Allergen Management Allergen recalls and vulnerability in the Food Safety System

Transcription

1 Allergen Management Allergen recalls and vulnerability in the Food Safety System Jennifer McCreary Technical Manager, Training and Education Services Global Food Division NSF International

2 Who is NSF International? Food safety and quality trainers Food safety and quality management consultants Scientists and research professionals Packaging, labelling and technical experts Third Party Auditors (NSF International Certification Body)

3 Program Outline 1. Review reasons for allergen recalls 2. Using Ishikawa (6M, fishbone) Identify opportunities for error proofing Identify opportunities for reducing mistakes Identify potential improvements to our food safety system.

4 Danger of Undeclared Allergens A hazard exists when an allergen is not declared on the label Only way to avoid allergic reaction is to avoid the food Allergic individuals rely on labels 4

5 Current status of allergen recalls Allergen Recalls FDA 38% 45% USDA 32% (43) 39% (58) UK 39% (22) 57% (32) 52% (63) 5

6 Known Causes of Allergen Recalls Most Common Number Wrong label or package 137 Terminology not correct 85 No carry-through of info from ingredient 70 Cross-contact 52 Wrong ingredient 31 Rework 9 Other Number Knowledge 28 Ingredient mislabeled 26 Not updated after formula change 22 Computer error 21 In process 19 Other 14 No declaration 12 Adapted from Gendel and Zhu, J. Food Protection 2013

7 Six Factors (Ishikawa, 6M, Fishbone) PEOPLE EQUIPMENT MATERIALS INCORRECT PACKAGE OR LABEL METHODS ENVIRONMENT MEASUREMENT 7

8 Error Proofing or Mistake Proofing Mistake proofing: The use of an automatic device or method that makes it impossible for an error to occur or makes the error immediately obvious. 8

9 Ishikawa, 6M, Fishbone - People PEOPLE training awareness INCORRECT PACKAGE OR LABEL 9

10 Capability Attitude Allergen & job training Adherence to procedures protocols and methods Barriers Competencies and abilities People 10

11 Allergen awareness Label and package knowledge Procedures knowledge People Training 11

12 Performance Monitoring Competency Assessment People Performance 12

13 People in the System-Complexity Complexity Assessment could include: Number SKUs Package/label changes per shift Decisions per individual Access to relevant and timely information 13

14 People Evidence of Process Distress Assess process robustness Near hits, errors caught and corrected System or people driven? 14

15 People - Error Proofing Step Training Training Application Reduces opportunities for error Knowledge check at end of training At line knowledge check Increases opportunities for error No Knowledge check No check of training activation at line on the job 15

16 Include Error Detection Step Error potential Decreases Error potential Increases Training Knowledge Check No Knowledge check Work Aids Images of labels at line Error detection Increases Routine refresher Images checked Error Detection Decreases No image check at all Image check without text check 16

17 Simplified Analysis for Error Proofing Step Reduces Opportunity for Mistakes Increases error detection likelihood Production changeover Line clearance procedure Sign off on line clearance by lead hand or supervisor. 17

18 Food Safety System-People 1. Personnel Policies 2. Job Descriptions (all levels) Responsibilities Authorities 3. Training Knowledge Procedures Training Activation 4. Supervision and management accountabilities Employee performance monitoring Employee competency assessment 18

19 Six Factors (Ishikawa, 6M, Fishbone) PEOPLE EQUIPMENT Functioning Appropriate INCORRECT PACKAGE OR LABEL 19

20 Equipment Equipment operation and maintenance Lug ensures peg can only fit into hole one way 20

21 Equipment operation and maintenance Error detection equipment Vision systems Bar code scanners Equipment The scan line of a laser barcode scanner must cross all bars in a linear barcode in order to ensure readability. 21

22 Equipment - Error Proofing Step Package application Inline UPC reader Reduces opportunities for error Packaging machine guides set for individual packages Verification of UPC code to match up with packaging Increases opportunities for error All packaging able to be loaded the same way No means of verification 22

