Professional Documents
Culture Documents
FSSC 22000 is a voluntary 3rd party private certification scheme which is based on the ISO 22000 Food safety management fra
Certification to FSSC 22000 (Food manufacturing) provides evidence that a facility meets the requirememnts as set out in
ISO 22000; 2005
ISO/TS 22002-1; 2009
and FSSC 22000 Certification Scheme 41. (see www.fssc22000.com)
An initial gap analysis shows that FSSC 22000( Food Manufacturing) is very closely aligned with the requirements of the PC rul
FSMA, like FSSC 22000, is based on an ISO foundation and both FSSC 22000 and FSMA share the common goal of achieving foo
To further confirm these results and to be of greater help to our stake holders we commissioned a second more in depth anal
This document includes this in depth comparison for reference.
For the most part the requirements of the PCHF are reflected in the requirements of FSSC 22000, either in ISO 22000 which ou
In some sections however, the line by line comparison identifies some “differences” where FSMA demands a more prescriptiv
These differences are identified both in this the document and in an FSSC 22000 supplementary document that can be used b
), “Current Good Manufacturing Practice, Hazard Analysis, and Risk Based Preventive Controls for Human F
0 Food safety management framework, with scope specific operational pre requisite programs. It is benchmarked by the GFSI and governe
quirememnts as set out in
d a second more in depth analysis in which we could map the individual requirements of the PC rule against those of FSSC 22000.
0, either in ISO 22000 which outlines the requirements for managenement system, or in ISO 22002-1 which describes the requirements fo
MA demands a more prescriptive level of detail than is provided in the more interpretive FSSC 22000.
document that can be used by certified facilities in conjunction with this document, to bridge the gap between the FSSC 22000 requirem
1
ve Controls for Human Food.”
em approach.
describes the requirements for the PRPs or in the additional FSSC 22000 requirements.
Acid foods or Acidified foods: Foods that have an equilibrium pH of 4.6 or below.
Adequate: That which is needed to accomplish the intended purpose in keeping with good public health practice.
Allergen cross-contact: The unintentional incorporation of a food allergen into a food.
Cleaning: The removal of soil, food residue, dirt, grease or other objectionable matter.
Clean in place (CIP): A system used to clean process piping, bins, tanks, mixing equipment, or larger pieces of equipment witho
can be readily washed away by the flow of the cleaning solution.
Clean out of place (COP): A system (e.g. cleaning tanks) used to clean equipment parts, piping, etc. after disassembly.
Correction: An action to identify and correct a problem that occurred during the production of food, without other actions ass
the likelihood that the problem will recur, evaluate all affected food for safety, and prevent affected food from entering comm
Corrective action: An action to identify and correct a problem that occurred during the production of food, including actions a
the likelihood that the problem will recur, evaluate all affected food for safety, and prevent affected food from entering comm
Control point (CP): Any step at which biological, physical, or chemical factors can be controlled.
Critical control point (CCP): A point, step, or procedure in a food process at which control can be applied and is essential to pr
acceptable level.
Critical limit (CL): A maximum and/or minimum value to which a biological, chemical, or physical parameter must be controlle
of a food-safety hazard.
End-Point Internal Product Temperature (EPIPT): A measurement of the internal temperature of the product at the end of th
Environmental pathogen: A pathogen capable of surviving and persisting with the manufacturing processing, packing, or hold
foodborne illness if that food is consumed without treatment to significantly minimize the environmental pathogen. Examples
Salmonella spp. but do not include the spores of pathogenic sporeforming bacteria.
Environmental sample: A sample that is collected from a surface or area of the plant for the purpose of testing the surface or
pathogens.
Facility: A domestic facility or foreign facility that is required to register under section 415 of the Federal Food, Drug, and Cosm
subpart H. Food: Includes (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used fo
ingredients.
Food allergen: A major food allergen as defined in section 201(qq) of the Federal Food, Drug, and Cosmetic Act (e.g., any of th
shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans. (2) A food
paragraph (1), except any highly refined oil derived from a food specified in paragraph (1) and any ingredient derived from suc
Food safety plan: A set of written documents that is based upon food safety principles and incorporates hazard analysis, preve
verification procedures to be followed, including a recall plan.
Food Safety System: The result of the implementation of the Food Safety Plan.
Food-contact surfaces: Those surfaces that contact human food and those surfaces from which drainage, or other transfer, on
during the normal course of operation. “Food contact surfaces” includes utensils and food-contact surfaces of equipment.
HACCP (Hazard Analysis and Critical Control Point): A system which identifies, evaluates, and controls hazards that are signific
Hazard analysis: The process of collecting and evaluating information on hazards and conditions leading to their presence to d
Hazard requiring a preventive control: A known or reasonably foreseeable hazard for which a person knowledgeable about th
based on the outcome of a hazard analysis (which includes the severity of the illness or injury if the hazard were to occur and
controls) establish one or more preventive controls to significantly minimize or prevent the hazard in a food and components
actions, verification and records) as appropriate to the food, the facility and the nature of the preventive control and its role in
hazard: A potential biological, chemical (including radiological), or physical hazard that is known to be, or has the potential to b
Hazard: Any biological, chemical (including radiological), or physical agent that has the potential to cause illness or injury.
Microorganisms: Yeast, molds, bacteria, viruses, protozoa, and microscopic parasites and includes species that are pathogens
microorganisms that are pathogens, that subject food to decomposition, that indicate that food is contaminated with filth, or
Operating limits: Criteria that may be more stringent than critical limits and are established for reasons other than food safety
Pest: Any objectionable animals or insects including birds, rodents, flies, and larvae.
Monitor: To conduct a planned sequence of observations or measurements to assess whether a process, point, or procedure
verification.
Prerequisite programs: Procedures, including Current Good Manufacturing Practices (CGMPs), that provide the basic environm
Plan.
Preventive controls qualified individual (PCQI): A qualified individual who has successfully completed training in the developm
equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through
Preventive controls: Those risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgea
food would employ to significantly minimize or prevent the hazards identified under the hazard analysis that are consistent wi
processing, packaging, or holding at the time of the analysis.
Qualified individual: A person who has the education, training, or experience (or a combination thereof) necessary to manufa
individual’s assigned duties. A qualified individual may be, but is not required to be, an employee of the establishment.
RTE (Ready-to-eat) food: Any food that is normally eaten in its raw state or any other food, including a processed food, for wh
further processing that would significantly minimize biological hazards.
Sanitize: To adequately treat cleaned surfaces by a process that is effective in destroying vegetative cells of pathogens, and in
but without adversely affecting the product or its safety for the consumer.
