CHAPTER 2 - ESTABLISHMENT INSPECTION METHODS AND PROCEDURES 2.0 Introduction to the Multi-Commodity Activities Program (MCAP)....1 2.1 Explanation of the inspection criteria in chapters 4 and 5...1 2.1.1 Chapter 4: General Inspection Criteria...1 2.1.2 Chapter 5: Manufacturing Controls...1 2.1.3 Table descriptions of Chapters 4 and 5...2 2.1.4 Risk Categories I, II, III, Sa, N/A and N/I....4 2.2 Steps in the inspection of an establishment...5 2.2.1 Determining the type of inspection to be conducted...5 2.2.2 Establishing inspection frequency...5 2.2.3 Creating the inspection team...6 2.2.4 Determining the inspection date...6 2.2.5 Notifying the establishment...6 2.2.6 Reviewing the establishment s file and other documentation relevant to the inspection...7 2.2.7 Preparing inspection material and equipment...7 2.2.8 Meeting with establishment management before the inspection...8 2.2.9 Determining the order of inspection with establishment representatives...9 2.2.10 Conducting the in-depth inspection...10 2.2.11 Recording observations on the worksheets during the inspection...11 2.2.12 Collecting product samples during or after the in-depth or directed inspection. 11 2.2.13 Writing the inspection report...11 2.2.14 Discussing the inspection results with establishment management...12 2.2.15 Discussing the action plan...12 2.2.16 Providing the inspection report and receiving the action plan...13 2.3 Compliance levels, action plan and corrective action...13 2.3.1 Follow-up for Category I deficiencies...14 2.3.2 Follow-up for Category II deficiencies...15 2.3.3 Follow-up for Category III deficiencies...16 2.3.4 Follow-up for Category II and III deficiencies...17 2.3.5 Critical health and safety implications...17 2.3.6 Repetitive deficiencies...17
2.4 Safe work practices during an establishment inspection...18 2.4.1 Manual material handling...18 2.4.2 Moving vehicles...19 2.4.3 Personal protective equipment...19 2.4.4 Slip and fall prevention...19 2.4.5 Establishment premises hazards...19 2.4.6 Climbing...20 2.4.7 Emergency procedures...20 2.4.8 Right to refuse...20 ANNEX I Method for Calculating Compliance Percentages (Overall Rating)...21 ANNEX II Sample Covering Letter...23 ANNEX III Health Canada Risk Assessment Model... 24
2.0 Introduction to the Multi-Commodity Activities Program (MCAP) The CFIA s Multi-Commodity Activities Program (MCAP) database is a computerized system that compiles the inspection data used to produce the establishment inspection reports. The inspection assessment criteria set out in Chapters 4 and 5 are found in the MCAP database. Should any criteria not appear in the MCAP database, refer to Chapters 4 and 5 of this manual. The inspection team must create a specific inspection worksheet that is customized for the type of establishment and the processes used in this establishment. The preprinted inspection worksheet will serve as the main reference during the inspection. For information on how to create inspection worksheets, refer to the MCAP manual. 2.1 Explanation of the inspection criteria in Chapters 4 and 5 Chapters 4 and 5 contain the inspection criteria that apply to the areas in an establishment to be inspected. In these chapters, we identify which task applies, depending to the establishment type, i.e.: Sugar bush operator (MSB): SEE THE CHAPTER 4 ONLY DATED FEBRUARY 2012 Maple products packing plant (MP): SEE THE CHAPTERS 4 & 5 DATED JANUARY 2007 Maple syrup shipper (MSS): SEE THE CHAPTERS 4 & 5 DATED JANUARY 2007 These establishment types are described in Chapter 1. 2.1.1 Chapter 4: General Inspection Criteria Chapter 4 sets out the general inspection criteria related to the prerequisite programs under the CFIA s Hazard Analysis Critical Control Point (HACCP) program. The chapter is divided into eight major sections: Premis es Transportation and storage Equipment Personnel Cleaning and sanitation Recalls Written programs Records 2.1.2 Chapter 5: Manufacturing Controls Chapter 5 sets out the inspection criteria for the major steps involved in controlling maple products preparation. The chapter is divided into ten major sections: 1
Incoming materials In-process packing and containers Product preparation/blending Filling Container closure Cooling Labelling Defective products and corrective action Written programs Records 2.1.3 Table descriptions of Chapters 4 and 5 The inspection criteria in Chapters 4 and 5 are presented in table format as follows: ö Section 4.1 PREMISES Subsection ö BUILDING INTERIORS Task & establishment type ö 4.1.4 Ventilation MP MSS Principle ö PRINCIPLE Adequate ventilation is provided to prevent excessive accumulation of heat, steam, condensation and dust and to remove contaminated air. Assessment criteria ö Assessment criteria - Ventilation provides sufficient air exchange to prevent excessive accumulation of heat, steam, condensation or dust. - Ventilation openings are equipped with close-fitting screens to prevent the entry of pests. Rating and examples Rating Examples ö I - N/ A II - Inadequate ventilation, condensation/mould evident, and risk of final product contamination. - Screens in ventilation openings not close-fitting. III - Inadequate ventilation, condensation/mould evident, but product contamination unlikely. - Condensation dripping on a food product that will undergo a further microorganism kill step. ö References References MPR None 2
