How ISO 9001:2015 can improve your food safety management. Dr. David Rosenblatt Sher Consulting and Training

Transcription

1 How ISO 9001:2015 can improve your food safety management Dr. David Rosenblatt Sher Consulting and Training

2 ISO management systems in the food industry A little bit of history

3 2000 ISO publishes the brand new ISO 9001 standard for all organizations

4 2001 ISO publishes ISO 15161, Guidelines on the application of ISO 9001:2000 for the food and drink industry

5 2005 ISO publishes ISO 22000, Food safety management systems - Requirements for any organization in the food chain

6 ISO is harmonized and compatible with ISO ISO becomes redundant and is withdrawn

7 Organizations throughout the food chain ask themselves: Now that I have ISO 22000, why do I need ISO 9001?

8 GOOD QUESTION! ISO 9001 has a few requirements that doesn t and vice-versa

9 Requirements Document Management Leadership Resources & Training Customer processes Product development Purchasing ISO ISO 9001

10 Requirements Process control Calibration Risk assessment Emergency preparedness Traceability Nonconformity management ISO ISO 9001

11 Requirements Customer satisfaction Internal auditing Data analysis Corrective action Preventive action Management review and continual improvement ISO ISO 9001

12 Because you want to manage all aspects of your quality system and not only those related to food safety Now that I have ISO 22000, why do I need ISO 9001?

13 In September, 2015 ISO published a new and improved version of ISO All certified organizations must make the transition before September 2018

14 Sadly, ISO 9001:2015 is not harmonized with anymore

15 However, it will be in the beginning of 2017!

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17 Organizational Context Interested Parties No Preventive Action Actions to address risks Actions to address opportunities

18 6. Planning 6.1 Actions to address risks and opportunities When planning for the quality management system, the organization shall consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed to:

19 a) give assurance that the quality management system can achieve its intended results; b) enhance desirable effects; c) prevent, or reduce, undesired effects; d) achieve improvement.

20 The replacement of the requirement for preventive action with the requirement to perform a documented risk assessment reflects an important realization

21 Spontaneous pessimism contradicts human nature... That is why it is so difficult to implement the ISO 9001:2000 requirement for preventive action!

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23 Methodological risk assessments have the ability to overcome our innate optimism. That is one of the secrets of HACCP s success

24 By now you might be asking yourself When I have ISO 9001:2015, will I still need ISO 22000?

25 GOOD QUESTION! Even though ISO 9001:2015 includes a requirement to perform a documented risk analysis, it shouldn t be considered as a replacement for ISO for two major reasons:

26 a) FSSC is GFSI benchmarked, and it s here to stay (FSSC includes ISO 22000). b) ISO 9001 lacks the detailed guidance provided by ISO s chapter 7 (Realization of safe products)

27 So, will my food safety management system benefit from the transition to ISO 9001:2015?

28 ANOTHER GOOD QUESTION! The answer is

29 For organizations that were never required to perform documented risk assessments, the RA requirement is the big novelty and challenge associated with 9001:2015 OMG! A risk assessment!!

30 However, for organizations throughout the food chain, a risk assessment is no big deal. OMG! Not another risk assessment!!

31 The novelty for us is the ISO 9001:2015 requirement to perform an opportunity assessment! YES! Opportunity assessment!!

32 Food safety specialists are trained and conditioned to identify and handle risk, but are often shortsighted when it comes to identifying opportunity. We are now obliged to actively seek opportunities to make food even safer by:

33 a) Adopting and adapting new technologies for reducing hazards and monitoring control measures b) Better integration of food safety into NPD processes designing safer food c) Food safety innovation