Conduct a More Effective Management Reviewmedicaldeviceacademy.com/wp-content/uploads/How-to-Conduct-a-More...Slide 1 of 31 November 12th 2013 ... [email protected] Conduct a More

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November 12th 2013

Rob Packard, Consultant

www.MedicalDeviceAcademy.com

[email protected]

Conduct a More Effective

Management Review

&

http://www.medicaldeviceacademy.com/

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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.


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Goals of this Webinar• Avoid nonconformities & 483’s

• Improve process efficiency

• Add value

(the kind that impacts the bottom line)


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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


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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…


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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


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Quality Policy

Clause 5.3

• Appropriate to purpose of your company

• Commitment to comply with regulations & maintain effectiveness


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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


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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.


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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


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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)


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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


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FDA Inspectors• What is an inspector allowed to see?

• What does inspector want to see?

FDA

“Helpful” Employee


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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


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Audit ResultsClause 5.6.2a)

• FDA Inspections

• Internal Audits

• Supplier Audits

• ISO Certification Audits

• JPAL Audits

• Etc.

Pareto Charts Identify Where Findings Come From


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Customer FeedbackClause 5.6.2b)• Complaints• Customer Surveys• Focus Groups• Customer Requirements/Contracts• Regulatory Communications• Journal Articles• Service Data• MAUDE Database• Device Registries


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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.


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CAPA StatusClause 5.6.2d)


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Example of Tracking Action Items


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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?


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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


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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.


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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


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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)



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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



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Resource NeedsClause 5.6.3c)

• New Hires (temporary & permanent)

• Training (in-house & external)

• Equipment & Software

• Work Environment


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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


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Example of Print PDF Output• Inputs are in the slide

• Discussion is documented in the notes

• Title includes cross-reference to applicable requirements


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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


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Q & A


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Schedule a Remote Internal Audit of Your 2013 Management Reviews

Rob PackardDecember 2013

31Tuesday

Only 49More Days


Documents

Conduct a More Effective Management Reviewmedicaldeviceacademy.com/wp-content/uploads/How-to-Conduct-a-More...Slide 1 of 31 November 12th 2013 ... [email protected] Conduct a More