Here is a snapshot of what we have put together as a "Validation & Effectiveness Report" for

SQF compliance. I have what you see below for the following SQF programs:
Customer Complaint Management
Business Continuity Plan
Document Control
Record Control
Food Safety Plan
Incoming Goods & Services
Product Release
Corrective & Preventive Action
Product Sampling, Inspection, & Analysis
Internal Auditing
Product Identification, Traceability, & Recall Programs
Food Defense
Allergen Management
Training Program
Premises & Equipment Maintenance
Calibration of Equipment
Management of Pests & Vermin
Cleaning & Sanitation
Personnel Hygiene & Welfare/Personnel Processing Practices
Monitoring Water & Air
Transport & Delivery
Control of Physical Contaminants
Waste Management

SQF System:
Policy 2.1.5 Customer Complaint Management
SQF Code Section 2.1.5 Complaint Management
VERIFICATION: (THIS PORTION IS ALL TYPED IN AS REFERENCE)
Method of
Verification Responsibility Freq
uency Verification Records

Review & approval of individual QA Director & Compliance Mgr. Prior

to closing each complaint XXX Software - Customer Complaint Module
complaint records

Monthly complaint summary reports Compliance

Mgr. Monthly Emails and
reports filed electronically
generated and distributed to
necessary
in Customer Complaint folder
management group

VALIDATION: (THIS PART ONLY THE METHOD & FREQUENCY ARE TYPED IN;
REMAINING IS FILLED IN DURING THE ACTUAL VALIDATION ACTIVITY)
Method of
Verification Frequency Vali
dated By: Date of Validation Result of
Validation
Review Customer Complaint History & Trending Twice per Year
Graphs as part of SQF Senior Management
Review Meetings. Review failure category trends
from year to year comparisons for validation of
continuous improvement in a variety of areas (i.e.
transport & delivery, control of physical contaminants,
etc.)
Verification Plan

Activity

Purpose

Frequency

Method

Respon-sibility

Post Verification Actions

Verification of CCP Monitoring as described in HACCP Plan

To verify that CCPs are kept in control as per HACCP Plan

Daily

(In case of production)

1. Verify recording of CCP monitoring in following documents:

2. Verify that implementation of HACCP Plan is effective.

FSTL

If verification does not demonstrate conformity with the planned arrangements, the FST shall
take action to achieve the required conformity.

Following actions may be taken:

a- Review of existing procedures and communication channels.

b- Review of the conclusions of the hazard analysis, the established OPRP(s) and the HACCP
plan.
c- Review of the PRP(s)

d- Review of the effectiveness of human resource management and of training activities.

Verification that input to Hazard Analysis is continually updated.

To update system according to changing circumstances

At any change in process / product / raw-materials / Infrastructure etc

1- Cross check the updating of Hazard Analysis Work sheet w.r.t. updating in following :

Product Characteristics

Flow Diagrams

Process Description

Control measure Categorization sheet.

FST

Verification of OPRP Monitoring as described in OPRP Plan

To verify that OPRPs are kept in control as per OPRP Plan

Weekly

1. Verify recording of PRP monitoring in following documents:

2. Verify that implementation of OPRP is effective.

FST

Verification of Prerequisite Program Implementation as described in PRPs Plan

To verify that all PRPs included in PRPs Plan are implementated and are effective

Monthly

1. Verify recording of PRP monitoring in following documents:

2. Verify that implementation of PRP is effective.

FST

Review of Monitoring and Corrective Action (in case of deviation in OPRP or CCP)

To show compliance with the Plans

Quarterly

FST

Verification that hazard levels are within identified acceptable levels

to ensure that levels of all the identified hazards are within specified acceptable levels.

Quarterly

Verify through QA-approved methods of verification that hazard levels are within acceptable
levels identified in Hazard Analysis Work Sheet.

FSTL

Updation of FSMS

Record all system updation activities and report them as input to Management Review

Quarterly

FSTL

Planning & Scheduling of verification activities

To verify the compliance of system to ISO22000:2005 requirements

Yearly

FSTL

Comprehensive verification of ISO22000:2005

1- To verify the compliance of system to ISO22000:2005 requirements

2- To verify that all procedures requred by ISO 22000 and by the organization are implemented
and effective.

