QMS - Johtaminen. Tom Ståhlberg FiHTA

Transcription

1 QMS - Johtaminen Tom Ståhlberg FiHTA

2 Management subsystem QSR and ISO 13485:2003 Responsibilities Quality Policy Resources Management representative Management Review Quality planning

3 Quality Management Systems: subsystems Design Controls Corrective & Preventive Actions Process and Production Controls Management Material Controls Records, Documents, & Change Controls Equipment & Facility Controls

4 Quality Management Systems: subsystems Suunnittelun hallinta Korjaavat ja ehkäisevät toimenpiteet Prosessien ja tuotannon hallinta Johtaminen Materiaalin hallinta Tulosteiden, dokumenttien ja muutosten hallinta Laitteistojen ja tilojen hallinta

5 Quality System = Management System Compliance with regulatory requirements But, not only for regulatory reasons: Loyal customers, added value for customers and stakeholders (creating trust) The right quality in products and processes Management tool how to best run the company, will-power systematized

6 US FDA QSIT inspection Begins with Management Controls, and ends with Management Controls Evaluate whether management with executive responsibility ensures that an adequate and effective quality system has been established and maintained

7 FDA QSR requirements for management Management w/ Executive Responsibility (a) Quality Policy (a) Organization (b) Responsibility and Authority (b) Resources (b) Management Representative (b) Management Review (c) Quality Planning (d) Quality System Procedures (e)

8 ISO 13485:2003 QMS Management Controls Management commitment Customer focus Quality policy QMS planning Responsibility, authority and communication Management representative Quality management review

9 ISO 13485:2003 Resource management Provision of resources Human resources Infrastructure

10 QSR vs :2003 Well aligned If following one, should comply with the other No major differences Both: management must be responsible for QMS

11 ISO 13485:2003 vs. ISO 9001: General requirement for quality policy Customer satisfaction goal Track customer satisfaction Quality policy limited to safe and efficiency No goal for customer satisfaction No commitment to continuous improvement Adds independence and authority for those affecting quality Adds, new/revised regulatory requirements to management review

12 ISO 13485:2003 vs. ISO 9001: Resources to enhance customer satisfaction Resources to ensure meet customer requirements Additional: infrastructure adds maintenance affecting quality Additional: work environment lots more requirements for contamination and environment

13 Management subsystem QSR and ISO 13485:2003 Responsibilities Quality Policy Resources Management representative Management Review Quality planning

14 Management? Management with Executive Responsibility Those senior employees of a manufacturer who have the authority to establish or make changes to the quality policy and quality system Top management

15 Management responsibility Senior management has the ultimate responsibility for ensuring that devices produced and distributed are safe and effective Management s commitment to the quality system and the communication of that commitment to all employees is crucial to the success of the quality system Without management commitment, employees gradually stop adhering to Quality system requirements, and the effectiveness of the program erodes

16 Management subsystem QSR and ISO 13485:2003 Responsibilities Quality Policy Resources Management representative Management Review Quality planning

17 FDA QSR requirements for management Management w/ Executive Responsibility (a) Quality Policy (a) Organization (b) Responsibility and Authority (b) Resources (b) Management Representative (b) Management Review (c) Quality Planning (d) Quality System Procedures (e)

18 QMS Quality Policy Quality manual Procedures Level 1 Defines Approach & Responsibility Level 2 Defines Who, What, When Work instructions Level 3 Answers How Records, documents Level 4 Provides a Quality Record

19 Quality Policy Safety Efficiency

20 Quality Policy Establish policy and objectives for quality Quality Policy - The overall intentions and direction of an organization with respect to quality, as established by management with executive responsibility Ensure that the policy is understood, implemented and maintained It is without question management s responsibility to undertake appropriate actions to ensure that employees understand management s policies and objectives <<<A4

21 Quality Policy (a) Management with executive responsibility: shall ensure that the quality policy is understood, implemented, and maintained at all levels of the organization

22 Management subsystem QSR and ISO 13485:2003 Responsibilities Quality Policy Resources Management representative Management Review Quality planning

23 Organization Establish adequate organizational structure Resources Responsibilities and authorities

24 QSR Sec Personnel (a) General. Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed

25 QSR Sec Personnel (b) Training. Each manufacturer shall establish* procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented. establish means define, document (in writing or electronically), and implement (1) As part of their training, personnel shall be made aware of device defects which may occur from the improper performance of their specific jobs

26 QSIT and training A review of employee training records to show they have been trained in the firm's quality policy and objectives can also be done. In particular, this should be done for those employees involved in key operations.

27 QSIT and training From your review of the other subsystems, you have a better idea on whether the management representative has the appropriate authority and responsibility, whether the organizational structure is adequate, whether the quality audits and management reviews are sufficient, whether the quality policy has really been implemented, and whether the training being provided is sufficient.

28 ISO Human resources General Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience

29 ISO Human resources Competence, awareness and training The organization shall a) determine the necessary competence for personnel performing work affecting product quality, b) provide training or take other actions to satisfy these needs, c) evaluate the effectiveness of the actions taken, d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and e) maintain appropriate records of education, training, skills and experience (see ).

