Critical to Quality Update for MDICmdic.org/wp-content/uploads/2015/03/MDIC-Update-3-18-2015...Critical to Quality . Update for MDIC . ... “Critical to Quality?” e.g., a “CtQ

Critical to Quality Update for MDIC

March 24, 2015

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William C. MacFarland FDA/CDRH/OC/Division of Manufacturing and Quality

Agenda • Why Critical to Quality (CtQ)? • Pilot – plan and results • DMQ’s 2014 CtQs • Tentative plan for 2015+ • Questions and Answers Throughout

2 CtQ Update for MDIC

WHY CRITICAL TO QUALITY?

CtQ Update for MDIC 3

• Barriers to quality whitepaper – The relationship between quality and

compliance – historically more focus on compliance than quality

– Historically underutilized comparative quality information

– Increasing complexity of devices and use environments with static quality practices

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Why Critical to Quality?

CtQ Update for MDIC Note1 http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM277323.pdf

Why Critical to Quality? • Manufacturer feedback:

• FDA focuses purely on compliance – not device quality. • Variety of means to focus on quality, including defining

what is Critical to Quality. • Foreign official feedback:

– Focus on what is Critical to Quality. – Prioritize audit findings based on criticality.

• Internal FDA feedback: – Chosen not to focus on quality – have compliance

programs – Need more interaction with firms on quality


Why Critical to Quality? • What is this term, “Critical to Quality” we

heard about?


“…the key output characteristic of a process. An example may be an element of a design or an attribute of a service that is critical in the eyes of the customer.”

- Implementing Quality: A Practical Guide to Tools and Techniques. By Ron Basu

“A CtQ is a product or service characteristic that must be met to satisfy a specification or requirement.”

- Six Sigma Best Practices. By Dhirendra Kumar

“Its purpose is to start with the high-level strategic goal of customer satisfaction and determine how this goal “flows down” into measureable goals.

- The Certified Six Sigma Handbook. By TM Kubiak and Donald W. Benbow


What is this term, “Critical to Quality?” e.g., a “CtQ tree”

PILOT – PLAN AND RESULTS


Pilot Plan and Results • Use inspectional guidance to promote

engagement on quality – inspectional pilot – “CtQs” generated via:

• Internal CDRH and ORA experts • Technical stakeholder input

– CtQs written into inspectional guidance • Shared with investigators • Shared with firms being inspected

– 4 inspections completed in 2014 CtQ Update for MDIC 9

Pilot Plan and Results Investigator feedback: • More efficiency and confidence in the

investigation • Asked more specific questions • Looked at documents they normally would not

have seen • Better understanding of the risk to patient if a

failure occurred • More focused on quality


Pilot Plan and Results Investigator Feedback: • More upfront preparation work than normal • Focused inspection on batteries and may not

have expanded to other areas • Issues in the CtQ guidance did not align with the

firm’s FMEA • Frankness of discussions with the firm remained

the same


Pilot Plan and Results Firm Feedback: • Helped to have CtQ indicators ahead of time • Drives quality before inspection, instead of after • Engages both sides of the inspection more • Informed investigator’s approach, but did not limit it • Drives quality before inspection, instead of after • Helped increase firm’s confidence in their batteries

Other Firm Comments: • Battery is important, but so are other components • Already know criticality of batteries regardless of FDA audit 12 CtQ Update for MDIC

Pilot Plan and Results Firm Recommendations: • Expand the CtQ approach to cover other

components and/or devices • Do not make this an expansion of the

investigation but part of it • Make CtQs flexible so that the inspection drives

which components are investigated further through CtQ


DIVISION OF MFG & QUALITY 2014 CTQ INFO DOCUMENTS


DMQ 2014 CtQs


PMA CtQ Info. Doc.

Tech. Stakeholder

CtQ Info. Doc.

RBWP CtQ Info. Doc.

Division Pilot 1

ASD Branch 4 1

CD Branch 2

POND Branch 1 1

REGO Branch 2

Total CtQ Information

Documents:

FDA CtQ Pilot: 1 DMQ division: 12 Total: 13

DMQ 2014 CtQs


Key characteristic

Impact of failure

Control

Reference to 820 Reference to QSIT

Sphericity and surface finish of the endplates are two key characteristics, because nonconformity of either one of these key characteristics can lead to excessive wear, which can ultimately lead to pain, metal debris inside the end-user’s body, and need for revision surgery.

A. Sphericity is primarily an output of the CNC Turning, CNC Milling, and Deburring processes and verified through the Dimensional Inspection Process [21 CFR 820.80] [QSIT P&PC Objective #2]

• Critical to Quality (CtQ) – current format

TENTATIVE PLAN FOR 2015


Tentative Plan 2015 • Need to update our info document

approach: – Make CtQs internally and externally available – Add mechanism for evaluating information

• Discussing how CtQ Info Documents can be used to improve quality over 3 years – Collaboratively – Proactively/Preventive


Tentative Plan 2015 • PMA CtQ Confirmation Pilot

– For those PMA manufacturing sections with no deficiencies in the original submission

– Applicant inspected within the last five years – For applicants willing to participate

• Applicant submits CtQs. FDA reviews. • Postapproval confirmation of controls. • Postapproval QSIT


Looking for Your Feedback! • Can you identify other tools that can be

proactively used to improve quality? • Are there particular devices or processes

that you’d recommend for the next launch of CtQ info docs?

• Public engagement is key – how to have an effective and flexible approach?

• Any other recommendations? CtQ Update for MDIC 20

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Contact Information Bill MacFarland Director, Division of Manufacturing and Quality FDA, Center for Devices and Radiological Health Office of Compliance Division of Manufacturing and Quality Building WHITE OAK #66, Rm 3680 10903 New Hampshire Avenue Silver Spring, MD 20993 Tel: 301-796-5547 Email: [email protected]

CtQ Update for MDIC