Yearly

1- Perform 1st Internal Documentation Review to check

- Compliance of documented FSMS w.r.t. ISO22000:2005.

- Integrity of documented FSMS

2- Internal Auditing as per Internal Audit Plan

FST
Reworking meat that has fallen on the floor can be perfectly acceptable if done correctly and a
great procedure is written. There are a few major things you have to consider and make sure
that it is followed every time.

1) Make sure you have responsible management individuals in charge of reworking that's
done for product that falls on the floor. This shouldn't be a regular production employee
unless they've been trained and you've verified them performing the procedure.

2) Designate equipment only for rework of product that has fallen on the floor and makes
sure it is cleaned and sanitized after every use. (Yellow handled knives or some way to
distinguish equipment) Make sure employee clothes/frocks/gloves are changed after
handling product.

3) Designate an area where the product is taken in a timely manner and make sure it's
not in contact with other pieces of meat. (Make sure this area is sanitized after every use
also)

4) Have a combination of water and an organic acid/lactic acid available to sanitize the
meat. The outer layer should be trimmed, sanitized, rinsed, and visually inspected by
management for release back to regular production.

5) If you're running product that needs to have it's identity preserved (i.e.
Kosher/Halal/allergens) make sure you're able to distinguish and keep that identity or
downgrade product if you must.

There's a lot to consider when trying to come up with a rework policy for meat that's fallen on
the floor but if it's done correctly it's a safe process and I've seen it done in front of USDA and
SQF Auditors alike. Follow your procedures and do some validation by testing meat
after following procedures. A simple swab test sent out to a lab on different pieces should be
fine. While you are validating it's best to designate your meat inedible or for lethality/cooking
only.

The Food Standards Agency - Meat Industry Guide- states:

''Dropped meat policy - procedures depend on the size of the piece of meat and the extent and
nature of any possible contamination. Large pieces of red meat or in-skin poultry carcases should
be trimmed immediately of visible contamination before processing is resumed. Pieces that are
not suitable for trimming should be disposed of as unfit food''

The below instructions come straight from a USDA training document on Sanitation Standard
Operating Procedures

Reconditioning Product
Although there is no regulatory requirement, establishments may have a
procedure in its Sanitation SOPs for reconditioning product that incidentally
comes in contact with a non-food contact surface (such as the floor). The
procedure usually consists of the following steps; an establishment employee will
remove product from the floor in a timely manner, trim contaminants from the
surface area, wash the product at a product wash station, and inspect it before
returning it to production. This procedure is used for occasional instances of
product contamination. If the establishment is following its written procedures and
monitoring these procedures, the establishment would not be required to take
corrective action that meets the requirements of 416.15 every time product falls
on the floor. If the establishment does not have a reconditioning procedure in its
Sanitation SOP, it would be required to take and document corrective actions
that meet the requirements of 416.15 each time product falls on the floor.
1) The requirements for PRPs in "haccp" typically relate to your GMP program and your hazard
analysis including some involved with both.
The choice of PRPs for an arbitrary "haccp Plan" is likely to relate to whomsoever is going to
audit the Plan. For example in USA, FDA audit seafood haccp plans and also publish a list of
the minimum activities required to be covered by PRP programs. Additionally some control
functions generated within the hazard analysis may also be designated as PRPs if
preferred/allowed.
if so permitted.
(2) If the choice is solely up-to-you, you could simply use iso 22002-1 and select from the listed
PRPs as appropriate to yr GMP program/Hazard analysis. Or use the list from USFDA.
(3) For fssc22000, you presumably need to implement the list of PRPs given in iso22002-1,
unless the activity is not relevant to yr system.