Validation: Obtaining and evaluating scientific and technical evidence that a control measure, combination of control measure
capable of effectively controlling the identified hazards.
Verification: The application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whe
been operating as intended and to establish the validity of the food safety plan.
1
Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry
https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM517417.pdf
2
ISO 22000:2005 Food safety management systems — Requirements for any organization in the food chain
https://www.iso.org/obp/ui/#iso:std:iso:22000:ed-1:v1:en
3
ISO/TS 22002-1: 2009 Prerequisite programmes on food safety -- Part 1: Food manufacturing
ISO/TS 22002-1:2009 Preview
ISO Terms and definitions2 ,3
certificate of
analysis ( COA )
cleaning
cleaning in place
(CIP)
cleaning out of
place (COP)
contaminant
contamination
control measure
correction
corrective action
critical control
point (CCP)
critical limit
disinfection
end product
establishment
(product) contact
food chain
food grade
food safety
food safety policy
label
material
specification /
product
specification
materials
monitoring
operational PRP
product recall
PRP prerequisite
programme
sanitation
sanitizing
updating
validation
verification
zoning
ms and definitions2 ,3
〈food safety〉 document provided by the supplier which indicates results of specific tests or analysis,
including test methodology, performed on a defined lot of the supplier’s product
〈food safety〉 removal of soil, food residue, dirt, grease or other objectionable matter
cleaning (3.5) of equipment by impingement or circulation of flowing chemical solutions, cleaning liquids
and water rinses into, on to and over surfaces in equipment or systems without dismantling and
designed for the purpose
system where equipment is disassembled and cleaned in a tank or in an automatic washer by circulating
a cleaning solution and maintaining a minimum temperature throughout the cleaning cycle
〈food safety〉 any biological or chemical agent, foreign matter or other substances not intentionally
added to food which may compromise food safety or suitability
〈food safety〉 introduction or occurrence of a contaminant (3.2) in food or food environment
〈food safety〉 action or activity that can be used to prevent or eliminate a food safety hazard (3.3) or
reduce it to an acceptable level
action to eliminate a detected nonconformity NOTE 2 A correction may be, for example, reprocessing,
further processing, and/or elimination of the adverse consequences of the nonconformity (such as
disposal for other use or specific labelling).
action to eliminate the cause of a detected nonconformity or other undesirable situation NOTE 1 There
can be more than one cause for a nonconformity.NOTE 2 Corrective action includes cause analysis and is
taken to prevent recurrence.
〈food safety〉 step at which control can be applied and is essential to prevent or eliminate a food safety
hazard (3.3) or reduce it to an acceptable level
criterion which separates acceptability from unacceptability NOTE 2 Critical limits are established to
determine whether a CCP (3.10) remains in control. If a critical limit is exceeded or violated, the products
affected are deemed to be potentially unsafe.
〈food safety〉 reduction, by means of chemical agents and/or physical methods, of the number of
microorganisms in the environment, to a level that does not compromise food safety or suitability
product that will undergo no further processing or transformation by the organization NOTE A product
that undergoes further processing or transformation by another organization is an end product in the
context of the first organization and a raw material or an ingredient in the context of the second
organization.
〈food safety〉 any building or area in which food is handled and the surroundings under the control of
the same management
stock rotation based on the principle of despatching earliest expiration dates first
〈food safety〉 stock rotation based on the principle of despatching earliest received products first
schematic and systematic presentation of the sequence and interactions of steps
all surfaces that are in contact with the product or the primary package during normal operation
sequence of the stages and operations involved in the production, processing, distribution, storage and
handling of a food and its ingredients, from primary production to consumption NOTE 1 This includes
the production of feed for food-producing animals and for animals intended for food production. NOTE 2
The food chain also includes the production of materials intended to come into contact with food or raw
materials.
lubricants and heat transfer fluids formulated to be suitable for use in food processes where there may
be incidental contact between the lubricant and the food
biological, chemical or physical agent in food, or condition of food, with the potential to cause an
adverse health effect
NOTE Food safety hazards include allergens.
NOTE In the context of feed and feed ingredients, relevant food safety hazards are those that
may be present be present in and/or on feed and feed ingredients and that may subsequently be
transferred to food through animal consumption of feed and may thus have the potential to cause an
adverse human health effect.
In the context of operations other than those directly handling feed and food (e.g. producers of
packaging materials, cleaning agents, etc.), relevant food safety hazards are those hazards that can be
directly or indirectly transferred to food because of the intended use of the provided products and/or
services and thus can have the potential to cause an adverse human health effect.
concept that food will not cause harm to the consumer when it is prepared and/or eaten according to its
intended use NOTE Food safety is related to the occurrence of food safety hazards (3.3) and does not
include other human health aspects related to, for example, malnutrition.
overall intentions and direction of an organization related to food safety (3.1) as formally expressed by
top management
〈food safety〉 printed matter that is part of the finished product package conveying specific information
about the contents of the package, the food ingredients and any storage and preparation requirements
EXAMPLE The term covers, but is not limited to: a) the package itself, printed matter attached to the
package, or a sticker used for over-labelling; b) multi-packs which have an inner label on the individual
product and an outer combined label for the whole contents.
〈food safety〉 basic conditions and activities that are necessary to maintain a hygienic environment
throughout the food chain suitable for the production, handling and provision of safe end products and
safe food for human consumption NOTE The PRPs needed depend on the segment of the food chain in
which the organization operates and the type of organization. Examples of equivalent terms are: Good
Agricultural Practice (GAP), Good Veterinarian Practice (GVP), Good Manufacturing Practice (GMP), Good
Hygienic Practice (GHP), Good Production Practice (GPP), Good Distribution Practice (GDP) and Good
Trading Practice (GTP).
all actions dealing with cleaning or maintaining hygienic conditions in an establishment, ranging from
cleaning and/or sanitizing of specific equipment to periodic cleaning activities throughout the
establishment (including building, structural, and grounds cleaning activities)
〈food safety〉 demarcation of an area within an establishment where specific operating, hygiene or other
practices may be applied to minimize the potential for microbiological cross-contamination NOTE
Examples of practices include: clothing change on entry or exit, positive air pressure, modified traffic
flow patterns.
Preventive Controls for
Human Food (PCHF) Rule FSMA Requirement
SUBPART B—CURRENT
GOOD MANUFACTURING
PRACTICE
Has the management of the establishment taken
§117.10 Personnel reasonable measures and precautions to ensure the
following:
Disease control
Cleanliness
Subpart C—HAZARD
ANALYSIS AND RISK-BASED
PREVENTIVE CONTROLS
§ 117.126 Food safety plan. Requirement for a Food Safety Plan (FSP)
General overview
§ 117.136 Circumstances in
which the owner, operator,
or agent in charge of a Have you considered if some of your hazards do not
manufacturing/processing require a preventive control by following the steps
facility is not required to below.
implement a preventive
control.
