authorities in accordance with applicable regulatory requirements. 58 7.3 Design and development It consists of 10 sub-articles. Often does not receive due care Records must be maintained for each stage. 59 7.3 Design and development 7.3.1 General The organization shall document procedure The thing to consider is; whether the procedure states all the operations in detail. 7.3.2 Design and development planning There must be a plan and shall be presented. It shall show all the stages of design and development chronologically and systematically 60 7.3 Design and development 7.3.2 Design and development planning a) the design and development stages; b) the review(s) needed at each design and development stage; c) the verification, validation, and design transfer activities that are appropriate at each design and development stage; d) the responsibilities and authorities for design and development; e) the methods to ensure traceability of design and development outputs to design and development inputs; f) the resources needed, including necessary competence of personnel. 61 7.3 Design and development 7.3.3 Design and development inputs functional, performance, usability and safety Risk requirements, management according to the Product idea information intended use derived from previous similar designs Regulatory requirements 62 7.3 Design and development 7.3.4 Design and development outputs -meet the input requirements -provide appropriate information for purchasing, production and service provision; -product specification 7.3.5 Design and development review -to evaluate the ability of the results of design and development to meet requirements; -to identify and propose necessary actions. 63 7.3 Design and development 7.3.6 Design and development verification Verification means confirming by examining and providing objective evidence that specified requirements have been met. verification plans that include -methods, -acceptance criteria -statistical techniques with rationale for sample size 64 7.3 Design and development 7.3.7 Design and development validation Validation: Confirmation through examination and provision of objective evidence that certain requirements can be consistently met for a particular intended use. validation plans that include -methods, -acceptance criteria -statistical techniques with rationale for sample size 65 7.3 Design and development 7.3.7 Design and development validation As part of design and development validation, the organization shall perform clinical evaluations or performance evaluations of the medical device in accordance with applicable regulatory requirements. 66 7.3 Design and development Requirement App/Not App Verification Measuremen Validation record t record record Dimensions Appropriate TD.001 2.8x3.98x4.9 CMM report should be Product 7 cm 3x4x5 cm technical drawing 67 7.3 Design and development 7.3.8 Design and development transfer -ensure that design and development outputs are verified as suitable for manufacturing -production capability can meet product requirements 68 7.3 Design and development 7.3.9 Control of design and development changes Validat Approv Review Verify e e 69 7.3 Design and development 7.3.10 Design and development files maintain a design and development file for each medical device type or medical device family 70 7.4 Purchasing 7.4.1 Purchasing process 7.4.2 Purchasing information 7.4.3 Verification of purchased product 71 7.4.1 Purchasing process establish criteria for the evaluation and selection of suppliers Distinguish between supplier and critical supplier There should be a difference between supplier and critical supplier evaluation Evaluation should be done in a logical manner 72 7.4.1 Purchasing process Supplier: Organisation or person that provides a product, a service or information, and which is outside of the QMS of the manufacturer Critical supplier: a supplier delivering materials, components, or services that may influence the safety and performance of the device 73 7.4.2 Purchasing information -product specifications; -requirements for product acceptance, procedures, processes and equipment; - requirements for qualification of supplier personnel; -quality management system requirements. 74 7.4.3 Verification of purchased product -QC of the purchased product -Reviewing the records of the service 75 7.5.1 Control of production and service provision production procedures, instructions, plans, forms; qualification of infrastructure; monitoring and measurement of process parameters and product characteristics 76 7.5.2 Cleanliness of product -product is cleaned by the organization prior to sterilization or its use; -product is supplied non-sterile and is to be subjected to a cleaning process prior to sterilization or its use; - product cannot be cleaned prior to sterilization or its use, and its cleanliness is of significance in use; - product is supplied to be used non-sterile, and its cleanliness is of significance in use; - process agents are to be removed from product during manufacture. 77 7.5.3 Installation activities Records of medical device installation and verification of installation performed by the organization or its supplier shall be maintained 7.5.4 Servicing activities The organization shall document servicing procedures, reference materials, and reference measurements, as necessary, for performing servicing activities and verifying that product requirements are met. The organization shall analyse records of servicing activities carried out by the organization or its supplier: a) to determine if the information is to be handled as a complaint; b) as appropriate, for input to the improvement process. 78 7.5.5 Particular requirements for sterile medical devices The organization shall maintain records of the sterilization process parameters used for each sterilization batch. Sterilization records shall be traceable to each production batch of medical devices. 