Regarding differences, it depends on you/ yr process/system. for example you may not
personally consider food defence a neccessity in(2). iso apparently does in (3).
For one hazard in one process step, we have 4 control measures.
Are all control measures to be assessed individually or common

E.g,
Recieinving of water
Hazard - Physical (Stones, mud, rust)
Control measures - 1. Micron filtration, 2. Approved vendor progarmme 3. Water tanker
inspection. 4. Incoming water analysis. 5. RO plant with sand filter

You can make an overall risk assessment for a specific hazard based on the nominated set of
control measures. As stated above, IMO yr specific hazard is not yet defined, eg it is unclear as
to what likely injury will be caused by "Mud".

Hi Mohan, I think your micron filter is your ccp and the other checks are prerequisites if the
hazard is foreign bodies then the micron filter is the last point the water will go through before
being bottled. There are some good water haccp plans on the forums as a guide just search
water and haccp.

CCP's and Prerequistes are all control programs.

Although you mention a physical contamination (foreign material - stones, etc.), the control for
the activities you mention are different.

The control of your micron filtration system is not exactly the same that you do with the control
of contamination from a vendor. Therefore you have separate risk assessments for these
activities.

Your risk assessment should be: identify activity, identify the associated risks, then identify the
controls. Your description seems to have it backwards: identify the risk and then identify all the
activities that have this risk.
I would really appreciate if you could write your opinion about this finding:

During our routine environmental swabbing and microbial tests the lab detected Listeria
monocytogenes in the swab taken from the floor of the processing room where we also cut raw
meat before cooking it. Precisely the floor drain was swabbed.

Listeria innocua was also detected in the same swab.

What do you think?

Because it's the floor, and so, theoretically, it could have come through shoes, and not
necessarily with the ingredients, is it normal or does it require anyway extraordinary measures?

I was thinking to provide:

proof of further testing (the drains again, the main food contact surfaces of the room, the raw
meat stored in the freezer, other areas [the more the better])

proof of actions with the employees, to reinforce the importance of using floor foamers when
entering and leaving the processing room

proof of further actions, for example increased frequency of automatic floor foaming

proof of actions with the supplier, in case of positive detection in meat samples

meat sampling based on the actual standard sampling plans, that is at least 5 samples collected.

Do you think this is enough?

(btw, audit happeining in a few days!!! - we got lucky eh?)

At what point in your process was the swab taken? During production or after cleaning? And do
you further process your product to reduce or eliminate bacteria, such as heat treatment?

Listeria is inherent to raw meat, if you look for it in this type of low care environment you will
find it. The fact it's found in your drain will most likely be caused by washing meat particles and
blood down it.

If the swab was taken after cleaning it really should have been removed, I would suggest a
review of the cleaning method, contact time, etc. I say it's inherent but there should still be
controls in place to manage it and limit it's spread through other areas of the factory by vehicles.

I work in a low care meat plant with BRC and the major U.K. retailers and we don't swab for
listeria as it is accepted the organism will be in the environment, however we also cook at a 90c
for 10min equivalent which eliminates Listeria.

It was during production.

But, if it came from the meat, in a good shipping and receiving program, shouldn't Listeria mono
be a zero tolerance criteria in the acceptance of incoming shipment?
Does what you said mean that if any time we receive a frozen meat delivery, we sample it, test
it, and find Listeria mono, we can accept the delivery only because the meat gets cooked?

you really need to consider the level of risk Listeria mono poses to your end product. This will
define the level of control you require now you have found it in your environment. For example,
do you really need such stringent controls if the product is then cooked to a temperature that
will eliminate it?

I would not expect incoming raw meat to be free from Listeria on every delivery. If an
assessment of risk ascertains it is zero tolerance you need, check the criteria for it on the
supplier specification and discuss with them to see what they can do to reduce.

My background before raw meat was high care ready to eat where the presence of Listeria mono
in the environment meant immediate shut downs of entire sections in the factory. In an entirely
low risk site normally the risk of end product contamination is much lower, but you will need to
determine how much control you need. In any case, I think points 1, 2 and 3 from your original
post are good practice and would show your auditor you are taking steps to reduce spread.
Continual improvement

In the context of ISO 22000, the term continual improvement refers

to an ongoing need to improve the effectiveness of a food safety
management system (FSMS). The effectiveness of any FSMS can
be continually improved through the use of communications,
management reviews, internal audits, corrective actions, system
updates, verification research, and validation studies.

