Haccp Risk Rating Calculation - PDF by yck50131

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1   Risks in the feed chain                         GMPplus Int 2010-2011
Risks analysis in the feed chain




The future is now




Niels Lucas luijckx, Consultant Risk Management Food
Safety
    Introduction

    • TNO: Knowledge for business!
       • Contract research organization in a broad range of
         technologies and themes
       • Independent and innovation driven
       • Multi-disciplinary

    • Niels Lucas Luijckx:
       • Biologist, toxicologist
       • Broad experience in risk assessment (CDI Lelystad, RIVM),
         risk communication (Schuttelaar, NIGZ) and risk management
         (Min VWS, LNV, TNO)
       • Science and consultancy



3   Risks in the feed chain                               GMPplus Int 2010-2011
    Content

    •   Risks, what are risks
    •   Type of risks in the feed chain
    •   Handling of hazards, threats and risks, legal compliance
    •   Risk matrix, HACCP, GMP+, FMEA
    •   Chain risk assessment ( SIGMA) - prioritization
    •   Dynamics of risk management

    • Interactive discussion / positions




4   Risks in the feed chain                                  GMPplus Int 2010-2011
    Risks ?

    • Risk is the function of { probability of occurrence } and {
      effect or impact }
        • Impact is a probability also, in most cases!!

    • Effect becomes a hazard  probability of exposure

    • Risk assessment: considers exposure / includes probability!

    • Probability of occurrence: risk management!  monitoring

    • Two subjects to discuss:
       • Hazard -matrix: examples
       • Monitoring: do you pick it up? Probability of detection 
         FMEA


5   Risks in the feed chain                               GMPplus Int 2010-2011
                                                  Impact / effect

                                           HIGH                          LOW

                               Take measures 



                                                                           ?
                     HIGH



                               Risk management =
                               Avoid, reduce, accept or
                               transfer
    Occurrence




                                                                De-prioritize,



                                            ?                   Wait for the holidays…..
                     LOW




6                Risks in the feed chain                                               GMPplus Int 2010-2011
    Risks in the feed chain

    • Chemical
    • Microbiological
    • Physical

    • HACCP / GMP

    • Perspective:
       • feed to food transfer
       • raw material to feed
       • feed processing
       • animal health
       • food to consumer (=health)



7   Risks in the feed chain           GMPplus Int 2010-2011
    Example of calculation

    • Score: impact 1 -10             but how?
    • Score: occurrence 1 - 5         but how?
    • Multiply:                       and then?

    • Always relate to actual situation and QA system (HACCP, GMP+)
    • It is a dynamic situation

    • What is the probability you will detect the hazard ?

    • Outcomes range from 1 to 100:
       • between 80 and 100: take measures
       • between 1 and 20: no worry
       • between 20-80: ????



8   Risks in the feed chain                                  GMPplus Int 2010-2011
                                                  Impact / effect

                                           HIGH                     LOW



                               80-100 20-80
                     HIGH
    Occurrence




                               20-80 1-20
                     LOW




9                Risks in the feed chain                                  GMPplus Int 2010-2011
     Example of interpretation

     • What does the figure 20 mean:
        • 2 x10  high impact or high occurrence  ??
        • 4 x 5  medium impact and occurrence  ??

     • Besides using the matrix, always keep in mind to address the
       high scores

     • What about detectability?
        • If you differentiate in your current process/procedures on
          detectability some hazards, exp medium scores:
             • If current systems allow detection with high probability –
               no worry
             • If not: install procedures, not analytics per se!



10   Risks in the feed chain                                   GMPplus Int 2010-2011
     Proposal Severity and Occurrence

     SEVERITY (1-10)

     • 10: immediate effects – serious effects on human health 
       precautionary principle
     • 8: expected effect on human health at relevant exposure, serious
       effect  prohibited substances, fraud
            • Also loss of information
     • 5: expected effect, not serious (reversible), discomfort
            • Possible loss of information
     • 3: no effect expected or slight effect, reversible
     • 1: no impact expected at all




11   Risks in the feed chain                               GMPplus Int 2010-2011
     Proposal Severity and Occurrence

     OCCURRENCE (1-5)

     • 5: occurs on a frequent basis, historically shown

     • 4: can occur frequently

     • 3: can occur

     • 2: will probably not occur

     • 1: will not occur (circumstances excepted)




12   Risks in the feed chain                               GMPplus Int 2010-2011
     Failure Mode Effect Analysis - Detectability

     • Any hazard identified, with added risk matrix outcome, requires
       attention.