Section Major divisions of Chapters 4 and 5, as described in sections 2.1.1 and 2.1.2 above. Subsection Subdivisions of the sections of Chapters 4 and 5. Task and establishment type Each task contains a single principle to which a number of assessment criteria are linked. The task is the basis for the rating system, i.e. the inspector assigns a rating to each task. Once each task has been rated, the inspector can calculate the establishment s overall compliance level. Chapters 4 and 5 indicate the establishment type(s) to which each task applies: MSB = Sugar bush operator: SEE THE CHAPTER 4 ONLY DATED FEBRUARY 2012 MP = Maple products packing plant: SEE THE CHAPTERS 4 & 5 DATED JANUARY 2007 MSS = Maple syrup shipper: SEE THE CHAPTERS 4 & 5 DATED JANUARY 2007 Principle A principle is a generic statement. A principle statement is broadly worded to allow a certain degree of flexibility for the introduction of new technologies and food commodities. Each principle statement has one or more assessment criteria. The principles are similar to the Codex Alimentarius General Principles of Food Hygiene and the International Organization for Standardization (ISO) standards. These statements imply that the operator controls all factors affecting health and safety. Assessment criteria The assessment criteria are the various items that the inspector must evaluate in order to decide whether there is compliance with the principle statement and to determine the rating for the task. As new technologies and/or commodities become available, the addition of new criteria may become necessary. For this reason, current assessment criteria should not be regarded as exhaustive. Rating and examples Examples are provided to guide inspectors in assessing the rating for each task, in accordance with the level of risk (see section 2.1.4 above). These examples provide inspectors with benchmarks, promoting uniformity of the level of risk in the assessment of the tasks. The examples are based on the experience of CFIA personnel and are meant to be as realistic as possible. It must be noted that they are examples only and not an exhaustive list of all possible deficiencies or situations. 3
References A list of regulatory and general references accompanies each task. The following abbreviations are used: CAP Act: Canada Agricultural Products Act MPR: Maple Products Regulations 2.1.4 Risk Categories I, II, III, Sa, N/A and N/I The risk categories and rating system are based on the Health Risk Assessment Model, which is found in Annex III to this chapter. The risk categories are as follows: Category I deficiencies entailing a risk with a high likelihood of occurrence and serious health consequences. Category II deficiencies entailing a moderate health risk or a direct source of contamination or adulteration. These can be direct sources of contamination or adulteration or repetitive regulatory infractions (e.g. sensitive ingredients, foreign materials). Category III deficiencies entailing regulatory violations, a low health risk or an indirect source of contamination or adulteration. Satisfactory (Sa) no health risks or risks of contamination or adulteration were observed. If Not Applicable (N/A) is indicated for a category, this means that there generally cannot be any deficiencies with this level of risk for this task. The inspector assesses the task and assigns a single rating to it, no matter how many assessment criteria the task has. The inspector must use the most severe deficiency as the basis for determining the rating of the task. Each task will therefore be rated I, II, III, Sa, or one of the following: Not Inspected (N/I) the item cannot be assessed because the equipment is not available for inspection or because the item to be assessed is related to a part of the establishment that is not operational. In this case, the lack of assessment of the item will have no impact on the overall establishment rating. Not Available (N/A) the task cannot be assessed because the item does not exist in the establishment. In this case, the lack of assessment will have no impact on the overall establishment rating. The method for calculating the overall establishment rating is found in Annex I to this chapter. 4
