Copyright 2016 Food Integrity Consulting Ltd All rights reserved. No part of the material may be transmitted or reproduced in any form (including

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1 Copyright 2016 Food Integrity Consulting Ltd All rights reserved. No part of the material may be transmitted or reproduced in any form (including photocopying or storage in any medium by electronic means) without the written permission of the copyright owner. Application for permission shall be addressed to Food Integrity Consulting Ltd, Shenna House, Cockley Road, Farthinghoe, NN13 5PD

2 Julia Pepler Food Integrity Consulting ltd Exposing and analysing manufacturing pitfalls QUALITY SUPPORT FOR SUCCESS 2

3 Why do auditors always raise non-conformances about allergen segregation in the warehouse? It s the lowest risk place in the factory! 3

4 Spillage kits? Will a dustpan and brush really do the job? 4

5 Auditor allergen training? Experience is key. 5

6 Take control of your audit to avoid inappropriate non conformances being raised. 6

7 Pitfall 1 Risk assessment weakness Taking control of your audit: Robust risk assessment is fundamental 7

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9 Establish the likelihood of cross contamination occurring And: The quantity of allergen involved At every potential cross contamination point Could the LIMIT OF DETECTION be achieved? 9

10 Typical low risk areas Storage and dispatch Floors and footwear Personal protective equipment No / minimal food contact cleaning equipment Spillage to floors / unopened raw material Typical high risk areas Any shared production equipment particularly where wet cleaning is difficult Sieving and dispense areas Assembly and packing lines 10

11 Ensure the risk assessment records the justification for the decision LIKELIHOOD - REASON SCORE QUANTITY of allergen if contamination occurred Egg free mixer close to egg mixer. Mixing processes can be quite aggressive and could lead to splash. However, there is 3m to travel. Egg in the form of minced boiled, with mayonnaise. Minimum batch size non egg 40kg. No observable splashing in vicinity of mixer. 1 Weight or splash estimated at 1g worse case scenario = % in 40kg batch 25 ppm. SCORE 2 11

12 Ensure the risk assessment records the justification for the decision LIKELIHOOD - REASON SCORE QUANTITY of allergen if contamination occurred Turbo depositor, used for mayonnaise on assembly lines. Also used with egg free salsa If it is not cleaned well, there will be contamination. Minimum batch salsa 10kg. 3 Estimated amount of mayonnaise remaining, worse case scenario 50g. Egg content 4% = 0.02% in 10kg. = 200 ppm SCORE 3 12

13 Ensure the risk assessment records the justification for the decision LIKELIHOOD - REASON SCORE QUANTITY of allergen if contamination occurred Minced egg spills from container into another container with no egg - this occurs because: - baskets are stacked at different heights, very close to each other and are regularly over filled. - also sometimes containers are not properly covered. 3 This could foreseeably exceed the LOD, or could result in a slug of contamination in product. SCORE 3 13

14 Risk Assessment Criteria Likelihood Definition Score Probable Possible Unlikely This is likely to occur on a regular basis This could occur but not frequently or regularly This is unlikely to occur although cannot be ruled out Quantity Definition Score Substantial Moderate Allergen is present to a level where it could substantially and / or regularly exceed the LOD Allergen is present to a level where it may occasionally exceed the LOD, but only to a very low level Minimal Allergen levels cannot achieve the LOD

15 Risk Assessment Criteria Quantity Minimal 1 Moderate 2 Substantial 3 Likelihood Unlikely 1 Probable Possible 3 15

16 Pitfall 2 Overcomplicated controls The best allergen control is no control! 16

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19 Psychological tools. 19

20 Pitfall 3 Validation errors Cleaning surfaces mystery and surprises: Sometimes surface contamination doesn t show in product. 20

21 Cleaning surfaces mystery and surprises: Some surfaces are harder to clean than they look. IT S ALL ABOUT VALIDATION! 21

22 Validation errors: Rapid test kits used. Validation not based on sound risk assessment. What has been validated? Non scientific methodology used 22

23 Cleaning validation fails what next? 23

24 You have validated your cleaning method how do you make sure you follow it every time you clean? What verification is required? How will you sleep at night..? Pitfall 4 Management control lacking 24

25 Effective management controls: Every risk point has a corresponding, identified control Each control is subject to verification 25

26 LIKELIHOOD - REASON SCORE QUANTITY of allergen if contamination occurred Minced egg spills from container into another container with no egg - this occurs because: - baskets are stacked at different heights, very close to each other and are regularly over filled. - also sometimes containers are not properly covered. 3 This could foreseeably exceed the LOD, or could result in a slug of contamination in product. SCORE 3 Control Verification 1. Baskets need to be replaced with an alternative fit for purpose - hard sided, easily cleanable, robust. 2. Staff retraining is required to establish correct filling levels for all containers and all products. 3. Add filling requirements to SOP's for all operators. Doc refs Prod SOP s 1-4 Version 6 August Filling of baskets to be included in weekly GMP audits. 2. Paperwork Controllers to do daily checks on fill levels and line leader to monitor and be held responsible. 26

27 Pitfall 5 Communication failures Something changes who knows? 27

28 Pitfall 6 Supplier Controls more communication Raw material worries have the right questions been asked? Do you know if your suppliers allergens are compatible with yours? 28

29 Why do auditors always raise non-conformances about allergen segregation in the warehouse? It s the lowest risk place in the factory! IS THE WAREHOUSE LOW RISK THEN? 29

30 IS THE WAREHOUSE LOW RISK THEN? YES! Miss picked ingredient errors. Big risk. But not cross contamination. Think - how easy is it to identify ingredients? Much more important than segregated storage. Pitfall 7 Ingredient mistakes 30

31 And the other main causes of problems... 31

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34 ANY QUESTIONS?