30 ISO Human resources Involvement of people Management should improve both the effectiveness and efficiency of the organization.through involvement and support of people by: providing ongoing training and career planning defining their responsibilities and authorities recognizing and rewarding facilitating the open, two-way communication of information continually reviewing the needs of its people creating conditions to encourage innovation ensuring effective teamwork communicating suggestions and opinions using measurements of its people s satisfaction investigating the reasons why people join and leave the organization

31 ISO Human resources Competence, awareness and training Management should ensure that the necessary competence is available for the effective and efficient operation Management should consider analysis of both the present and expected competence needs as compared to the competence already existing in the organization. Consideration of the need for competence includes sources such as: future demands related to strategic and operational plans and objectives anticipated management and workforce succession needs changes to the organization s processes, tools and equipment evaluation of the competence of individual people to perform defined activities statutory and regulatory requirements, and standards, affecting the organization and its interested parties

32 Organization Sufficient in number Determine necessary level of expertise and competence for personnel Communicate importance of job and how it affects quality objectives Evaluate performance to ensure competence and understanding Identify training needs, verify or provide as needed Document education, training, skills and experience Personnel shall be made aware of defects and errors that may be encountered as part of their performance

33 Interrelations Product / project Proposal Production & Maintenance F2 Review Interrelations involves defining how different functions work together and share responsibilities and at what point in processes SBE Mgmt Requirements Analysis P0 Review F1 Review Release Review Production Planing Development Planning Detailed testing plan development Testing (Application & Technology) F0 Review Detailed software design & Implementation Detailed hardware design & Implementation TP Review

34 Organization (b) Organization: Shall establish and maintain an adequate organizational structure to ensure that devices are designed and produced in accordance with the requirements of this part Assure independence

35 Independence Separate QA funcions to review records and release material not reporting to manufacturing, or with authority to act independently Person s decision on product acceptance must be based on data, not subject to forces by management Internal auditor require independence Independent Design Reviews

36 Responsibility and authority Top management s job is to delegate Must be documented somewhere job descriptions define responsibility usually a procedure defines who has authority to sign or approve documents and materials Responsibilities and authority must be communicated throughout company How communication is done must be defined

37 Organization (b)(2) Resources: Shall provide adequate resources including the assignment of trained personnel, for management, performance of work, and assessment activities, including internal quality audits, to meet the requirements of this part Timeliness in quality activities such as complaint investigations, nonconformance closures, MDR reports is a must if not, sign of too small resources

38 Management subsystem QSR and ISO 13485:2003 Responsibilities Quality Policy Resources Management representative Management Review Quality planning

39 FDA QSR requirements for management Management w/ Executive Responsibility (a) Quality Policy (a) Organization (b) Responsibility and Authority (b) Resources (b) Management Representative (b) Management Review (c) Quality Planning (d) Quality System Procedures (e)

40 Management representative Appointed by top management Must be a member of management May have other duties Documented somewhere could be in a procedure or quality manual Requires high knowledge of QMS In the US, this is the first one to go to jail together with the CEO

41 Management subsystem QSR and ISO 13485:2003 Responsibilities Quality Policy Resources Management representative Management Review Quality planning

42 Management review (c) Management Review: Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure the QS satisfies the requirements of this part One of the most critical functions performed by management Essential to an effective quality system

43 Management review Review suitability and effectiveness of the quality system to ensure it meets the QSR and manufacturer s quality policy and objectives Goes beyond the requirements for quality audits

44 Management reviews Top management must attend define who that is and what if cannot attend Must be held at planned intervals What is enough? Annually, bi-annually, or quarterly? Someone has to keep minutes or records of the meetings What to include? Agenda, decisions, actions, discussion topics

45 Management review inputs Calibration Product reviews Process validations Management reviews Quality performance reviews Internal audits Supplier audits Delivery chain audits Key Performance Metrics Complaints, non-conformanices MDRs, recalls CAPAs External audits: authorities External audits: customers New or changed regulations Resource needs

46 Management review outputs Attendees, date, agenda etc. as separate document Document in minutes of meeting: Any decisions made Any actions assigned Improvements to processes or QMS Resource requirement man, machine, or material Product improvement related to customer needs Must be documentation that items are completed

47 Management subsystem QSR and ISO 13485:2003 Responsibilities Quality Policy Resources Management representative Management Review Quality planning

48 FDA QSR requirements for management Management w/ Executive Responsibility (a) Quality Policy (a) Organization (b) Responsibility and Authority (b) Resources (b) Management Representative (b) Management Review (c) Quality Planning (d) Quality System Procedures (e)

49 Quality planning: quality objectives Must be established by top management Derived from quality policy Major objective at highest level and then split into smaller objectives at each level in the organization Must be measurable and reported on Must support quality system and product requirements

50 Quality system procedures Identify the processes needed for the QMS Communicate and implement these processes throughout the organization Develop methods to ensure the effectiveness and control of the processes Ensure adequate resources are available to support and monitor these processes

51 Summary: Johdon sitoutuminen Quality Policy and Objectives - Laatupolitiikka ja päämäärä Organizational Structure - Organisaation rakenne Management Representative - Johdon edustaja Management Reviews - Johdon katselmukset Quality Audits - Laatuauditoinnit Quality System established and maintained - määritelty, dokumentoitu ja toteutettu sekä ylläpidetty