Better control of DHR (Design History Record) during processing

E

erniemc

#1
#1
Hello all,

We are a biotech manufacturing facility and our DHR's are all on paper and therefore are not being carried around during processing and filled out immediately. My main question is can I make a laminated copy of the DHR that they could fill out with lot number etc and carry it around with them when information needs to be filled out? They would then transfer the data to the original paper DHR the same day. Is this a violation of any GMP procedure? Or does the laminated copy also need to be filed with the original DHR or can it be erased and then reused when the same product is manufactured?
 
Highly Rated Gage Tracking - Learn More
Elsmar Forum Sponsor
somashekar

somashekar

Leader
Admin
#2
#2
Re: Better control of DHR during processing

Welcome here erniemc ~~~
If what you describe works well and true to you, you are good.
What are the risks that you see for a missing data on the laminated sheet before it is transferred on to the paper, since you say they are erasable on the laminated copy ?
 
E

erniemc

#3
#3
Re: Better control of DHR during processing

Thanks for the welcome!
I think the laminated copy would only be erased at the end of the process so we would be able to review it before it is erased. The fact that you say we are good is the best news to me!
 
Y

yodon

Leader
Super Moderator
#4
#4
Re: Better control of DHR during processing

Personally, I wouldn't want to try to defend this process. Both transferring data and destroying original data are not exactly good practices and leave you pretty exposed. Further, recorded data is expected to be done as permanent. What you describe is basically allowing original data to be erased and replaced. If you choose to go down this path, I would suggest you take extraordinary measures to ensure reliability. Maybe attach a photo-copy of the original data and attach it to the 'final' copy and have a QA rep attest that it's all good.

Side question: are you able to ascribe the recorded data to the person originally entering it?

I also don't understand - if they can carry around a laminated copy, why can't they carry around a (final) hardcopy?
 
E

erniemc

#5
#5
Re: Better control of DHR during processing

The reason the hardcopy is not carried around is there is a lot of water involved and they are afraid they would smear the pages by wetting them. My biggest concern is exactly what you mentioned by allowing them to transfer data and not having the original copy available. The data is identified by initialing and dating the step performed on the laminated copy, so your suggestion of a photo-copy/QA approval is also good.
I am beginning to investigate if only certain procedures associated with a DHR would need to be laminated i.e. temperature monitoring every 15 minutes for 2-3 hours. This would reduce photo-copying and data transfer.
My main intent here is to get the DHR filled out properly and on time instead of a bunch of notes stuck in the DHR folder and filled out a few days later!
 
Y

yodon

Leader
Super Moderator
#6
#6
Re: Better control of DHR during processing

Sounds like a challenging situation and it sounds like you're well aware of the challenges (recognition is important). Another thought might be a ruggedized laptop.