Control measure

Control measures are actions or activities that are used to manage

and control food safety hazards. Control measures must be capable
of preventing or eliminating food safety hazards or reducing them
to an acceptable level.

See Codex at http://www.codexalimentarius.net

for examples of specific control measures.

Corrections

A correction is any action that is taken to eliminate a nonconformity.

In the context of the ISO 22000 standard, a correction is any action
that is taken to deal specifically with potentially unsafe products
(nonconforming products).

Corrections may include the following types of actions:

reprocessing or further processing of potentially unsafe products,
assigning them to a different use, or simply destroying them.

In the context of this standard, a correction is not the same as a

corrective action (see below). Corrections are carried out in order to
deal immediately with unsafe products, while corrective actions are
designed to prevent recurrence by addressing causes. Corrective
actions often take a longer term perspective and tend to take a
more systemic approach.

Corrective actions

Corrective actions are steps that are taken to eliminate the causes
of an existing nonconformity. The corrective action process includes
causal analysis and is designed to prevent recurrence.

Critical control point (CCP)

A critical control point (CCP) is the point (or step) at which a

control measure must be applied. It is a point that is critical or
essential to safety. It is the point where a control measure can
be used to prevent or eliminate a food safety hazard or to
reduce it to an acceptable level.

Critical limits (see below) are set at critical control points.

Critical limit

A critical limit is a criterion or boundary that is used to distinguish

between what is acceptable (safe) and what is unacceptable
(unsafe). A critical limit is a value of a parameter or variable.

Critical limits (values) are used to ensure that a process produces

safe food products. When critical limits are violated or exceeded,
products are deemed to be potentially unsafe.

Critical limits are established at critical control points (CCPs).

They are used to determine whether or not a CCP is still under
control. Whenever critical limits are violated or exceeded, CCPs
are out of control and the associated products are considered
to be potentially unsafe.

End product

An end product is a finished product. It requires no further

processing or transformation. However, an end product for
one organization could be an ingredient or raw material for
another (customer) organization.

Food chain

The food chain consists of the entire sequence of stages and

operations involved in the creation and consumption of food
products. This includes every step from initial production to final
consumption. It includes the production, processing, distribution,
storage, and handling of all food and food ingredients.

The food chain also includes organizations that do not directly

handle food. These include organizations that produce feed for
animals that produce food and organizations that produce feed
for animals that will be used as food. It also includes organizations
that produce materials that will eventually come into contact with
food or food ingredients.

Food safety

The basic food safety concept is this: food will not harm the
consumer so long as intended use guidelines are followed when
it is prepared or eaten. Conversely, food is potentially harmful
whenever it has been exposed to hazardous agents and
intended use guidelines have not been followed.

Food safety hazard

A food safety hazard is an agent or condition that could

potentially cause an adverse human health effect. Agents
are either in or on food and can be either biological, chemical,
or physical. Furthermore, the condition of the food itself can
also be hazardous.

Food safety hazards can also be found in or on animal feed and

feed ingredients. Since these may be transferred to food through
the consumption of animal products, they can also cause adverse
human health effects.

Organizations that do not directly handle food and feed may also
compromise food safety. These include producers of packaging
materials, cleaning agents, and other products that eventually come
into contact with food or feed. If such products have been exposed
to hazardous agents and they come into contact with food or feed,
adverse human health effects can occur.

Food safety hazard analysis

A food safety hazard analysis is done in order to determine which

hazards need to be controlled, how much control is needed, and
which combination of control measures should be used in order to
make sure that food is safe. In the context of ISO 22000 (section 7.4),
a food safety hazard analysis is carried out in the following way:

1. Identify your organizations food safety hazards.

2. Pinpoint where each hazard may be introduced.
3. Specify acceptable hazard levels for each hazard.
4. Assess each hazard and decide how to control it.
5. Select control measures to control your hazards.
6. Use OPRPs and HACCP plans to manage hazards.

OPRPs are operational prerequisite programs.

HACCP is hazard analysis critical control point.

