n 2012, the FDA Issued 219 findings against management responsibilities and the management review process. The Management Review meeting minutes may be officially “out of reach,” but there are FDA inspectors that will ask for this document anyway. Do you really want to be perceived as hiding something? Does the CEO and CFO of your company complain about the length of management review meetings? Did you receive a nonconformity during your last audit, because you forgot to include one of these required items? Eight Inputs Three Outputs Review of the Quality Policy Review of the Quality Objectives Review of the QMS effectiveness Join us for this webinar presentation as our speaker shows you how to use the free template (which he has been using since 2003). You will receive some practical advice on how to avoid FDA 483s and how to keep your senior executive team engaged during management review meetings. This webinar will cover: Management review requirements Documentation of meeting minutes Delegating meeting preparation Minimizing boredom Improving the bottom line What you will receive: Access to the Recording on Demand Our Presentation Slide Deck Template for the Management Review Who should attend? OEMs and contract manufacturers both need to conduct management reviews to ensure the effectiveness of the Quality Management System. The ISO 13485 Standard and 21 CFR 820 both require that your company conduct a management review. Therefore, everyone in top management at a medical device company should watch this webinar. If you are the management representative, you can’t afford to miss this opportunity. If you hate Management Reviews, you will like our method better. PLEASE FILL OUT THE FORM at http://medicaldeviceacademy.com to receive the free recording

1. Conduct a More
Effective
Management Review
&
Slide 1 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com

2. Your Speaker
Rob Packard
Slide 2 of 31
November 12th 2013
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 13485
and ISO 14971 certification. From 2009-2012, 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 13485
certification. The firm has grown to seven consultants in one year.
The most favorite part of his job is training others.
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com

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
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com

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
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com

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.
Slide 5 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com
I get no respect…

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
8.2.1 is different :
Customer Satisfaction vs. Customer Feedback
Slide 6 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com

7. Quality Policy
Clause 5.3
• Appropriate to purpose of your company
• Commitment to comply with regulations &
maintain effectiveness
Slide 7 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com

8. Quality Objectives
Clause 5.4.1
• 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
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com

9. QMS Planning
Clause 5.4.2
• Plan QMS to meet requirements and Quality
Objectives
• Integrity of the QMS is maintained when QMS
changes are planned and implemented
For example:
When an employee leaves the
company or when a regulation
changes.
Slide 9 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com

10. Responsibility & Authority
Clause 5.5.1
• 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
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com

11. Management Representative
Clause 5.5.2
• 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 5.5.3 – Internal Communication)
Slide 11 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com

12. Management Review
Clause 5.6
• 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
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com

13. FDA Inspectors
• What is an inspector allowed to see?
• What does inspector want to see?
FDA
“Helpful”
Employee
Slide 13 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com

14. 8 Management Review Inputs
Clause 5.6.2
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
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com

15. Audit Results
Clause 5.6.2a)
• FDA Inspections
Pareto Charts Identify Where Findings Come From
• Internal Audits
• Supplier Audits
• ISO Certification Audits
• JPAL Audits
• Etc.
Slide 15 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com

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
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com

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
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com

18. CAPA Status
Clause 5.6.2d)
Slide 18 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com

19. Example of Tracking Action Items
Slide 19 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com

20. Changes that could affect QMS
Clause 5.6.2f)
• New product launches
• Product obsolesce
Do you have a
transition plan for
• Down-sizing
departure of critical
• Rapid Growth
personnel?
• Relocation
• New Enterprise Software
• Mergers
Slide 20 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com

21. Recommendations for
Improvement
Clause 5.6.2g)
• 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
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com

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
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com

23. 3 Management Review Outputs
Clause 5.6.3
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
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com

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
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com

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
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com

26. Resource Needs
Clause 5.6.3c)
• New Hires (temporary & permanent)
• Training (in-house & external)
• Equipment & Software
• Work Environment
Slide 26 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com

27. Your Template
•
•
•
•
•
8 Required Inputs – clause 5.6.2
3 Required Outputs – clause 5.6.3
Quality Policy – clause 5.3
Quality Objectives – clause 5.4.1
Continued Effectiveness of the QMS
– clause 5.1
Slide 27 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com

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
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com

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
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com

30. Q &A
Slide 30 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com

31. Schedule a Remote Internal
Audit of Your 2013
Management Reviews
Rob Packard
December 2013
31
Only 49
More Days
Tuesday
Slide 31 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
rob@13485cert.com