Auditing + Inspection Processes
What is poka-yoke an example of?
Bonus double points: Provide a real world example of this concept.
Mistake proofing
Bonus: Specialized trays/dishes to check all parts are present, an intervention device to catch mistakes before resulting in a non-conformance, etc. (Make a collective judgment on the example)
What does FD&C stand for?
Bonus double points: Name 1 major FD&C Act change (in the regulation's history)
Food, Drug & Cosmetic
Bonus
1938 Added med devices to scope
1976 Medical device amendments
1990 Safe Medical Devices Act (AMDA)
1997 FDA Modernization Act (FDAMA)
2012 Food and Drug Administration Safety and Innovation Act (FDASIA)
2012 Medical Device User Fee and Modernization Act (MDUFUMA III - part of FDASIA)
What is EU MDR's regulation #?
2017/745
Why was MDSAP created?
Bonus double points: What does MDSAP stand for?
Super bonus double points (not MDSAP related): What are the two Chinese organizations for medical devices/products?
To allow 3rd party organizations to audit to MDSAP and satisfy several country requirements at once on a 3 year cycle
Bonus: Medical Device Single Audit Program
Super bonus: National Medical Products Administration (NMPA), Center for Medical Device Evaluation (CMDE)
3.21 The retention of prior audit records is of the greatest value to an audit function because of which of the following?
a. It assists in the orientation and training of new auditors
b. Determines the timing necessary for a follow up audit
c. It assists in the preparation for the next audit
d. It can provide a backup record in case the client misplaces their report
c. It assists in the preparation for the next audit
Name 3 reasons why record retention (for auditing and inspections) is important.
Bonus double points: what records should be maintained per ISO 19011
Evaluating progress of audited areas
Follow-up on continuing corrective action success
Reference when developing future checklists
Future audit reference to ensure adequacy of coverage
Potential litigation
Bonus: Records related to individual audits, results of audit program reviews, records relating to audit personnel covering subjects
Name 3 things you need to avoid being considered misbranded.
Include manufacturer, packer, distributor identification and address
Include uniform device descriptions and instructions for safe use
Issue notification of unreasonable risks or conduct postmarked surveillance
Be manufactured, prepared, propagated, and compounded and/or processed in a facility registered in compliance with FD&C Act regulations
Be included on facility's registered list of devices
Comply with applicable standards and premarket approval requirements prior to sale
Not be dangerous when used in the manner, frequency or duration instructed on its labeling
Submit labeling for review by FDA
What are the 3 categories of Safety and Performance Requirements?
General requirements
Design and Manufacturing requirements
Information supplied with device requirements
What licenses are needed for devices in Canada?
Bonus double points: What is the name and number of the main medical device regulation in Canada?
MDEL (Medical Device Establishment License) - for Class I manufacturers
MEL (Medical Device License) + 13485 cert needed for class II-IV manufacturers
Bonus: CMDR (Canadian Medical Device Regulation) SOR 98-282
3.62 The audit report should include:
a. A summary of audit results and findings
b. Details of how the audit team was selected
c. Identification of person(s) who prepared the checklists
d. Qualifications of personnel who performed the audit
a. A summary of audit results and findings
What are the 5 principles of auditing?
Ethical conduct
Fair presentation
Independence
Due professional care
Evidence-based approach
What information is needed for a recall?
Bonus double points: What is RR&R?
Specific device
Device Brand Name
Common Name
Model
Catalog/Product Code #
Other identifying info (batch, lot, etc.)
Bonus: Repair, Replacement and Refund Orders (a never actually used part of the regulation)
What are the 4 CE mark requirements?
Placed on the device or primary package, shipping/sales package, and IFU
Must be direct marked for reusable devices
Must appear as directed by annexes
Must be 5 mm high
What is the ARTG?
Bonus double points: What are the main medical device regulations for Australia?
Super bonus double points: What is the Australian definition of a sponsor?
Australian Register of Therapeutic Goods, register of information for therapeutic goods for human use, most medical devices must be included in ARTG to be supplied in Australia
Bonus: Therapeutic Goods Act 1989, Therapeutic Goods Regulations 1990, Therapeutic Goods (Medical Devices) Regulations 2002
Super Bonus: Must be a resident or carrying on business in Australia, legally responsible for supplying product in Australia (may be the manufacturer)
3.5 When asked to make recommendations on how to correct any deficiencies noted in the exit report, the auditor(s) should:
a. Make the best recommendation possible
b. Confer with the client first
c. Avoid a recommendation in writing but help the auditee, if possible
d. Offer no specific advice and few suggestions
d. Offer no specific advice and few suggestions
What risks should be accounted for when prioritizing an audit report?
Hint: 2 perspectives
Auditor's perspective: Risk of reporting an area of concern compared to benefit gained if the concern has merit
Auditee's perspective: Risk of being able to fix the noncompliance within a reasonable time frame at a reasonable expense
Briefly describe the requirements for the 3 device classes.
Class 1 - General Controls, exempt from premarket regulatory requirements
Class 2 - General + Special Controls, requires 510k clearance
Class 3 - General Controls + Premarket Approval, potentially human clinical trial
What changed in the MDD to MDR transition? Name 3 topics.
Bonus double points: What inciting incident caused the MDD to MDR change?
Product scope expansion
Device reclassification
Qualified persons indications
Product Specifications
UDI
Safety and Performance
Clinical evidence
Postmarket Oversight
Bonus: Improper material used for breast implants
What is the difference between the Cadastro and Registro for Brazil?
Bonus double points: What does ANVISA stand for?
Cadastro: Lower-risk Class I and II, simplified application (more of a notification)
Registro: Higher-risk Class III and IV
Bonus: Agência Nacional de Vigilância Sanitária (National Agency for Health Regulation)
3.12 An auditor observes several inspectors using outdated inspection procedures. The auditee has proposed the replacement of the procedure pages as the proposed corrective action. Is this corrective action adequate?
a. Yes, if the inspection supervisor is also reprimanded
b. Yes, this seems to be a reasonable corrective action
c. No, because considerable product may require reinspection
d. No, because this action has not addressed the root cause
d. No, because this action has not addressed the root cause
What 3 things must be determined for a permanent corrective action?
Root cause analysis identified full extent of the problem
Corrective action will eliminate or prevent recurrence
Corrective action is realistic and maintainable
Name 3 prohibited acts.
Misbrand, adulterate, mutilate, sell, ship, manufacture, make false claims about performance, move, etc. devices or labeling
Submit false reports or falsify and disseminate untrue information
Use trade secrets or bribery for personal gain
Not register/list the establishment or devices per section 510 or leave out required information
Restrict record access, data access, or facility access when required for inspections or adverse event reporting
Not submit appropriate documentation for clinical trials
Give an example of each MDR device class.
Should have provided one for Class I, IIa, IIb, III
Google if the given devices are the right class :)
What is the Japan MAH?
Bonus double points: What is the main medical device regulation for Japan?
Market Authorization Holder - foreign manufacturers must get an MAH license, the MAH must be in Japan, the MAH is legally responsible for the release of product in Japan, and product and processes related to quality and safety
Bonus: PMD Act (Pharmaceuticals and Medical Devices Act)
3.38 Consider the statement, "Even if corrective action is taken immediately for a finding during the audit, all significant deficiencies should be detailed in the written report." This statement is:
a. True, because the auditor is responsible for an accurate report of all findings
b. False, because the audit report should include only unresolved deficiencies
c. False, because the corrective action can be verified during the audit
d. True, because a follow-up audit will need to be made on all findings
a. True, because the auditor is responsible for an accurate report of all findings