Override provision During an inspection, conditions may be found to increase or decrease the likelihood of occurrence of a hazard. In such cases, the inspector may choose to override the prescribed assigned rating. Overrides, when used, must be clearly identified on the inspection worksheet together with a written justification for the change. These unusual cases are evaluated against the Health Risk Assessment Model, which is found in Annex III to this chapter. 2.2 Steps in the inspection of an establishment 2.2.1 Determining the type of inspection to be conducted There are two types of inspection. An in-depth inspection includes all general-type inspection criteria from Chapter 4, as well as all process-specific criteria from Chapter 5, to the extent that they are applicable to the establishment. A directed inspection draws selectively from Chapters 4 and 5. This type of inspection is often referred to as a partial or Good Manufacturing Practices inspection. This inspection focusses on: - serious deficiencies noted during previous in-depth inspections. Prior to arriving at the establishment, the inspector must review the establishment file to determine the outstanding tasks for the directed inspection. The priority is to review the corrective action taken for Category I and II deficiencies identified in the action plan. - product inspection as outlined in work plan requirements, such as verification of grade, net quantity, ingredients and closure quality, as well as product sampling in accordance with the laboratory analysis sampling plan. The Maple Products Inspection Manual provides more details about product inspection. 2.2.2 Establishing inspection frequency Each federally inspected establishment should be subject to an in-depth establishment inspection at the following frequencies: Type of establishment Sugar bush operator Maple products packing plant Maple syrup shipper Frequency of in-depth inspection Once every 2 years Once a year Once a year 5
2.2.3 Creating the inspection team The inspection team concept is useful for the inspection of prepared maple products establishments, particularly for larger, high-risk establishments. The decision on whether one or more inspectors are required can be made at the area or regional level depending on the complexity of the preparation processes, the size of the establishment and the time frame in which the in-depth inspection is to be conducted. The team approach is used for the following reasons: a) One inspector can remain to observe the operator s processing activities, while the other inspector may inspect the preparation activities. Inspectors may exchange places during the inspection in order to provide a fresh perspective on a particular activity. b) Two inspectors with different experience and backgrounds have a broader experience base. The inspection team will have more confidence when discussing critical deficiencies, and the team approach is a good way to prevent intimidation by the company. c) The team concept greatly improves inspection uniformity, provided that the same two inspectors do not always work together. Each inspector learns something from the other inspector, making the Area more consistent in its identification and scoring of infractions. d) The inspection team size will vary depending on the type of inspection being conducted (in-depth/directed). e) For specific safety purposes, it may be preferable for the inspection to be conducted by two inspectors. According to the situation, other government agencies may be involved and conduct inspections. 2.2.4 Determining the inspection date Sugar bush establishments are in production on a seasonal basis, i.e. in early spring, and are therefore inspected during this period. Inspections of packing and shipper establishments can generally be conducted year-round. 2.2.5 Notifying the establishment Under normal circumstances, the inspector must not notify the establishments management of the date of the in-depth inspection. If production is irregular, the inspector can verify that the establishment is operating on that date. It is helpful if an establishment representative accompanies the inspection team. The owner or person in charge of a place and every person found in that place shall give the inspector all reasonable assistance to enable the inspector to carry out the inspector s duties and functions and shall furnish the inspector with such information with respect to the administration of the legislation as the inspector may reasonably require. 6
2.2.6 Reviewing the establishment s file and other documentation relevant to the inspection Establishment s file The inspection team must review the establishment s file and determine the type of process to inspect, in order to: - identify establishment manager and key personnel by name; - review previous in-depth inspection reports, action plans and corrective action; - review directed inspection summaries; - review consumer and competitor complaints; - have an understanding of the size and age of the establishment as well as the products prepared there; - consult the establishment s flow diagram showing the general movement of raw, in-process, and finished products within the establishment, if such a diagram is available; - take note of any unique features of the establishment, such as equipment, preparation schedules, size or product lines; and - decide, if possible, where the inspection will begin and find out when operations, major cleaning and sanitation, and a second shift (if applicable) can be observed. Other documentation to be reviewed - Canada Agricultural Products Act; Maple Products Regulations; Food and Drugs Act and Food and Drug Regulations; Consumer Packaging and Labelling Act (CPLA) - Maple Products Establishment Inspection Manual - Guide to Food Labelling and Advertising, CFIA - Any available technical and scientific information on the products being prepared, the preparation methods and the equipment being used in the establishment. 2.2.7 Preparing inspection material and equipment Each inspector must have the following equipment and must use or wear it where appropriate: Identification inspector s CFIA identification card business cards Protective clothing clean, Canadian Standards Association (CSA)-approved safety hat (white) hairnet and beard net (if applicable) in good condition nuisance dust mask CSA-approved eye and hearing protection clean, white lab coat with snap or velcro fasteners and with no pockets above the waist (or equivalent, e.g. coveralls) five-finger overgloves 7
