Allergen Management
Allergen recalls and vulnerability in
the Food Safety System
Jennifer McCreary
Technical Manager, Training and Education Services
Global Food Division
NSF International
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)
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.
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
Current status of allergen recalls
Allergen Recalls 2012 2014 2015
FDA 38% 45%
USDA 32% (43) 39% (58)
UK 39% (22) 57% (32) 52% (63)
5
Known Causes of Allergen Recalls
Most Common Other
Number Number
Wrong label or package 137 Knowledge 28
Terminology not correct 85 Ingredient mislabeled 26
No carry-through of info from Not updated after formula
70 22
ingredient change
Cross-contact 52 Computer error 21
Wrong ingredient 31 In process 19
Rework 9 Other 14
No declaration 12
Adapted from Gendel and Zhu, J. Food Protection 2013
Six Factors (Ishikawa, 6M, Fishbone)
PEOPLE EQUIPMENT MATERIALS
INCORRECT
PACKAGE
OR LABEL
METHODS ENVIRONMENT MEASUREMENT
7
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
Ishikawa, 6M, Fishbone - People
PEOPLE
training
awareness
INCORRECT
PACKAGE
OR LABEL
9
People
• Capability
• Attitude
• Allergen & job training
• Adherence to procedures
protocols and methods
• Barriers
• Competencies and abilities
10
People Training
• Allergen awareness
• Label and package knowledge
• Procedures knowledge
11
People Performance
• Performance Monitoring
• Competency Assessment
12
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
People – Evidence of Process Distress
Assess process robustness
• Near hits, errors caught and
corrected
• System or people driven?
14
People - Error Proofing
Step Reduces opportunities for Increases opportunities
error for error
Training Knowledge check at end of No Knowledge check
training
Training At line knowledge check No check of training
Application activation at line on the
job
15
Include Error Detection
Step Error potential Error potential Error detection Error
Decreases Increases Increases Detection
Decreases
Training Knowledge Check No Knowledge Routine
check refresher
Work Aids Images of labels at Images • No image
line checked check at all
• Image check
without text
check
16
Simplified Analysis for Error Proofing
Step Reduces Opportunity for Increases error detection
Mistakes likelihood
Production changeover Line clearance procedure Sign off on line clearance
by lead hand or
supervisor.
17
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
Six Factors (Ishikawa, 6M, Fishbone)
PEOPLE EQUIPMENT
Functioning
Appropriate
INCORRECT
PACKAGE
OR LABEL
19
Equipment
Equipment operation and
maintenance
Lug ensures peg can only
fit into hole one way
20
Equipment
• Equipment operation and
maintenance
• Error detection equipment
– Vision systems
– Bar code scanners
The scan line of a laser barcode
scanner must cross all bars in a linear
barcode in order to ensure readability.
21
Equipment - Error Proofing
Step Reduces opportunities for Increases opportunities
error for error
Package Packaging machine guides All packaging able to be
application set for individual packages loaded the same way
Inline UPC Verification of UPC code to No means of verification
reader match up with packaging
22
Food Safety System - Equipment
• Preventive Maintenance
• Documented procedures for
equipment set-up
23
Six Factors (Ishikawa, 6M, Fishbone)
PEOPLE EQUIPMENT MATERIALS
Accuracy
Current
INCORRECT
PACKAGE
OR LABEL
24
Package and Label Materials
• Incorrect Print
• Misprints
• Out of date text
• Interleaving and roll splicing.
25
Wrong Label or Package- Print Error
26
Materials - Print Error
At the Printers or in-house
printing
1. Mistake during label design
2. Incorrect Information at label
production set up and
production
27
Materials - Customer Communication
• Communication disconnect
• Supplier changes
• Lack of effective engagement
28
Package and Label Materials - at Line
• Brand products look alike
• Print text hard to read
• Text not in language of
personnel.
29
Materials- Error Proofing
Step Reduces opportunities for Increases opportunities
error for error
Package Color coding or numbering SKUs have similar design
design to identify allergens for brand recognition
Segregation No mixing of SKUs on Mixing of different
pallets or racking package labels permitted
30
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
Six Factors (Ishikawa, 6M, Fishbone)
PEOPLE EQUIPMENT MATERIALS
INCORRECT
PACKAGE
Double OR LABEL
checks
Short
cuts
METHODS
32
Methods
• Line error
• Used Incorrect Label
• Packed in wrong package
• Production steps:
– Receiving
– Picking
– Staging
– Loading
– Running
33
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
Error Proofing
Step Chances of error Chances for error
Reduced Increased
Picking Label SKU number matched to pick No documented SKU
sheet and recorded number check
Staging QC checks staged packages and Packaging for the shift
matches to production schedule staged in production area
Loading Package SKU number matched to No documented check
schedule before loading in
packaging equipment
35
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
Six Factors (Ishikawa, 6M, Fishbone)
PEOPLE EQUIPMENT MATERIALS
INCORRECT
PACKAGE
OR LABEL
visibility
workload
METHODS ENVIRONMENT
37
Environment
• Physical
– Light
– Noise (communication),
– Space
• Behaviour- Sociological, psychological
– Cultural norms and expectation
– Work pace
38
Physical - Light
Light to easily read and observe at all relevant stations
• Labels, text
• Lot numbers
• SKU numbers
39
Physical - Noise
Noise
• Verbal Communication
• Distraction
40
Physical Environment Space
• Lack of easy access to
materials to conduct checks
• No workstation for label check
41
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
Environment – Error Proofing
Step Chances of error Chances for error
Reduced Increased
Package checks during Operators conducting Skipping label or package
package and label loading packaging checks checks and relying on QC
and start up checks because of
production pressures
43
Environment - Food Safety System
• Storage – proper storage of packaging
• Facility – light levels
44
Six Factors (Ishikawa, 6M, Fishbone)
PEOPLE EQUIPMENT MATERIALS
INCORRECT
PACKAGE
Mode OR LABEL
Mgmt of
Change
METHODS ENVIRONMENT MEASUREMENT
45
Measurement – Information at Line
• Availability
• Access
• Accuracy
– Schedules
– Schedule changes
– Allergen Cleaning
– Label information
– SKU numbers
46
Measurement – Error Proofing
Step Chances of error Chances for error
Reduced Increased
Production scheduling Production schedule easily Production scheduling not
accessible by computer at “real time”
workstation
47
Measurements - Food Safety System
• Production Systems
• QA and QC
– Label review
– Labelling checks
48
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
Thank you
Jennifer McCreary
Technical Manager, Training and Education Services
Global Food Division
NSF International
jmccreary@nsf.org
