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 ?
3.11 Management of 2.6 Product Identification,
Chapter in standard 8.9.5 Withdrawal/recall 8.9.5 Withdrawal/recall 5.9 Management of incidents...
incidents... Trace, Withdrawal and Recall
The organization shall be able to For both FSSC 22000 and FSSC KO N° 9: There shall be an effective The company shall have a The responsibility and methods
ensure the timely 22000-Quality certification, the procedure for the withdrawal and plan and system in place used to withdraw or recall
withdrawal/recall of lots of end requirements for the recall of all products, which ensures to manage incidents product shall be documented
products that have been development, implementation that involved customers are informed, effectively and enable the and implemented
identified as potentially unsafe, and maintenance of the Food as soon as possible. This procedure withdrawal and recall of
by appointing competent Safety Management System shall include a clear assignment of products should this be
Description person(s) having the authority (FSMS) are laid down in the responsibilities. required.
to initiate and carry out the standard ISO 22000:2018 “Food
withdrawal/recall. safety management systems -
Requirements for any
organization in the food chain”.

Withdrawn/recalled products Same Other chapter 5.10 Management of 3.8 Control of 2.4.5 Non-conforming Product
and end products still in stock non-conformities and nonconforming nonconforming product or Equipment
shall be secured or held under products
Dealing with products the control of the organization
until they are managed in
accordance with 8.9.4.3.
shall verify the implementation Same withdrawal procedure shall be subject The product recall and The product withdrawal and
and effectiveness of to regular internal testing, based on withdrawal procedures recall system shall be reviewed,
withdrawals/recalls through the hazard analysis and assessment of shall be tested, at least tested and verified as effective
Verification of process use of appropriate techniques associated risks but carried out at least annually, at least annually.
(e.g. mock withdrawal/recall or once a year.
practice withdrawal/recall)

notifying relevant interested Same Snomination and training of a crisis A documented incident Records of all product
parties team, an alert contact list, sources of management procedure withdrawals, recalls and mock
Documented legal advice (if necessary), contacts is required; a recalls shall be maintained.
handling withdrawn/recalled availability, customer information, and documented product
information products as well as products still a communication plan, including withdrawal and recall
in stock; information to consumers. 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 ARTICLE 50. RAPID ALERT SYSTEM
operators
I3. Without prejudice to other Community
4. Why If a food business operator considers or has reason legislation, the Member States shall immediately
to believe that a food which it has imported, notify the Commission under the rapid alert system
produced, processed, manufactured or distributed is of:(a) any measure they adopt which is aimed at
not in compliance with the food safety restricting the placing on the market or forcing the
requirements, it shall immediately initiate withdrawal from the market or the recall of food or
procedures to withdraw the food in question from feed in order to protect human health and
the market where the food has left the immediate requiring rapid action;
control of that initial food business operator and
inform the competent authorities…
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

Process is implemented
department-wide. A
continuous review &
improvement
process is implemented to
Process is implemented. exchange lessons-learned &
(People assigned. address required changes
Communication to relevant proactively. Mock simulations
people done. are done in defined intervals.
Training done. etc.). Handled
Process is defined. There is recall and records available.
procedure and forms. Only team responsibilities.
Implementation is yet
missing or ongoing. Maybe
recall happened, but not
Awareness if process exists in followed as defined.
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.
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 CONTENT LEARN MORE

Suitable for those wishing to In the first part of the training More valuable webinars:
conduct audits of suppliers either participants will receive
to evaluate a new supplier’s instruction on the implementation
ability to meet your of different models for effective 30.08.2019
contractual/food safety & quality supplier evaluation; including
requirements or to re-evaluate an evaluation of service providers with
existing supplier’s performance. complete categorization of all
suppliers.
Web - Trainer: Surčinski Vladimir
In the second part of the training [email protected]
participants will receive instruction
on developing an audit program,
auditors, audit checklists and an
audit plan.