MEDICAL DEVICES SECTOR BUSINESS PROCESS MANAGEMENT MATURITY (BPMM) ASSESSMENT. Friday, November 15, 2013

Transcription

1 MEDICAL DEVICES SECTOR BUSINESS PROCESS MANAGEMENT MATURITY (BPMM) ASSESSMENT Presented at Business Building Capability conference Las Vegas, NV Nov 11-15, 2013, Ph.D Vice Executive President -Medical Devices Sector Saudi Food Drug Authority Saudi Arabia Friday, November 15, 2013 Dr. Saleh S. AlTayyar

2 Content Introduction BPM Maturity Model Levels BPMM assessment steps Results and Development Plan

3 Introduction Ø ü ü Saudi Food and Drug Authority (SFDA) was established under the Council of Ministers resolution no (1) dated March here was no regulations for medical devices. Saudi Arabia was an open market for various manufactures from all over the world.

4 Introduction (cont) Ø ü ü ü ü Medical devices Sector (MDS) Journey to establish Medical Devices regulations and control the Saudi Medical Devices market was enhanced by: Government support Available resources Strong IT Qualified Staff

5 Introduction (cont) This led to the establishment of a state of the art MDS with: Ø Ø Mature and comprehensive medical devices regulation in harmony with GHTF guidance. Adopt strong e-solutions that allow stakeholders to communicate with MDS via internet in speedy and efficient way.

6 Introduction (cont) Ø Recruit a highly committed specialized staff in various areas of regulatory affairs (252 staff) Ø Transfer Saudi Arabian Medical Devices market from an open and non-regulated market to a well regulated one in a relatively short time.

7 Introduction (cont) This could not have happened without A well documented and managed Business Processes that govern regulations of medical devices through out the stages of their life cycle.

8 Medical Devices Life Cycle Pre-market On-market Post-market

9 SFDA Medical Device Regulations Interim Regulation National Provisions Force Of Law Implementing Rules Guidance Documents Announcements

10 Dr. Saleh S. AlTayyar

11 Dr. Saleh S. AlTayyar

12 Dr. Saleh S. AlTayyar

13 MDEL ECP IMPORTER DISTRBUTER AR Local Manuf. E- SERVICES FSN Market Authorization E. License Insp. Report MDNR Number OUTPUTS International Bodies NCMDR IMPORTER DISTRBUTER AR Local Manuf. Health Provider MDMA AR Local Manuf. MDEL IMPORTER DISTRBUTER AR MDNR IMPORTER DISTRBUTER AR Local Manuf. E- SERVICES

14 Area of responselities of Assistant VP for Admin affairs Area of responselities of Assistant VP for operations Vice President Assistant VP manager Executive manager Division head Organization Structure for Medical Devices Sector Sector Relation Office (liaison with shared/corporate core functions) International relations and business support office VP Medical Devices Sector quality control Department National Center for Medical Devices Information (NCMDI) Scientific Advisory Committees Strategy & Planning Asst. VP for Admin Affairs Asst. VP for Operations Business support unit and archiving Executive Management of Medical Devices laboratories Executive Management for Communication & Awareness Executive Management for Pre-market Approval & Scientific Evaluation Executive Management for Registration & Licensing Executive Management for Compliance & Enforcement Executive Management for Surveillance & Biometrics Center of Radiation Safety and Protection Directorate of Consumer Awareness Directorate of Quality & Risk Management Directorate of Establishment Licensing Directorate of Port of Entries Directorate of Medical Devices Surveillance Directorate of Radiation Safety & Protection Division of Awareness Division of Complaints Directorate of Industry professionals awareness & technical support Division of Complaints Directorate of Healthcare providers support Division of awareness Division of Quality Management Division Of Risk Management Directorate of Standards & Guidelines Division of Standards Division of Guidelines Division of Advertising Directorate of Medical Devices Scientific Evaluation Division of Devices Classification Division of Clinical Trials Division of Importer and Distributer Licensing Division of Manufacturers & Authorized Representatives Licensing MDNR Directorate of Medical Devices Registration Division of Clinical Trails Approvals Division of MD Registration Division of IVD Registration Directorate of Enforcement Division of Enforcement Division of Follow - Up Directorate of Compliance Assessment Division of Medical Devices Compliance Assessment Division of IVD Compliance Assessment Division of Establishments Compliance Assessment Directorate of Inspection Division of Collecting & Published Division of Follow-up & Communication Directorate of Reporting & Crisis Management Division of Incident Investigations Division of Risk & Crisis Management Directorate of Auditory & Biometrics Division of Auditory Division of Biometrics Division of radiological devices usage assessment Division of Radiation Quality Control Division of Radiation Safety & Protection Standards Division of Operation Requirements Division Directorate of Radiological Devices Surveillance Division of Radiological Devices Risk Assessment Division of Radiological Devices Measurements & Calibration Division of Radiological Devices Programs Division of Complaints Directorate of Publication Division of New Technology Assessment Division of Performance Evaluation Directorate of Marketing Authorization Division of Scientific &Technical Auditing Division of Scientific &Technical Evaluation Division of Advertising Approval Directorate of Non-MD Licensing Division of Non-IVD Licensing Division of Chemical & Distillation Licensing Division of Documents Revision Division of Medical Devices Inspection Division of IVD Inspection Division of Establishment Inspection Division of Special Access Products Dr. Saleh S. AlTayyar

