Conduct a More Effective Management Review. Rob Packard, Consultant

Transcription

1 Conduct a More Effective Management Review & Slide 1 of 31

2 Your Speaker Rob Packard Rob Packard is a regulatory consultant with 20 years experience in the medical device, pharmaceutical and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies including President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO and ISO certification. From , he was a Lead Auditor and instructor for BSI. Rob s specialty is regulatory submissions of high-risk medical devices for CE marking and Canadian medical device applications. He founded Medical Device Academy in 2012 as a consulting firm focused on helping medical device companies with regulatory submissions and ISO certification. The firm has grown to seven consultants in one year. The most favorite part of his job is training others. Slide 2 of 31

3 Goals of this Webinar Avoid nonconformities & 483 s Improve process efficiency Add value (the kind that impacts the bottom line) Slide 3 of 31

4 Management Commitment Clause 5.1 Provide evidence of commitment to develop & implement QMS & maintain its effectiveness Communicate importance of meeting customer and regulatory requirements Establish Quality Policy & Quality Objectives Conduct Management Reviews Ensure Available Resources Slide 4 of 31

5 Show Commitment by 1. This training is required for every manager 2. Assign one Quality Objective to everyone 3. Use management reviews for business planning. The way my luck is running, if I was a manager I d work in quality. I get no respect Slide 5 of 31

6 Customer Focus Clause 5.2 Top management shall ensure that customer requirements are determined and are met In ISO 9001, this clause includes the aim of enhancing Customer Satisfaction vs. safety and performance of medical devices, and Clause is different : Customer Satisfaction vs. Customer Feedback Slide 6 of 31

7 Quality Policy Clause 5.3 Appropriate to purpose of your company Commitment to comply with regulations & maintain effectiveness Slide 7 of 31

8 Clause Quality Objectives Established at relevant functions and levels Shall be measurable and consistent with the quality policy Where we are Action taken Where we re going Slide 8 of 31

9 QMS Planning Clause Plan QMS to meet requirements and Quality Objectives Integrity of the QMS is maintained when QMS changes are planned and implemented Slide 9 of 31 For example: When an employee leaves the company or when a regulation changes.

10 Responsibility & Authority Clause Responsibilities & authorities are defined, documented and communicated Establish the interrelation of all personnel who manage, perform and verify work affecting quality to ensure independence and authority Note: Regulations require nomination of specific persons for post-production activities & adverse event reporting Slide 10 of 31

11 Management Representative Clause Ensure processes needed for QMS are established, implemented and maintained Reporting to Top Management on the QMS and need for improvements Insuring promotion and awareness of customer and regulatory requirements (see Clause Internal Communication) Slide 11 of 31

12 Clause 5.6 Management Review Review the QMS at planned intervals Ensure continuing suitability, adequacy and effectiveness Assess opportunities for improvement and the need for change including Quality Policy and Quality Objectives Records shall be maintained Slide 12 of 31

13 FDA Inspectors What is an inspector allowed to see? What does inspector want to see? FDA Helpful Employee Slide 13 of 31

14 8 Management Review Inputs Clause a) Audit results b) Customer feedback c) Process performance & product conformity d) CAPA Status e) Follow-up of actions from previous management reviews f) Changes that could affect QMS g) Recommendations for Improvement h) New or revised regulatory requirements Slide 14 of 31

15 Clause 5.6.2a) FDA Inspections Internal Audits Supplier Audits Audit Results ISO Certification Audits JPAL Audits Etc. Pareto Charts Identify Where Findings Come From Slide 15 of 31

16 Customer Feedback Clause 5.6.2b) Complaints Customer Surveys Focus Groups Customer Requirements/Contracts Regulatory Communications Journal Articles Service Data MAUDE Database Device Registries Slide 16 of 31

17 Process Performance & Product Conformity Clause 5.6.2c) Each process should have a quality objective Products should have NCR trending Note: If you have a lot of products, you only need to review the trends that require discussion. Slide 17 of 31

18 Clause 5.6.2d) CAPA Status Slide 18 of 31

19 Example of Tracking Action Items Slide 19 of 31

20 Changes that could affect QMS Clause 5.6.2f) New product launches Product obsolesce Down-sizing Rapid Growth Relocation New Enterprise Software Mergers Do you have a transition plan for departure of critical personnel? Slide 20 of 31

21 Clause 5.6.2g) Recommendations for Improvement You want a list prior to the meeting of suggestions Each manager should provide at least one These could be possible Preventive Actions These may become Management Review Action Items Slide 21 of 31

22 New & Revised Regulations Clause 5.6.2h) You need to cover ALL the global regulations You need a systematic process for this Do not rely upon one source alone even me Note: It s impossible to be perfect, but your goal should be to update your external Standards list at least quarterly. Slide 22 of 31

23 3 Management Review Outputs Clause a) Improvements needed to maintain QMS effectiveness b) Improvement of product related to customer requirements c) Resource needs Note: Includes action items and records of discussions during the Management Review Slide 23 of 31

24 Improvements needed to maintain QMS effectiveness Clause 5.6.3a) This should include all the suggestions for improvement that were agreed upon during the meeting Especially those from Clause 5.6.2g) Note: Includes action items and records of discussions during the Management Review Slide 24 of 31

25 Improvement of product related to customer requirements Clause 5.6.3b) This should include all the suggestions for improvement that were agreed upon during the meeting Especially those from Clause 5.6.2b) Feedback Especially those from Clause 5.6.2c) NCRs Note: Includes action items and records of discussions during the Management Review Slide 25 of 31

26 Clause 5.6.3c) Resource Needs New Hires (temporary & permanent) Training (in-house & external) Equipment & Software Work Environment Slide 26 of 31

27 Your Template 8 Required Inputs clause Required Outputs clause Quality Policy clause 5.3 Quality Objectives clause Continued Effectiveness of the QMS clause 5.1 Slide 27 of 31

28 Example of Print PDF Output Inputs are in the slide Discussion is documented in the notes Title includes crossreference to applicable requirements Slide 28 of 31

29 Call to Action 1. Require 100% of top management to watch this webinar 2. Create your own Management Review template or improve the one you have 3. Fill out my survey and you get a training certificate 4. Take a training effectiveness exam Slide 29 of 31

30 Q & A Slide 30 of 31

31 Schedule a Remote Internal Audit of Your 2013 Management Reviews Rob Packard December Only 49 More Days Tuesday Slide 31 of 31