Food > Honey > Honey Establishment Inspection Manual > Chapter 2 - Establishment Inspection Procedures
CHAPTER 2 - ESTABLISHMENT INSPECTION PROCEDURES
2.1 ESTABLISHMENT INSPECTION
GUIDELINES |
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2.1.1 |
Background for Chapters 4 & 5 |
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2.1.2 |
Principle Statement |
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2.1.3 |
Assessment Criteria |
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2.1.4 |
Ratings Examples |
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2.1.4.1 Risk Assessment Model |
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2.1.5 |
Reference |
2.2 PREPARATION FOR AN IN-DEPTH
ESTABLISHMENT INSPECTION |
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2.2.1 |
Assessment of Frequencies |
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2.2.2 |
Determination of Inspection Team |
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2.2.3 |
Notification of the Establishment |
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2.2.4 |
Review of Establishment File |
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2.2.5 |
Gathering of Inspection Tools |
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2.2.6 |
Professionalism |
2.3 INSPECTION |
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2.3.1 |
Arrival at Establishment Introductions |
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2.3.2 |
Establishment Representative |
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2.3.2.1 Scheduling |
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2.3.2.2 Order |
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2.3.3 |
General Inspection Considerations |
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2.3.4 |
Rating of Tasks |
2.4 POST INSPECTION |
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2.4.1 |
Reporting Inspection Results |
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2.4.2 |
Overall Establishment Rating |
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2.4.3 |
Exit Meeting with Management |
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2.4.3.1 Types of Establishments |
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2.4.4 |
Final Report and Covering letter |
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2.4.4.1 Written Action Plan |
2.5 NON SATISFACTORY IN-DEPTH
INSPECTIONS |
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2.5.1 |
Follow-up Inspections |
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2.4.5.1 Category I
Deficiencies |
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2.4.5.2 Category II
Deficiencies |
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2.4.5.3 Category III
Deficiencies |
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2.4.5.4 Multiple Category Deficiencies |
2.6 DIRECTED/GMP ESTABLISHMENT INSPECTION |
APPENDICES |
Appendix 1 |
Covering Letter - Example |
Appendix 2 |
Directed Inspection Worksheet |
2.1 ESTABLISHMENT INSPECTION GUIDELINES
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There are three types of inspections conducted: an in-depth, a follow-up
inspection and a directed/GMP inspection (Good Manufacturing
Practices).
An in-depth inspection includes inspecting all aspects of
the establishment. This means that all inspection tasks from Chapter 4 and Chapter 5 are
assessed.
A follow-up inspection (for additional
details, see section 2.5.1) is conducted only for establishments which
do not achieve the minimum compliance level during an in-depth
inspection. The purpose is to evaluate the establishments corrective
actions and to determine if the establishment has met the minimum compliance
level.
A directed/GMP inspection (for additional details, see section 2.6) is conducted at all packing
and pasteurizing establishments which have achieved the minimum compliance
level during an establishment inspection. The GMP incorporates selective tasks from
the Honey Establishment Inspection Program (Chapters 4
and 5 of this manual) along with infractions noted during the previous
in-depth inspection.
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2.1.1 |
Background for Chapters 4 & 5
The inspection assessment criteria tasks are found in Chapters 4 and 5 of
this manual and in the CFIA MCAP database.
Chapter 4 includes generic inspection standards
which may be applied to all honey establishments and consists of seven
sections: Premises, Transportation and Storage, Equipment, Personnel,
Sanitation and Pest Control, Complaints and Recall, and General Records.
Chapter 5 contains the Manufacturing Controls
related to processing and packaging honey.
Chapters 4 and 5 are laid out in table format. The tables outline the
general tasks in an establishment to be inspected. The tables are broken down
as follows:
X.1 |
SECTION |
X.1.1 |
SUB-SECTION |
X.1.1.1 |
Task Code |
XXXX |
Task number |
PRINCIPLE |
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Assessment Criteria |
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Rating Examples |
I |
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II |
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III |
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References |
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Each Principle Statement outlines the outcome for the task. The Assessment
Criteria identify factors which determine if the situation being assessed is in
compliance with the principle statement. The assessment criteria are
accompanied by Rating Examples for each of the three health and safety
classification categories which can be assigned against the principle
statement. The rating examples are intended only as a reference to indicate
potential situations within each Category. The rating examples may or may not
be a reflection of the actual situation in the establishment.
