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Transcript of Who’s Minding the External Standards? Presented by: Michelle Johnston Advanced Quality System...
Who’s Minding Who’s Minding the External the External Standards?Standards?
Presented by: Michelle Johnston Advanced Quality System Solutions MD&M East Session 202 June 3, 2008 ©Advanced Quality System Solutions
A Little NY Wisdom
"Make sure you have finished speaking before your audience has
finished listening."
-- Dorothy Sarnoff (accomplished Broadway singer and Brooklyn native)
AgendaQuality System RequirementsWhat Do You Need?Best Practice and Tips
Procedural ConsiderationsQuality System LinkagesPractical Dos and Don’ts
Recap
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What I’ve Seen This process rarely gets the attention it deserves
Procedures lack detail and don’t define the process
Companies are not aware of new or revised standards
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QS Requirements
Not a lot of visibility in quality system requirements (except for ISO 13485)Regulatory agencies expect standards to be used as appropriate
Demonstrate devices are safe and effectiveHarmonization
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Let’s Clear Up a Misconception
The use of standards is VOLUNTARY
However…
Likely least burdensome approach and considered “best practice”
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How Many Is Enough?
How Many—Well…it DependsDriven by various factors:
Market strategies (where are you going to sell your device(s)
Customer requirements
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Product Considerations:
Sterile or reusable
Biocompatibility
Materials
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How Many—Well…it Depends
Product Considerations:
Labeling/Packaging
Performance Testing
Software
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How Many—Well…it Depends
Environmental/Mfg Considerations:
Clean room
ESD
RoHS and WEEE compliance
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How Many—Well…it Depends
General Considerations:
Risk Management
Design
Clinical Trials
Sampling Plans12
How Many—Well…it Depends
How Do You Know What You Need? Start researching!
Sources of InformationInternet
Professional organizations (ASQ, AAMI)
Standards websites (ANSI, CEN, ISO, ASTM, Tech Street, etc.)
Regulatory agency websites 13
Notified Body websites and newsletters
Authorized representative
Test labs
Industry publications/journals
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How Do You Know What You Need?
So…Who is Minding the Standards?
A Few Scenarios…
Designated Department (typically RA)
Non-centralized. If a standard is needed, it’s ordered. A designated person usually maintains a listing.
Each document is assigned an owner/dept responsible for tracking
What’s Best for You--A Few Things to Consider
Current Resources/knowledge Can be time-consumingOne person may not have the knowledge
Many different types of standards from many sources (budgetary concerns)
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What’s Best Practice?
Clearly define the process including responsibilities based on previously discussed factors—no one size fits all
May want to utilize a subscription service
Define the process in a written procedure
Train employees 18
Procedural Considerations
Doesn’t have to be stand alone procedure
Clearly define responsibilities—process owner(s)
Define how documents are identified—typically a master listing
Defined controls to stay current19
Electronic/paper or both?
Distribution-copyright laws?
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Procedural Considerations
Linkage to Other ProcessesDesign Control—link inputs/outputs to standards
CE Marking—Technical file procedure should reference the use of harmonized standards—this is a MUST for ER Checklist
Management review—identify significant changes to regulations/quality system standards
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Internal Audits—GD 210 for Canadian requirements?
Complaint handling/adverse event reporting and recalls—guidance docs for processing
Purchasing—reference to standards/regs on POs
Training—do employees need to be trained on specific documents?
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Linkage to Other Processes
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Practical Do’s and Don’ts
Practical Do’s and Don’ts
Let’s start with the Do’s:
Forget the “kitchen sink” mentality. Filter, filter, filter! Develop guidelines for inclusion/exclusion.
Recognize that some standards are the same but issued by different standards organizations.
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Practical Do’s and Don’ts
Audit this part of your quality system
Make sure that the status of each standard is known-- current, withdrawn/obsolete, reference?
If a standard is not adopted in its entirety, document justification in appropriate records.
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Practical Do’s and Don’ts
If You Choose to Use a Non-Current Standard:
Perform a risk assessment and document your findings (what has changed and what is the impact?)
May not fly for CE marked product. Reference to “state of the art” in the Directive.
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Practical Do’s and Don’ts
Develop an easy to use external doc listing Document title (in full) Document number (if applicable) Document date/revision Document status
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Recognize that some documents (IEC 60601-1, 3rd Edition) have a transition period and plan accordingly. Gap analysis is beneficial.
Maintain traceability in instances where standards are withdrawn/superceded. EN 540 replaced by EN 14155-1, -2, EN 868-1 replaced by EN ISO 11607-1.
Maintain non-current versions for historical purposes
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Practical Do’s and Don’ts
And some Don’ts
Don’t pay for documents that aren’t copyrighted. You can download them from the internet. These include:
Regulations Most Guidance documents
Don’t forget to purchase amendments29
Practical Do’s and Don’ts
Don’t order more than one version of the same document. For example…
CAN/CSA-ISO 13485:2003 is identical to BS EN ISO 13485 is identical to EN ISO 13485.
Don’t automatically make standards current on your master list until you’ve had a chance to review and implement. (update procedures, employee training?)
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Practical Do’s and Don’ts
Adequate control is not exercised in the identification and distribution of documents of external origin. A review of the standards list found that many documents listed were outdated or not applicable to mitral valve devices.
The organization has not implemented a written procedure that defines how documents or external origin are identified or controlled.
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Actual Audit Nonconformities
Are You Current?
MEDDEV 2.12-1 rev 5 Vigilance Guidance effective 1/1/08. ANSI/AAMI/ISO 10993-6:2007 -- Biological evaluation of medical devices - Part 6: Tests for local effects after implantationANSI/AAMI/ISO 15223-1:2007 -- Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General Requirements
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To Recap…
Give the process the attention it deserves. Shouldn’t be an afterthought. An effective process adds value to the organizationStay current! Know what’s on the horizonReview impact of new or revised standards Written procedure, not blurb in Quality ManualLinkage to other processes
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Thanks for your attention. Questions?
Michelle Johnston, RACPrincipal/Owner
Advanced Quality System SolutionsVista, CA
858.722.4471 www.advqss.com