no jewellery or watches while performing the inspection (only unremovable plain wedding bands are tolerated, provided they are covered by sanitary gloves) sanitized rubber safety boots clean, CSA-approved non-slip safety footwear Inspection equipment case flashlight in good working order light meter accurate thermometer with a steel shaft refractometer (portable) colorimeter (portable) sampling containers box for transporting samples dipper pencil or pen (without a cap) for filling out inspection worksheets and reports, and clipboard that can be easily sanitized Forms MCAP Inspection Worksheet detention and release forms sufficient quantity of self-adhesive CFIA detention tags sampling form, if necessary sufficient quantity of self-adhesive CFIA sample labels CFIA-identified sealing tape References copy of the regulations copy of the establishment inspection manual 2.2.8 Meeting with establishment management before the inspection Opening Meeting When meeting with establishment management, the inspection team must demonstrate courtesy and professionalism by following these rules: - Ask for the establishment manager or person in charge. - Present identification cards or business cards and introduce the team members. - Explain what the team will do and agree on an inspection time frame. - Inform management that the results will be discussed once the inspection has been completed, and arrange a time to meet and discuss the results. - Invite an establishment representative to accompany the inspection team. 8
Professionalism A well-organized, well-groomed, properly equipped inspector reflects the professional image expected of the Agency. Demonstrating cleanliness and tidiness is way to practise what we preach about sanitation. The inspector is an official representative of the Agency and must project 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. However, the Access to Information and Privacy (ATIP) office, may make the inspection reports available according to the requirements of the Access to Information Act (including its exemptions and exclusions). Establishment representative Some establishment managers will insist on accompanying the inspection team or on having a foreman or quality assurance person accompany the inspection team at all times. This is preferable to being left on one s own, because questions can be asked on the spot and serious deficiencies can be pointed out as observed; this way, immediate action can be taken. Assistance is also needed in reviewing records and programs, and some guidance may be required if the facility is a new establishment. As well, establishment personnel are encouraged to carry out their own in-depth inspections both with the inspection team and independently as required by their establishment. However, inspectors must not allow accompanying plant personnel to rush the inspection or to lead them away from the non-compliance. Scheduling The inspection team must determine what the establishment working schedule will be during the course of inspection (i.e. shift work, hours of work, etc.). To ensure that the inspection goes as smoothly as possible, the inspection team and establishment management must establish an inspection schedule. Every effort must be made to assess the items in an operational condition. Where applicable, it may also be desirable to examine the equipment during disassembly, washing and sanitizing. 2.2.9 Determining the order of inspection with establishment representatives The inspection team must make every effort to minimize the risk of cross-contamination. The in-depth inspection usually must: a) begin with the critical control factors preparing steps (e.g. packaging) and areas where major problems were identified during the last inspection(s); and b) finish with other areas, from the least contaminated to the most contaminated. 9