Further explanation on the use of the inspection assessment criteria and the
establishment rating system follows.
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2.1.2 |
Principle Statement
Principle statements are generic, broad, outcome based statements
(objectives) which are similar in style to the Codex Alimentarius Commission
General Principles of Food Hygiene and the International Organization for
Standardization (ISO) standards. These statements imply that the manufacturer
controls all factors that may impact on health and safety. Principle statements
are absolute and do not allow for variance.
Under each task number, principle statements express the intent of the
Canada Agricultural Products Act (CAP), Honey
Regulations (HR), Food and Drug Act and Regulations
(FDA&R) and Consumer Packaging and Labelling Act and
Regulations (CP&L) and are written to permit flexibility with
respect to the introduction of new technologies and/or new food commodities. A
principle statement may have more than one set of assessment criteria,
depending on the type of process, however, a task can only be assessed
once.
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2.1.3 |
Assessment Criteria
Assessment criteria list most of the factors that will be evaluated by an
inspector to determine if a manufacturer is in compliance with the principle
statement of each sub-section. Where appropriate, examples are used to clarify
assessment criteria. Assessment criteria provide transparency to the food
industry with respect to the specific factors required and assessed by the
CFIA.
As new technologies and/or new food commodities become available, evaluation
of additional criteria may become necessary. For this reason, assessment
criteria provided in this standard should not be regarded as exhaustive..
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2.1.4 |
Rating Examples
Rating examples provide benchmarks to inspectors and promote uniformity and
transparency in the assessment of non-satisfactory conditions and operations in
the registered establishment. The examples illustrate a range of categories
(I, II, III) for all deficiencies. The examples do not cover all
possible deficiencies or concerns. All deficiencies are evaluated against the
Health Risk Assessment Model (refer to 2.1.4.1) and the appropriate risk is
assigned based on likelihood of occurrence and severity of consequences.
Category I, Category II,
Category III are defined as:
Category I
- |
Deficiencies relating to the principle statement of the standard
which would result in a risk with a high likelihood and
serious health consequences. |
Category II
- |
Deficiencies relating to the principle statement of the standard
which could result in a moderate health risk or a direct
source of contamination or adulteration. |
Category III
- |
Deficiencies relating to the principle statement of the standard
which could result in a low health risk or an indirect source
of contamination or adulteration. |
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2.1.4.1 |
Risk Assessment Model
The Health Risk Assessment Model (Figure I) has
been developed using the risk assessment principles outlined in the October 1,
1993, Health Protection Branch document entitled "Health Issues: Risk
Assessment". It is the basis for assessment of all health and safety risks
in this standard.
The model uses likelihood of occurrence and severity of consequences to
determine the rating for all deficiencies which impact on health and safety.
The severity of consequences for a particular concern is fixed (e.g. subclinical, temporary disability or permanent
disability/death) whereas the likelihood of occurrence varies with the degree
of control exercised by the manufacturer. Population at risk and level of risk
were not included in the Model because they had little impact at the
sub-section level except where sensitive populations are involved. Sensitive
populations include infants, the elderly, immunocompromised individuals and
those individuals who consume products as a sole source of nutrition.
The rating examples and the discussion in this section (2.1.4.1) are
intended to be a source of guidance for inspectors in assessing risk. The
Health Risk Assessment Model may be used by the inspector when additional
consideration is required.
[D]
"Likelihood of occurrence" relates to the level of control the
establishment exercises to eliminate the hazard that would exist if the
principle statement were not adhered to. For example:
Remote |
- |
Where the operator has well established control measures. |
Low |
- |
Where the operator has established good control measures, but minor
infractions can be found. |
Medium |
- |
Where the operator has established some control measures, but gaps or
inconsistencies exist. Minor infractions and major infractions can be
found. |
High |
- |
Where the operator has little or no control. Where major and critical
infractions can be found. |
"Severity of Consequences" relates to the type of hazard that
would result if a particular principle statement were not adhered to. The
hazard could be physical, chemical, or microbiological contamination resulting
in health problems or serious illness, which would constitute a high severity
of consequences, or it could be physical, chemical, or microbiological
contamination resulting in very minor or no consequences.
Biological Hazard
Biological hazards are hazards that are caused by pathogenic micro organisms
and could be assessed as low, medium or high depending on the severity of
consequences of the hazard. Clostridium
botulinum is known to occur in honey and is not currently
controlled by processes in the establishment. It is an uncontrolled hazard and
control is limited to public education which recommends not feeding honey to
infants or immunologically compromised persons. However, biological hazards
associated with under processing (e.g. honey
products and unstandardized products manufactured in the registered
establishment) are given a high severity of consequences and are again assessed
as Category I, II or III depending on the likelihood of occurrence.
