What is the Minimum Regulatory Requirement for Record Retention of DHR by Suppliers

C

CharlieB

#1
What is the minimum regulatory requirement for record retention for records generated/ maintained by Suppliers that we source some of our product’s components from?
 
Elsmar Forum Sponsor

GStough

Leader
Super Moderator
#2
Re: *** Record Retention of DHR by Suppliers ***

What is the minimum regulatory requirement for record retention for records generated/ maintained by Suppliers that we source some of our product’s components from?
What is the life of your product? Usually, the record retention period is tied to the life or service of the product, and then add a couple years to that.

I suppose I should ask first, what kind of product does your company make? My comment above is strictly regarding medical devices.
 
Last edited:

Marc

Fully vaccinated are you?
Leader
#3
Re: What is the Minimum Regulatory Requirement for Record Retention of DHR by Supplie

Just to be clear, what is DHR?
 

GStough

Leader
Super Moderator
#4
Re: What is the Minimum Regulatory Requirement for Record Retention of DHR by Supplie

Just to be clear, what is DHR?
In the medical device world, a DHR is a Device History Record. It is usually a compilation of records of manufacture, inspection, testing, etc. and is very helpful when investigating customer complaints or other issues that need to be resolved. An FDA inspector can also ask to see a DHR as part of a facility inspection. Similarly, a third party auditor may ask to see one as part of an ISO registration or surveillance audit. Also, an internal auditor may review DHRs as part of internal audits of the manufacturing processes.
 
Last edited:

Marc

Fully vaccinated are you?
Leader
#5
Re: What is the Minimum Regulatory Requirement for Record Retention of DHR by Supplie

Just making sure we're all on the same page here. You know what acronyms can do when misinterpreted.
 
C

CharlieB

#6
Re: What is the Minimum Regulatory Requirement for Record Retention of DHR by Supplie

So correct, DHR is 'Device History Record' - this being all manufacturing records associated with a device amongst others.
 
C

CharlieB

#7
Re: *** Record Retention of DHR by Suppliers ***

What is the life of your product? Usually, the record retention period is tied to the life or service of the product, and then add a couple years to that.

I suppose I should ask first, what kind of product does your company make? My comment above is strictly regarding medical devices.
Our problem is that we don't have definitive lifespan of product for all existing product. We manufacture humidifiers for hospital ICU as well as CPAP application devices for home market.
 

GStough

Leader
Super Moderator
#8
Re: What is the Minimum Regulatory Requirement for Record Retention of DHR by Supplie

So correct, DHR is 'Device History Record' - this being all manufacturing records associated with a device amongst others.
Yes. Also to consider is which international, federal/national and/or regional requirements may apply. These additional regulations or standards may have more specific record retention requirements, not to mention any Customs regulations that may need to be complied with.
 
C

CharlieB

#9
Re: What is the Minimum Regulatory Requirement for Record Retention of DHR by Supplie

Yes. Also to consider is which international, federal/national and/or regional requirements may apply. These additional regulations or standards may have more specific record retention requirements, not to mention any Customs regulations that may need to be complied with.
Our major markets are US, Europe and Japan so the regulatory requirements of these places apply. Remember, I'm specifically after the retention period of SUPPLIER'S component manufacturing records which may be different from the retention period for the manufacturing records required by a FINISHED DEVICE MANUFACTURER.

Cheers :)
 

jkuil

Quite Involved in Discussions
#10
Re: What is the Minimum Regulatory Requirement for Record Retention of DHR by Supplie

You should define the life time of your product in order to define the retention time of your records.

If the quality of the supplied items can be assured by records obtained at incomming inspection (inspection test results, supplier CoC / CoA) and spported by supplier qualification data you are at less risk with not having supplier DMRs available. These records should therefore also be retained for the lifetime of your product.

If not, you must request your supplier to retain their DMRs according to your own retention schedule.
 
Thread starter Similar threads Forum Replies Date
F Regulatory Compliant Quality Management System - Bare Minimum EU Medical Device Regulations 2
S Minimum Samples for DFM discussion APQP and PPAP 10
S Minimum Retention Time for Records of internal audit results as per AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
M Minimum/ mandatory core processes AS9100 Process Maps, Process Mapping and Turtle Diagrams 6
C Document Record/Template Minimum Requirements ISO 13485:2016 - Medical Device Quality Management Systems 3
F Self-test minimum requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
S Help needed in choosing the method of calculating the minimum sample size Internal Auditing 12
P Minimum Distance from Floor to Underneath of Machine Human Factors and Ergonomics in Engineering 5
D LiPo battery minimum requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
P Search function minimum length Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 3
M Minimum sample size - Guidance and statistical rationale Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
Q Capability study with a minimum spec Statistical Analysis Tools, Techniques and SPC 8
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 techniques like diameter least squares and circularity or minimum/ maximum diameter Calibration and Metrology Software and Hardware 5
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) 4
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
JoshuaFroud Change Control - Minimum Requirements and Unhappy Staff ISO 13485:2016 - Medical Device Quality Management Systems 16
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
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
J Minimum staff per 21 CFR Part 820 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
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 11
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

Similar threads

Top Bottom