SBS - The best value in QMS software

How much detail in DHR (Device History Record) is too much?

Q

QA_CRM

#1
Hi everyone, it's awesome to find this huge forum. I'm a Certified Records Manager who finds herself working (for the past 2 years) for a manufacturer of DME. We have experienced staff who are familiar with FDA etc., and I've been letting them guide me as concerns what documents need to be retained as relevant to the device history record.

Specifically, I'm told - but feel compelled to question - that we must keep a copy of every packing slip that goes out with manufactured product to the end user, whether the product be durable or disposable.

From what I've read on this forum, delivery information at this level of detail is irrelevant to the DHR.

Please enlighten me!! :confused:
 
Elsmar Forum Sponsor
A

arios

#2
Re: How much detail in DHR is too much?

These are the QSR requirements for a DHR:

"The DHR shall include, or refer to the location of, the following information:
(a) The dates of manufacture;
(b) The quantity manufactured;
(c) The quantity released for distribution;
(d) The acceptance records which demonstrate the device is manufactured in accordance with the DMR;
(e) The primary identification label and labeling used for each production unit; and
(f) Any device identification(s) and control number(s) used."

The ISO 13485 requirements are less prescriptive (they are noted at the end of section 7.5.1), but in essence similar to the QSR.

I don't think a copy of a packing slip is mandatory for a DHR. Packing slips can be kept apart as part of your shipping records, and may include more than one batch, whereas the DHR goes by individual batches. Your DHR cover page could indicate the amount produced and released, thus extra copies of other documents are not necessary.

On a place I used to work before, big efforts were made to reduce the complexity and redundancy of the DHR's (e.g. several blank spaces which were never used, many peer signatures, lots of extra copies, etc...). This used to be a bottle neck on the product release process. Several opportunities for improvement were identified on our DHR preparation process and these were successfully reduced while kept compliant.

I hope this helps.
 
Last edited by a moderator:
D

DeviceMaker

#3
I wanted to weigh in on the record keeping question. The DHR is for information pertaining fo the manufacture, up to release of the device. The packing slips that you are referring to include the distribution records – 21CFR 820.160 states that:

(b) Each manufacturer shall maintain distribution records which include or refer to the location of:
(1) The name and address of the initial consignee;
(2) The identification and quantity of devices shipped;
(3) The date shipped; and
(4) Any control number(s) used.

Thus the records need to be kept, but do not need to be kept in the DHR. I hope this helps.
:)
 
M

MIREGMGR

#4
Somewhere in the business determination, it's desirable to consider the regulatory nature of the product.

If it's a nonsterile Class I commodity without a traceability requirement and with very low ISO 14971 residual risk, the regulatory need for distribution records is minimum.

If it's a higher-class, higher-ISO-14971-residual-risk product, perhaps sterile, perhaps for an invasive or communicating-path application, the need for distribution records is much greater.

If it's a product with a specific traceability requirement, the need for distribution records is paramount.
 
Thread starter Similar threads Forum Replies Date
P ISO 9001:2015 4.2 and 6.1 - Interested Parties - How much detail is required? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
Q Document Control Procedure - Too much detail? Document Control Systems, Procedures, Forms and Templates 8
N Quality Program Plan - How much detail does the customer want? Quality Manager and Management Related Issues 1
R Updated Process FMEA: How much detail? Closure of an External Corrective Action FMEA and Control Plans 3
C What is acceptable quality manual content? How much detail to put in here? Quality Management System (QMS) Manuals 25
K Supplier Audits - How far do we have to go? How much detail? Supplier Quality Assurance and other Supplier Issues 12
D Showing Interrelationships - How Much Detail? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
D Quality plans - How much detail is required? What is typically included? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
A How much does a complete biocompatibility test package cost? Other ISO and International Standards and European Regulations 1
J How much to charge for helping a startup company with initial ISO 13485 certification? Consultants and Consulting 3
M Hiring Decisions - How much effort do you put into the hiring process these days? (7/2020) Misc. Quality Assurance and Business Systems Related Topics 6
M Do I Expect Too Much of Job Candidates? Career and Occupation Discussions 33
B ISO 9001:2015 Transition: Much Easier Than You Think! Misc. Quality Assurance and Business Systems Related Topics 0
E How much a bioequivalence study will cost in the UK Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
P So much turnover, How to improve our training process? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 32
T ISO 9001:2008 to 2015 transition - How much work to change? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
I How much does an eQMS (Electronic/Software QMS) cost? Quality Assurance and Compliance Software Tools and Solutions 1
J Process Capability - How much percentage of tolerance? VDA Standards - Germany's Automotive Standards 3
W How much would it cost to setup a Quality System for a Repackager or Relabeler? Quality Manager and Management Related Issues 1
G How much to pay a Freelance Six Sigma Trainer in India Six Sigma 1
M 7.5.3.2 Traceability - How much traceability is required? ISO 13485:2016 - Medical Device Quality Management Systems 6
S How much do trainers charge typically for an Adobe Connect / WebEx based training? Training - Internal, External, Online and Distance Learning 3
kedarg6500 How much test force to be applied for Vickers hardness Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
D AS9100 Recertification Audits - How much in advance of the Certificate Expiration AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
J Sourcing a Sterile Product - Asking for supplier for too much regulatory stuff? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
D IMR (Individuals and Moving Range) Chart for Short-Run SPC - How much data to include Statistical Analysis Tools, Techniques and SPC 1
V How much Supplier Information do I have to provide to a Customer? APQP and PPAP 6
V For an RSM, how much R-sq is good R-sq Using Minitab Software 3
R How much Protective Current Rating of Building Branch Circuit should be considered? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R How much "harder" is an ISO 13485 Registration Audit compared to ISO 9001 ISO 13485:2016 - Medical Device Quality Management Systems 6
M MSA - According to the formula cg how much tolerance should be put in place? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
Sidney Vianna The frequent flyers that flew too much... Unlimited AAirpass Coffee Break and Water Cooler Discussions 11
E Consulting Fees - How much to charge Career and Occupation Discussions 33
A How Much Validation is needed for OTS Software - Marketing material only 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
G How much time must pass after the first Certification Audit for us to appear in OASIS AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
A Advice on setting up BD Distribution Deals - How much oversight is required? Quality Manager and Management Related Issues 2
K Key Employees and Officers - How much conflict is tolerable? Quality Manager and Management Related Issues 19
A How much effort is needed for Certification of Class II Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 9
Stijloor Thank you very much!! Covegratulations 5
K Supplier Audit - How much information do we have to give them? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
somashekar Too much data, Too little analysis - Manual Stages Assembly Shop Data Collection Quality Tools, Improvement and Analysis 2
R OASIS Database Fees - How much are you paying your CB? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
M Defining what is a Medical Device Accessory and what isn't - Much Confusion EU Medical Device Regulations 8
A Customer SQE - Within Specification but too much Variance Customer Complaints 7
A What to do when customer requirements are too much? Quality Manager and Management Related Issues 29
D How much Tolerance do I use to Calibrate a 150kgs capacity Scale? General Measurement Device and Calibration Topics 5
M How much Process Description is required or needed? ISO 13485:2016 - Medical Device Quality Management Systems 10
D How much Deviation is Acceptable when Calibrating a Hygrometer? General Measurement Device and Calibration Topics 3
L FDA Audit - How much advance notice do foreign manufacturers get? ISO 13485:2016 - Medical Device Quality Management Systems 4
R MSDS Sheets for Products - How much is too much - Or is there ever too much? Occupational Health & Safety Management Standards 12

Similar threads

Top Bottom