Chemical Hazard
Chemical hazards could be assessed as Category I,
Category II or Category III
depending on the severity of consequences (nature of the hazard) and likelihood
of occurrence (quantity).
Allergens, additives (non-permitted or improperly used) and nutrients
(insufficient or improperly used) are related to a chemical hazard. For more information on
allergens please see:
http://www.inspection.gc.ca/english/fssa/labeti/allerg/allerge.shtml
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(i) |
A chemical hazard related to an adverse reaction
Chemical hazards related to a known history of producing anaphylactic
reaction in sensitive individuals such as allergens may have a medium or high
severity of consequences, depending on the nature of the allergen. A non
declared ingredient or additive can have severe consequences to an individual
who may be allergic to that substance. This is primarily applicable to honey
products and non standardized products produced in a registered
establishment.
Honey contaminated with products not approved for use (e.g. non approved veterinarian drugs or agricultural
chemicals) may have a high severity of consequences depending on the nature of
the product.
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(ii) |
A chemical hazard related to food additives
Where the food additive is not permitted for use or has not been approved
for use with a certain food as defined in the Food and Drugs Act and
Regulations, the severity of consequences could be low, medium or high
depending on the quantity, nature and the type of deficiency. Where there is no
health risk involved, deficiencies will be rated as a Category III. This is primarily applicable to honey products and non
standardized products produced in a registered establishment.
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(iii) |
A chemical hazard related to nutrition
Where a nutrient has not been added (underage or overage) in prescribed
amounts as permitted by the Food and Drugs Act and Regulations or
where the additive is not present in the declared amount at the end of the
expected shelf life of the product, the severity of consequences could be low,
medium or high depending on the quantity, nature and the type of deficiency.
Where there is no health risk involved, deficiencies will be rated as a
Category III. This is primarily applicable to honey
products and non standardized products produced in a registered
establishment.
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Physical Hazard
Physical contamination refers to the introduction or occurrence of
objectionable material in a food or food environment of a non-health nature.
Physical contamination risks are assigned as Category I, Category II or Category III, depending on the likelihood of occurrence and severity of
consequences. Physical contamination risks impacting on health and safety are
rated as health risks; a physical hazard, such as contamination with glass,
could be a Category I, Category II or Category III health risk,
depending on the severity or nature of the hazard and likelihood of
occurrence.
Non-hazardous Regulatory Violations
Non-hazardous regulatory violations include deficiencies that contravene the
legislation but are not necessarily associated with a health or contamination
risk (e.g. improper use of approved food
additives). They are rated Category III.
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2.1.5 |
Reference
The reference refers to the legal authority and guidelines that the
principle statement is based on.
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2.2 PREPARATION FOR AN IN-DEPTH ESTABLISHMENT
INSPECTION
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To properly prepare for an in-depth inspection the inspector needs to:
- assess the frequencies of the establishment;
- determine the members of the inspection team;
- determine when to carry out the inspection of the establishment;
- carry out a review of the establishment file;
- and gather the required inspection tools.
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2.2.1 |
Assessment of Frequencies
Each federally registered establishment will be subject to an in-depth
establishment inspection at least once a year, as per national program
requirements.
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2.2.2 |
Determination of Inspection Team
The inspection will be done by at least one qualified honey inspector.
Depending on the complexity of the manufacturing processes, the size of the
establishment and the time frame in which the in-depth inspection is conducted,
decisions can be made at the area or regional level as to whether one or more
qualified honey inspectors are required.
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2.2.3 |
Determination of When to Carry Out the
Inspection
The inspector should not notify the management of the
establishment of the date of the in-depth inspection. In order to conduct
effective inspections, the inspector needs to determine when the establishment
is operating. This may be accomplished by contacting the provincial apiarist or
other local producers.
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2.2.4 |
Review of Establishment File
The inspector should review the establishment file in order to:
- Identify establishment manager and key personnel by name.
- Review previous in-depth inspection reports, action plans and follow-up
actions.
- Review directed inspection summaries, consumer complaints, recalls, lab
reports, etc.
- Have an understanding of the size and age of the establishment as well as
products packed or processed.