Food safety management system (FSMS)

A food safety management system (FSMS) is a network of

interrelated elements that combine to ensure that food does not
cause adverse human health effects. These elements include
programs, plans, policies, procedures, practices, processes, goals,
objectives, methods, controls, roles, responsibilities, relationships,
documents, records, and resources. A FSMS is often one part of a
larger management system.

In spite of the fact that it is all about establishing a food safety

management system, ISO 22000 does not formally define this
concept. As a result, weve given it a try.

Food safety policy

A food safety policy statement formally defines an organization's

commitment to food safety. It expresses, in general terms, what
top management intends to do about food safety and describes
the direction the organization wishes to take.

More precisely, a food safety policy statement should express an

organizations commitment to the implementation and ongoing
maintenance of its food safety management system (FSMS).
The food safety policy should drive the establishment of the
FSMS and should also encourage people to update and
improve its overall effectiveness.
Food safety record

A food safety record is a document that contains objective evidence

which shows how well food safety activities are being performed or
what kind of results are being achieved. It always documents what
has happened in the past.

HACCP

HACCP stands for Hazard Analysis and Critical Control Point.

HACCP is a methodology and a management system. It is used
to identify, prevent, and control food safety hazards. HACCP
management systems use the following methodology:

1. Conduct a hazard analysis.

2. Identify critical control points (CCPs).
3. Establish critical limits for each critical control point.
4. Develop procedures to monitor critical control points.
5. Design corrective actions to handle critical limit violations.
6. Create a food safety record keeping system.
7. Validate and verify your safety system.

HACCP was developed by the Codex Alimentarius

Commission. See: http://www.codexalimentarius.net/.

While we characterize the seven steps as a methodology,

they are traditionally referred to as HACCP principles.

HACCP plan

An HACCP plan is a written document that describes how you plan

to manage and control your organizations food safety hazards.
An HACCP plan contains at least the following information:

1. Critical control points (CCPs).

2. Hazards that will be controlled at each CCP.
3. Control measures that will be used at each CCP.
4. Critical limits that will be applied at each CCP.
5. Procedures that will be used to monitor CCPs.
6. Actions that will be taken when limits are violated.

Consider using your HACCP plan

to manage a control measure:

If strict control must be applied.

If your control measure is likely to fail in the future.
If a control failure would have severe consequences.
If monitoring and rapid corrective action is feasible.
If your control measure must be able to cope
with significant processing variability.
If your control measure is designed to eliminate
or reduce the level of a specific food safety hazard.
If your control measure's place in the system makes
it convenient to make it part of your HACCP plan.
If a control measure helps to boost the effectiveness
of another control measure that is also part of your
particular HACCP plan.

If the above conditions do not seem to apply to your specific

control measure, consider using an operational prerequisite
program (OPRP) to manage it.

NOTE: HACCP plans use critical control points (CCPs) and

critical limits to control food safety hazards, while operational
prerequisite programs (OPRPs) do not.

Internal audit

An internal audit is a systematic evidence gathering process

that is carried out in order to determine how well a food safety
management system (FSMS) meets a set of expectations.
According to section 8.4.1 of this standard, your internal audits
should determine how well your FSMS complies with both the
ISO 22000 requirements as well as your organizations own
requirements and arrangements. In addition, section 8.4.1
expects internal auditors to evaluate how well the FSMS
has been implemented and how well it is being updated
and improved.

Management review

The purpose of a management review is to evaluate the overall

performance of an organization's food safety management system
and to identify improvement opportunities. These reviews are
carried out by the organization's top managers and are done
on a regular basis.

Nonconforming products

In the context of ISO 22000, nonconforming products are products

that are potentially unsafe. They are potentially unsafe because they
were produced or manufactured during a period when critical limits
were violated or exceeded or when an organization has lost control
of a prerequisite program (PRP) or an operational prerequisite
program (OPRP).

Operational prerequisite programs (programmes)

Operational prerequisite programs (OPRPs) are prerequisite

programs (PRPs) that are essential. They are essential because
a hazard analysis has shown that they are necessary in order
to control specific food safety hazards.

