8 replies to this topic

[kconf]

Hi all,

What does BRCGS say on "hold" material. We have some held sugar pallets and packaging material for 9-10 months. 

Do they need to be reviewed and updated frequently? 

[Scampi]

yes

 

Why have you not disposed of these after all this time?  they won't change into acceptable materials

[kconf]

Thanks Scampi. It was beyond my control.

How often do they need to be reviewed? Do I change "hold labels" too with new dates? 

[kingstudruler1]

In 3.7, one of the requirements is that you develope appropriate timescales for the completion of corrective and preventive actions.   This would include the disposition of materials - IMO

 

If anything, I would update the timescale with reasoning on what ever document that you use to track non conformities.  If you are worried about it for audit purposes, it does look pretty bad that it has not been adressed for an extended period of time.   You really need to finish its disposition - release, return, discard, etc.   

[kconf]

Thanks Kings,

I am worried about it for audit purposes. What explanation would sound reasonable? Do I assign new CAPAs to them? 

[Scampi]

I would prepare a new CAPA and review the HOLDS monthly (including emails to upper management about final disposition/disposal)

 

Management is putting your company/products at risk by keeping materials that have been deemed unsuitable

[kingstudruler1]

Thanks Kings,

I am worried about it for audit purposes. What explanation would sound reasonable? Do I assign new CAPAs to them? 

I would not suggest you assign a new CAPA or change the date to give the illusion that you are dealing with nonconformities in a more timely manner.  However, im pretty sure this happens somewhat frequently.

 

If the decision has been made to discard, I would probably just declare that methods for discarding are being reviewed by senior managment.  Why its on hold and what is to be done with it would determine how you document this.   I would make sure you have clearly documented that the items are still on hold and need disposition.   This could be in your monthly FS meeting, other meetings, emails, etc.   At least, appear to be aware that you still need disposition of the products and they are not forgotten.

Edited by kingstudruler1, Today, 04:04 PM.

[kconf]

Perfect! Thanks everyone.

Just a quick question - do all "hold" materials have to have CAPA? 

What if something is temporarily on hold? 

[Scampi]

The short answer is yes

 

A HOLD is a HOLD however temporary it may be