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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
 
QMS for Medical Device Companies
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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
 
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