§ 117.137 Provision of
Are you a facility that provides a written Assurance
assurances required under as above in § 117.136. If not, you must
§ 117.136
A5
Do you have a process in place to ensure that you
B document all verification activities conducted in
accordance with this section
I
Are you identifying the test microorganism(s) or
Ii other analyte(s)
Are you specifying the procedures for identifying
Iii samples, including their relationship to specific lots
of product
Are you including the procedures for sampling,
Iv including the number of samples and the sampling
frequency
Are you identifying the test(s) conducted, including
V the analytical method(s) used
Iv
§ 117.180 Requirements
applicable to a preventive Do you have a written procedure in place to make
controls qualified sure that one or more preventive controls qualified
individual and a qualified individuals (PCQI) oversee the following:
auditor.
A1 Preparation of the food safety plan;(117.126)
4i Validation; and
4viii Reanalysis;
SUBPART F—
REQUIREMENTS APPLYING
TO RECORDS THAT MUST
BE ESTABLISHED AND
MAINTAINED
a
Your records must contain the actual values and
b observations obtained during monitoring and, as
appropriate, during verification activities
c Are your records accurate, indelible, and legible
Your records must be created concurrently with
d performance of the activity documented
Your records must be as detailed as necessary to
e provide history of work performed; and include the
following:
Information adequate to identify the plant or
F1 facility (e.g., the name, and when necessary, the
location of the plant or facility)
The date and, when appropriate, the time of the
F2 activity documented
The signature or initials of the person performing
F3 the activity
Where appropriate, the identity of the product and
F4 the lot code, if any
§ 117.315 Requirements for Do you have a procedure for retaining all relevant
records at the plant or facility for at least 2 years
record retention. after the date they were prepared
A1
authorized officials
Section 117.136(a)(2);
Section 117.136(a)(3);
Section 117.136(a)(4);
Section 117.430(c)(2);
Section 117.430(d)(2); or
Section 117.430(e)(2);
SUBPART G SUPPLY -
CHAIN PROGRAM
§117.405 Requirement to
establish and implement a
supply-chain program.
§117.410 General
Does the supply-chain program include all of the
requirements applicable to following
a supply-chain program
a
a1 Using approved suppliers as required by §117.420
d1iiiB
a1
Except as provided by paragraphs (a)(3) and (4) of
this section, has the receiving facility determined
a2 and conducted appropriate supplier verification
activities, and satisfied all documentation
requirements of this subpart.
Has the entity other than the receiving facility done
any of the following, provided that the receiving
a3 facility reviews and assesses the entity's applicable
documentation, and documents that review and
assessment:
a
Are there written procedures for receiving raw
b materials and other ingredients.
§117.425 Determining
appropriate supplier Has the appropriate supplier verification activities
verification activities (including the frequency of conducting the activity)
(including determining the been determined in accordance with the
frequency of conducting requirements of §117.410(d).
the activity)
a
Have you considered, except as provided by
paragraph (b)(2) of this section, when a hazard in a
raw material or other ingredient will be controlled
b1 by the supplier and is one for which there is a
reasonable probability that exposure to the hazard
will result in serious adverse health consequences
or death to humans:
B
Have you considered that the following may be
substituted for an onsite audit, provided that the
c1 inspection was conducted within 1 year of the date
that the onsite audit would have been required to
be conducted:
ISO/TS 22002-1: 6.5, 8.5 and 8.6 Comparable 6 Utilities- Air, Water, Energy
8 Equipment Suitability,
Cleaning and Maintenance
Different – addressed in
FSSC2000 as food, 5 Layout of Premises and Workspace
ISO/TS 22002-1: 5.7 and 7 packaging materials, 7 Waste
ingredients and non- disposal
food chemicals
16 Warehousing
ISO 22000: 7.3.3.1 Comparable
16 Warehousing
9 Management of
purchased materials
ISO/TS 22002-1: 5.7, 9.3, 10 and 16 Comparable
10 Measures for Prevention
of Cross Contamination
16 Warehousing
Comparable - although
ISO 22000: 7.6.2 and ISO/TS 22002-1: FSSC22000 does not
10 address heat blanching
specifically
Comparable- although
ISO 22000: 7.6.2 and ISO/TS 22002-1: FSSC22000 does not
10 address these
preparations specifically
10 Measures for Prevention of Cross
ISO 22000: 7.6.2 and ISO/TS 22002-1: Comparable Contamination
10
10 Measures for Prevention of Cross
Contamination
Comparable- although
ISO 22000: 7.6.2 and ISO/TS 22002-1: FSSC22000 does not
10 address moisture level
control specifically
Comparable although
ISO 22000: 7.6.2 and ISO/TS 22002-1: FSSC22000 does not
10 address pH control
specifically
Different – FSSC22000
does not specifically
ISO 22000: 7.10
address aiming for
lowest defect level
Different – FSSC22000
does not specifically
ISO 22000: 7.10 address defect levels or
mixing with adulterated
food
ISO 22000: 4
Comparable
ISO 22000: 7.2-7.4
ISO 22000: 4.2.1 Comparable
Different –while
FSSC22000 requires a
responsible Food safety
Team Leader, it does not
ISO 22000: 5.5, 6.2
address the specific
training curriculum,
education or experience
required
Comparable - FSSC
22000 considers
ISO 22000: 7.2.3
sanitation when
establishing PRPs
Comparable –
FSSC22000 considers
ISO 22000: 7.2.3
employee hygiene when
establishing PRPs
Comparable –
FSSC22000 refers to
control measures that
ISO 22000: 7.4.4 and 7.6.2 could be managed either
through operational
PRPs or HACCP
ISO 22000: 7.2, 7.4.4, 7.5 and 7.6 Comparable
Comparable - however
