Minimum staff per 21 CFR Part 820

J

Jennifer27

#1
Dear Experts,

I work with a small firm located in the US. We want to completely outsource creation and maintenance of all quality systems documents to a consulting firm. Only an accountant and few R&D engineers are at the company site. Is there any minimum staff requirements per the 21 CFR Part 820 or FDA QSR that must be there at the company site?

Even though we are outsourcing everything to a consulting firm, do we need to have Quality Engineer or Director at the least at our company site?

Is there anything specific that you would recommend to look for when selecting a consulting form to maintain our QSR documents?

Thanks a lot!
Jen
 
Elsmar Forum Sponsor
T

treesei

#2
I don't think 820 specifies the minimal staff number or the necessary function on site.

TO select a consulting firm, I would look at my needs in doc control etc., compare them to the requirements, and come up with a "I want" list. Ask the candidate how they will satisfy your needs.
 

phoenix2368

Starting to get Involved
#3
It depends on what kind of manufacturing your company has and what class of medical devices you guys carry. I think there supposed to be someone to play a role in QA within the company familiar to your day to day operations and has knowledge of devices you carry.
Consulting firm can deal Complaints, Complaint Investigations, Can suggest Corrective and Preventive actions, can make decisions on recalls (if needed), Issuing of NCMRs etc but they would be asking a lot of information all the times and i think it would not be the consulting firm who would be receiving the devices and doing inspection and testing activities. There is always a chance that some product would be non conformed, so your company would be able to relay everyday record to the consultants or they themselves would be doing all inspection and testing activities and than releasing the stuff to your company for onward release to the customers.
Everything depends on the size and operations of your company.
If your company is a small entrepreneur and is working more like an initial distributor than probably it would work out fine.
 
Thread starter Similar threads Forum Replies Date
JoshuaFroud Change Control - Minimum Requirements and Unhappy Staff ISO 13485:2016 - Medical Device Quality Management Systems 16
L Significant Production Run - How 300 was determined to be the minimum quantity APQP and PPAP 2
Marco Bernardi MMC & LMC modifiers and CMM measuring techinques like diameter least squares and circularity or minimum/maximim diameter. Calibration and Metrology Software and Hardware 2
shimonv Minimum 60601 requirements for a clinical trial IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
J Minimum Supplier Certifications for Food Supplements Food Safety - ISO 22000, HACCP (21 CFR 120) 2
J What is the minimum standard for automotive component traceability? Manufacturing and Related Processes 2
M Applicability of IEC 60950-1 Table K2 - Minimum clearances between circuits Various Other Specifications, Standards, and related Requirements 0
M Characterization Testing - NO acceptance criteria, no minimum performance requirement Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
K Is minimum repair or replace guarantee period for medical devices in EU the same as consumer guarantee law of 2 years? EU Medical Device Regulations 5
S Designing the experiment with minimum run Statistical Analysis Tools, Techniques and SPC 0
S Designing the experiment with minimum run Statistical Analysis Tools, Techniques and SPC 0
J IATF Minimum Automotive Quality Management System Requirements for Sub-Tier Suppliers IATF 16949 - Automotive Quality Systems Standard 12
N ETO Sterilisation Validation - EO Residual Minimum Sample Requirement ISO 13485:2016 - Medical Device Quality Management Systems 2
F Regulatory Compliant Quality Management System - Bare Minimum EU Medical Device Regulations 2
S What is the minimum pressure differential required for ISO Class 8 Clean Room? ISO 13485:2016 - Medical Device Quality Management Systems 3
somashekar ISO 13485 plus ISO 9001:2015 will now attract a minimum 2 day upgrade audit ISO 13485:2016 - Medical Device Quality Management Systems 9
D What is the minimum Sample Size for Weibull Analysis Reliability Analysis - Predictions, Testing and Standards 12
S Is there a minimum industry standard for PpK ? Statistical Analysis Tools, Techniques and SPC 8
K What are the minimum requirements for Process Validation (Software)? ISO 13485:2016 - Medical Device Quality Management Systems 5
C Battery Powered Beauty Products minimum Legal Certifications Requirements CE Marking (Conformité Européene) / CB Scheme 7
B What is the minimum sample required for Performance Evaluation for IVD ? EU Medical Device Regulations 3
D Minimum requirements/experience/qualifications to be head of quality Career and Occupation Discussions 6
R Minimum Essential Receiving Inspection (M.E.R.I.) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
S What is the minimum samples required for Customer Survey? Quality Manager and Management Related Issues 3
J Minimum number of parts to do an attribute gage R&R Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 8
I Minimum and Maximum Validation Batch Size Requirements Qualification and Validation (including 21 CFR Part 11) 3
A Minimum Number of Parts for Attribute (Go / NoGo) Data Gage R&R Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
S Minimum documents required by AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
N Minimum Design factor for CE Marking for machinery CE Marking (Conformité Européene) / CB Scheme 2
J Minitab Sample Size Calculation: 1 Sample t vs Minimum Sample Size for Means Using Minitab Software 3
G Why for a Shewhart chart the minimum feasible value for APL is 2401 units? Statistical Analysis Tools, Techniques and SPC 8
A Minimum Testing Requirements for a Clear Protective Equipment Barrier (Class II 510K) Other US Medical Device Regulations 1
V Critical Characteristics - Capability for a Minimum Specification APQP and PPAP 6
BradM What is the minimum size chamber for mapping? ISO 13485:2016 - Medical Device Quality Management Systems 2
Q Minimum Organization Structure to support TS16949 IATF 16949 - Automotive Quality Systems Standard 5
Q Minimum content required in a Quality Manual as per ISO 9001:2008 Quality Management System (QMS) Manuals 6
A ISO 13485 Supplier Monitoring Minimum Requirements Supplier Quality Assurance and other Supplier Issues 3
T New Packaging Line Performance Qualification (PQ) - Minimum Test Times ? Qualification and Validation (including 21 CFR Part 11) 3
F How to calculate the minimum Value of Mass needed for Scales Calibration? General Measurement Device and Calibration Topics 6
W ITAR (International Traffic in Arms Regulations) Minimum Requirements or Shalls Other ISO and International Standards and European Regulations 9
JoCam Equipment Guarding - Safe Distance - Is there a specified minimum distance? Occupational Health & Safety Management Standards 6
F How to Calculate Cpk with only a Minimum Tolerance Capability, Accuracy and Stability - Processes, Machines, etc. 11
H SOP containing Minimum Requirements for Master Production Record US Food and Drug Administration (FDA) 1
S What is the 10d in the owner's manual for a balance's minimum weight? General Measurement Device and Calibration Topics 5
M Questions pertaining to our last audit - Fix or Minimum Document Retention time? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
S Minimum US FDA Labeling Requirements for a Class II Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
K Minimum Requirements for Effective Document Control Document Control Systems, Procedures, Forms and Templates 2
G What are the Minimum Requirements of a Quality Manual? Quality Management System (QMS) Manuals 12
J Internal Quality Auditor Minimum Requirements Internal Auditing 48
C Minimum Requirements for Suppliers without ISO 9001 or TS 16949 IATF 16949 - Automotive Quality Systems Standard 8

Similar threads

Top Bottom