process validation & verification (v&v) for medical devices
DESCRIPTION
Six focus areas to drive a succesful process V&V. Presentation from the MedTeck UK 2014 Conference.TRANSCRIPT
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Process Validation and Verification
Rina Nir
105/2014
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[email protected] 205/2014
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Process Validation and Verification
From Prototype To ProductSix Focus Areas
305/2014
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Consistent Output
405/2014
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Controlled Process
505/2014
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[email protected] 05/2014
Erez Adiv, MedicSenseNeomi Katz, Pharma Quality EuropeChris Monchinski, Automated ControlSun Kim, QbD WorksMarkus Roemer, Comes Compliance ServicesKirsi Rosenqvist, MedtentiaLine Szlamka, 4Echo, member of MEPY BENELUXOne anonymous (off-record)
Interviewees:(In alphabetic order)
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GET YOUR CEO COMMITTED#1
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Management Commitment?
Quality
We stand for quality.
We live our quality system according to ISO 9001:2008 and ISO 13485:2012.
www.<NAME>.com/quality
805/2014
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Management Commitment!
Using photo: http://upload.wikimedia.org/wikipedia/commons/1/1d/Auguste_Rodin-The_Thinker-Legion_of_Honor-Lincoln_Park-San_Francisco.jpg by Yair Haklai .Using: Entypo Font
905/2014
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[email protected]://www.imdrf.org/documents/doc-ghtf-sg3.asp
1005/2014
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[email protected]://www.imdrf.org/documents/doc-ghtf-sg3.asp
1. Body - 11 pages2. Intro to statistics – 10 pages3. Example – 12 pages
1105/2014
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Culture Change
1205/2014
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Culture Change
1305/2014
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What Could Go Wrong?
1405/2014
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[email protected] 1505/2014
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Affected pumps were manufactured in 1998.Recall issued in 2014!
1605/2014
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ESTABLISH AN INTERDISCIPLINARY TEAM
# 2
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Where Magic Happens
1805/2014
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What variability do we allow?
1905/2014
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What Risk Exists If Parameters Are Out Of Range?
DiameterComposition
CurvatureSoaking liquid
Etc.
2005/2014
Are They All Equally Important?
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Consistently Producing A Stunning Product
2105/2014
The Free4 Concept Wheelchair. Designer: Mr. Markus Ofner, FH JOANNEUM GesmbH
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Requires Multidisciplinary Expertise
2205/2014
The Free4 Concept Wheelchair. Designer: Mr. Markus Ofner, FH JOANNEUM GesmbH
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START EARLY# 3
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[email protected] 2405/2014
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[email protected] 2505/2014
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Wishful Thinking
2605/2014
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A More Practical Approach
2705/2014
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V Model Planning
05/2014
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KNOW YOUR SUPPLIERS AND SUBCONTRACTORS
#4
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Not Equal Partners
3005/2014
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Contractor Selection
• According to level of risk (criticality).• Expertise.• ISO-13485 for this particular type of process.• Certification by a reputed body.• Serves big companies.• Pre-contract audit.• Quality agreement.
3105/2014
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Quality Decision
3205/2014
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Quality Decision
3305/2014
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Quality Agreement
• Quality decision details.• Certification Of Compliance and other forms.• Quality process commitments (V&V).• Forbid non-authorized modifications.• Record retention (with Escrow agreement).• Audit right.
3405/2014
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Where Magic Happens
3505/2014
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MAP YOU PROCESS#5
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Know Your Process
“If you ask people to describe their process, very often different people will describe it differently…. There is no consensus about how the process is.They have many work instructions but not a single schema which describes the process.”
Markus Roemer
3705/2014
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Process Map
3805/2014
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“Obtaining a process that consistently conforms to requirements requires a balanced approach using both mistake proofing and variation reduction tools”
GHTF Guideline
3905/2014
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Poka-Yoke
No way to get it wrong
4005/2014
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MANAGE THE MANUFACTURING RECORDS
#6
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Data Flow Complements Your Process Map
4205/2014
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One FDA Investigation Report
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/UCM382514.pdf4305/2014
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A Thorough Investigation
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/UCM382514.pdf
4405/2014
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Controlling Computerized Systems
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/UCM382514.pdf
4505/2014
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Paper-Forms and Back-Dating
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/UCM382514.pdf4605/2014
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Do Not Use Sticky Notes!
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/UCM382514.pdf4705/2014
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Using Excel In Manufacturing
4805/2014
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When Subcontracting
• Include records related commitments in the Quality Agreement:– Access– Retention– Escrow
• Include records investigation in your audits.
4905/2014
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CONCLUSION
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1. Gain CEO commitment.2. Establish a multidisciplinary team.3. Start Early.4. Know your suppliers and sub-contractors.5. Map your process.6. Manage the manufacturing records.
5105/2014
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[email protected] 05/2014
Erez Adiv, MedicSenseNeomi Katz, Pharma Quality EuropeChris Monchinski, Automated ControlSun Kim, QbD WorksMarkus Roemer, Comes Compliance ServicesKirsi Rosenqvist, MedtentiaLine Szlamka, 4Echo, member of MEPY BENELUXOne anonymous (off record)
Interviewees:(In alphabetic order)