- Review the flow diagram showing the general movement of raw, in process and
finished product within the establishment, if available.
- Take note of any unique features of establishment (e.g. equipment, processing schedules, size, product
lines).
- Decide where the inspection will begin, identify when a major clean up can
be observed and find out when a second shift (if applicable) can be observed,
if possible.
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2.2.5 |
Gathering of Inspection Tools
Each inspector must have the following equipment which will be used and/or
worn in appropriate situations while conducting an establishment inspection
(please refer to the Occupational Safe Work Practices Section in the
Introduction):
(a) Identification
- inspector's identification card
- business cards
(b) Clothing
- a clean white safety hat (if applicable)
- hairnet and beardnet (if applicable)
- ear and eye protection (if applicable)
- a clean, white, lab coat/coveralls with snap or velcro fasteners, no
pockets above waist
- sanitary gloves for covering of unremovable plain wedding bands
- sanitized rubber safety boots (if applicable)
- appropriate clean footwear
- nuisance dusk mask (if applicable)
- bee veil/netting (if applicable)
(c) Equipment
- laptop computer and portable printer
- a flashlight in good working order
- a light metre - calibrated
- an accurate thermometer with steel shaft - calibrated
- an appropriate writing tool and clip board, that can be easily
sanitized
(d) Forms and References
- inspection worksheet (Honey Facility)
- detention and release forms
- an up-to-date copy of the Honey Regulations
- an up-to-date copy of the Honey Establishment Inspection Manual
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2.2.6 |
Professionalism
A tidy, neatly-dressed, well prepared inspector exemplifies the
professionalism expected from the Agency. The inspector is an official
representative of CFIA and must exhibit a
professional image when dealing with establishment officials. This includes
respect for establishment policies and good interpersonal skills. All
information discussed and obtained from a specific company must remain
confidential.
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2.3 INSPECTION
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2.3.1 |
Arrival at Establishment and Introductions
The inspector should park in an appropriate area and ensure that their
clothing (Section 2.2.5(b)) and behaviour is appropriate (no jewellery, watch,
gum chewing, etc.).
To demonstrate courtesy and professionalism, the inspector should:
- Ask for the establishment manager or person in charge
- Present identification card or business card
- Explain what will be done and agree on an inspection time frame
- Inform management that the results will be discussed once the inspection
has been completed and arrange for a tentative time to meet and discuss the
results
- Request to be accompanied by a representative of the establishment
- Ask for any special protective equipment requirements and safety measures
specific for that
- particular plant
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2.3.2 |
Establishment Representative
Some establishment managers will insist on accompanying the inspector or
have a foreman or quality assurance person with the inspector at all times.
This situation is preferable to being left alone because questions can be asked
on the spot and serious infractions can be pointed out as observed; this way
immediate action can be undertaken. Some help is also needed to assist in
record and program reviews. Some guidance may be needed if the facility is a
new establishment. As well, establishment personnel are encouraged to carry out
their own independent in-depth inspection alongside the CFIA inspector. Inspectors must be
careful not to allow plant personnel who may accompany them to rush the
inspection or lead them away from infractions.
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2.3.2.1 |
Scheduling
The inspector must determine what the establishment working schedule will be
during the course of inspection (e.g. shift
work, hours of work, etc.). To facilitate the
best order of inspection, the inspector and establishment management should
formulate an inspection schedule. Every effort must be made to assess
inspection tasks while the plant is operating.
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2.3.2.2 |
Order
Where applicable, every effort must be made by the inspector to minimize the
risk of cross-contamination. The inspector should commence the inspection in
the microbiologically cleanest area and finish in an unclean area of the
establishment (e.g. start at packaging and end
in raw receiving or establishment exterior). As well, the inspector must
utilize hand washing/sanitizing facilities as frequently as required.
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2.3.3 |
General Inspection Considerations
The following is a set of suggested rules for use during inspection:
(a) All team members are to write up their own worksheet and ratings.
(b) Where an establishment representative is present during an inspection,
infractions are pointed out to the representative as the inspection is
conducted through the establishment. These infractions are documented and
assessed even if they are taken care of immediately, however, it is also noted
that the infraction has been corrected.
(c) Ask establishment management questions rather than the workers. An
exception may be when you might want to determine if a worker understands what
he/she is doing or what procedures he/she has been directed to follow during
regular production or when there is a problem or deviation.
(d) Follow establishment policies when applicable (e.g. when a wash basin is present in an inspection area,
wash your hands).