15 BPM Maturity Model Levels

16 BPM Maturity Model Levels Initial Managed Unit process discipline Basic project and process management Individual process flow Individual planning Standardized Standardized methodology BPM competence center Predictable Optimizing Focus on process improvement Integrated Processes Processes are measured and controlled

17 BPMM Assessment Objective: BPMM assessments aim to assist the SFDA Medical Devices Sector in evaluating, tracking, crafting and forecasting its journey towards a more mature process centric operation. The main objectives are: Ø Understand the quality of process management currently in effect in the SFDA Medical Devices Sector.

18 BPMM Assessment (Cont) Ø Ø Ø Ø Increase the shared understanding of BPM concepts and practices across the Medical Devices Sector. Determine the current and target levels of BPM Maturity. Understand the best way to achieve the target levels. Develop a roadmap of initiatives and projects to achieve the target levels of BPM maturity over an appropriate timescale.

19 BPMM Assessment (Cont) Assessment Steps

20 BPMM Assessment (Cont) I. Kickoff Meeting Ø MD Sector BPMM started in March, 2013 by External Auditor (Leonardo Consulting) Ø Introductory and kickoff meeting was conducted with processes owners, participants and stakeholders to: ü Explain the BPMM and its levels. ü Inform all survey participants about the survey date, time and explain the survey methodology.

21 BPMM Assessment (Cont) II. Survey Ø The Survey was developed by BPTrends Associate (a global pioneer and a leader in business process management, methodology and practice) The sample included Ø Purpose: departments managers. processes owners. processes stakeholders. ü measure the MDS maturity in managing processes. ü Collect informed opinions of people inside the organization about their personal experiences.

22 BPMM Assessment (Cont) The survey was divided into two major areas: Ø ü ü ü ü ü ü Enterprise level: The activities Focused on: Strategy Process architecture Performance Alignment Governance Support

23 BPMM Assessment (Cont) Ø ü ü ü ü Process level: The sub topics canvassed by the survey was: Business processes defined Measures & managers Redesign Improvement

24 BPMM Assessment (Cont) Ø Survey quality validate: a group of processes experts were selected to compare their response with all other responses. The following was done to validate the survey s data: ü Distribution of answers across the sample for each question. ü Compare general responses against reference group. ü Reasonableness check (unusual patterns).

25 BPMM Assessment (Cont) III. Interviews Ø Interviews were conducted with all processes owners. They allow more extensive and experiential discussions about the practical application of BPM approaches and give practical insights about current effectiveness, and future challenges, for process based management.

26 BPMM Assessment (Cont) Ø Questions focused on: ü Availability of Process documents. ü Process in documents vs. in reality. ü Documented measurements and KPI tracking. ü Change management and control. ü Process improvement projects.

