Can we show Photocopied Uncontrolled Copies of Documents to an FDA Auditor?

v9991

Trusted Information Resource
#1
Under what circumstances does the FDA auditor accept Xerox/uncontrolled copies?
 
Last edited by a moderator:
Elsmar Forum Sponsor

somashekar

Leader
Admin
#2
Re: Can we show Xerox/uncontrolled copies of documents to an FDA auditor?

Hi v9991.
You may elaborate with more details what you would like to know. What uncontrolled photocopies you possess that you are using within your system ? Why is it so ?
Even before the FDA auditor, can we ask and answer ourselves this question.
 
D

Duke Okes

#3
Re: Can we show Xeroxed Uncontrolled Copies of Documents to an FDA Auditor?

You can show them anything, but whether or not you should show them uncontrolled documents depends on what you are showing them and why. Also, it depends on what your document control procedure says.
 

Wes Bucey

Prophet of Profit
#4
Re: Can we show Xeroxed Uncontrolled Copies of Documents to an FDA Auditor?

Under what circumstances does the FDA auditor accept Xerox/uncontrolled copies?
What do YOU think you mean by "uncontrolled?" (Many folks have added unjustified definitions to "controlled" which are not understood or acknowledged by the FDA.)

There are many ways that Xerox copies of documents are acceptable for FDA inspectors - similarly to printing hard copies from electronic files - they may still be considered "controlled" as long as you can define the "chain of possession" from the master copy to the one in the FDA agent's hands.
 

Al Rosen

Leader
Super Moderator
#5
Re: Can we show Xeroxed Uncontrolled Copies of Documents to an FDA Auditor?

An uncontrolled copy is not the same as an uncontrolled document. You can show the FDA an uncontrolled copy of a controlled document that you have verified as being at the latest revision level. A controlled copy is a copy that you issue and and are able to retrieve when the controlled document is revised.
 
#6
Under what circumstances does the FDA auditor accept Xerox/uncontrolled copies?
I have changed the title from "xerox" to "photocopied". In India, xerox is used commonly for the photocopied :)

v9991 - can you pl clarify if your question refers to use of

  • photocopied versions of controlled copies, or
  • photocopied versions of uncontrolled copies, or
  • uncontrolled copy with original signatures

If you are refering to procedures or work instructions, FDA will only accept controlled copies only, which has been duly maintained by a distribution log.
 

v9991

Trusted Information Resource
#7
Thank you all for quick response. I must have added detailed scenario thru my initial post...here u go...

Product is developed at R&D site and FDA audit manufacturing site and asks for some of the development documents/data from R&D site.

In such a scenario,
1)can we show the photocopied documents to FDA?...
2)Should that photocopy be a controlled or uncontrolled copy!
3)in what circumstances FDA accepts uncontrolled copies ( or vice versa, in what circumstances FDA does not accept uncontrolled) ...

thank you in advance.
 
P

pthareja

#8
Product is developed at R&D site and FDA audit manufacturing site

and [Auditor] asks for some of the development documents/data from R&D site.

In such a scenario,
1)can we show the photocopied documents to FDA?...
2)Should that photocopy be a controlled or uncontrolled copy!
3)in what circumstances FDA accepts uncontrolled copies ( or vice versa, in what circumstances FDA does not accept uncontrolled) ...

thank you in advance.
In most probability controlled copies shall be available atleast with the Process Owner and also the MR. (Additionally, or unless, more departments/ authorities have been designated to preserve (libraries)/ need to interface (incl. stakeholders) with controlled copies. Legitimate users (whose process Quality will be governed by such controlled documents shall also be assigned to use controlled copies). So the question the auditee must ask himself is 'Do I have a reason to possess the controlled copy?' if not -a photocopy is a great substitute.

To reiterate, as says Al Rosen "A controlled copy is a copy that you are able to retrieve when the controlled document is revised."

A controlled copy thus is an important document of 'performance' value. If an auditor requires say, a reference to a procedure; and photocopy truly fulfills the historical purpose, that's all. If the process/ domain being audited must be assessed for conformance, then as Ajit says FDA will only accept controlled copies only - for typical procedures or work instructions in assessment, and which have been duly controlled and maintained by a distribution log.