     • Possible control measures, monitoring, ….

     • But, if these measures are in place and procedures are followed
       accurately, the actual priority lowers. This is the function of the
       detectability:
        • Any procedure to detect the hazard is scored
        • A priority number is assigned
        • Additional measures required or not (priority)
        • New priority rating evolves



13   Risks in the feed chain                                   GMPplus Int 2010-2011
     Proposal (Sev and Occ) detectability

     DETECTABILITY (3-1)

     Reverse numbering!

     • 1: likely to be detected: procedure +, applied +  proof!

     • 2: possibly detected: procedure applied, reliability/frequency not
       appropriate or knwon

     • 3: UN-likely to be detected: no procedure applied




14   Risks in the feed chain                                  GMPplus Int 2010-2011
     Interpretation of assigned numbers

     • Any score of 10 for severity, and
     • Any score of 5 for occurrence

     Needs attention, whatever the end outcome of risk matrix OR
      priority rank.

     A substance that is carcinogenous (sev = 10?) but has a low
      occurrence probability (3 = can occur): might score low in total,
      but needs to be addressed anyhow,

     Albeit for public affairs-sake!




15   Risks in the feed chain                                 GMPplus Int 2010-2011
     FMEA 2 - example

      contaminant              Sev   Occ   x    Det Prio   New    Occ   Det Prio
                                                           Add    ???       new
                                                           Meas
      X                        10    4     40   1   40     Avoid 3      1         30


      Y                        8     4     32   2   64     Analy 4      1         32


      Z                        3     5     15   3   45     Analy 4      2         24
                                                           Moni
                                                           Other




16   Risks in the feed chain                                                GMPplus Int 2010-2011
17   Risks in the feed chain   GMPplus Int 2010-2011
     Handling hazards

     •   First obligation is legal compliance
     •   Private obligations: GMPplus, other cert’s
     •   Secondary obligations (but business priority): Customer specs
     •   Internal standards

     • Luckily: they are mostly all look-a-likes!

     • Important is: dynamic risk management and communication in
       the chain and with stakeholders.
         • Authorities
         • OLFs  other legitimate factors
         • Risk management is central between assessment and
           communication, it should be the basis for trust and safety



18   Risks in the feed chain                                 GMPplus Int 2010-2011
     Truth or dare ….

     • Take responsibility


     • “Posteriorize” …..


     • Communicate


     • Out of the box thinking:

     • But also realistic and practical,
       expect this from customers and stakeholders



19   Risks in the feed chain                         GMPplus Int 2010-2011
20   Risks in the feed chain   GMPplus Int 2010-2011
     Dynamics of risk management

     • Stay up to date: revisit your risk analysis

     • Be aware of dynamics in sourcing

     • Emerging risks and issues

     • Stakeholder involvement

     • Supply chain  feed chain  food chain

     • Datasharing

     • Basic strategy: (legal compliance)  Avoid  reduce  transfer 
       accept
         (not necessarily in this order)



21   Risks in the feed chain                                   GMPplus Int 2010-2011
     Positions



              It seems the chain keeps itself and
               Food chain is a strange economic
              each other in a stranglehold …
                 Risk assessment is natural science,
               phenomenon:
                  Competitors and,
                 unprejudiced; share data and trust
              start datasharing! it’s economic and?
                  Value added chain social science
                 Risk management is– suppliers
                      Need for integral distance
              thinking and reduces at aapproach
                  customers – held cost. It creates
              trust and safety.



22   Risks in the feed chain                  GMPplus Int 2010-2011
     Contact Information

     • General information: www.tno.nl

     • Business Unit Quality and Safety / account and sales:
        • Mr Marcel van Zandvoort, +.31.30.69.44.595
            • Marcel.vanzandvoort@tno.nl
        • Mr. Martin Ham, +.31.30.69.44.540
            • Martin.ham@tno.nl

     • Risk management, legal compliance, emergency response
       service:
        • Mr. Niels B. Lucas Luijckx, consultant risk management
            +.31.30.69.44.082
            • Niels.lucasluijckx@tno.nl



23   Risks in the feed chain                                   GMPplus Int 2010-2011

								
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