27 Results and Development Plan Results Target Development Plan

28 Results and Development Plan (Cont) Survey Interviews Recommended Assessment Results Target +12 months months Note: only 25% of organizations, who are taking a process approach, are at Level 4 or above. (BP trend report the state of Business Process Management 2012)

29 Results and Development Plan (Cont) 1) Staff survey reported a current BPMM of 3.0, and a 12 month target of 3.9. Based on interviews, it was assessed as ) Reference group assessment ü 2.8 for the current environment ü 3.5 for the 12 month target. 3) Adopting level 4 target is very challenging task for 12 month ü 3.5 (12 month) ü 4.0 (18 month)

30 Results and Development Plan (Cont)

31 Results and Development Plan (Cont) ENTERPRISE LEVEL Question (CURRENT) Overall Score 3.2, SD 1.02 Average (FUTURE) Overall Score 3.9, SD 0.93 Average Executive attitude Business process architecture Measures Process management Alignment BPM Center

32 Results and Development Plan (Cont) Ø The largest perceived gap is in the area of office BPM. This indicates agreement among respondents on the importance of BPM office and the need to further develop it. Ø Measures and alignment have the second largest gap. They both have the lowest score for the current environment and also need to be further developed.

33 Results and Development Plan (Cont) PROCESS LEVEL Question (CURRENT) Overall Score 2.8, SD 1.06 (FUTURE) Overall Score 3.8, SD 1.07 Average Average Business process defined Measures and managers Redesign Improvement Implementation

34 Results and Development Plan (Cont) Ø The current values are lower than those for the enterprise level. Ø All gaps are higher than those of the enterprise level. Ø The target level are consistent with the enterprise level, but the current value are generally lower.

35 Results and Development Plan (Cont) Gap Areas The following gap areas were identified:

36 Results and Development Plan (Cont) Development Plan A) Enterprise Process Architecture EPA A detail business Process Architecture model was developed to address the main three levels (i.e Strategic, medium and operational level) along with the key performance indicators KPIs for each level

37 Results and Development Plan (Cont) (EPA Level 1) M REGULATE MEDICAL DEVICES M1: Premarket M2: on Market M3: Post Market M4: Monitor and Inspect M5: Communication and Awareness M6: Quality Control First level shows the main process areas that include main functionalities.

38 Results and Development Plan (Cont) (EPA Level 2) M REGULATE MEDICAL DEVICES M1: Premarket M2: on Market M3: Post Market M1.1: Register Est. And Devices M1.2: License Est. And Devices M4: Monitor and Inspect M4.1: Inspect Establishment M4.2: Inspect Device M2.1: Clear Shipments M3.1: Manage Adverse Device Events M3.2: Resolve Adverse Device Events M5: Communication and Awareness M5.1: Increase Awareness M5.2: Manage Communication M6: Quality Control M6.1: Control Process M6.2: Manage Improvements

39 Results and Development Plan (Cont) (EPA Level 3) M1 Premarket M1.1 Register Establishment and Device M1.1.1 Register Establishment on MDNR M1.1.2 List MD in MDNR M4 Monitor and Inspect M4.1 Inspect Establishment M1.2 License Establishment and Device M1.2.1 License MD Importer and Distributer M1.2.2 License MD Authorized Representative M1.2.3 Issue Medical Devices Market Authorization M1.2.4 License Devices Ads M4.1.1 Inspect Establishment M2 On Market M2.1 Clear Shipments M2.1.1 Inspect medical Device at Ports of Entry M3 Post Market M3.1 Manage Adverse Device Events M3.1.1 Register New NCMDR User M3.1.3 Prepare Weekly Report for NCMDR M3.2 Resolve Adverse Device Events M3.2.1 Gather, add, publish international FSNs / Recalls M3.2.3 Investigate Adverse Event/Incident M4.1.2 Assess Establishment Inspection M3.1.2 Follow up and Communicate FSNs-Recalls M3.2.2 Gather, add, publish national FSNs / Recalls M4.2 Inspect Medical Device M4.2.1 Inspect Medical Device M4.2.2 Assess Medical Device Inspect M5 Communication & Awirness M5.1 Increase Awareness M5.1.1 Conduct Workshops M5.1.2 Participate in social event -conferences M5.1.3 Subscribe to the Emergency Care Research Institute (ECRI) Services M5.2.1 M5.2.1 Publish Publish material material on on M5.2 Manage MD MD Website Website Communication M5.2.3 M5.2.3 Facilitate, Develop, Publish Publish MD MD Material Material M5.2.2 Update and Maintain MD Internal web site M5.2.4 Manage Medical Devices Sector s address M6 Quality Control M6.1 Control Processes M6.2 Manage Improvements M6.1.1 Control Document M6.1.2 Conduct Internal audit M6.2.1 Improve Processes