23 Food Safety System - Equipment Preventive Maintenance Documented procedures for equipment set-up 23

24 Six Factors (Ishikawa, 6M, Fishbone) PEOPLE EQUIPMENT MATERIALS Accuracy Current INCORRECT PACKAGE OR LABEL 24

25 Package and Label Materials Incorrect Print Misprints Out of date text Interleaving and roll splicing. 25

26 Wrong Label or Package- Print Error 26

27 At the Printers or in-house printing 1. Mistake during label design 2. Incorrect Information at label production set up and production Materials - Print Error 27

28 Materials - Customer Communication Communication disconnect Supplier changes Lack of effective engagement 28

29 Package and Label Materials - at Line Brand products look alike Print text hard to read Text not in language of personnel. 29

30 Materials- Error Proofing Step Package design Segregation Reduces opportunities for error Color coding or numbering to identify allergens No mixing of SKUs on pallets or racking Increases opportunities for error SKUs have similar design for brand recognition Mixing of different package labels permitted 30

31 Food Safety System - Materials Purchasing-Supplier Approval Design Approval Preproduction approval Regulatory Compliance and Food Safety personnel Receiving Procedures- Label/package inspection Production Procedures-Pre-use review In Production review QA Function-Label review program Change Management (formulations, packaging) New Customers New or revised products 31

32 Six Factors (Ishikawa, 6M, Fishbone) PEOPLE EQUIPMENT MATERIALS Double checks INCORRECT PACKAGE OR LABEL Short cuts METHODS 32

33 Methods Line error Used Incorrect Label Packed in wrong package Production steps: Receiving Picking Staging Loading Running 33

34 Errors in Methods (Procedures and Practices) Lack of standardized procedures Workflow Procedures are efficiency driven & lacking safety components. Change management at line Labels at line are uncontrolled Label checks by untrained personnel Label checks frequency not matched to product changes. 34

35 Step Picking Staging Error Proofing Chances of error Reduced Label SKU number matched to pick sheet and recorded QC checks staged packages and matches to production schedule Chances for error Increased No documented SKU number check Packaging for the shift staged in production area Loading Package SKU number matched to schedule before loading in packaging equipment No documented check 35

36 Methods - Food Safety System Contracting Acceptance, design and approval Supplier Approval Processes, proof approval, quality system, certifications Receiving sampling and testing Storing Identification and rotation (obsolete labels) Picking - mistake proofing Production Systems QA and QC Label design and approval Label review Labelling checks 36

37 Six Factors (Ishikawa, 6M, Fishbone) PEOPLE EQUIPMENT MATERIALS visibility INCORRECT PACKAGE OR LABEL workload METHODS ENVIRONMENT 37

38 Environment Physical Light Noise (communication), Space Behaviour- Sociological, psychological Cultural norms and expectation Work pace 38

39 Physical - Light Light to easily read and observe at all relevant stations Labels, text Lot numbers SKU numbers 39

40 Noise Verbal Communication Distraction Physical - Noise 40

41 Physical Environment Space Lack of easy access to materials to conduct checks No workstation for label check 41

42 Environment - Culture Food Safety Culture relies on behaviour Are rules always followed? Is it expected that efficiency efforts may override other requirements. Work Pace causing dysfunction 42

43 Environment Error Proofing Step Package checks during package and label loading and start up Chances of error Reduced Operators conducting packaging checks Chances for error Increased Skipping label or package checks and relying on QC checks because of production pressures 43

44 Environment - Food Safety System Storage proper storage of packaging Facility light levels 44

45 Six Factors (Ishikawa, 6M, Fishbone) PEOPLE EQUIPMENT MATERIALS Mode INCORRECT PACKAGE OR LABEL METHODS ENVIRONMENT Mgmt of Change MEASUREMENT 45

46 Availability Access Accuracy Measurement Information at Line Schedules Schedule changes Allergen Cleaning Label information SKU numbers 46

47 Measurement Error Proofing Step Production scheduling Chances of error Reduced Production schedule easily accessible by computer at workstation Chances for error Increased Production scheduling not real time 47

48 Measurements - Food Safety System Production Systems QA and QC Label review Labelling checks 48

49 Package and Label Function Review Summary People Equipment Materials Method and procedures Environment Information Do the processes increase or decrease opportunities for error or opportunities to detect error? 49

50 Thank you Jennifer McCreary Technical Manager, Training and Education Services Global Food Division NSF International