Quality & Food Safety Webinar Food Safety

Sustainabilit Operations Auditor Trainer presenter Expert

y Associate Associate IFSQN

-Development -More than 300 Emergency

of food safety audits of -Trainer for Preparedness - Regular
-More than 500 calibration/train
food safety audits store auditing different food safety and Response;
aplication tool standard standards – Traceability of ing of food
-More than 1000 -Auditor for ISO HACCP, ISO food in auditors
employees -Responsible for 9001, 14001, 22000, FSSC Restaurants and -Witness
trained for food 3 countries and
safety OHSAS 18001, 22000, Global Fast Food; Safe auditing of food
362 stores at ISO 22000, FSSC GAP Food vs Healthy auditors
the time 22000, HACCP Food;
BASICS
Recall / Withdrawal

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 WHAT ARE THE REQUIREMENTS ?
Chapter in standard 8.9.5 Withdrawal/recall
The organization shall be able to
ensure the timely
withdrawal/recall of lots of end
products that have been
identified as potentially unsafe,
by appointing competent
Description person(s) having the authority
to initiate and carry out the
withdrawal/recall.
Withdrawn/recalled products
and end products still in stock
shall be secured or held under
Dealing with products the control of the organization
until they are managed in
accordance with 8.9.4.3.
shall verify the implementation
and effectiveness of
withdrawals/recalls through the
Verification of process use of appropriate techniques
(e.g. mock withdrawal/recall or
practice withdrawal/recall)
notifying relevant interested
parties
Documented
handling withdrawn/recalled
information products as well as products still
in stock;
8.9.5 Withdrawal/recall
For both FSSC 22000 and FSSC
22000-Quality certification, the
requirements for the
development, implementation
and maintenance of the Food
Safety Management System
(FSMS) are laid down in the
standard ISO 22000:2018 “Food
safety management systems -
Requirements for any
organization in the food chain”.
Same
Same
Same
5.9 Management of incidents...
KO N° 9: There shall be an effective
procedure for the withdrawal and
recall of all products, which ensures
that involved customers are informed,
as soon as possible. This procedure
shall include a clear assignment of
responsibilities.
Other chapter 5.10 Management of
non-conformities and nonconforming
products
withdrawal procedure shall be subject
to regular internal testing, based on
hazard analysis and assessment of
associated risks but carried out at least
once a year.
Snomination and training of a crisis
team, an alert contact list, sources of
legal advice (if necessary), contacts
availability, customer information, and
a communication plan, including
information to consumers.
3.11 Management of 2.6 Product Identification,
incidents... Trace, Withdrawal and Recall
The company shall have a The responsibility and methods
plan and system in place used to withdraw or recall
to manage incidents product shall be documented
effectively and enable the and implemented
withdrawal and recall of
products should this be
required.
3.8 Control of 2.4.5 Non-conforming Product
nonconforming product or Equipment
The product recall and The product withdrawal and
withdrawal procedures recall system shall be reviewed,
shall be tested, at least tested and verified as effective
annually, at least annually.
A documented incident Records of all product
management procedure withdrawals, recalls and mock
is required; a recalls shall be maintained.
documented product
withdrawal and recall
procedure.
BASICS OF WITHDRAWAL/RECALL PROCESS
Every withdrawal/recall process has five aspects:

What is done when, how and why?

Who is accomplishing which task and where?

Which kind of information is transferred? How?

Is the process reaching its target?

Who is authorized to do what within the process?