careful consideration of
sanitation as an oPRP
ISO 22000: 7.2.3 and ISO 22002-1: 11
will be recommended in
an FSSC 22000
supplement
Different: No such
ISO 22000: 7.4.4
provision in FSSC22000
Different: No such
ISO 22000: 7.4.4
provision in FSSC22000
Different: No such
ISO 22000: 7.4.4
provision in FSSC22000
Different: No such
ISO 22000: 7.4.4
provision in FSSC22000
Different: No such
ISO 22000: 7.4.4 provision in FSSC22000
Different: No such
ISO 22000: 7.4.4
provision in FSSC22000
Different: No such
ISO 22000: 7.4.4 requirement in
FSSC22000
Different: No such
ISO 22000: 7.4.4 requirement in
FSSC22000
Different: No such
ISO 22000: 7.4.4 requirement in
FSSC22000
Different: No such
ISO 22000: 7.4.4 requirement in
FSSC22000
Different: No such
ISO 22000: 7.4.4 requirement in
FSSC22000
Different: No such
ISO 22000: 7.4.4 requirement in
FSSC22000
Different: No such
ISO 22000: 7.4.4 requirement in
FSSC22000
Different: No such
ISO 22000: 7.4.4 requirement in
FSSC22000
Different: No such
ISO 22000: 7.4.4 requirement in
FSSC22000
Different: No such
ISO 22000: 7.4.4 requirement in
FSSC22000
Different: No such
ISO 22000: 7.4.4 requirement in
FSSC22000
Different: No such
ISO 22000: 7.4.4 requirement in
FSSC22000
Different: No such
ISO 22000: 7.4.4 requirement in
FSSC22000
Different: No such
ISO 22000: 7.4.4 requirement in
FSSC22000
Different: No such
ISO 22000: 7.4.4 requirement in
FSSC22000
Different: No such
ISO 22000: 7.4.4 requirement in
FSSC22000
Different: No such
ISO 22000: 7.4.4 requirement in
FSSC22000
ISO 22000: 7.10.4 Comparable although
ISO 22002-1: 15 difference in terminology
9 Management of purchased
ISO/TS 22002-1: 9 Comparable
materials
ISO/TS 22002-1: 9.2 9 Management of purchased
FSSC 22000 Part 2, Requirements for Comparable materials ,
Certification 2.1.4.1 2.1.4.1 Management of Services
Different: No such
ISO 22000: 8
provision in FSSC22000
Different: No such
ISO 22000: 8
provision in FSSC22000
Different: No such
ISO 22000: 8
provision in FSSC22000
Different: No such
ISO 22000: 8
provision in FSSC22000
Different: No such
ISO 22000: 8
provision in FSSC22000
Different: No timeline
ISO 22000: 7.6.4
specified in FSSC22000
Comparable, although
no timing expectation
ISO 22000: 7.8
contained within
FSSC22000
Comparable - although
ISO/TS 22002-1: 11.5 FSSC 22000 does not 11 Cleaning and sanitizing
FSSC 22000 Part 2: Requirements for address specific
2.1.4.7 Environmental monitoring
Certification 2.1.4.7 procedures in such detail
Comparable:
Environmental
ISO/TS 22002-1: 11.5 monitoring must meet 11 Cleaning and sanitizing
requirements of ISO
22000
Comparable: However,
FSSC22000 calls for
ISO 22000: 8.5.2 continuous updating but
does not specify a
minimum frequency
Different: No such
ISO 22000: 7.8 timeline requirement in
FSSC22000
Different: No such
ISO 22000: 7.8 specific provision in
FSSC22000
Different: No specific
ISO 22000: 5.5 timeline required in
FSSC22000
Different: No such
ISO 22000: 5.5 provision in FSSC22000
Different: No such
ISO 22000: 5.5 timeline requirement in
FSSC22000
ISO 22000: 5.5 and 8.4.1 Comparable
N/A N/A
N/A N/A
N/A N/A
N/A N/A
N/A N/A
N/A N/A
N/A N/A
N/A N/A
N/A N/A
N/A N/A
N/A N/A
N/A N/A
N/A N/A
N/A N/A
N/A N/A
ISO/TS 22002-1 and ISO 22000: 4.2 Comparable All
Different: No specific
ISO/TS 22002-1 and ISO 22000: 4.2 retention time stipulated
in FSSC22000
Requirements shall be
detailed in an FSSC
22000 Supplement
Different: No specific
retention time stipulated
in FSSC22000
Requirements shall be
detailed in an FSSC
22000 Supplement
Different: No specific
retention time stipulated
in FSSC22000
Requirements shall be
detailed in an FSSC
22000 Supplement
Different: No specific
retention time stipulated
in FSSC22000
ISO/TS 22002-1 and ISO 22000: 4.2
Requirements shall be
detailed in an FSSC
22000 Supplement
Different: No specific
retention time stipulated
in FSSC22000
Requirements shall be
detailed in an FSSC
ISO/TS 22002-1 and ISO 22000: 4.2 22000 Supplement ISO/TS 22002-1
Different: No such
ISO/TS 22002-1 and ISO 22000: 4.2 requirement in
FSSC22000
Different: No such
ISO/TS 22002-1 and ISO 22000: 4.2 requirement in
FSSC22000
Different: No such
ISO/TS 22002-1 and ISO 22000: 4.2 requirement in
FSSC22000
Different: No such
ISO/TS 22002-1 and ISO 22000: 4.2 requirement in
FSSC22000
Different: No such
ISO/TS 22002-1 and ISO 22000: 4.2 requirement in
FSSC22000
Different: No such
ISO/TS 22002-1 and ISO 22000: 4.2 requirement in
FSSC22000
Different: No such
ISO/TS 22002-1 and ISO 22000: 4.2 requirement in
FSSC22000
Different: No such
ISO/TS 22002-1 and ISO 22000: 4.2 requirement in
FSSC22000
Different: No such
ISO/TS 22002-1 and ISO 22000: 4.2 requirement in
FSSC22000
Different: No such
ISO/TS 22002-1 and ISO 22000: 4.2 requirement in
FSSC22000
Different: No such
ISO/TS 22002-1 and ISO 22000: 4.2 requirement in
FSSC22000
Different: No such
ISO/TS 22002-1 and ISO 22000: 4.2 requirement in
FSSC22000
Different: No such
ISO/TS 22002-1: 9.2
exemption in FSSC22000
Different: No such
ISO/TS 22002-1: 9.2
exemption in FSSC22000
Different: No such
ISO/TS 22002-1: 9.2
exemption in FSSC22000
Different: No such
ISO/TS 22002-1: 9.2
provision in FSSC22000
ISO/TS 22002-1: 9.2 Comparable
Different: No sprecific
requirement to verify
ISO/TS 22002-1: 9.2 third-party entity
documentation in
FSSC22000
Different: There is no
specific requirement in
FSSC22000 for supplied-
ISO/TS 22002-1: 9.2
chain-applied controls,
or to verify third-party
entity documentation
Different: There is no
specific requirement in
ISO/TS 22002-1: 9.2
FSSC22000 for supplied-
chain-applied controls
9 Management of purchased
ISO/TS 22002-1: 9.2 Comparable
materials
Different: Not addressed
ISO/TS 22002-1: 9.2
specifically in FSSC22000
Different: There is no
specific requirement in
FSSC22000 for supplied-
ISO/TS 22002-1: 9.2
chain-applied controls.
