The Most Cited Topics and Areas of FDA Audits

Topics/areas cited by FDA auditor at your facility.

  • Facility & Equipment Controls

    Votes: 0 0.0%
  • Material Controls

    Votes: 0 0.0%
  • Records - Documentation - Change Control

    Votes: 1 33.3%
  • Production & Process controls

    Votes: 1 33.3%
  • sterilization process controls

    Votes: 0 0.0%
  • Design cotrols

    Votes: 0 0.0%
  • CAPA

    Votes: 3 100.0%
  • Medical Device Tracking

    Votes: 0 0.0%
  • Reports of Correction / Removal

    Votes: 0 0.0%
  • Medical Device Reporting

    Votes: 0 0.0%
  • Management

    Votes: 1 33.3%

  • Total voters
    3

v9991

Trusted Information Resource
#1
one of the way of getting insight into above query, is through warning letters and 483s published on FDAs website.
However, whats your recent and current experience of facing FDA Audits!!!
btw, above areas are based on the QSIT(quality systems inspections technique) guide.
(btw your individual-options polled above are not made public, so go ahead and contribute to poll...let us help ourselves have current understanding on trends of FDA audit observations)
 
Last edited:
Elsmar Forum Sponsor

v9991

Trusted Information Resource
#3
Yes, since they are related to verify the adequacy of process controls as well. However pl. note that as per QSIT guide,
Process validation may be conducted concurrently with design validation.
Hence validation could also sometimes tied with design controls.

so, in our context of discussion, if the observation sited by FDA was in relation to your design controls then post/vote it accordingly.

http://www.fda.gov/downloads/ICECI/Inspections/UCM142981.pdf
 

v9991

Trusted Information Resource
#4
Current tally is as follows.
area percent
CAPA (38%)
Records - Documentation - Change Control (19%)
Production & Process controls (13%)
Medical Device Reporting (13%)
Management (13%)
Design cotrols (6%)

1) in the real world where exigencies/urgency/priorities of business are driving(testing or stretching) the resilence of quality systems,...It is not surprising to see "CAPA" & "documentation/Change control" constitute nearly 60% of observations; (yes it could also be contributed because of the (in)capability/competency of QS to drive the effectiveness of respective processes);
In fact 'Management' controls reflect the above trend with nearly equal contribution to the above cause.

2) while the adequacy of systems is so much in scrutiny by certification & regulatory agencies; and also internal quality systems...its surprising to see the same still contributing nearly 13%. !!!

keen to hear your perspectives and insights into the above scenarios/trends resulting into current state..
 