40 Results and Development Plan (Cont) B) Measures and Governance Process owners have been appointed and every process has an owner now and every process are currently measured to evaluate performance and efficiency

41 Results and Development Plan (Cont) B) Measures and Governance (cont.) Ø Establishing Change Management (CM) Board with following responsibilities: ü Approve any change in the MD sector process architecture ü Approve any change or improvement in a process ü Approve any change in process measurements and KPIs Ø Change Management Members: ü Department executives ü MD Quality Control Department

42 Results and Development Plan (Cont) C) Process Improvement Projects A series of workshops have been conducted to Analyze and recommend identify the business processes area of improvements using Business Process Trends and Six Sigma

43 Results and Development Plan (Cont) Example: Ø Compliance and Enforcement Process: ü Process definition: Inspect, monitor and apply enforcement action to medical device establishments that violate SFDA regulations. ü Process scope: All establishments that import, export, distribute or manufacturing medical devices in Saudi Arabia

44 Results and Development Plan (Cont) Example (Cont): Ø Targets and Goals: ü Increase number of inspections. ü Decrease time needed in each case. ü Optimizing utilization of inspection. Ø Has Three Main Processes: ü Inspect Establishment. ü Assess Inspection Findings. ü Enforce Establishment.

45 Results and Development Plan (Cont) Example (Cont): Initiate Review Documents Scope and Schedule Inspect Review Findings Assess Findings Request CAP Followup Prepare Comm. meeting Make Action Prepare Enfor. Action Report Integration with Registration system Automate scheduling Auto-generate reports based on user input Time reduced: instead of search for the establishment manually Time reduced: Establishments interacts and confirm suggested visit dates. System can avoid overlapped visits for the same inspectors Time reduced: The system will generate all reports with the required format. This will save good deal of time in comparison of doing each report manually.

46 Results and Development Plan (Cont) Example (Cont): Ø Improvement Results Targets Old Process New Process # of inspections per year Time to close case * 5 Months 2-3 Months Inspector utilization 35% 95% * Time needed from case initiation to close case in assessment or enforcement stage.

47 Results and Development Plan (Cont) D) BPM Communication Plan Ø BPM monthly committee: ü SFDA BPM office. ü Medical Device sector Quality Control Department. ü Food sector Quality Control Department. ü Drug sector Quality Control Department.

48 Results and Development Plan (Cont) E) Capability Development

49 Results and Development Plan (Cont) E) Capability Development (cont.) Training Type BPM (on Methodology) Performance Measurement Six Sigma certifications Goal All staff in managerial levels All process owners All staff in quality office

50 Results and Development Plan (Cont) E) Capability Development (cont.) Training Type Goal Achieved BPM (on Methodology) Performance Measurement Six Sigma certifications All staff in managerial levels All process owners All staff in quality office 10 executives and managers All process owners One black belt certified and several green belt

51 What Help MDS Achieve this Result? Ø Ø Ø Ø Ø Establishing Quality Management System (QMS) Standard Operating Procedures Implementation s ISO9001:2008 certification Monitoring Key performance Indicators (KPIs) Improvements Projects ü Six sigma

52 What Helped MDS Achieve this Result? (Cont) Obtained ISO9001:2008 certificate

53