PHASES OF CONSTRUCTING THE WITHDRAWAL/RECALL
1. Regulation aspect
STEPS EXPLANATIONS

1. What is done Which regulative in your country is defining recall process? Demands of regulative?

2. When Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 – Food Safety Law
/ ARTICLE 19 and ARTICLE 50

3. How ARTICLE 19. Responsibilities for food: food business
operators
4. Why If a food business operator considers or has reason
to believe that a food which it has imported,
produced, processed, manufactured or distributed is
not in compliance with the food safety
requirements, it shall immediately initiate
procedures to withdraw the food in question from
the market where the food has left the immediate
control of that initial food business operator and
inform the competent authorities…
ARTICLE 50. RAPID ALERT SYSTEM
I3. Without prejudice to other Community
legislation, the Member States shall immediately
notify the Commission under the rapid alert system
of:(a) any measure they adopt which is aimed at
restricting the placing on the market or forcing the
withdrawal from the market or the recall of food or
feed in order to protect human health and
requiring rapid action;
PHASES OF CONSTRUCTING THE WITHDRAWAL/RECALL
2. Organizational aspect
STEPS EXPLANATIONS
Internal procedures and
Is there already defined procedure? When was the last time procedure verified? Standard requirement?
standards
Company size and employee number; internal organization
Responsibilities
Food safety team members + top management; external responsibilities

Resources Transport of recall/withdrawal

Storage area for nonconforming products

Destruction or rework process (internally or externally)

Communication elements (phones, internet…) / Contact list

Documentation - records, forms

PHASES OF CONSTRUCTING THE WITHDRAWAL/RECALL
3. Informational aspect

DEPARTMENT / Name SUB PROCESS

Customer Complaint PUBLIC

Sales department Reception Customer

info

Quality department Review Record Process Recall

Control check

Process
Production check Recall
Process
Warehouse check s
Recall

External Recall
PHASES OF CONSTRUCTING THE WITHDRAWAL/RECALL
4. Controlling aspect
STANDARD ALIGNMENT COMMUNICATION
 Requirements fulfilled measurement  Whether or not any to the hazard to those
 Records available  Process customers disease or injuries have individuals who may be
 Process architecture & stakeholders already occurred from at greatest risk.
the use of the product.  Assessment of the
 Process output
 Assessment of hazard to degree of seriousness of
various segments of the the health hazard to
population, e.g., children, which the population at
surgical patients etc., risk would be exposed.
GOVERNANCE who are expected to be  Assessment of the
 Process management  Process metrics & exposed to the product likelihood of occurrence
decision making performance being considered, with of hazard.
particular attention paid
 Process roles &  Process management
responsibility controls

METHODS / PROCEDURES
 Process design  Process control &
& modeling measurement
 Process implementation  Process improvement
& execution & innovation
PHASES OF CONSTRUCTING THE WITHDRAWAL/RECALL
5. Safety aspect
PRODUCTION LANDING PROCESS
PROCESS  Time for job processing
 Production time  Customer satisfaction
<  Machine availability index
 Time organization

EVALUATION- ADMINISTRATION
PROCESS PROCESS
 Mock simulation  Computer availability
 Measurements in  Number of open
process of recall and positions
traceability  Time for expense
 Mock effectivenes reports
 Qualified staff
WITHDRAWAL/RECALL PROCESS LEVEL IN COMPANY

Awareness if process exists in
the organization.
(Planning) activities have
started for the definition of
the subject. No recall
No structured process happened or no records yet.
activities , steps are not
implemented, no standard
requirements or regulative
considered or known.
Process is defined. There is
procedure and forms.
Implementation is yet
missing or ongoing. Maybe
recall happened, but not
followed as defined.
Process is implemented.
(People assigned.
Communication to relevant
people done.
Training done. etc.). Handled
recall and records available.
Only team responsibilities.
Process is implemented
department-wide. A
continuous review &
improvement
process is implemented to
exchange lessons-learned &
address required changes
proactively. Mock simulations
are done in defined intervals.
CASE AND CHECKLIST
Small food production company model (10-50 employees)

Define one responsible person/and replacement for process / Make a decision and communicate to organization

Make a list of regulative requirements that needs to be covered / Include regulative inspection as experts

Make a list of contacts (suppliers, customers, experts, certification body)

Make a list of standard requirements that needs to be covered (customer, external consultant)

Define procedure for recall/withdrawal and communicate the same to organization (follow steps of process
definition)

Perform changes of transport, warehouse and production for proper handling with nonconforming product