Thread starter Similar threads Forum Replies Date
E Why is the (theoretical) pH slope sometimes cited without the negative sign? General Measurement Device and Calibration Topics 1
V Nature of references allowed to be cited in the SOP US Food and Drug Administration (FDA) 2
T What is PESS? Cited in Edition 3.1 of IEC 60601, clause 14.1 note 2 IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
Jim Wynne Customer-Specific Requirements Cited in TS 16949 Scope of Certification? IATF 16949 - Automotive Quality Systems Standard 7
R Why is 10 MHz cited as the reference frequency? Measurement Uncertainty (MU) 2
M 30% Max Study Variation Criterion - Where Cited? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
T Procedures Cited in OHSAS 18001 Appendix Occupational Health & Safety Management Standards 4
Marc NYC Man Cited for 1775 Submarine in New York's East River World News 0
Douglas E. Purdy What is required of an organization when cited with a Major Nonconformance? TS16949 IATF 16949 - Automotive Quality Systems Standard 5
Ron Rompen Audit Finding or Nonconformance? Gage cited on Control Plan and Inspection Record IATF 16949 - Automotive Quality Systems Standard 13
B Supplier Development - Cited for 'no evidence of subcontractor development' Supplier Quality Assurance and other Supplier Issues 7
S Product Shelf Life - Plastics manufacturer - Cited for no system to address AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 17
D If records are cited in procedures, do they have to be cited in work instructions? Records and Data - Quality, Legal and Other Evidence 2
Johnnymo62 Non Aerospace topics - Anything for military trucks, trailers, Humvee type vehicles? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
SATHYABALARAMAN What are the topics to be covered for Training the employee as per IATF 16949:2016 IATF 16949 - Automotive Quality Systems Standard 2
M Poka-yoke - Key Topics and Points Problem Solving, Root Cause Fault and Failure Analysis 11
L Departmental Management Meetings -Topics which should be included IATF 16949 - Automotive Quality Systems Standard 4
T Searching for books which have content of 7.1.4. Change Control topics Book, Video, Blog and Web Site Reviews and Recommendations 2
V Medical Device Conference - May 2014 - Interesting topics and presentations Book, Video, Blog and Web Site Reviews and Recommendations 1
A Complaint System Internal Audit - Topics to Emphasize Internal Auditing 12
E MSA 3th edition vs. 4th - What are the topics, formats, criteria, new formulas, etc. Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
Marc Three Email Topics Funny Stuff - Jokes and Humour 3
C Topics for Company's Quality Newsletter - Suggestions Misc. Quality Assurance and Business Systems Related Topics 11
L Quality Objectives - Objectives related to Quality topics or the business? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
N Nissim Shaked is dealing with these topics at his desk Imported Legacy Blogs 14
B Weekly Quality Topics - A basic quality primer Training - Internal, External, Online and Distance Learning 3
7 New Book Topics Needed - Help Coffee Break and Water Cooler Discussions 1
Marc The Controversial Topics forum - Keep forum or New posts to peoples blogs Forum News and General Information 9
O Quarterly Review with Suppliers - Discussion topics Supplier Quality Assurance and other Supplier Issues 1
SteelMaiden Competency evaluation records - Direct correlation to EMS-related topics Miscellaneous Environmental Standards and EMS Related Discussions 7
I Weekly or monthly brief Quality Topics or short power point presentations Training - Internal, External, Online and Distance Learning 2
F CAPA Training - Tips on making CAPA training topics interesting! Nonconformance and Corrective Action 3
A Ergonomics & Time study - Concepts for experiments in above mentioned topics? Human Factors and Ergonomics in Engineering 3
M Lean training for new team - Thoughts on topics for a kick-off meeting? Lean in Manufacturing and Service Industries 6
P Which topics of AS9100 the auditors (UK) are most focussed on AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
T TS-16949 for Dummies presentation - Hot Topics - Open Discussion IATF 16949 - Automotive Quality Systems Standard 11
C The Top 10 Training Topics for Customer Focus Registered Visitor Articles Archive 13
L Seeking: Medical Device SOP Templates for several topics Document Control Systems, Procedures, Forms and Templates 6
Claes Gefvenberg Internal auditor get together meeting - Your suggestions on discussion topics? Internal Auditing 2
A Use of Computer Aided Learning for Quality Topics - E-Learning Training - Internal, External, Online and Distance Learning 20
Raffy What kind of Training do we need for Calibration? What topics? General Measurement Device and Calibration Topics 1
Geoff Cotton "Todays Active Topics" a suggestion. Coffee Break and Water Cooler Discussions 2
C Who offers QS9000 training (in Spanish) on topics like PPAP, FMEA, etc QS-9000 - American Automotive Manufacturers Standard 2
M Informational US FDA – Priority List of Patient Preference-Sensitive Areas Medical Device and FDA Regulations and Standards News 0
R How far apart can you schedule separate areas or departments in your internal audit? Internal Auditing 4
Sidney Vianna IATF 16949 Areas of Impact - Rules 5th Edition Document (February 2017) IATF 16949 - Automotive Quality Systems Standard 0
P How to Scientifically Prove the Importance of a Process - CMMI Process Areas Software Quality Assurance 7
N ESD and Humidity Monitoring in Work Areas Manufacturing and Related Processes 1
W Determining the Status and Importance of the Processes and Areas to be Audited Internal Auditing 7
B AS9100C 7.5.1 d and calibrated equipment in the production areas AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5

Similar threads

Top Bottom