This will addressed in an
FSSC 22000 Supplement.
9 Management of purchased
ISO/TS 22002-1: 9.2 Comparable
Different: There is no
ISO/TS 22002-1: 9.2 mention of this in
FSSC22000
Different: There is no
ISO/TS 22002-1: 9.2 mention of this in
FSSC22000
Different: There is no
ISO/TS 22002-1: 9.2 mention of this in
FSSC22000
Different: There is no
ISO/TS 22002-1: 9.2 mention of this in
FSSC22000
ISO/TS 22002-1: 9.2 Comparable
Different: There is no
ISO/TS 22002-1: 9.2 mention of frequency in
FSSC22000
Different: There is no
distinction made in
ISO/TS 22002-1: 9.2 FSSC22000 for
SAHCODHA hazards
Different: There is no
distinction or
ISO/TS 22002-1: 9.2 exemptions in
FSSC22000 for qualified
facilities
Different: There is no
distinction or
ISO/TS 22002-1: 9.2 exemptions in
FSSC22000 for qualified
facilities
Different: There is no
ISO/TS 22002-1: 9.2 mention of frequency in 9.2 Selection and management of
suppliers
FSSC22000
Different: There is no
ISO/TS 22002-1: 9.2 mention of frequency in
FSSC22000
Different: There is no
ISO/TS 22002-1: 9.2 mention of frequency in
FSSC22000
Different: There is no
ISO/TS 22002-1: 9.2 requirement for this in
FSSC22000
Different: There is no
ISO/TS 22002-1: 9.2 requirement for this in
FSSC22000
Different: There is no
ISO/TS 22002-1: 9.2 mention of this in
FSSC22000
Different: There is no
ISO/TS 22002-1: 9.2 requirement for this in
FSSC22000
Different: There is no
ISO/TS 22002-1: 9.2 mention of this in
FSSC22000
Different: There is no
ISO/TS 22002-1: 9.2 mention of this in
FSSC22000
Different: There is no
ISO/TS 22002-1: 9.2 mention of this in
FSSC22000
Different: There is no
ISO/TS 22002-1: 9.2 mention of this in
FSSC22000
Different: There is no
ISO/TS 22002-1: 9.2 mention of this in
FSSC22000
Different: There is no
ISO/TS 22002-1: 9.2 mention of this in
FSSC22000
Different: There is no
ISO/TS 22002-1: 9.2 mention of this in
FSSC22000
Different: There is no
ISO/TS 22002-1: 9.2 mention of this in
FSSC22000
Different: There is no
explicit requirements for
ISO/TS 22002-1: 9.2
documentation in
FSSC22000
Different: There is no
ISO/TS 22002-1: 9.2 mention of this in
FSSC22000
Comparable
Comparable
9 Management of Purchased
Materials
Comparable
Comparable
Comparable
Comparable
Comparable
Different: There is no
explicit requirement for
documentation around
ISO/TS 22002-1: 9.2 this in FSSC22000
6.6 Lighting
The lighting provided (natural or artificial) shall allow personnel to
operate in a hygienic manner. The intensity of the lighting should be appropriate to the
nature of the operation. Light fixtures shall be protected to ensure that materials,
product or equipment are not contaminated in the case of breakages.
5.7 Storage of food, packaging materials, ingredients and non-food chemicals: ( as
above)
6.4 Air quality and ventilation
The organization shall establish requirements for filtration,
humidity (RH%) and microbiology of air used as an ingredient or for direct product
contact. Where temperature and/or humidity are deemed critical by the organization, a
control system shall be put in place and monitored. Ventilation (natural or mechanical)
shall be provided to remove excess or unwanted steam, dust and odours, and to facilitate
drying after wet cleaning.
Room air supply quality shall be controlled to minimize risk from airborne microbiological
contamination.Protocols for air quality monitoring and control shall be established in
areas where products which support the growth or survival of microorganisms are
exposed. Ventilation systems shall be designed and constructed such that air does not
flow from contaminated or raw areas to clean areas. Specified air pressure differentials
shall be maintained. Systems shall be accessible for cleaning, filter changing and
maintenance.
Exterior air intake ports shall be examined periodically for physical integrity.
16.1
General requirements:
Materials and products shall be stored in clean, dry, well-ventilated spaces protected
from dust, condensation, fumes, odours or other sources of contamination.
5.7 Storage of food, packaging materials, ingredients and non-food chemicals Facilities
used to store ingredients, packaging and products shall provide protection from dust,
condensation,
drains, waste and other sources of contamination.
5.7 Storage of food, packaging materials, ingredients and non-food chemicals ( as above)
8.5
Cleaning plant, utensils and equipment (as above)
6.2 Water supply
The supply of potable water shall be sufficient to meet the needs of the production
process(es). Facilities for storage, distribution and, where needed, temperature control of
the water shall be designed to meet specified water quality requirements. Water used
as a product ingredient, including ice or steam (including culinary steam), or in contact
with products or product surfaces, shall meet specified quality and microbiological
requirements relevant to the product.
13.2 Personnel hygiene facilities and toilets
Personnel hygiene facilities shall be available to ensure that the degree of personal
hygiene required by the organization can be maintained. The facilities shall be located
close to the points where hygiene requirements apply and shall be clearly designated.
Establishments shall:
a) provide adequate numbers, locations and means of hygienically washing, drying and,
where required, sanitizing hands (including wash-basins, supply of hot and cold or
temperature controlled water, and soap and/or sanitizer);
All Sections
This
Technical Specification specifies requirements for establishing, implementing and
maintaining prerequisite programmes (PRP) to assist in controlling food safety hazards.
Facilities used to store ingredients, packaging and products shall provide protection from
dust, condensation, drains, waste and other sources of contamination.
Facilities used to store ingredients, packaging and products shall provide protection from
dust, condensation, drains, waste and other sources of contamination.
16.2 Warehousing requirements
A separate area or other means of segregating
materials identified as non-conforming shall be provided.
9.1 General requirements
Purchasing of materials which impact food safety shall be controlled to ensure that the
suppliers used have the capability to meet the specified requirements. The conformance
of incoming materials to specified purchase requirements shall be verified.
9.2 Selection and management of suppliers
There shall be a defined process for the selection, approval and monitoring of suppliers.
