5 replies to this topic

[Esoto728]

Hi Team- Am putting together an appeal. Would like feedback on what I have done already. Thanks!
Minor Non-Conformance; Clause 4.9.3.1 – “A broken acrylic light lens was noted on a ceiling fixture opposite dock door #3. This exposed unprotected glass in an area where goods are moved.”

Per BRC v8 Clause 4.9.3.1 states Glass or other brittle materials shall be excluded or protected against breakage in areas where open products are handled or there is a risk of product contamination.

Our receiving area is defined as an enclosed product area, therefore not vulnerable to environmental contamination.

Reviewing BRC Appendix 2 High-Risk, High-Care and Ambient High-Care Production Risk zones the following sections are noted.

Production risk zones or areas are classified as:
- open product areas, consisting of:
high risk (chilled and frozen)
high care (chilled and frozen)
ambient high care
low risk
enclosed product areas (e.9. warehouses and storerooms)
non-product areas (e.9. canteens, laundries and offices).
The decision trees (Figures 4 and 5) provide an additional guide to defining the risk zones



Our receiving area is not categorized under the following classifications per BRC appendix. All raw material is enclosed in packaging, verified then stored in chilled or frozen storage. No open product is recevied from our suppliers. For High risk and high care our finished goods product is not ready to eat and requires full cook prior to consumption, consumer baking instructions are provided. Product is vacuum packed or packaged in overwrap film. Product then may be packaged in a carton before being placed in a master case. All final goods are enclosed in packaging prior to shipment.

OPEN PRODUCT AREAS
Wherever ingredients, intermediates or finished products are not protected from the factory environment, there is a potential risk of product contamination by foreign bodies, allergenic material or micro-organisms in the environment.
HIGH RISK (CHILLED AND FROZEN)
It should be noted that where the product has cooking instructions for the consumer that are equivalent to a full cook, then the product may be considered as low risk.
HIGH CARE (CHILLED AND FROZEN)
It should be noted that where the product has cooking instructions for the consumer that are equivalent to a full cook, then the product may be considered as low risk.
AMBIENT HIGH CARE
Ambient products that are handled in these areas are vulnerable, as the pathogens are known to survive on the product (i.e. this area is different from low-risk areas because products handled in low-risk areas either intrinsically, or by design, do not support the growth or survival of pathogens, or are designed to undergo a later validated kill step).
The finished products are ready to eat or ready to heat or, on the basis of known consumer use, are likely to be eaten without adequate cooking
Figure 4 PRODUCTION ZONE DECISION TREE 1 – chilled and frozen products were used for guidance of materials brought in on our receiving dock.

Raw Material is recevied Chilled or Frozen
Products or ingredients within area are not open to the environment.
Concluding, product or ingredients are considered enclosed product areas
The following is defined under BRC Enclosed Product Areas

An enclosed product area is defined as an area of the factory where all of the products are fully enclosed and therefore not vulnerable to environmental contamination (e.g. foreign bodies or micro-organisms). This includes areas where:

• the product is fully enclosed within packaging (e.g. raw material and finished product storage and dispatch areas)

• the product is fully enclosed within equipment shielding the product from physical or microbiological contamination from the production equipment during production – this may include enclosure within transfer pipework and fully enclosed equipment, and also where the equipment maintains its own environment to protect the product (e.g. aseptic filling equipment).

Whenever product lines are entered, for example for cleaning, maintenance or sampling, documented processes must be in place to ensure that the potential for contamination is minimised and the line is returned to the correct standard to maintain the enclosed product status.

[Kara S.]

I think if you wanted to appeal you should focus on the below points. You are bringing up how the product is enclosed during the process, but how are those raw materials being handled and opened? If there was something broken, like the light fixture, how could you ensure that pieces of that, which may have ended up on the outer packaging of the raw materials during receiving will not enter the product stream once you open the package? 

 

 

 

1. Defining that this is not an open product area

• I like the use of the definitions. I think that will strengthen the case. 

2.Justifying how this will not cause risk to product. 

• I am not sure what the damage looked like but you should specify that the cover is shatter resistant (and bulb if that is true). If its shatter resistant, then all pieces would be found and small shards are an unlikely source of contamination. Those pieces should be large enough to identify that it would not cause a risk to that product. 
• Focus on what goes in and out of that area 
• Focus on how you handle the raw materials when you go to use them - how are you ensuring that something on the outside of the package is not entering the product stream. 
• If you have records for changing lightbulbs, maybe you can identify that a bulb has not been changed in that area and there was no damaged lightbulbs that would have caused risk to raw materials. 

 

I would still order a replacement shield to correct the issue.

[Charles.C]

Hi Esoto,

 

If the NC referred above was the only one found in the audit bar the self-generated Ma-NC previously mentioned, I suggest you merely implement appropriate CAs, RCAs, carry out last line of Post 2, and focus on other more immediate problems.

[Scampi]

A couple of more thoughts to add to above:

 

Had you noted the broken light prior to the audit?

 

Had you entered a work order prior to the audit?

 

Is the area on your glass/brittle plastic register?

 

If you answered NO to the above---you'll not likely win your appeal 

[wtheriot]

IMHO, I do not think that is worth an appeal. If a fixture is broken where is the investigation into how it was broken and what date and time was it reported? Where are all the pieces from the broken fixture? Where is the work order to have it repaired?

 

Unless you can show in detail, answers to all the questions above and clearly show it was in the process of being repaired, you will not win the appeal.

 

It is easier to make the work order, repair the fixture and do training on proper procedures for broken glass/brittle breakage. 

[sqflady]

Just fix it and move on.  Not worth the appeal as Charles and wtheriot mentioned.