2.2.10 Conducting the in-depth inspection A basic set of rules is essential for carrying out an inspection at a food preparing establishment. When these rules are followed, a meaningful inspection report will result, accurately reflecting the conditions in the establishment. a) Before entering any preparing area, the inspection team must put on all necessary clean protective clothing. As well, the inspectors must utilize hand washing/sanitizing facilities as frequently as possible. The inspectors must also gather appropriate inspection aids, such as clipboards, worksheets, flashlights, etc. b) All team members must write up their own worksheet and ratings. c) The inspection team must observe and record deficiencies as they are found and/or obtain product samples as required. The team immediately brings deficiencies of a serious nature to the attention of establishment management and ensures that corrective action is implemented. When an establishment representative is present during an inspection, deficiencies are pointed out to the representative as the inspection takes place. The deficiencies and corrective action are documented and assessed even if they are addressed immediately. d) The inspection team must direct its questions to establishment management rather than to the workers, except when the team wants to determine whether a worker understands what he or she is doing or what procedures he or she has been directed to follow during regular production or when there is a problem or deviation. If a worker gives problematic answers, judgement must be exercised by assessing the background of the situation (e.g. potential labour dispute). e) The inspection team must set a good example for workers (e.g. when a wash basin is present in the inspection area, the team members must wash their hands). f) If possible, the inspection team must observe a major cleaning and sanitation before start-up (pre-operation) or after shut-down (post-operation). g) If more than one shift is operating, the inspection team must try to observe the shift change-over. The team must monitor the change-over operations, in comparison to normal periods, between as many shifts as possible. h) In the storage, mixing and blending areas, the inspection team must make a note of all ingredients, additives, and processing aids so they can be verified against the Maple Products Regulations and the Food and Drug Regulations. i) In the labelling area(s), the inspection team must obtain a sample label of the product currently being prepared. The team must review the label declarations while in the establishment and attach the label to a worksheet so that it can be reviewed more closely back at the office. In certain cases, a sample lithographed container or a document with the stamp that is applied to the container must be obtained instead. 10
j) When in the boiler room, the inspection team must make a note of the boiler additives being used, especially if live steam (direct contact) is being used on any product in the establishment. k) During the inspection, the inspection team must locate the area where cleaning and sanitizing chemicals are stored and note the cleaning compounds used so that they can be reviewed against the establishment cleaning and sanitation program. It is recommended to use products included on the CFIA s Reference Listing of Accepted Construction Materials, Packaging Materials and Non-Food Chemical Products (available on the CFIA Web site) or otherwise recognized for food use (e.g., letter of guarantee, 3A standards, or NSF), but it is not a registration requirement (not rated). These chemicals must be stored centrally, away from the main traffic stream and from 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. 2.2.11 Recording observations on the worksheets during the inspection The inspection results are recorded on the MCAP Inspection Worksheet. This a working document in which the rating for each inspection task (principle statement) is recorded along with a description of the deficiencies identified during the on-site inspection that were related to that inspection task. 2.2.12 Collecting product samples during or after the in-depth or directed inspection During or after an in-depth or directed inspection, product samples may be requested. The inspection team must always notify establishment management of the exact nature of the samples required and the purpose of sampling. The samples must be drawn randomly and according to the sampling plans and the program directives. Wherever possible, the types of checks or analyses carried out on those samples must reflect the deficiencies observed in the establishment. 2.2.13 Writing the inspection report When the inspection is completely finished, the team of inspectors must meet behind closed doors to discuss the inspection results. A suitable location is necessary to protect the confidentiality of the information. For example, the meeting could be held in a meeting or training room with a door that can be closed or in the establishment manager s office. The meeting could also take place in a nearby CFIA office. All deficiencies found during the establishment inspection must be indicated in writing on the worksheet. Together, the inspectors must review all the deficiencies and ratings recorded on their worksheets and agree on a final rating for each task. They must then calculate the overall establishment rating. It is important that establishment management understand the inspection 11
findings and the reasons why certain items are unsatisfactory and require correction or improvement. 12