OPRPs are used to reduce the likelihood that products will be

exposed to hazards, that they will be contaminated, and that hazards
will proliferate. OPRPs are also used to reduce the likelihood that the
processing environment will be exposed to hazards, that it will be
contaminated, and that hazards will proliferate in that environment.

Consider using an operational prerequisite program

(OPRP) to manage a control measure:

If strict control is not needed.

If your control measure is unlikely to fail in the future.
If a control failure would not have severe consequences.
If monitoring and rapid corrective action is not feasible.
If your control measure does not need to be able
to cope with significant processing variability.
If your control measure is not designed to eliminate
or reduce the level of a specific food safety hazard.
If your control measure's place in the system
makes it convenient to make it part of your OPRP.
If a control measure helps to boost the effectiveness of
another control measure that is also part of your OPRP.

If the above conditions do not apply to your specific control

measure, consider using your HACCP plan to manage it.

NOTE: HACCP plans use critical control points (CCPs) and

critical limits to control food safety hazards, while OPRPs do not.

Prerequisite programs (programmes)

Prerequisite programs (PRPs) are the conditions that must be

established throughout the food chain and the activities and
practices that must be performed in order to establish and maintain
a hygienic environment. PRPs must be suitable and be capable of
producing safe end products and providing food that is safe for
human consumption. PRPs support HACCP plans.

In order to select the most suitable PRPs, organizations

must consider their type of organization and their own unique
circumstances, as well as the capabilities of their suppliers and
service providers. In order to select the most suitable PRPs, they
must also consider customer needs and expectations; they must
consider statutory and regulatory requirements; they must consider
good practices in their segment of the food chain; and they must
consider all relevant standards and guidelines.

PRPs are also referred to as good hygienic practices,

good agricultural practices, good production practices,
good manufacturing practices, good distribution practices,
and good trading practices.

See the Codex website at http://www.codexalimentarius.net for

examples of PRPs and access to all food safety publications.

Procedure

Procedures control processes or activities. A well defined

procedure controls a logically distinct process or activity, including
the associated inputs and outputs. Such a procedure defines the
work that should be done, and explains how it should be done, who
should do it, and under what circumstances. In addition, it explains
what authority and what responsibility has been allocated, which
supplies and materials should be used, and which documents and
records must be used to carry out the work. While procedures may
be documented or undocumented, ISO usually expects them to be
documented.

Traceability system

Traceability is the ability to identify and trace the history, location,

and application of products and materials. A traceability system
records and follows the trail as products and materials come from
suppliers and are processed and distributed as end products.
Update

An update is an immediate or planned activity. Its purpose is

to ensure that the most recent information is being applied.

Validation

Validation is a process that is used to ensure that food safety

control measures are capable of being effective. The validation
process uses evidence to determine whether control measures
are capable of controlling food safety hazards and ensuring
that end products are safe.

Control measures must be validated before they are implemented.

Control measures are implemented and managed using operational
prerequisite programs (OPRPs) and HACCP plans.

Verification

Verification is a process that uses objective evidence to confirm

that specified requirements have been met. In the context of this
ISO 22000 standard, you are expected to verify that your food
safety management system (FSMS) has been implemented.
More precisely, you are expected to do at least the following:

1. Verify that your PRPs have been implemented.

2. Verify that hazard analysis inputs are updated.
3. Verify that your hazard levels are acceptable.
4. Verify that OPRPs are implemented and effective.
5. Verify that HACCP plan is implemented and effective.
6. Verify that procedures are implemented and effective.
In my view, integrating incident management, product recall and crisis management is very
important. Every company will have an incident - there is no such thing as perfect systems,
processes or people; some may lead to a product recall but it does not have to be a crisis - that
is totally dependent on how the company responds.

I like to use the following steps - although I should note that incidents are rarely linear so
jumping around the steps is normal.

