Storage & Inventory - Our product has no shelf life

L

Lmccrary

#1
#1
We are transitioning from QS - TS and have a question regarding storage and inventory requirement 7.5.5.1

The standard states that "in order to detect deterioration, the condition of product in stock SHALL be assessed at appropriate planned intervals."

Our product has no shelf. This being the case, please suggest what the planned intervals could be. Once they are packed in customer designated packaging and placed in storage (stored in doors at no risk of being damaged) the condition will not change.

Any suggestion is appreciated.

LMM
 
Elsmar Forum Sponsor
S

Sam

#3
#3
If you are convinced that is the case, then insert those words, or similar wording in your warehouse work instructions.
 
R

Randy Stewart

#4
#4
Defined Interval

No one says that you have to do it at any certain time frame. Not knowing what the product is, I would question the EC level applicability. How do you know the product is up to date? That may be your interval. Product is check at an engineering change. Other than that you could check it every 100 years and that would be acceptable according to the standard.
 
M

M Greenaway

#5
#5
As stated above, if you have determined that your product does not deteriorate under normal storage conditions then you do not need to continually assess its condition.

As an auditor I might question how you have determined this (unless of course it was obvious), and might like to see some testing or data pertaining to shelf life - although this would depend on the complexity of the product and its constituent materials.
 
SteelMaiden

SteelMaiden

Super Moderator
Super Moderator
#6
#6
Re: Storage & Inventory

Lmccrary said:

Our product has no shelf. This being the case, please suggest what the planned intervals could be. Once they are packed in customer designated packaging and placed in storage (stored in doors at no risk of being damaged) the condition will not change.

Any suggestion is appreciated.

LMM
Click to expand...
As long as you are absolutely certain that there is no way that product can be damaged during storage (lots of product has no shelf life, but sometimes you run the risk of damaging things in the course of normal storage...

Why not just say that you verify the condition when stored, and again when shipping? also, (something I have done in a previous life) an option is to assess condition during the normal inventory process. Just a comment on the inventory sheets will work: All product condition OK, or such and such ID number had damaged packaging, product was not affected.

Make it easy on yourself, I am sure that you have people in your storage areas that are looking for damaged packages during the course of their shift anyway, so figure out a way to make that work for you. Good luck
 
M

M Greenaway

#7
#7
Yes Steel

At a previous company we included it into the cycle counting process.

The laugh was that cycle counting itself caused more damage than just letting the product sit there :vfunny:
 
M

Manoj Mathur

Quite Involved in Discussions
#8
#8
O.K. During storage, material may not spoil, but what if material gets damage or become unusable during transfer of one rack to another or from incoming rack to storage rack or storage rack to issue rack. Who will be accountable for this recording? I feel a register may be opened and if any material damage or become unfit for use during transition (Inside only) or storage, the data should be captured and analysis is required to mitigate this.
 
M

M Greenaway

#9
#9
True Manoj

However in todays world of the 'process approach' and process auditing an auditor should not hang you a non-compliance against this clause unless he can find damaged or deteriorated product.

If it is not a problem to you then its not a problem, and wont show up in audit, or worse customer complaint !
 
M

Manoj Mathur

Quite Involved in Discussions
#10
#10
Due regards to you since you are more knowledgeable to me but I would like to add that while adopting any QMS one should consider every aspect of business and not only Process and Quality. Why I said that any aspect which is useful or adding any value to business and bottom line MUST be included in QMS. If by doing analysis we are getting benefited our business is getting benefited I feel one can not say “That is not my problem or Auditor Problem”. If it is problem for any business it is a problem for auditor also. ISO & QMS is a way of life and to improve business and not system for showing Auditor.

