3 replies to this topic

[Evez]

Hello, 
in our hazard analysis wherein Pathogen is the identified Biological Hazard, the auditor questioned why severity is "Serious Illness".
she mentioned, it should be Fatality?

i think most cases of pathogen related issues are up to Serious Illness??

 

(btw, severity category: Insignificant - Customer Complaint - Product Recall - Serious Illness - Fatality)

 

hope to get insights from here.

[Charles.C]

Hello, 
in our hazard analysis wherein Pathogen is the identified Biological Hazard, the auditor questioned why severity is "Serious Illness".
she mentioned, it should be Fatality?

i think most cases of pathogen related issues are up to Serious Illness??

 

(btw, severity category: Insignificant - Customer Complaint - Product Recall - Serious Illness - Fatality)

 

hope to get insights from here.

Hi Evez,

 

I deduce you/your auditor are arguing over individually subjective issues within a risk matrix.

 

"customer complaint/product recall", per se, are IMO not suitable Safety-related risk gradation terminologies. (I appreciate others may disagree).

 

It is unclear which microbial Pathogen in OP is being discussed by auditor.?

Pathogens could be differentiated regarding relative Severities (eg zero tolerant vs non-zero tolerant species) but afaik it is currently more usual to group all microbial pathogens together as, for example, V. High Severity,  in contrast to, say, Physical Hazards being limited to "High" Severity. These are also  Subjective interpretations of course.

Edited by Charles.C, 28 August 2023 - 07:02 AM.
edited

[Scampi]

Which pathogen is your concern?  That will dictate your response

[G M]

Hello, 
in our hazard analysis wherein Pathogen is the identified Biological Hazard, the auditor questioned why severity is "Serious Illness".
she mentioned, it should be Fatality?

i think most cases of pathogen related issues are up to Serious Illness??

 

(btw, severity category: Insignificant - Customer Complaint - Product Recall - Serious Illness - Fatality)

 

hope to get insights from here.

 

I would make the grading less specifically worded.  I just use a number range, 1-5 for severity and 1-5 for likelihood, then do a simple multiplication.

 

Values 5-10 require procedures to manage risk, and over 10 requires a subsequent CCP to manage it.