(e) The inspector(s) should observe the general cleanliness of the
equipment/facility before start-up and if necessary, observe a major clean-up
before start-up (pre-operation) or after shut-down (post-operation).
(f) If more than one shift is operating, then try to observe the change-over
conditions between shifts. Monitor the change-over routine between as many
shifts as possible.
(g) In the storage, mixing and blending areas, take note of all ingredients,
additives and processing aids, so that they can be verified with the Honey
Regulations and the Food and Drug Regulations.
(h) In the labelling area(s), obtain a sample label of the product currently
being processed and packed. Review the required label declarations while in the
establishment. Attach the label to a worksheet so it can be reviewed more
closely back at the office.
(i) While in the establishment, locate the area where non-food chemicals
(e.g. cleaning chemicals, boiler water
additives, etc.) are used and stored. Make note of these chemicals and their
manufacturer so they can be reviewed against the establishment sanitation
program and also against the CFIA's Reference Listing of
Accepted Construction Materials, Packaging Materials and Non-Food Chemical
Products (refer to CFIA Internet site:
http://www.inspection.gc.ca/english/ppc/reference/cone.shtml). These
chemicals should be stored centrally, away from the main traffic areas of the
establishment, where there can be no contact with incoming raw materials,
ingredients and packaging materials. Other poisonous chemicals such as
pesticides must be stored in a separate area (preferably restricted) away from
all cleaning chemicals and food products.
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2.3.4 |
Rating of Tasks
The inspector should note conditions as they are found in the
comments/observations/infraction column of the Inspection Worksheet (Honey
Facility). The inspector should evaluate the task and record the rating on this
worksheet as per Chapter 4 and Chapter 5 using the assessment criteria and the
rating examples. All tasks can be rated only once and for non-satisfactory
conditions, the inspector shall assign one rating per task based on the most
severe risk category.
Each task will be rated as one of the following:
Satisfactory |
Satisfactory conditions - no deficiencies were noted which would result in
a health risk or risk of contamination or adulteration. |
Category I |
Non-satisfactory conditions (deficiencies) relating to the principle
statement of the standard which would result in a risk with a
high likelihood and serious health consequences.
Note: Category I infractions must be immediately
brought to the attention of the establishment management for corrective action.
(Refer to 2.5.1.1 for immediate actions to be taken).
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Category II |
Non-satisfactory conditions (deficiencies) relating to the principle
statement of the standard which could result in a moderate
health risk or a direct source of contamination or adulteration. |
Category III |
Non-satisfactory conditions (deficiencies) relating to the principle
statement of the standard which could result in a low health
risk or an indirect source of contamination or adulteration. |
Not Applicable |
The task is not evaluated because it is not relevant to the establishment
(e.g. heat treatment equipment in a producer
grader establishment). The lack of assessment of the task in this case will not
apply against the overall establishment rating. |
Not Rated |
The task is relevant to the establishment but not evaluated at the time of
inspection (e.g. extracting equipment not
being used - packing is the only operation at the time of inspection). The lack
of assessment of the task in this case will not apply against the overall
establishment rating. |
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2.4 POST INSPECTION
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2.4.1 |
Reporting Inspection Results
The MCAP
database is the computerized system which stores all data that is entered from
the Inspection Worksheet (Honey Facility). The system will generate specific
establishment reports:
- Inspection Worksheet
- Non-Compliance Report
- Non-Compliance Summary Report
- Outstanding Task List
The inspection results are entered into the Inspection Worksheet (Honey
Facility) in the MCAP database. This is the
worksheet where the rating for each inspection task is recorded along with a
description of the deficiencies found during the in-depth inspection.
The Non-Compliance Report summarizes the infractions into Categories I, II, and III.
The Non-Compliance Summary Report provides an overall compliance
percentage rating per category.
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2.4.2 |
Overall Establishment Rating (Non-Compliance Summary
Report)
An in-depth inspection is considered to be satisfactory if a minimum
compliance is achieved as follows:
- Category I 100%
- Category II
75% (greater than or
equal to)
- Category III
65%
(greater than or equal to)
In Table I, the Category rating classifies an
establishment according to risk and provides a basis for risk management,
program planning and resource allocation. The minimum
Compliance rating is based on health risk and compliance with
the regulations and it reflects the percentage of the principle statements that
are found to comply during the inspection. The Action Plan
Submission column defines the maximum timeframe (from the date of
receipt of inspection results) for the establishment to submit their written
correction action plan. The Corrective Action column defines
the maximum timeframe an establishment should take to be in compliance.
