Need ideas on managing Shelf Life Studies within an organization

PeterLe

Involved In Discussions
#1
Hello everyone. I first off want to say this is a great forum with a wealth of information.

I just recently transferred to a Quality Engineer position from R&D. I've been asked to take over some shelf life studies that have been idle for quite sometime now. Currently, I'm assigned to complete 6 shelf life studies.

We have an issue of an overall system to keep track of the various shelf life studies. Currently there isn't a system. It is pretty much whoever is responsible for the aging study, they handle all communication with the Outside Testing Laboratory. Now we have ran into issues for various reasons: Turnover within the company, lack of system, lack of priorities, etc.

I'm curious to find out what are the systems out there everyone is using for their shelf life studies. Below are some of the issues we are having:

  • Can't find documentation - Sterilization reports, gross leak tests, seal strength tests, etc
  • No designated area for storage of samples and no system to keep track of samples
  • Lack of priority - There is no set time to complete studies so motivation to complete ASAP isn't there

The team was talking in regards to using tools like Microsoft outlook to create a specific email address to send all communications to and also using it for reminders. But again, there isn't a system in place.

Any help or suggestions would be greatly appreciated! Thank you in advance!
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
MSeibert47 Daily Quality Topics - Need Ideas Please! Food Safety - ISO 22000, HACCP (21 CFR 120) 18
T Need ideas on Synchronization of Processes Design and Development of Products and Processes 2
B Need ideas for a friendly bet - Year-end food drive Coffee Break and Water Cooler Discussions 6
K BioHazard Cleaning of Returned Devices - Small Medical Device company - Need Ideas ISO 13485:2016 - Medical Device Quality Management Systems 9
C Need help error proofing valve. All ideas welcome. Human Factors and Ergonomics in Engineering 31
J Supplier Manual for a Fastener Distributor - Need Content Ideas Supplier Quality Assurance and other Supplier Issues 1
B Logistics FMEA - Never Have done One - Need Ideas FMEA and Control Plans 12
P Poster ideas needed - Need for washing hands - Food Environment Food Safety - ISO 22000, HACCP (21 CFR 120) 11
T Need 5 why’s help AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
H Need guidance on importation of Custom-made devices into Japan Japan Medical Device Regulations 1
T Need help understanding AS6174 clause 3.1.5. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
B Spare parts of medical device need CE mark? EU Medical Device Regulations 0
F Change in address for critical supplier - does NB need to be informed? CE Marking (Conformité Européene) / CB Scheme 19
leftoverture REACH Folks - We Need Common Sense! RoHS, REACH, ELV, IMDS and Restricted Substances 23
B Whose waste carrier licence do I need? ISO 14001:2015 Specific Discussions 8
I I need some fun examples of teaching the 5 Whys Lean in Manufacturing and Service Industries 43
R First Time Managing Calibration and Measurement System. Need Help. General Measurement Device and Calibration Topics 19
M CE marked medical device - do they need UKAS certified calibration provider ISO 17025 related Discussions 4
C I need some clearing on requirements of Asuring the validity of results ISO 17025 related Discussions 2
C Need help in determining applicable clause for an audit finding (based on AS9120B) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
K Subcontractors Providing Services Under MDD or MDR need ISO 13485 from EU Notified Body? CE Marking (Conformité Européene) / CB Scheme 8
E Need some peer advice Quality Manager and Management Related Issues 18
S Need clarification on UKCA and "Approved Body" UK Medical Device Regulations 7
S What types of changes need to be notified to NBs? Registrars and Notified Bodies 1
B Do I need a Cleanroom to manufacture Medical Devices? ISO 13485:2016 - Medical Device Quality Management Systems 2
J CMO in Canada do they need MDSAP/13485 certification? ISO 13485:2016 - Medical Device Quality Management Systems 1
M Attempting to Poke Yoke a wire crimping process...need help Design and Development of Products and Processes 3
C I need your help to find the action plan for these quality objectives Misc. Quality Assurance and Business Systems Related Topics 23
ChrisM Class 1 non-sterile device, need certified QMS or not? EU Medical Device Regulations 2
Steve Prevette I need a template to solve world hunger, a world class Quality Program, and make lots of money Coffee Break and Water Cooler Discussions 5
C Need to understand difference between an actual Calibration vs. a Calibration check General Measurement Device and Calibration Topics 3
S How many tester quantity we need on the line based on the cycle time and peak volume Manufacturing and Related Processes 3
R Need help on calibration result analysis Measurement Uncertainty (MU) 17
M Do i need to have equipment validation if 100% testing is completed? Qualification and Validation (including 21 CFR Part 11) 6
G Need Help with Run @ Rate for Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 0
F Need help in IMS management review Management Review Meetings and related Processes 3
S I need help in corrective action plan Nonconformance and Corrective Action 15
A Do clinical performance studies for IVDs need to be conducted in a member state? EU Medical Device Regulations 2
A Do clinical performance studies for IVDs need to be conducted in a member state? CE Marking (Conformité Européene) / CB Scheme 0
D Weird spec sheet - need help Measurement Uncertainty (MU) 3
E Do I need test reports for all standards mentioned in my 510k application? Other Medical Device Related Standards 8
J Japan registration need manual without temperature reading Japan Medical Device Regulations 0
Ashland78 Need IATF 16949 ISO Gap Analysis Excel File Internal Auditing 3
R Need for an Importer outside EU? EU Medical Device Regulations 0
T Do I need to add non-product related service providers to my ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
K Need Help With Auditing Suppliers Against ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 50
A Need career advice on QMS & HSE (No hands on experience) Career and Occupation Discussions 6
B Need assistance with documents CE Marking (Conformité Européene) / CB Scheme 2
R Lead auditor scenario (Need help) is this non conforming to ISO13485 Manufacturing and Related Processes 2
Ashland78 Need to show evidence in accordance with QR-11012 and SPB-00001-09 Customer and Company Specific Requirements 5

Similar threads

Top Bottom