Establishing Quality Management Systems

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1 Establishing Quality Management Systems Dr. Petra Dörr Head of Management Services and Networking Swissmedic, Swiss Agency for Therapeutic Products 14th ICDRA Workshop H 2 December 2010, Singapore Swissmedic Schweizerisches Heilmittelinstitut Hallerstrasse 7 CH-3000 Bern

for Therapeutic Products petra.doerr@swissmedic.

2 Swissmedic Quality Management System Outline of presentation Quality Management at Swissmedic Key Elements of the Quality Management System Critical Success Factors / Lessons learnt Summary and Outlook 2

Elements of the Quality Management System Critical

3 Quality Management at Swissmedic: Accredited units Swissmedic Inspectorate Accredited since 2006 According to ISO/IEC 17020:1998 (general criteria for the operation of various types of bodies performing inspection) Official Medicines Control Laboratory Accredited since 1996 (pharmaceuticals) and 2000 (biologics) According to ISO/IEC 17025:2005 (general requirements for the competence of testing and calibration laboratories) 3

Official Medicines Control Laboratory Accredited since 1996 (pharmaceuticals) and 2000 (biologics)

4 Quality Management at Swissmedic: Change process Analysis of processes and organisation Reorganisation Project QMS Risk-based evaluation of resource allocation Strategy Review* ( ) Apr 06 Oct 06 Aug 07 Jan 09 Jan 10 Sep 10 *Strategic goals (i.a.): Optimisation of processes Modernisation of infrastructure 4

allocation Strategy Review* (2011-2014) Apr 06 Oct 06 Aug 07 Jan 09 Jan 10 Sep

5 Quality Management at Swissmedic: Change process Analysis of processes and organisation (2006) Outcome: Need to improve transparency, consistency and efficiency New structure at management board level High-level process map Reorganisation (2007) Process-oriented structure QM functions integrated Detailed process map High-level process description 5

at management board level High-level process map Reorganisation (2007) Process-oriented

6 High-level Process Map 6 Corporate Governance, QM, Business Continuity Management Management processes Market Surveillance Marketing Authorisation Licensing Enforcement/Penal Action Support Processes Communication, IT, Lab testing, Facility management Signal Decision Measure Application Action

Authorisation Licensing Enforcement/Penal Action Support Processes

7 Quality Management Functions Executive Director: Management representative Head of Sector: Process owner Support/Head of Division: Responsible for process 7

8 Quality Management at Swissmedic: Change process Project QMS Establish Swissmedic-wide QMS as a supporting management tool and provide necessary structures for the implementation of the QM policy. ISO 9001:2008 as guiding principle Certification not a primary goal ( certifiable ) 8

necessary structures for the implementation of the QM policy.

9 Quality Management at Swissmedic: Change process Project QMS Problem statement: Lack of basic principles and standards for process management Lack of a process-centred culture Lack of network-oriented thinking Static, structure-oriented thinking rather than dynamic view of a network-oriented flow of processes 9

of a process-centred culture Lack of network-oriented thinking Static,

10 Quality Management at Swissmedic: Change process Project QMS Key elements/figures Duration: Aug 2008 Jan 2009 Phased approach: Processes split in three groups according to priorities Number of days (employees): 2245 (= 11 years) Cost: CHF/$ 10

approach: Processes split in three groups according to

11 Key Elements of the Quality Management System 1. QM Policy Security Stakeholder QM System Mission / legal mandate & Regulatory environment QM policy Effectiveness and efficiency 11

12 Key Elements of the Quality Management System 2. QM Organisation Management representative: Executive Director Central unit Quality Management Defined process owner and responsible for processes Accredited units with separate QM functions 12

Director Central unit Quality Management Defined process

13 QM Organisation Head of Management Services and Networking Head of process sector 1 Process owner Executive Director (Mgmt representative) Process team 1 consists at least with: process responsible and BPE or Employee Quality Management Quality manager Secretary Lead-Auditor QM-responsible Inspectorate QM-responsible OMCL Head of process sector 2 Process owner Process team 2 consists at least with: process responsible and BPE or Employee Head of process sector n Process owner Process team n consists at least with: process responsible and BPE or Employee Head of accredited sectors Inspectorate and OMCL Head of Inspection Inspectorate (accredited) Technical manager OMCL (accredited) 13

sector 2 Process owner Process team 2 consists at least with: process responsible and BPE or Employee Head of process sector n Process owner Process team n consists at

14 Key Elements of the Quality Management System 3. Continual Improvement Internal audits Feedback process (negative and positive) Training / introduction of new employees Process engineering Description of process as is Process improvement (increased efficiency) Process optimisation 14

positive) Training / introduction of new employees Process engineering

15 Key Elements of the Quality Management System 4. Transparency Internal All valid QM documents are available on the intranet External Selected documents are published on the internet 15

16 Key Elements of the Quality Management System 5. Process Management Guideline Process Management Unified format Process description Processes New processes Changes to existing processes Withdrawal of processes Checklist Processes Formal requirements Comprehensiveness/ completeness 16

description Processes New processes Changes to existing processes

17 Key Elements of the Quality Management System 6. Performance Measurement Performance indicators Degree of transparency (%) Quality of specifications (from internal audits) Quality of execution (from internal audits) Number of complaints (customer satisfaction) 17

transparency (%) Quality of specifications (from internal audits)

18 Critical Success Factors / Lessons Learnt (1) Bottom up vs. Top down Specialist input and top management commitment both are equally important Resource planning Amount of resources needed for work on processes and other specifications was widely underestimated Dedicated and committed project manager Driving force Internal resource 18

Resource planning Amount of resources needed for work on processes and other

19 Critical Success Factors / Lessons Learnt (2) No external consultants running the project Only methodological support for project manager Communication (int./ext.) Information for staff members available on the intranet Information on website can be improved (traceability) Less may be more? ~ 165 processes; ~ 1800 documents 1 (as of today) 1 including different language versions (e.g. standard letters in ger/f/it/e) 19

) Information for staff members available on the intranet Information on website can be improved

20 Critical Success Factors / Lessons Learnt (3) Training is key Training of new employees Introduction day (key elements) Process training (relevant processes for function; defined in job description) Training following introduction of new processes/ process changes Positive and negative feedback instead of complaints Database feedbacks contains both positive feedback (including proposals for improvement) and negative feedback 20

following introduction of new processes/ process changes Positive and negative feedback instead of

21 Summary and Outlook Successful implementation High level of acceptance Entering into a phase of consolidation Implementation of new IT-architecture Business process engineering necessary for computerisation Cooperation IT/QM/specialist divisions QMS specifications/documents as pilot for electronic document management in

22 Thank you for your attention! 22

TÜV UK Ltd Guidance & Self Evaluation Checklist

ISO 9001:2015 Revision TÜV UK Ltd Guidance & Self Evaluation Checklist Why ISO 9001 is changing All ISO management system standards are subject to a periodic review under the rules by which they are written.