CHAPTER 2 - ESTABLISHMENT INSPECTION PROCEDURES

2.1 ESTABLISHMENT INSPECTION GUIDELINES

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:

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.

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.

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..

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:

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.

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"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:

"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

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.

The reference refers to the legal authority and guidelines that the principle statement is based on.

2.2 PREPARATION FOR AN IN-DEPTH ESTABLISHMENT INSPECTION

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.

Each federally registered establishment will be subject to an in-depth establishment inspection at least once a year, as per national program requirements.

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.

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.

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.

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

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.

2.3 INSPECTION

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

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.

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.

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.

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.

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:

2.4 POST INSPECTION

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.

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

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.

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.

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).

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.

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).

2.5 NON-SATISFACTORY IN-DEPTH INSPECTIONS

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.

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.

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.

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.

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.

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.

2.6 DIRECTED/GMP ESTABLISHMENT INSPECTION

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.