Procedures defined in Section 2.5 should be followed for non satisfactory
inspections.
TABLE I - Category Compliance and
Required Actions
Category |
Compliance |
Action Plan Submission |
Corrective Action Completed |
CFIA
Activity |
I
|
100%
|
None required
|
None required
|
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Less than 100%
Non-satisfactory
|
Immediate
|
Immediate
|
- Review Action Plan
- Follow-up Inspection ASAP
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II
|
75% to 100%
|
Less than two weeks*
|
Less than one
month*
|
- Review Action Plan
- Directed/GMP
Inspection
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Less than 75%
Non-satisfactory
|
Less than two weeks*
|
Less than one
month*
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- Review Action Plan
- Follow-up Inspection within 30 days of receipt of an action plan
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III
|
65% to 100%
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Less than one month*
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Less than one year*
**
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- Review Action Plan
- Directed/GMP
Inspection
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Less than 65%
Non-satisfactory
|
Less than one month*
|
Less than one year*
**
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- Review Action Plan
- Follow-up Inspection within 60 days of receipt of an action plan
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Note: All time frames start from the date of the
exit meeting with the establishment.
* For seasonal operators action plan submissions will be less than 6 months
and corrective actions prior to next season's operations.
** For structural items which have no immediate impact on food safety, Long
Term Action Plans (longer than one year) will be reviewed and may be accepted
by inspection staff.
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2.4.3 |
Exit Meeting with Management
Immediately after the establishment inspection, the inspector must meet with
the appropriate member(s) of the establishment management team to review the
inspection, highlight the unsatisfactory conditions and to discuss and decide
on a time period or a date for correction. The time and location of the meeting
should be carefully chosen in order to facilitate an effective meeting. Ample
time should be made available to discuss unsatisfactory conditions with the
plant management. A quiet area, preferably within the plant, would be an
acceptable environment to discuss the inspection results.
At the meeting the inspector should explain the purpose of the inspection in
a positive manner and provide a third party view of the status of the
establishment and its operations from a regulatory perspective. The overall
inspection will be reviewed, all unsatisfactory tasks will be discussed
highlighting the Category I, II and III infractions in that
order.
A verbal commitment from the establishment's management will be obtained
as to how and when corrective action will be taken. The inspector must then
indicate the requirement for submission of a written action plan with expected
correction time frames (refer to Table I). Corrective
action should always identify the problem to prevent its recurrence.
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2.4.3.1 |
Commitment/Responsibility of Establishment
The establishment is responsible to correct all non-compliance tasks and
achieve minimum compliance in all categories. Once minimum compliance, in all
categories, has been achieved the goal of the establishment should be to
continue to initiate corrective actions for all deficiencies above the minimum
standard. Lack of plant responsibility is indicated by inaction by the plant
either to formulate any action plans or to carry out any
corrective actions (see section 2.4.4.1).
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2.4.4 |
Final Report and Covering letter
If not presented during the exit meeting, the inspector must forward a
printed copy of the Non-Compliance Report and the results of the Non-Compliance
Summary Report. For those establishments which meet minimum compliance levels,
the reports and covering letter (Appendix 1) must be sent within 4 to 6 weeks
of the inspection. For those establishments which do not meet minimum
compliance levels, the reports and covering letter must be sent out within one
week of the inspection. A signed copy of the covering letter and all output
reports must be kept in the inspector's file.
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2.4.4.1 |
Written Action Plan
The signed written action plan submitted by the establishment must address
all infractions reported in the Non-Compliance Report according to the time
frames outlined in Table I. All action plans will be
reviewed by the inspector and incomplete or unacceptable plans will be returned
to the establishment for correction (e.g.
critical infractions not addressed, time frames unacceptable). If the action
plan is not submitted within the appropriate time frame, the inspector should
contact the establishment as a reminder. Further action, in consultation with
the regional office, should be taken if the establishment management is
uncooperative (Chapter 3).
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2.5 NON-SATISFACTORY IN-DEPTH INSPECTIONS
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Minimum compliance level for each risk category is outlined in Table I of Section 2.4.2. For all non-satisfactory in-depth
inspections, it is important that the inspector informs the Supervisor, the
Inspection Manager, the Regional Program Officer and the Area Program Network
Specialist. Joint consultation should take place to determine the action to be
taken.