Documenting your process (whatever you come up with) with the rationale for why you have to do it that way would help you should you be audited.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
qualprod ISO 9001 Risk control method - What could be the better way to control risks? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
H A better Lot/bin system Preventive Action and Continuous Improvement 2
H Better to retain previous made parts or one part that is perfect Reliability Analysis - Predictions, Testing and Standards 2
PQ Systems Better Data Visualization & Communication with Statistical Indices Using SQCpack Software 0
A Is there a better way to do a complete assessment of our QMS? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
C AIAG/VDA FMEA - Is the new better? FMEA and Control Plans 0
J Your opinion on the better training org for IATF16949 Internal auditor and Lead Auditor IATF 16949 - Automotive Quality Systems Standard 3
M Informational TGA – Several proposed changes to classification to better align with the EU MDR Medical Device and FDA Regulations and Standards News 0
M Medical Device News FDA's Policies and Procedures Should Better Address Postmarket Cybersecurity Risk to Medical Devices Other US Medical Device Regulations 0
O Which is better - Quietly quit using a supplier or tell supplier? Supplier Quality Assurance and other Supplier Issues 11
M Can we change the ProCode if a better one is found? Other US Medical Device Regulations 3
Don Fardie CAPA vs. Risk Assessment - Changing a product material for better performance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
J Is Bench or Clinical testing better? Other US Medical Device Regulations 2
T Comparative Design of Experiment to pick better Trimming Blade Supplier Six Sigma 5
D GHG Emissions - Can a Prevention is better than Cure strategy help Imported Legacy Blogs 4
M Risk Probability - Is there a Better System? ISO 14971 - Medical Device Risk Management 18
L The proposed changes to ISO 14001: Better or just bigger? ISO 14001:2015 Specific Discussions 5
R Should transfer of certificates be better scrutinized by accreditation bodies? Registrars and Notified Bodies 5
S Which one is better to calculate, Cpk or Ppk? Statistical Analysis Tools, Techniques and SPC 11
L Flammability Rating - is FT4 a better rating than FT1? Other US Medical Device Regulations 2
M Learning ISO 13485 - Getting a better understanding of the requirements ISO 13485:2016 - Medical Device Quality Management Systems 6
L Working closer and better with Suppliers - Practical ideas to improve? Supplier Quality Assurance and other Supplier Issues 8
M Which metric is better for Cost of Poor Quality (COPQ)? Quality Tools, Improvement and Analysis 17
R What is better ASQ or QA (Quality American ) Certifications? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 3
AnaMariaVR2 Nonviolent videos better for preschoolers' sleep World News 1
C A better Instrument (Measurement Device) Identification System Misc. Quality Assurance and Business Systems Related Topics 7
T Taguchi DOE Analysis - What S/N ratio (Nominal is best or smaller is better) to use? Quality Tools, Improvement and Analysis 5
C Tool Monitoring - Controlling a Process with Better Tool Monitoring Manufacturing and Related Processes 4
R Change Prints to accommodate Worn Tooling - There has to be a better way! Supplier Quality Assurance and other Supplier Issues 8
hogheavenfarm Need better Job Tracking Method - Fabricated in several departments at once Manufacturing and Related Processes 5
E Msc in Regulatory Affairs - Which Universities offer online course & which is better? Career and Occupation Discussions 3
T Finding the Root Cause - Which technique is better? Problem Solving, Root Cause Fault and Failure Analysis 84
Q Need a new CA/PA Procedure to better interface with Portal Systems Nonconformance and Corrective Action 9
E Integrated Standards Quality Manual Structured According to Clauses is better? Quality Manager and Management Related Issues 3
C FTA (Fault Tree Analysis) Software - Which is better/best Quality Assurance and Compliance Software Tools and Solutions 1
S How to better manage files on a personal computer? After Work and Weekend Discussion Topics 8
Jim Wynne Someone better "diffuse" me before I asplode Coffee Break and Water Cooler Discussions 7
P Xbar-R Chart better than Xbar-S Chart when the subgroup size is small - Why? Capability, Accuracy and Stability - Processes, Machines, etc. 12
S Which type of study would be better for Solder Paste Height Measurement system Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 10
M The near future will be better? Coffee Break and Water Cooler Discussions 9
P What is the appropriate indicator better than GDP and GNP? Coffee Break and Water Cooler Discussions 0
T PC or Apple MacIntosh - Which is better? After Work and Weekend Discussion Topics 53
J Which is better: Plasma, LCD or LED TV? After Work and Weekend Discussion Topics 39
C Gage R&R Study - Better to use parts or gage blocks? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
S CQE Primer or CQE handbook - Which one is better Professional Certifications and Degrees 20
Sidney Vianna Should we leave a better world for our children? Coffee Break and Water Cooler Discussions 4
S Is RABQSA desperate or do they offer better value? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 12
Stijloor Why "drinking" wine, beer or any other liquor is better... Funny Stuff - Jokes and Humour 21
P OEE - Is there a company that offers a better display than others? And how effective Lean in Manufacturing and Service Industries 19
H Achiever Plus - Are there alternative products that are better than Achiever Plus? Quality Assurance and Compliance Software Tools and Solutions 5

Similar threads

Top Bottom