1. Identification - understanding that an incident has occurred whether it be product

related, an accident, a criminal act; whatever it is the company needs to recognise
something has happened, and escalate it to the right people quickly. Good plans identify
triggers and escalation points, contact lists etc
1. a) Emergency response - immediate actions that need to be taken to protect
people - staff and consumers, and key assets
2. Investigation - some incidents are significant enough that they require investigation. That
may include getting internal or external tests done, engaging an expert in a certain ares,
going back through production records etc etc. Good plans contain an investigation
checklist to make sure key elements are not missed
3. Assessment - this is a process of determining the risk to consumers, customers and other
stakeholders from not just a health and safety point of view but also a reputation point
of view. Good plans have a simple to follow but well structured methodology for
assessing risk.
4. Response strategy - this is the development of an appropriate response taking into
account the expectations of key stakeholders. A good response strategy identified the
key question - how do we want to be seen by our key stakeholders when this incident is
resolved? Good plans require the management team to ask key questions and come up
with a clear strategy for responding
5. Communications - development of key messages that relate to the response strategy.
Many companies outsource this to PR companies. Don't do it! Pr companies are masters
at coming up with corporate PR bumph that most consumers see right through. Social
media has become the great leveller when it comes to communications. Good plan
include guidance on how to put together key messages and a communication plan - and
then use PR companies to get YOUR message out
6. Implementation - this might include implementation of recall or instigation of a business
continuity plan. In a large scale incident it includes setting up a comms centre and
fielding communications. Good plans provide easy to follow guidance on how to
implement a response
7. Measure - constantly reviewing the effectiveness of your response so, if neccessary, the
strategy or implementation can be adjusted. Good plans contain some guidance on key
performance indicators and how to measure performance against them
8. Close - this includes letting people know the results of your response and getting back
into business. In reality, companies should start planning for and implementing a plan for
getting back to business early. These plans are often included within business continuity
plans but are just as important in product recall situations
9. Learn - it is important to review and identify lessons learned and changes that need to
be made. This includes things that went well as well as things that didn't. While most
people understand the need to make an improvement as a result of a failure, if you
understand why something worked well and document it so you can repeat it, it is just
good luck!
As you can see this process relates to any type of incident. By having an integrated plan you can
ensure you have a consistent approach to any incident that occurs. Many companies have
separate, disconnected recall and crisis management plans. Unfortunately that often means that
the more crisis related parts (assessment, response and communications) only get looked at
after a recall goes pear-shaped. You are then dealing with a crisis that you didn't have to have!
For more information, check out the new International standard for product recall, ISO10393.
While not specifically directed at food, it contains good guidance and a broader perspective on
responding to incidents.
an agenda for the meeting and wrote responsible departments. Meeting will include both ISO
9000 and ISO 22000 standards. I asked the people to send their data analyses for the meeting.
Exp. customer satisfaction surveys, analyses of non-conformity reports during the 2006, anaylsis
of external audit reports,..etc.

1- Follow up actions from last year's management review

2- Quality and Food Safety Policy and Results of 2006 Objectives (all managers)
3- Internal Audit Reports (Quality Assurance)
4- Statistic of Customer and Consumer Complaints (Marketing Management, Supply Chain
Management)
5- Measurement of Customer and Customer Satisfaction (Marketing Management, Supply Chain
Management)
6- Measurement of Employee Satisfaction (Human Resources Management)
7- Non-conformity reports of finish products which are collected from sales points (Quality
Control)
7- Non-conformity reports of production lines (Quality Control, Factory Management)
8- Statue of corrective, preventive and improvement actions (Quality Assurance)
9- Analysis of results of verification activities (HACCP Team)
10- Changing circumtances that can effect food safety (HACCP Team)
11- Emergency situations, accidents and withdrawal (includes recalls) (Supply Chain Department,
Factory Management)
12- Review of communication activities, including customer feed-back. (Marketing Management,
Supply Chain Management)
13-External audits and inspections (Quality Assurance)

Only for 9, 10 and 12 we do not have data analyses. How can we measure them? Only
discussion in the meeting is enough?