The process used shall be justified by hazard assessment, including the potential risk to
the final product, and shall include:
a) assessment of the supplier’s ability to meet quality and food safety expectations,
requirements and specifications;
b) description of how suppliers are assessed;
NOTE Examples of a description of how suppliers are assessed include:
1) audit of the supplying site prior to accepting materials for production;
2) appropriate third party certification.
c) monitoring the performance of the supplier to assure continued approval status.
NOTE Monitoring includes conformity with material or product specifications, fulfilment
of COA requirements,satisfactory audit outcomes.
9.3 Incoming material requirements (raw/ingredients/packaging)
Delivery vehicles shall be checked prior to, and during, unloading to verify that the quality
and safety of the material has been maintained during transit (e.g. integrity of seals,
freedom from infestation, existence of temperature records).
Materials shall be inspected, tested or covered by COA to verify conformity with specified
requirements prior to acceptance or use. The method of verification shall be
documented.
NOTE The inspection frequency and scope can be based on the hazard presented by the
material and the risk assessment of the specific suppliers.
Materials which do not conform to relevant specifications shall be handled under a
documented procedure which ensures they are prevented from unintended use.
Access points to bulk material receiving lines shall be identified, capped and locked.
Discharge into such systems shall take place only after approval and verification of the
material to be received.
15.1 General requirements
Systems shall be in place to ensure that products failing to meet required food safety
standards can be identified, located and removed from all necessary points of the supply
chain.
4.2 Environment
Consideration shall be given to potential sources of contamination from the local
environment.
Food production should not be carried out in areas where potentially harmful substances
could enter the product.
The effectiveness of measures taken to protect against potential contaminants shall be
periodically reviewed.
10 Measures for prevention of cross-contamination
10.1 General requirements
Programmes shall be in place to prevent, control and detect contamination. Measures to
prevent physical, allergen and microbiological contamination shall be included .
8.5 Improvement
7.10 Control of nonconformity
8.5 Improvement
7.1 General
The organization shall plan and develop the processes needed for the realization of safe
products.
The organization shall implement, operate and ensure the effectiveness of the planned activities
and any changes to those activities. This includes PRP(s) as well as operational PRP(s) and/or the
HACCP plan.
7.10.1 Corrections
The organization shall ensure that when critical limits for CCP(s) are exceeded (see 7.6.5), or
there is a loss of control of operational PRP(s), the products affected are identified and
controlled with regard to their use and release.
Top management shall ensure that responsibilities and authorities are defined and
communicated within the organization to ensure the effective operation and maintenance of
the food safety management system. All personnel shall have responsibility to report problems
with the food safety management system to identified person(s). Designated personnel shall
have defined responsibility and authority to initiate and record actions.
The organization shall provide adequate
resources for the establishment, implementation, maintenance and updating of the food safety
management system.
6.2.1 General
The food safety team and the other personnel carrying out activities having an
impact on food safety shall be competent and shall have appropriate education, training, skills
and experience .
7.2.1 The organization shall establish, implement and maintain PRP(s) to assist in controlling
a) the likelihood of introducing food safety hazards to the product through the work
environment,
b) biological, chemical and physical contamination of the product(s), including cross
contamination between products, and
c) food safety hazard levels in the product and product processing environment.
7.3.3.1 Raw materials, ingredients and product-contact materials All
raw materials, ingredients and product-contact materials shall be described in documents to the
extent needed to conduct the hazard analysis (see 7.4), including the following, as appropriate:
a) biological, chemical and physical characteristics;
b) composition of formulated ingredients, including additives and processing aids;
c) origin;
d) method of production;
e) packaging and delivery methods;
f) storage conditions and shelf life;
g) preparation and/or handling before use or processing;
h) food safety-related acceptance criteria or specifications of purchased materials and
ingredients appropriate to their intended uses.
The organization shall identify statutory and regulatory food safety requirements related to the
above. The descriptions shall be kept up-to-date including, when required, in accordance with
7.7.
7.10 Control of Nonconformity (as above)
7.10.1 Corrections
The organization shall ensure that when critical limits for CCP(s) are exceeded (see 7.6.5), or
there is a loss of control of operational PRP(s), the products affected are identified and
controlled with regard to their use and release. A documented procedure shall be established
and maintained defining a) the identification and assessment of affected end products to
determine their proper handling (see 7.10.3), and
b) a review of the corrections carried out.
Products manufactured under conditions where critical limits have been exceeded are
potentially unsafe products and shall be handled in accordance with 7.10.3. Products
manufactured under conditions where operational PRP(s) have not been conformed with shall
be evaluated with respect to the cause(s) of the nonconformity and to the consequences
thereof in terms of food safety and shall, where necessary, be handled in accordance with
7.10.3. The evaluation shall be recorded.
All corrections shall be approved by the responsible person(s), and shall be recorded together
with information on the nature of the nonconformity, its cause(s) and consequence(s), including
information needed for traceability purposes related to the nonconforming lots.
b) a review of the corrections carried out.
Products manufactured under conditions where critical limits have been exceeded are
potentially unsafe products and shall be handled in accordance with 7.10.3. Products
manufactured under conditions where operational PRP(s) have not been conformed with shall
be evaluated with respect to the cause(s) of the nonconformity and to the consequences
thereof in terms of food safety and shall, where necessary, be handled in accordance with
7.10.3. The evaluation shall be recorded.
All corrections shall be approved by the responsible person(s), and shall be recorded together
with information on the nature of the nonconformity, its cause(s) and consequence(s), including
information needed for traceability purposes related to the nonconforming lots.
7.1 General
The organization shall plan and develop the processes needed for the realization of safe
products. The organization shall implement, operate and ensure the effectiveness of the
planned activities and any changes to those activities. This includes PRP(s) as well as operational
PRP(s) and/or the HACCP plan.
7.2.1 The organization shall establish, implement and maintain PRP(s) to assist in controlling
a) the likelihood of introducing food safety hazards to the product through the work
environment,
b) biological, chemical and physical contamination of the product(s), including cross
contamination between products, and c) food safety hazard levels in the product and product
processing environment
7.3.1 General
All relevant information needed to conduct the hazard analysis shall be collected, maintained,
updated and documented. Records shall be maintained.
7.4.1 General
The food safety team shall conduct a hazard analysis to determine which hazards need to be
controlled, the degree of control required to ensure food safety, and which combination of
control measures is required.
4.2.1 General
The food safety management system documentation shall include
a) documented statements of a food safety policy and related objectives (see 5.2),
b) documented procedures and records required by this International Standard, and
c) documents needed by the organization to ensure the effective development, implementation
and updating of the food safety management system.
6.2.1 General
The food safety team and the other personnel carrying out activities having an impact
on food safety shall be competent and shall have appropriate education, training, skills and
experience.
