We all know how much emphasis FDA inspectors and ISO auditors place on your customer complaint and CAPA processes. And rightfully so. But what if there were things you could do to minimize the struggles and challenges associated with customer complaint and CAPA management? Good news. You can decrease the number of customer complaints and reduce the volume of issued CAPAs through good product development Design Controls and Risk Management practices. Specifically this presentation will cover: -Influence Design Controls has on Customer Complaints -How Customer Complaints impact your CAPA system -Best practices for Design Controls -Best practices for Risk Management -Risk-based approaches to Customer Complaint and CAPA management

1. How Design Controls & Risk Management
Best Practices Reduce
Customer Complaints & CAPAs

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Jon Speer is the Founder & VP QA/RA of
greenlight.guru.
• 19+ years in medical device industry
• Product development engineer, quality
manager, regulatory specialist
• 40+ products to market
• Expert at QMS implementations
• Dozens of ISO audits & FDAinspections
@greenlightguru
Jon.Speer@greenlight.guru
+1 317 960 4280

3. Purpose of Training
• Influence Design Controls has on Customer Complaints
• How Customer Complaints impact your CAPA system
• Best practices for Design Controls
• Best practices for Risk Management
• Risk-based approaches to Customer Complaint and
CAPA management
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Some data . . .

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Source: https://goo.gl/admxTZ

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• You did not have a firm grasp on the User Needs. End-users were not
involved in the activity.
• You did not finalize your Design Outputs. You did not work with production
personnel to ensure the documents required to build the product were
accurate and complete.
• You did not do a thorough job during Design Verification. All of the issues
communicated via medical device complaints should have been discovered
before product assembly and shipping.
• You did not have Design Reviews throughout to ensure all Design Controls
had been satisfied.
• You did not conduct a formal Design Validation study of any kind. You
accepted verbal comments and feedback.
• You did not successfully complete Design Transfer.
Design Controls Influence on Complaints

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USER NEEDS – What the end-user expects.
DESIGN INPUTS – What your product will do.
DESIGN OUTPUTS – The “recipe” for building your
product.
DESIGN VERIFICATION – Demonstrates your Design
Outputs meet Design Inputs. That you designed the
product correctly.
DESIGN VALIDATION– Demonstrates your medical device
meets User Needs. That you designed the correct product.

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There is a difference between
defining a prototype/ concept
and defining a medical device!

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Design inputs need to be organized and
differentiated between users, customers
and stakeholders. Design inputs must be
clear and verifiable.
820.30(c)
ISO 13485:2016 7.3.3
Design Inputs

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Design Inputs are the single
most important factor during
medical device product
development.
“There’s never time to do it right
but there’s always time to do it
over!”
• Comprehensive – per risk
• Methodical
• Linked to clinical or other rationale
820.30(c)
ISO 13485:2016 7.3.3
Design Inputs

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820.30(f)
ISO 13485:2016 7.3.6
Design Verification
Did I design my
medical device
correctly?
Design Input
(Requirement)
Design Output
(Specification)
Design Verification

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820.30(g)
ISO 13485:2016 7.3.7
Design Validation
Did you design the
correct medical
device?
User Needs Medical Device Design Validation

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21 CFR Part 820.30 Design Control
b) Design & Development Planning
c) Design Input
d) Design Output
e) Design Review
f) Design Verification
g) Design Validation
h) Design Transfer
i) Design Changes
Planning
Design
Input
Design
Output
Design
Review
Design
Verification
Design
Validation
Design
Transfer
But the process really looks more like this:
Design & Development Planning
Design Input
Design Output
Design Verification
Design Validation
Design Transfer
Design Review
820.30(h)
ISO 13485:2016 7.3.8
Design Transfer
Which gets visualized as:

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My Design Outputs,
Design Verifications,
and Design Validations
can be used as Risk
Control Measures.

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Have me help you
with risk / benefit
analysis of your
product.
Medical benefits of the medical
device need to outweigh the risks
to patients and end-users.

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• Poorly Defined Product Development Processes
• Poor Understanding Of User Needs
• Too Little Time Spent Defining Design Inputs
• Starting Risk Management Too Late
• Poor Design Reviews
• Design Verification Misses The Mark
• Design Validation Is Ineffective
• Poor Design Change Practices
Design Controls Influence on Complaints – Summary

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Complaint Process

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• Not all complaints require CAPA.
• Systemic issues are CAPA worthy.
• Tracking & trending – know your products.
• Complaint process poorly defined.
Complaints Influence on CAPA

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• Everything is a CAPA.
• The issue identified doesn’t need to be a CAPA.
• Reacting is better than being proactive.
• Measure the time it takes to close a CAPA.
• Root cause is easy.
• Effectiveness verification is not always required.
• CAPAs do not have to link to other quality management systems or
processes.
• CAPA does not tie back to design controls or risk management.
CAPA Myths

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1.Create CAPA request and submit for review. Identify sources of CAPA
worthy issue.
2.Review CAPA request. Determine whether or not issue requires CAPA
investigation.
3.Accept or reject CAPA request.
4.If accepted, issue and initiate CAPA.
5.Finalize CAPA sources (i.e. products, processes).
6.Determine CAPA cross-functional team.
7.Identify any immediate actions and corrections required.
8.Investigate and capture findings.
9.Determine root cause(s).
10.Specify corrective and/or preventive action plan.
11.Complete action plan.
12.Review CAPA for completeness.
13.Approve CAPA actions.
14.Specify steps for effectiveness verification.
15.Verify effectiveness of CAPA.
CAPA Process Steps

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From FDA QSIT guidance:
“The purpose of the corrective and preventive action subsystem is
to collect information, analyze information, identify and investigate
product and quality problems, and take appropriate and effective
corrective and/or preventive action to prevent their recurrence.
Verifying or validating corrective and preventive actions,
communicating corrective and preventive action activities to
responsible people, providing relevant information for
management review, and documenting these activities are
essential in dealing effectively with product and quality problems,
preventing their recurrence, and preventing or minimizing device
failures. One of the most important quality system elements is
the corrective and preventive action subsystem.”

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Major sub-systems defined by FDA Quality System Inspection Technique
(QSIT) guidance

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• Poor Design Controls will increase Complaints.
• Not every Complaint is CAPA worthy.
• CAPA for addressing systemic issues.
• Risk Management is TPLC process.
• QMS processes MUST be interconnected.
Summary

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It’s time to

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61. Premarket Quality Management Software
Design Control
Document Management
Risk Management

62. Postmarket Quality Management Software
Audit Management
CAPA
Change Management
Complaint Management
Design Control
Document Management
Nonconformance Management
Risk Management
Training

63. COMPLIANCEIS YOUR STARTING LINE.

64. QUALITY IS YOUR ACCELERATOR.

65. SHIFT FROM JUST COMPLIANCETO TRUE QUALITY.

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@greenlightguru
Jon.Speer@greenlight.guru
+1 317 960 4280
Questions?