Simon, now I can understand that section 12 could be reviewed with customer complaints
analysis and satisfaction surveys. they are customer feed-back.
Regarding the occurrence of combination control measures (CMs) you can find iso-decision trees
having at least 3 (maybe more) different approaches to determine whether a combination
CM is a CCP or OPRP, all methods seem to be acceptable to auditors

(a) a single CM which achieves control is regarded as favouring a CCP while a combination CM
which achieves the same control (ie works) is regarded as favoring a OPRP. Such trees may
ignore mention of synergy.
(b) a single CM whch achieves control is regarded as no different to a combination CM, ie either
may ultimately be a CCP or OPRP depending on the other ISO-criteria. Such trees may ignore
mention of synergy.
(c) a single CM which achieves control is regarded as favoring a CCP while a combination CM is
regarded as favoring a OPRP but only IF the combination CM involves Synergy. Such trees
will probably mention Synergy. ((c) is a restricted version of (a))
(d) a 4th possibility which I think can occur in practice (see link below) could be where a single
CM might work but a combined CM works better due to synergy. Afaik there are so far
no specific iso-decision trees for such a scenario.

Your tree appears to be similar to type (c) above.

It is also possible to find some iso-analyses which consider the occurrence of Synergy favors a
CCP (!) but I think these are in the minority.

Welcome to the world of ISO-HACCP !

I can probably direct you to published examples of all the above if you need.

If you would like to see a brief illustration of synergy (sort of type (d) above) can try the
attachment/link in this post

http://www.ifsqn.com...d-g/#entry85830

PS - if the query was not iso-oriented, you will need to clarify further.
7.4.4 d talks about the likelihood of failure of control measure but not likelihood of occurence of hazard? My
understanding is that if the likelihood of occurence of a hazard is high, then it is more likely to be controlled as
CCP.
It is important to follow the sequence of paragraphs in iso22000.
7.4.3 deals primarily with the determination of significant hazards. The decision as to whether a CM is CCP/OPRP
remains open.
7.4.4 deals with proposing/evaluating/validating control measures (CM) which can handle the determined
significant hazards. And the categorization of a validatable CM option to CCP/OPRP.

Quote
However, if the control measure is easy to fail, then the hazard will not be securely controlled, we should select
another control measure which is stable so that the hazard can be securely controlled. I wonder if this is
a selection criterion rather than categorization criterion? I am still stuck at this concept.

iso22004 (2005) suggests (not demands) a degree of prioritization (for a CCP) towards elements (abe)
within (a-g). Such an approach typifies Tree methods (eg Procert) although in practice the choice of
prioritization varies between authors. In contrast, Modarress method uses equal weighting to obtain an
'average", other variations of Modarres use unequal weights. (Note that iso22004 (2014) may have now added
further suggestions, have no idea.)
But in practice most auditors, so far, typically seem to not care regarding subtleties such as the above. They
simply require a logical method for section 7.4 which is relatable to the iso standard. Note that iso22004
(2005) comments that it does not really matter if you conclude CCP or OPRP provided that FS is achieved (ie
CM validation regarding achieving the acceptable level exists) and monitoring is feasible within an adequate
time frame.

Quote
For synergistic effects, may I use your yogurt hazard analysis as example. In the "Raw milk inspection and off
loading into Raw Milk Silo" step, the control for chemical is a CCP. The score for 7.4.4 (g) was 3, would you
kindly help to use this example to explain more on synergistic effects? e.g. what are the pair/group of synergistic
control measures relevant to this control measure?

TBH, I should have slightly updated the above CCP. As per the excel comments, I struggled conceptually
regarding this specific CM. I would now tend to classify it as a PRP (via ISO22002-1) since the result is less likely
to be auditor debated.

This is an idea of Synergy

synergy,pH-Aw.pdf 59.26KB 53 downloads

A practical illustration of Synergy is here

http://www.fda.gov/F...P/ucm073110.htm
I wouldnt worry too much about about this element unless its a well-documented situation.
Regarding the excel yoghurt analysis (g), note that I modified Modarress scoring concept, (see the note in
sheet 4).

The above text illustrates what is IMO a major defect in the iso22000 standard. Section 7.4.4 is highly non-
prescriptive other than that the output must be either CCP, OPRP, or go back to square 1.
IMO the optimum procedure is probably one which (a) suits yr process, (b) takes the least analysis time,
minimizes yr subsequent workload, (d) satisfies the auditor. Not necessarily in that order.