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2.5.1 |
Follow-up Inspections
A follow-up inspection is a continuation of a non-satisfactory in-depth
inspection to target identified deficiencies. The objective of the follow-up
inspection is to verify that the establishment meets minimum standards of 100%
for Category I, 75% and above for Category II and/or 65% and above for Category III. If upon follow-up inspection the establishment does not
meet minimum requirements, refer to Chapter 3.
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2.5.1.1 |
Category I
Deficiencies
The compliance level required is 100%. Any establishment
that does not meet this requirement must take corrective measures immediately
or as soon as possible, depending on the situation. When a Category I deficiency is found while doing the inspection:
- Appropriate corrective actions must be determined and implemented
immediately, if required.
- All potentially unsafe product should be placed on voluntary hold or be
detained for further investigation.
- The potential cause of the infraction must be determined to evaluate
product safety.
- If the cause of the infraction cannot be determined immediately and product
safety cannot be evaluated, production should be halted until satisfactory
corrective measures have been established and implemented.
- If additional corrective actions are not required immediately, the company
must submit an action plan in writing within 24 hours and corrective actions
must be implemented to the satisfaction of the inspector.
A follow-up inspection will then be carried out to ensure any deficiencies
or related product irregularities are corrected. Procedures indicated in
program guidelines must be used for follow-ups on detained and recalled
products. If the establishment does not adequately follow their corrective
action plan, please proceed to Chapter 3.
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2.5.1.2 |
Category II
Deficiencies
The minimum compliance level required is 75%.
Any establishment that does not meet this requirement must:
- Determine the potential cause of the infraction and evaluate product
safety.
- All potentially unsafe product should be placed on voluntary hold or will
be detained for further investigation.
- Implement appropriate corrective actions.
- Submit an action plan, in writing, within 2 weeks of the exit meeting and
corrective actions. must be implemented within 30 days (as outlined in Table
I) of the inspection date or to the satisfaction of
the inspector.
A follow-up inspection must be performed within 30 days after the receipt of
the action plan for all Category II non-conformities
to ensure deficiencies or related product irregularities are corrected.
Procedures indicated in program guidelines must be used for follow-ups on
detained and recalled products. If the establishment does not adequately follow
their corrective action plan, please refer to Chapter 3.
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2.5.1.3 |
Category III
Deficiencies
The minimum compliance level required is 65%.
Any establishment that does not meet this requirement must:
- Determine the potential cause of the infraction and evaluate product
safety.
- All potentially unsafe product should be placed on voluntary hold or will
be detained for further investigation.
- Implement appropriate corrective actions.
- Submit an action plan, in writing, within 1 month of the exit meeting and
corrective actions must be implemented within 1 year (as outlined in Table
I) of the inspection date or to the satisfaction of
the inspector.
A follow-up inspection must be performed within 60 days after the receipt of
the action plan for all Category III
non-conformities to ensure deficiencies or related product irregularities are
corrected. Procedures indicated in program guidelines must be used for
follow-ups on detained and recalled products. If the establishment does not
adequately follow their corrective action plan, please proceed to Chapter
3.
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2.5.1.4 |
Multiple Category Deficiencies
If the plant fails multiple categories (less than 100% for Category I and/or, less than 75% for Category II and/or less than 65% for Category III) complete action plans must be submitted and follow-up
inspections performed as per Table I.
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2.6 DIRECTED/GMP ESTABLISHMENT INSPECTION
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A Directed/GMP
establishment inspection is a partial inspection of all packing and
pasteurizing establishments which have achieved the minimum compliance level
during an in-depth establishment inspection. The Directed/GMP inspection incorporates selective
tasks from Chapters 4 and 5 along with infractions noted during the previous
in-depth inspection.
This is an unannounced activity conducted by CFIA inspectors to evaluate the
establishment's action plan, review the corrective actions taken by the
establishment to correct Category II and III infractions, and to assess good manufacturing practices at
registered honey establishments under actual processing conditions. Product
inspection as outlined in work plan requirements, such as taking lab samples,
grade verification, net quantity, label and ingredient verification may also be
conducted.
Prior to the arrival at the establishment, the inspector should review the
establishment file to determine the outstanding tasks and evaluate the
establishment's action plan. Before beginning the inspection, inspectors
are encouraged to spend ten or fifteen minutes observing the employees at work
(their personal hygiene practices, food handling practices and movement
throughout plant) to better evaluate inspection items described in Chapter 4,
section 4.4.2.