7.4.1 General
The food safety team shall conduct a hazard analysis to determine which hazards need to be
controlled, the degree of control required to ensure food safety, and which combination of
control measures is required
Written analysis:
7.6.1 HACCP plan: The HACCP plan shall be documented and shall include the following
information for each identified critical control point (CCP): a) food safety hazard(s) to be
controlled at the CCP (see 7.4.4); b) control measure(s) (see 7.4.4) c) critical limit(s) (see 7.6.3);
d) monitoring procedure(s) (see 7.6.4); e) corrections and corrective action(s) to be taken if
critical limits are exceeded (see 7.6.5); f) responsibilities and authorities;
7.4.4 Selection and assessment of control measures
Based on the hazard assessment of 7.4.3, an appropriate combination of control measures shall
be selected which is capable of preventing, eliminating or reducing these food safety hazards to
defined acceptable levels.
In this selection, each of the control measures as described in 7.3.5.2 shall be
reviewed with respect to its effectiveness against the identified food safety hazards. The control
measures selected shall be categorized as to whether they need to be managed through
operational PRP(s) or by the HACCP plan.
7.5 Establishing the operational prerequisite programmes (PRPs):
The operational PRPs shall be documented and shall
include the following information for each programme: a) food safety hazard(s) to be controlled
by the programme (see 7.4.4); b) control measure(s) (see 7.4.4); c) monitoring procedures that
demonstrate that the operational PRPs are implemented; d) corrections and corrective actions
to be taken if monitoring shows that the operational PRPs are not in control (see 7.10.1 and
7.10.2, respectively); e) responsibilities and authorities; f) record(s) of monitoring
7.6.2 Identification of critical
control points (CCPs)
For each hazard that is to be controlled by the HACCP plan, CCP(s) shall be identified for the
control measures identified (see 7.4.4).
7.10.4 Withdrawals
To enable and facilitate the complete and timely withdrawal of lots of end products which have
been identified as unsafe a) top management shall appoint personnel having the authority to
initiate a withdrawal and personnel responsible for executing the withdrawal, and
b) the organization shall establish and maintain a documented procedure for
1) notification to relevant interested parties (e.g. statutory and regulatory authorities,
customers and/or consumers),
2) handling of withdrawn products as well as affected lots of the products still in stock, and 3)
the sequence of actions to be taken.
8.1 General
The food safety team shall plan and implement the processes needed to validate control
measures and/or control measure combinations, and to verify and improve the food safety
management system.
4.1 General requirements:
The organization shall establish, document, implement and maintain an effective food
safety management system and update it when necessary in accordance with the requirements
of this International Standard.
The organization shall define the scope of the food safety management system. The scope shall
specify the products or product categories, processes and production sites that are addressed
by the food safety management system.
4.2.1 General
The food safety management system documentation shall include
a) documented statements of a food safety policy and related objectives (see 5.2),
b) documented procedures and records required by this International Standard, and
c) documents needed by the organization to ensure the effective development, implementation
and updating of the food safety management system.
7.7 Updating of preliminary information and documents specifying the PRPs and the
HACCP plan
Following the establishment of operational PRP(s) (see 7.5) and/or the HACCP plan (see 7.6), the
organization shall update the following information, if necessary:
a) product characteristics (see 7.3.3);
b) intended use (see 7.3.4);
c) flow diagrams (see 7.3.5.1);
d) process steps (see 7.3.5.2);
e) control measures (see 7.3.5.2).
If necessary, the HACCP plan (see 7.6.1) and the procedures and instructions specifying the
PRP(s) (see 7.2) shall be amended .
8.5.2 Updating the food safety management system
Top management shall ensure that the food safety management system is continually updated.
7.4.1 General
The food safety team shall conduct a hazard analysis to determine which hazards need to be
controlled, the degree of control required to ensure food safety, and which combination of
control measures is required
7.4.2 Hazard identification and determination of acceptable levels
7.4.2.1 All food safety hazards that are reasonably expected to occur in relation to the type of
product, type of process and actual processing facilities shall be identified and recorded. The
identification shall be based on a) the preliminary information and data collected according to
7.3,
b) experience,
c) external information including, to the extent possible, epidemiological and other historical
data, and
d) information from the food chain on food safety hazards that may be of relevance for the
safety of the end products, intermediate products and the food at consumption.
The step(s) (from raw materials, processing and distribution) at which each food safety hazard
may be introduced shall be indicated.
7.6.1 HACCP plan:
The HACCP plan shall be documented and shall include the following information
for each identified critical control point (CCP): a) food safety hazard(s) to be controlled at the
CCP (see 7.4.4); b) control measure(s) (see 7.4.4) c) critical limit(s) (see 7.6.3); d) monitoring
procedure(s) (see 7.6.4); e) corrections and corrective action(s) to be taken if critical limits are
exceeded (see 7.6.5); f) responsibilities and authorities;
7.2 Prerequisite programmes (PRPs)
7.2.1 The organization shall establish, implement and maintain PRP(s) to assist in controlling
a) the likelihood of introducing food safety hazards to the product through the work
environment,
b) biological, chemical and physical contamination of the product(s), including cross
contamination between products, and
c) food safety hazard levels in the product and product processing environment.
7.3.3 Product characteristics
7.3.3.1 Raw materials, ingredients and product-contact materials
All raw materials, ingredients and product-contact materials shall be described in documents to
the extent needed to conduct the hazard analysis (see 7.4), including the following, as
appropriate:
a) biological, chemical and physical characteristics;
b) composition of formulated ingredients, including additives and processing aids;
c) origin;
d) method of production;
e) packaging and delivery methods;
f) storage conditions and shelf life;
g) preparation and/or handling before use or processing;
h) food safety-related acceptance criteria or specifications of purchased materials and
ingredients appropriate to their intended use.
7.3.3 Product characteristics (as above), 7.4
Hazard Analysis 7.4.2
Hazard identification and determination of acceptable levels
7.4.2.1 All food safety hazards that are reasonably expected to occur in relation to the type of
product, type of process and actual processing facilities shall be identified and recorded. The
identification shall be based on
a) the preliminary information and data collected according to 7.3,
b) experience,
c) external information including, to the extent possible, epidemiological and other historical
data, and
d) information from the food chain on food safety hazards that may be of relevance for the
safety of the end products, intermediate products and the food at consumption.
7.2.3 When selecting and/or establishing PRP(s), the organization shall consider and utilize
appropriate information [e.g. statutory and regulatory requirements, customer requirements,
recognized guidelines, Codex Alimentarius Commission (Codex) principles and codes of
practices, national, international or sector standards].
