conduct a more effective management...
TRANSCRIPT
Slide 1 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
Conduct a More Effective
Management Review
&
Slide 2 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
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 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.
Slide 3 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
Goals of this Webinar• Avoid nonconformities & 483’s
• Improve process efficiency
• Add value
(the kind that impacts the bottom line)
Slide 4 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
Management CommitmentClause 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 5 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
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 6 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
Customer FocusClause 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 7 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
Quality Policy
Clause 5.3
• Appropriate to purpose of your company
• Commitment to comply with regulations & maintain effectiveness
Slide 8 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
Quality Objectives
Clause 5.4.1
• Established at relevant functions and levels
• Shall be measurable and consistent with the quality policy Where we are
Where we’re going
Action taken
Slide 9 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
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 10 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
Responsibility & AuthorityClause 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 11 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
Management RepresentativeClause 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 12 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
Management ReviewClause 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 13 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
FDA Inspectors• What is an inspector allowed to see?
• What does inspector want to see?
FDA
“Helpful” Employee
Slide 14 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
8 Management Review InputsClause 5.6.2a) Audit resultsb) Customer feedbackc) Process performance & product conformityd) CAPA Statuse) Follow-up of actions from previous
management reviewsf) Changes that could affect QMSg) Recommendations for Improvementh) New or revised regulatory requirements
Slide 15 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
Audit ResultsClause 5.6.2a)
• FDA Inspections
• Internal Audits
• Supplier Audits
• ISO Certification Audits
• JPAL Audits
• Etc.
Pareto Charts Identify Where Findings Come From
Slide 16 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
Customer FeedbackClause 5.6.2b)• Complaints• Customer Surveys• Focus Groups• Customer Requirements/Contracts• Regulatory Communications• Journal Articles• Service Data• MAUDE Database• Device Registries
Slide 17 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
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 18 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
CAPA StatusClause 5.6.2d)
Slide 19 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
Example of Tracking Action Items
Slide 20 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
Changes that could affect QMSClause 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 21 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
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 22 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
New & Revised RegulationsClause 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 23 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
3 Management Review OutputsClause 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 24 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
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 25 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
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 26 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
Resource NeedsClause 5.6.3c)
• New Hires (temporary & permanent)
• Training (in-house & external)
• Equipment & Software
• Work Environment
Slide 27 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
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 28 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
Example of Print PDF Output• Inputs are in the slide
• Discussion is documented in the notes
• Title includes cross-reference to applicable requirements
Slide 29 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
Call to Action1. 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 30 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
Q & A
Slide 31 of 31
November 12th 2013
Rob Packard, Consultant
www.MedicalDeviceAcademy.com
Schedule a Remote Internal Audit of Your 2013 Management Reviews
Rob PackardDecember 2013
31Tuesday
Only 49More Days