Question 2)- Should that photocopy be a controlled or uncontrolled copy!
is a good question.
Ajit has answered the question.
I am reminded of a joke. Before the old records were being put forth a shredder, the boss remarks: ' have you kept xeroxed copies of every document, before these are subjected to the shredder?' if not, please do it fast.
A controlled photocopy is as good a controlled copy. Infact it is a good idea, as it can not be tempered.(not xeroxed but a bromide / amonia copy). Pdf is similar.
I remember when I tried to mechanise our awards submission process for an end semester process, and wanted to submit the excel output duly printed, the document was returned with the remarks not filled in by hand. In my view former could not be tempered but the latter could be. And I had to submit what the customer desired. Today, after about 6 years, the major chunk works by the typed output.

To explore the third question, (i) Can we impress on the criticality of our processes vis-a-vis the enforceable documents/ instructions in question, and (ii) to what extent is the process owner responsible for the custody of controlled copy of document in question?

Priyavrat Thareja
 
A

arios

#9
This the QSR (21 CFR 820) requirement

Sec. 820.180 General requirements.
"All records required by this part shall be maintained at the manufacturing establishment or other location that is reasonably accessible to responsible officials of the manufacturer and to employees of FDA designated to perform inspections. Such records, including those not stored at the inspected establishment, shall be made readily available for review and copying by FDA employee(s)"

Based on this statement the FDA inspector can review your records and then request copies (except for some like Management reviews and Audit reports). I have seen Warning letters where the FDA has even made comments out of information written on Post It notes affixed on official records so even what you state on those "unofficial" files can be taken as evidence, so there is no such a line between controlled and uncontrolled for them when it comes to gather evidence. If you present records to them regardless their status then they can become part of the evidence they are collecting and be used against you given the case, so my best advice is you to be very careful on what you present, say and claim. Many folks first screen what they will provide for review, for example do not show drafts because they will be deemed as uncontrolled procedures and turn into an observation, and be sure you teach your employees good documentation practices so they follow them
 
#10
This the QSR (21 CFR 820) requirement

Sec. 820.180 General requirements.
"All records required by this part shall be maintained at the manufacturing establishment or other location that is reasonably accessible to responsible officials of the manufacturer and to employees of FDA designated to perform inspections. Such records, including those not stored at the inspected establishment, shall be made readily available for review and copying by FDA employee(s)"

Based on this statement the FDA inspector can review your records and then request copies (except for some like Management reviews and Audit reports). I have seen Warning letters where the FDA has even made comments out of information written on Post It notes affixed on official records so even what you state on those "unofficial" files can be taken as evidence, so there is no such a line between controlled and uncontrolled for them when it comes to gather evidence. If you present records to them regardless their status then they can become part of the evidence they are collecting and be used against you given the case, so my best advice is you to be very careful on what you present, say and claim. Many folks first screen what they will provide for review, for example do not show drafts because they will be deemed as uncontrolled procedures and turn into an observation, and be sure you teach your employees good documentation practices so they follow them
arios has made a very good point here.
When the design centre is at a far off site from the manufacturing, the design output that the manufacturing follow must need to be controlled. Anything other than this which forms a part of the design process documents or records and is not in the issue and control to the manufacturing can be sought from the design centre and demonstrated which would most likely get recorded, and the design department stand responsible for this. Similarly, we have supported this way many times from India (manufacturing site) to our customer in US (design centre) certain documents at the specific request of customer and they have had smooth FDA inspection process
 