The inspector should observe and record infractions as they are found. The
Directed/GMP Inspection
will be recorded on the Directed/GMP Inspection Worksheet (CFIA/ACIA
0992, see appendix 2) and will be recorded within MCAP when available. Infractions
of a serious nature must be immediately brought to the attention of the
establishment management and corrective action should be implemented. Prior to
leaving the establishment the inspector must review the inspection with
management and obtain verbal commitment for corrective actions (corrective
actions noted on Directed/GMP worksheet).
i) Category I
Infractions - This could be due to the occurrence of direct product
contamination (e.g. glass).
- If any of these items are non-satisfactory, immediate action must be taken
to isolate affected product manufactured during the occurrence of the
problem.
- If the establishment has not demonstrated to the inspector that the product
is under control or safe, it should be detained (see Chapter 3, section
3.6.3).
- If product has been distributed, the inspector should immediately contact
the appropriate Area Program Specialist and Recall Co-ordinator with the
relevant details to determine if a product recall is necessary as per the
recall protocol.
- In addition to controlling the affected product, the establishment must
also take the appropriate measures to prevent a recurrence of the problem.
ii) Category II
and III Infractions - These must be noted
on the worksheet, with an agreed upon completion date, and on the CFIA/ACIA
form0992.
iii) Lack of Establishment
Responsibility/Commitment - Once it is evident that there is a lack of
establishment commitment to formulate and implement any action plans with dates
from in-depth or directed/GMP inspections, a Regional/Area
meeting should be set up with the appropriate responsible plant management to
thoroughly explain the deficiencies and why they must be corrected. The meeting
should end with a mutually agreed upon action plan being developed and
commitment for its implementation. See Chapter 3 if no establishment commitment
can be obtained.
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Appendix 1 - COVERING LETTER - EXAMPLE
Canadian Food Inspection Agency
Address of Office
Date
Mr. Honey
Manager
Honey Products Ltd.
123 Anywhere Street
Somewhere, Canada
Subject: Establishment Inspection Results
Mr. Product:
Please find enclosed the Non Compliance Report as generated from your
in-depth inspection of date. The Honey Establishment
Inspection Manual was used to assess your establishment during this inspection.
The inspection was completed by myself. During the exit interview all deficient
items were discussed with you or your staff.
Deficient items in Health and Safety Categories have resulted in a plant
rating of _____% in Category I, _____% in
Category II and _____% in Category III. You are reminded that you may be in contravention of the
Honey Regulations under the Canada Agricultural Products Act (note:
critical deficiencies should be identified and reference made to the
appropriate section of the regulations).
The Non Compliance Report may be used to indicate corrective actions and
dates for those items found un-satisfactory. Please forward your written and
signed action plan to this office no later than date (see
Table 1 for dates)
We would like to thank you and your staff for the cooperation shown to us
during this inspection. Please do not hesitate to contact me if you have any
questions.
Yours truly,
Honey Inspector
Attachment
c.c: Area Program Network Specialist
Operations Officer
Appendix 2 - Directed/GMP Inspection Worksheet
Establishment__________________________________
Reg. No._____________________
Contact_______________________________________
Date _______________________
1.0 Manufacturing
Controls |
Inspection Task |
S/NS |
Corrective Action |
Date |
1.1 Label accuracy (5101) |
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1.2 Incoming material control (5301) |
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1.3 Empty container control - handling, storage and use of - glass, barrels
etc. (5302, 5401, 5701 ) |
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1.4 Batch preparation (5501) |
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1.5 Control of filling and labelling (5601,5801) |
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2.0 Hygienic
Practices |
2.1 Sanitary handling of product, ingredients & packaging material
(1202) |
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2.2 Well controlled movement of personnel & equipment between areas
(101) |
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2.3 Absence of cross contamination
- pests (1301)
- returned products (503)
- garbage (104)
- structure (101, 201, 202)
- lighting (102)
- non food chemicals (501)
- metal detector (901)
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2.4 Appropriate clothing, grooming and health condition of personnel. Usage
of hand washing and sanitizing stations as required. Controlled movement of
personnel & equipment between areas (1101, 1102) |
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2.5 Product Complants and Records (1401) |
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3.0 Outstanding Task List /
Action Plans |
Review of Outstanding task list (attach list from MCAP) |
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Review of Establishments' Action Plan |
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Observations/Comments:
Inspector's Signature :
Signature of Plant Management:
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