Perform simulation minimally once per year (record time, actions for improvements)

If you answered “no" to most of these questions, consider familiarizing your self with the concepts and demands of recall/withdrawal
process.
CASE AND CHECKLIST
Medium and large food production company model (over 100 employees)

Define responsible team (responsibilities per department/process step) / Make a decision and communicate to
organization

Make a list of regulative requirements that needs to be covered / Include regulative inspection/agencies

Make a list of contacts (suppliers, customers, experts, certification body)

Make a list of standard requirements that needs to be covered (customer, external consultant)

Define procedure for recall/withdrawal and communicate the same to organization (follow steps of process
definition)

Communicate the procedures to suppliers of services – transport, storage, export agencies…

Perform simulation minimally once per year in cooperation with customer and supplier (record time, actions for
improvements)

If you answered “no" to most of these questions, consider familiarizing your self with the concepts and demands of recall/withdrawal
process.
RECALL/ WITHDRAWAL – CRISIS COURSE
Differentiation of crisis depending of time of detection

1. PHASE 2. PHASE 3. PHASE 4. PHASE

Potential Latent Acute/ manageable Acute /not manageable
company crisis company crisis company crisis company crisis
Early detection Intensity of (real)
requirement destructive effect
Crisis handling
requirement

Crisis prevention/ Crisis

handling potential

(usual) Identification
potential

Crisis prevention
requirement
(potential) time
destructive effect
RECALL/ WITHDRAWAL – CRISIS COURSE
Course of crisis process with beginning, turning point and end

Begin End
SURVIVAL CHANCES

Turning point

End
CONSTRUCTING THE SIMULATION WITHDRAWAL/RECALL
Mock
STEPS EXPLANATIONS
Procedure / requirements Simulation is done according to predefined procedure and requirements of implemented standard

Simulation is performed minimally once per year, and each time there is change in
When to perform
system/process/product

What should be considered Defined form/log of simulation

Include traceability test (to ingredients, of ingredients and to customers, affected products)
Define product for recall and think about different reasons for recall

Include all departments, top management especially, and if possible suppliers and customers

Evaluate the effectiveness of simulation

Communicate the effectiveness and success / Lessons learned - training

CONSTRUCTING THE SIMULATION WITHDRAWAL/RECALL
Mock
STEPS EXPLANATIONS

Procedure / requirements Evaluate the effectiveness of simulation

When to perform Communicate the effectiveness and success / Lessons learned

A. Production Volume :
What should be considered
B. Remaining Stock Volume :
C. Distributed Volume :
D. Retention Volume :
E. Other usage (e.g. lab analysis, etc.) :

% Mock Recall Effectiveness: B+ C+ D+ E X 100 = % Effectiveness

A

Completion Time: __________________

*** Note: Mock Recall must be completed within four hours of start time.

If Mock Recall is less than 100%, outline cause and indicate corrective action required:
 KEY THINGS TO REMEMBER

TRACEABILITY REQUIREMENTS CYCLE TIME COMMUNICATION DOCUMENTATION

Define simple way of Of regulative, of Perform time limited Make clear Make procedures
tracking traceability. customer, of mock recalls, record responsibilities, simple and recording
implemented time for traceability include suppliers, forms simpler and
standards… simulations regulative inspection, train employees
customers
Practical Supplier Auditor Training
INFORMATION
Suitable for those wishing to
conduct audits of suppliers either
to evaluate a new supplier’s
ability to meet your
contractual/food safety & quality
requirements or to re-evaluate an
existing supplier’s performance.
CONTENT LEARN MORE
In the first part of the training More valuable webinars:
participants will receive
instruction on the implementation
of different models for effective 30.08.2019
supplier evaluation; including
evaluation of service providers with
complete categorization of all
suppliers.
Web - Trainer: Surčinski Vladimir
In the second part of the training vladimir.surcinski@gmail.com
participants will receive instruction
on developing an audit program,
auditors, audit checklists and an
audit plan.