79 7.5.6 Validation of processes for production and service provision Re- validation Producti on Validation 80 7.5.7 Particular requirements for validation of processes for sterilization and sterile barrier systems 81 Copyright: https://www.i3cglobal.com/sterilization-validation/ Identification and Traceability 82 7.5.8 Identification mandatory procedure shall be in line with Regulatory requirements 7.5.9 Traceability shall be in line with Regulatory requirements Records of the name and address of the shipping package consignee shall be kept for implantable medical devices 83 7.5.10 Customer property The organization shall identify, verify, protect, and safeguard customer property provided for use or incorporation into the product while it is under the organization’s control or being used by the organization. If any customer property is lost, damaged or otherwise found to be unsuitable for use, the organization shall report this to the customer and maintain records. 84 7.5.11 Preservation of product -activities done during processing, storage, handling, and distribution to protect the product -documenting requirements for special conditions needed if packaging alone cannot provide preservation 85 7.6 Control of monitoring and measuring equipment Calibration plan Traceability of monitoring and measuring equipment Calibration records Have the calibrations been performed within the range in which the equipment was used? Verification records CHECK 86 8 Measurement, analysis and improvement 87 8.1 General -demonstrate conformity of product; -ensure conformity of the quality management system; -maintain the effectiveness of the QMS !Statistical techniques! 88 8.2.1 Feedback Customer satisfaction Customer complaint 89 The information collected during the feedback process serves as a possible input for monitoring and maintaining product requirements, as well as risk management for product realization or improvement processes. If applicable legal requirements require the organization to gain certain experience from post-production activities, reviewing this experience should be part of the feedback process. 90  Feedback How to collect data from production and post-production activities. Feedback data Used to control As a process input for Product Realization or monitoring and improvement and as an maintaining product input to the Risk requirements. Management Process. 91 8.2.2 Complaint handling a timely manner -receive and record no matter what -investigate -report to Regulatory authority if needed (MDR Article 87) -determine the need to initiate corrections or corrective actions 92 8.2.3 Reporting to regulatory authorities If applicable regulatory requirements require notification of complaints, the organization shall document procedures for providing notification to the appropriate regulatory authorities. Records of reporting to regulatory authorities shall be maintained 93 8.2.4 Internal audit The organization shall conduct internal audits at planned intervals to determine whether the quality management system: a) conforms to planned and documented arrangements, requirements of this International Standard, quality management system requirements established by the organization, and applicable regulatory requirements; b) is effectively implemented and maintained. The organization shall document a procedure to describe the responsibilities and requirements for planning and conducting audits and recording and reporting audit results. An audit program shall be planned, taking into consideration the status and importance of the processes and area to be audited, as well as the results of previous audits. The audit criteria, scope, interval and methods shall be defined and recorded (see 4.2.5). The selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work. Records of the audits and their results, including identification of the processes and areas audited and the conclusions, shall be maintained. The management responsible for the area being audited shall ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities shall include the verification of the actions taken and the reporting of verification results. 8.2.5 Monitoring and measurement of processes 95 8.2.6 Monitoring and measurement of product monitor and measure the characteristics of the product to verify that product requirements have been met The identity of the person authorizing release of product shall be recorded. For implantable medical devices, the organization must record the identity of the personnel performing the examination or testing. 96 8.3 Control of nonconforming product controls and related responsibilities and authorities for the identification, documentation, segregation, evaluation and disposition of nonconforming product. 97 8.3.2 Actions in response to nonconforming product detected before delivery taking action to eliminate the detected nonconformity; taking action to preclude its original intended use or application; authorizing its use, release or acceptance under concession. nonconforming product is accepted by concession only if the justification is provided, approval is obtained and applicable regulatory requirements are met. Records of the acceptance by concession and the identity of the person authorizing the concession shall be maintained 98 8.3.3 Actions in response to nonconforming product detected after delivery issuing advisory notices 99 8.3.4 Rework After the completion of rework, product shall be verified to ensure that it meets applicable acceptance criteria and regulatory requirements. 100 8.4 Analysis of data determination of appropriate methods, including statistical techniques and the extent of their use 101 8.4 Analysis of data feedback, conformity to product requirements, characteristics and trends of processes and product, including opportunities for improvement; suppliers; audits; service reports, as appropriate 102 8.5 Improvement continued suitability, adequacy and effectiveness of the QMS as well as medical device safety and performance quality policy quality objectives audit results postmarket surveillance analysis of data CAPA management review 103 8.5.2 Corrective action The organization must take measures to eliminate the causes of non-conformity in order to prevent recurrence. Any necessary corrective action must be taken without delay. Corrective actions should be proportionate to the effects of the nonconformities encountered. 104 8.5.3 Preventive action In order to prevent the occurrence of possible nonconformities, the organization must determine the action to eliminate the causes of these incompatibilities. Preventive actions should be proportionate to the effects of potential problems. 105