Thread starter Similar threads Forum Replies Date
G Kpi doesn't show action plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
M How to show the effect of the failure mode on the manufacturing process as a customer of product design process? FMEA and Control Plans 3
Ashland78 Need to show evidence in accordance with QR-11012 and SPB-00001-09 Customer and Company Specific Requirements 5
Nihls When the MSA results show no operator influence Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
S Which department should prepare the control plan? could you show me a standard regarding to this matter. FMEA and Control Plans 17
E Our company is planning to file MDD not MDR next month. Do we require to show chemical characterization report ? CE Marking (Conformité Européene) / CB Scheme 2
B IATF16949 audit requirement - Auditor request UCL and LCL must be show Xbar-R, IATF 16949 - Automotive Quality Systems Standard 7
F Hi friends, can anyone show me an example of a procedure for ISO 13485 6.4.1 Work Environment? ISO 13485:2016 - Medical Device Quality Management Systems 4
R How to SHOW the importance of checklists, through some team gaming or play? Training - Internal, External, Online and Distance Learning 37
Wes Bucey International Manufacturing Technology Show - 10 September 2018 - Chicago (meet up?) Coffee Break and Water Cooler Discussions 6
S What records are required to show compliance to ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 1
K Questions on Technical File to show it is current EU Medical Device Regulations 5
D How do I show compliance to RoHS, REACH and Conflict Minerals? REACH and RoHS Conversations 6
K Operator Checks - How to show that they were completed on a checklist as acceptable IATF 16949 - Automotive Quality Systems Standard 2
M Metric/Way to show how Internal DPPM and External DPPM relate to each other Nonconformance and Corrective Action 1
R Is it legal to attend a trade show while you have a 510(k) application pending? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M Presentation displays for malls, etc. for exhibition to show products Coffee Break and Water Cooler Discussions 5
D Medica show in Dusseldorf - Has anyone else gone? Other Medical Device and Orthopedic Related Topics 3
W How to show compliance to multiple CE Directives ? CE Marking (Conformité Européene) / CB Scheme 4
T Is there a requirement in TS16949 that PO's show a revision level? IATF 16949 - Automotive Quality Systems Standard 3
S Which non Salmonella organisms show positive in Wellcolex? Test kit ? US Food and Drug Administration (FDA) 1
C Do I need to show fasteners in my BOM's/DMR etc? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
G What is needed to show competency Clause 6.2.2 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
W DIN ISO 1101 - Show me the General Dimensioning Tolerance Value Other ISO and International Standards and European Regulations 3
M Unapproved System Display at a Mexican Trade Show Other Medical Device Regulations World-Wide 2
L CE Auditor Using ISO audit reports to show compliance to the MDD?? EU Medical Device Regulations 4
P Is it necessary to show Model Number on the Labeling (meter box, label and manual)? Other US Medical Device Regulations 3
Hershal Reality TV show contest Coffee Break and Water Cooler Discussions 1
AnaMariaVR2 Design of Experiments in a Cooking Show Coffee Break and Water Cooler Discussions 0
T How to Show "Date/time" Data Graphically in Minitab Please? Using Minitab Software 2
S Suggested process to show compliance for this 820.120(a) for Label Integrity 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
R How do we show our Software Develoment Life Cycle is similar to IEC 62304 Other US Medical Device Regulations 3
L Old and New Primary Standards show a difference between them General Measurement Device and Calibration Topics 9
Marc Questions about the Internet circa 1994 on NBC's "The Today Show" After Work and Weekend Discussion Topics 1
H Can anyone show me a sample of a Cleaning Program for Food Manufacturing? Food Safety - ISO 22000, HACCP (21 CFR 120) 5
Ajit Basrur How to show percentage in an Excel graph? Excel .xls Spreadsheet Templates and Tools 13
P Rework Notification - Is it sufficient to show how we control rework process Manufacturing and Related Processes 1
Anerol C How I can show evidence that quality related activities are impacting the financials ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
L BSI Logo - Requirements when using the BSI logo to show certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
G Japan's PMDA Response to Question on Trade Show Display of Non-approved Device Japan Medical Device Regulations 9
P Must show Sub-Supplier details? Supplying a Tier 2 company IATF 16949 - Automotive Quality Systems Standard 7
JoCam How do I show the benefits of a QMS to the Design Team? ISO 13485:2016 - Medical Device Quality Management Systems 23
I In ISO 9001:2008 - Can we show an Internal Department as our Client/Customer ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
Marc Land a Million Show - Aviation Funny Stuff - Jokes and Humour 0
B Can somebody help me to show a 'delta-FMEA' example? FMEA and Control Plans 10
S How to show Approval for Documents and Training? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
V Competency - How I can show experienced operators are competent? Document Control Systems, Procedures, Forms and Templates 3
S How to show that policies are properly communicated & Training Effectiveness ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Stijloor GM to take back 5 Delphi plants, contract details show World News 0
T Prison Break Fans ?? - TV Show Coffee Break and Water Cooler Discussions 10

Similar threads

Top Bottom