Manoj Mathur
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
jasonb067 Clause 7.5.5.1 (Storage and Inventory) requirements in ISO/TS 16949:2009 IATF 16949 - Automotive Quality Systems Standard 8
Douglas E. Purdy Storage & Inventory - Assessing Stock for Deterioration at Planned Intervals 7.5.5.1 IATF 16949 - Automotive Quality Systems Standard 9
R 7.5.5.1 Storage and Inventory - We don't use FIFO for everything - How can we comply? IATF 16949 - Automotive Quality Systems Standard 5
D Offsite storage of QMS documents ISO 13485:2016 - Medical Device Quality Management Systems 9
Anonymous16-2 Dietary Supplement Raw Material/Component Storage and Production Manufacturing and Related Processes 1
C Ambient temperature_how we claim storage condition in label? Other Medical Device Related Standards 2
Y Labeling difference for storage and operating conditions EU Medical Device Regulations 1
D Cleanroom Cleaning Products and Storage Other Medical Device and Orthopedic Related Topics 18
S Medical device storage conditions Other Medical Device and Orthopedic Related Topics 1
E OSHA - 1926.252(e) - Oily Rag Storage Occupational Health & Safety Management Standards 22
C ETO Sterilised Class II Medical Device - Required Temperature Storage ISO 13485:2016 - Medical Device Quality Management Systems 1
Sidney Vianna NASA to Develop a Novel Approach for All-Electric Aircraft Using Cryogenic Liquid Hydrogen as Energy Storage World News 2
T QMS - Documentation Cloud Storage EU Medical Device Regulations 0
Kuldeep Singh How to verify the Storage and Transport environmental condition for Medical Device Miscellaneous Environmental Standards and EMS Related Discussions 3
T 5ºC Storage Temperature Validation - Urology disposable devices EU Medical Device Regulations 3
Q Weigh Scale Electronics - Suggested Storage Humidity and Temperature Manufacturing and Related Processes 7
S Document Storage/Archival Procedure Document Control Systems, Procedures, Forms and Templates 18
shimonv Storage Conditions of 5-40 Celsius - Accelerated and real time aging - Dilemma EU Medical Device Regulations 3
O Storage of Calibrated Tools General Measurement Device and Calibration Topics 12
T Validation of Dropbox for File Sharing, Storage, and Retrieval ISO 13485:2016 - Medical Device Quality Management Systems 10
M SOP or template for a study to Define Storage Conditions of Orthopaedic Implants EU Medical Device Regulations 3
R Saudi Arabia - Temperature Storage Requirements Other Medical Device Regulations World-Wide 4
D Sterile Medical Device Temperature and Humidity (Storage) Labeling Requirements EU Medical Device Regulations 5
B Supplier Approval of electronic document storage service ISO 13485:2016 - Medical Device Quality Management Systems 8
Y Process Characteristics for Inspection and Storage FMEA and Control Plans 4
R Medical Device Storage Temperature Tests and Requirements EU Medical Device Regulations 14
D Requirements for Storage of Food Allergen Ingredients Manufacturing and Related Processes 1
T Sterile Medical Device Storage Requirements ISO 13485:2016 - Medical Device Quality Management Systems 5
A Hazardous material storage shed flooring material Miscellaneous Environmental Standards and EMS Related Discussions 6
R Digital Storage of ITAR Controlled Documentation Other ISO and International Standards and European Regulations 7
L Intellectual Property Protection - Storage, Access, Distribution, etc ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
B IEC 60601-2-24 - Defining Storage Volume IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
B Determining the "storage volume" (ISO 8536-8:2004 clause 6.14) Other Medical Device Related Standards 4
A FDA guidance for MDDS, Medical Images Storage, Medical Image Communications 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
A Calibration/Verification of thermo-hygrometer in storage areas ISO 13485:2016 - Medical Device Quality Management Systems 9
W Micrometer Storage while not in use General Measurement Device and Calibration Topics 4
shimonv Storage of finished medical devices per 21 CFR Part 820.150 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
A Cleaning of Medical Device Storage Areas ISO 13485:2016 - Medical Device Quality Management Systems 1
E Empty Test Tube Storage - Suggestions Please Manufacturing and Related Processes 8
A Outsourced Processes Control (Finished Medical Device Delivery, Storage) ISO 13485:2016 - Medical Device Quality Management Systems 10
S Package Storage Direction in an I.T. Warehouse ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
P Storage Temperature Marking for something Temperature Degrades IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
R Storage Symbol for Labeling ISO 13485:2016 - Medical Device Quality Management Systems 3
M Critical Limits for CCP in a food storage warehouse Food Safety - ISO 22000, HACCP (21 CFR 120) 4
S Insulin Pen Injector Storage Requirements Other Medical Device and Orthopedic Related Topics 1
AmandaMusser How are Storage Requirements Determined for Epoxy, Paste, Solder, etc. ISO 13485:2016 - Medical Device Quality Management Systems 6
M Temperature and Humidity requirements for Raw Material Storage and Quality Labs IATF 16949 - Automotive Quality Systems Standard 13
S Checklist for a Chemical Storage Audit Document Control Systems, Procedures, Forms and Templates 12
R 5% to 95% Non-Condensing Humidity Storage Test Conditions and Failure Modes APQP and PPAP 2
R Test House Transport and Storage Conditions Verified IEC 60601 - Medical Electrical Equipment Safety Standards Series 3

Similar threads

Top Bottom