NOTE Annex C gives a list of relevant Codex publications.The organization shall consider the
following when establishing these programmes:
a) construction and lay-out of buildings and associated utilities;
b) lay-out of premises, including workspace and employee facilities;
c) supplies of air, water, energy and other utilities;
d) supporting services, including waste and sewage disposal;
e) the suitability of equipment and its accessibility for cleaning, maintenance and preventative
maintenance;
f) management of purchased materials (e.g. raw materials, ingredients, chemicals and
packaging), supplies (e.g. water, air, steam and ice), disposals (e.g. waste and sewage) and
handling of products (e.g. storage and transportation);
g) measures for the prevention of cross contamination;
h) cleaning and sanitizing;
i) pest control;
j) personnel hygiene;
k) other aspects as appropriate.
7.4.2 Hazard identification and determination of acceptable levels All food safety hazards
that are reasonably expected to occur in relation to the type of product, type of process and
actual processing facilities shall be identified and recorded.
The operational PRPs shall be documented and shall include the following information for each
programme: a) food safety hazard(s) to be controlled by the programme (see 7.4.4); b) control
measure(s) (see 7.4.4); c) monitoring procedures that demonstrate that the operational PRPs
are implemented; d) corrections and corrective actions to be taken if monitoring shows that the
operational PRPs are not in control (see 7.10.1 and 7.10.2, respectively); e) responsibilities and
authorities; f) record(s) of monitoring.
7.6.2 Identification of critical control points (CCPs)
For each hazard that is to be controlled by the HACCP plan, CCP(s) shall be identified for the
control measures identified (see 7.4.4).
7.2.3 When selecting and/or establishing PRP(s), the organization shall consider and utilize
appropriate information [e.g. statutory and regulatory requirements, customer requirements,
recognized guidelines, Codex Alimentarius Commission (Codex) principles and codes of
practices, national, international or sector
standards].
NOTE Annex C gives a list of relevant Codex publications.
The organization shall consider the following when establishing these programmes:
a) construction and lay-out of buildings and associated utilities;
b) lay-out of premises, including workspace and employee facilities;
c) supplies of air, water, energy and other utilities;
d) supporting services, including waste and sewage disposal;
e) the suitability of equipment and its accessibility for cleaning, maintenance and preventative
maintenance;
f) management of purchased materials (e.g. raw materials, ingredients, chemicals and
packaging), supplies (e.g. water, air, steam and ice), disposals (e.g. waste and sewage) and
handling of products (e.g. storage and transportation);
g) measures for the prevention of cross contamination;
h) cleaning and sanitizing;
i) pest control;
j) personnel hygiene;
k) other aspects as appropriate.
Verification of PRP(s) shall be planned (see 7.8) and PRP(s) shall be modified as necessary (see
7.7). Records of verifications and modifications shall be maintained.
Documents should specify how activities included in the PRP(s) are managed
7.2.3 When selecting and/or establishing PRP(s) ( as above)
Documented procedures shall be established and maintained for the appropriate handling of
potentially unsafe products to ensure that they are not released until they have been evaluated
(see 7.10.3).
7.10 Control of nonconformity
7.10.1 Corrections
The organization shall ensure that when critical limits for
CCP(s) are exceeded (see 7.6.5), or there is a loss of control of operational PRP(s), the products
affected are identified and controlled with regard to their use and release.
A documented procedure shall be established and maintained defining
a) the identification and assessment of affected end products to determine their proper
handling (see 7.10.3), and b) a review of the corrections carried out.
7.6.5 Actions when monitoring results exceed critical limits (as above)
7.10.2 Corrective actions ( as above)
7.6.5 Actions when monitoring results exceed critical limits (as above)
7.10.2 Corrective actions ( as above) 8.5.2
Updating the food safety management system
Top management shall ensure that the food safety management system is continually updated.
In order to achieve this, the food safety team shall evaluate the food safety management
system at planned intervals. The team shall then consider whether it is necessary to review the
hazard analysis (see 7.4), the established operational PRP(s) (see 7.5) and the HACCP plan (see
7.6.1).
The evaluation and updating activities shall be based on
a) input from communication, external as well as internal, as stated in 5.6,
b) input from other information concerning the suitability, adequacy and effectiveness of the
food safety management system,
c) output from the analysis of results of verification activities (see 8.4.3), and
d) output from management review (see 5.8.3).
System updating activities shall be recorded and reported, in an appropriate manner, as input to
the management review (see 5.8.2).
7.6.5 Actions when monitoring results exceed critical limits (as above)
7.10.2 Corrective actions ( as above)
8.4 Food safety management system verification
8.4.3 Analysis of results of verification activities
The food safety team shall analyse the results of verification activities, including the results of
the internal audits (see 8.4.1) and external audits. The analysis shall be carried out in order
a) to confirm that the overall performance of the system meets the planned arrangements and
the food safety management system requirements established by the organization,
b) to identify the need for updating or improving the food safety management system,
c) to identify trends which indicate a higher incidence of potentially unsafe products,
d) to establish information for planning of the internal audit programme concerning the status
and importance of areas to be audited, and
e) to provide evidence that any corrections and corrective actions that have been taken are
effective. The results of the analysis and the resulting activities shall be recorded and shall be
reported, in an appropriate manner, to top management as input to the management review
(see 5.8.2). It shall also be used as an input for updating the food safety management system
(see 8.5.2).
8.1 General
The food safety team shall plan and implement the processes needed to validate control
measures and/or control measure combinations, and to verify and improve the food safety
management system. Records of the results of calibration and verification shall be
maintained.
8 Validation, verification and improvement of the food safety management system (as above)
8 Validation, verification and improvement of the food safety management system (as above)
7.6.4 System for the monitoring of critical control points (as above)
7.8 Verification planning
Verification planning shall define the purpose, methods, frequencies and responsibilities for the
verification activities. The verification activities shall confirm that
a) the PRP(s) are implemented (see 7.2),
b) input to the hazard analysis (see 7.3) is continually updated,
c) the operational PRP(s) (see 7.5) and the elements within the HACCP plan (see 7.6.1) are
implemented and effective,
d) hazard levels are within identified acceptable levels (see 7.4.2), and
e) other procedures required by the organization are implemented and effective.
The output of this planning shall be in a form suitable for the organization's method of
operations.
Verification results shall be recorded and shall be communicated to the food safety team.
Verification results shall be provided to enable the analysis of the results of the verification
activities (see 8.4.3).
If system verification is based on testing of end product samples, and where such test samples
show nonconformity with the acceptable level of the food safety hazard (see 7.4.2), the affected
lots of product shall be handled as potentially unsafe in accordance with 7.10.3.