7 replies to this topic

[Bingo67]

 We are a small dry blending manufacturing facility - SQF Certified and regulated by USDA & FDA.  We just had a customer audit and received this NC:

The HACCP assessment identifies hazards associated with each process step, but it does not include an evaluation of the likelihood and severity of these hazards, nor does it explain how the final risk and control measures were determined.

 

I am attaching:

Hazard Analysis Template 1 - this is what we are currently using

Hazard Analysis Template 2 - considering switching to ( but I want to remove the words Preventative ) 

 

Advice? Any other template recommendations?

 

The auditor's opinion & best practices advice is that the industry is moving towards more aligning HACCP & FSMA (Preventative Controls) I currently have PC's (Process, Allergen, Sanitation & Suppliers) listed but only have the Process Control (metal detection) listed as a CCP.  Based on risk and previous/current data I should consider the majority of my current PC"s ( except metal)  as just controls - justifying this through my PRP programs. or consider them all as CCP's.  

 

What are your thoughts/opinions on this? 

[kconf]

I don't see anything attached.

You do need ingredients evaluation - how biological, chemical, physical, radiological contaminations are controlled. 

[Bingo67]

Here are the attachments,

Attached Files

•  Hazard Analysis 1 8.20.24.docx   34.15KB   92 downloads
•  Hazard Analysis 2.pdf   780.54KB   84 downloads

[kconf]

Looks good.

List your ingredient, known hazards [B, C, P, A (cross contamination), S/F (substitution or fraud), R], Risk (Probability/Severity), Programs in effect to assure safety. 

[kfromNE]

With dual jurisdiction and SQF, I always label things as CCP/PC except with seafood - then it's a PC. Takes away the confusion for auditors who are used to one way or the other. 

 

Metal inspection as your only CCP makes sense. However if you are a RTE facility - then you may need other CCPs to prove this. 

 

 

 

"The HACCP assessment identifies hazards associated with each process step, but it does not include an evaluation of the likelihood and severity of these hazards, nor does it explain how the final risk and control measures were determined."

 

For the first page - add a risk assessment matrix tool and likelihood of occurrence. Then with the explanations like below based upon your numbering system. 

 

1 – The hazard is under control no further action necessary.

2 – The hazard is under control no further action necessary.

3 – The hazard is under control with a robust pre-requisite program.

4 – The hazard will require either a robust pre-requisite program or a preventative control or CCP.

5 – The hazard requires a preventative control or CCP.

Edited by kfromNE, 20 August 2024 - 06:26 PM.

[nwilson]

I use the following which is a quantitative way of reviewing the risk.  Works for FSP/HACCP, Material RA, and so on.  There are others out there and use the same method type as per above @kfromNE.  I add in to the risk assessment table (Hazard Analysis) the consequence, frequency, then the result all quantified, then list the risk (low, med, high).  This shows a bit more work into your risk assessment and helps with the justification of the hazard being controlled.  

 

 

Consequences (Severity)

Frequency (likelihood)

Risk Assessment

     

1. Fatality

A. Common Occurrence

High = <10

     

2. Serious Illness

B. Known to Occur

Medium = 10-20

     

3. Product Recall

C. Could Occur (published)

Low = 20+

     

4. Customer Complaint

D. Not Expected to Occur

       

5. Insignificant

E. Practically Impossible

                   

A.

B.

C.

D.

E.

 

 COMMON

KNOWN TO OCCUR

COULD OCCUR

NOT EXPECTED TO OCCUR

PRACTICALLY IMPOSSIBLE

1. FATALITY

1

2

4

7

11

2.SERIOUS ILLNESS OR INJURY

3

5

8

12

16

3.PRODUCT RECALL

6

9

13

17

20

4.CUSTOMER COMPLAINT

10

14

18

21

23

5.INSIGNIFICANT

15

19

22

24

25

                         

1.0           Instructions

 

1.1           The Decision Tree Matrix determines the risk of hazards based on a quantitative risk assessment

 

1.2           The Matrix serves as a logical, systemic method for determining the significance of a hazard in a repeatable way.

 

1.3           Preventive Controls (PC)/Critical Control Points (CCP's) and Process Controls (PRC)/Control Points (CPs) are determined by the established reasoning that if the decision is within a range of 1-10 on the matrix it will be considered a PC/CCP; if the decision is within a range of 11+ on the matrix it will be considered a PRC/CP.

 

1.4           Risk assessments will be continuously revisited with the evolution of scientific and industrial change of standards. This will occur annually during Food Safety Plan review or upon a change in standard (whichever should come first).

           

[nwilson]

Prior cut and paste didn't translate so well in the forum, see attached. 

Attached Files

•  DMT.pdf   25.84KB   68 downloads

Edited by nwilson, 20 August 2024 - 07:19 PM.

[kfromNE]

Prior cut and paste didn't translate so well in the forum, see attached. 

 

I had the same problem and that's why I didn't give an example. I should have tried a pdf.