The manuals, legislation, regulations and guidelines identify some sanitation requirements and references, and indicate some responsibilities, but many times a specific problem and the way to address that problem are not specified. It is therefore necessary to exercise judgment and common sense with respect to the health and safety implications of that situation within a specific context. Inspection Report It consists of: the worksheet, that includes the non-compliances noted during the inspection; the overall compliance percentage rating for the establishment (see Annex I, method for calculating); the sample covering letter (see Annex II, for the example) 2.2.14 Discussing the inspection results with establishment management Closing Meeting After the establishment inspection, the inspection team meets with the appropriate member(s) of the establishment management team to review the inspection, highlight any unsatisfactory conditions and discuss and decide on a time period or a date for the correction of unsatisfactory conditions. The time and location must be carefully considered when discussing inspection reports with plant management. Ample time must be set aside to discuss unsatisfactory conditions. A quiet area, preferably within the establishment, would be an acceptable environment for discussing the inspection results. At the meeting with management, the senior inspector should take the lead, explaining the purpose of the inspection, making the presentation as positive as possible, and giving the establishment a third-party view of the status of the establishment and its operations from a regulatory perspective. The session should begin with general remarks pointing out any positive comments that are appropriate. The inspector explains that the report contains the infractions observed during the inspection, while anything that was found to be satisfactory, good and in compliance is not mentioned in the report. The inspector then presents the deficiencies recorded in the inspection report. Finally, the inspector describes the follow-up action expected, which constitutes the establishment s action plan. 2.2.15 Discussing the action plan 13
The inspector must plan the corrective action with front-line management so that the problems do not recur. Each critical and major deficiency must be clearly identified with a correction date. The action plan must include provisions for all deficiencies reported in the Inspection Report in accordance with the time frames outlined in Table 1 in section 2.3 below. The urgency of corrective action is always a function of the degree of existing hazard related to health and safety issues. A responsible party from management must review, sign and keep a copy of the action plan. 14
2.2.16 Providing the inspection report and receiving the action plan The inspector will leave a printed copy of the inspection report on site if the inspector carries a laptop and printer. Otherwise, he will leave a hand-written copy with the operator and send a complete printed report within 10 working days. If the operator does not provide an action plan to the inspector on site, he must forward it as requested in the sample covering letter (see Annex II). For professional reasons, we recommend a written or verbal acknowledgment of receipt (with a note on file) be transmitted to the establishment following reception of an acceptable action plan. The action plan must be kept on the establishment's file. The inspector will refuse an incomplete action plan and will request corrections. If the action plan is not submitted within the appropriate time frame, the inspector should contact the responsible person as a reminder. Further action, in consultation with the regional office, may be taken (see Chapter 3). The inspection team enters the Directed Inspection report into the MCAP database. A signed copy of each report must be kept in the Region's file. 2.3 Compliance levels, action plan and corrective action Table I Category Compliance Level Action Plan Submission Time Frame Corrective Action Time Frame I < 100% Immediate * Immediate * II $75% Less than one month * Less than two months * or according to the action plan < 75 % Less than 2 weeks * Less than one month * III $65% Less than one month * Less than one year * or according to the action plan < 65 % Less than one month * Less than one year * 15
* After the closing meeting date of the inspection An establishment meets the CFIA registration maple products program requirements when the following overall rating is obtained : 100 % for category I, 75% or greater for category II, 65% or greater for category III.. The ratings I, II and III used in the Category column of the above table is described in section 2.1.4 of this chapter. The Minimum Compliance column is based on health risk and compliance with the legislation and regulations. Adding up the ratings assigned to each of the tasks makes it possible to calculate percentages that indicate an establishment s compliance level. This calculation is explained in Annex I to this chapter. The Action Plan Submission Time Frame column indicates the time period given to the establishment to submit its written corrective action plan. The Corrective Action Time Frame column indicates the time frame given to the establishment to take the corrective action. 2.3.1 Follow-up for Category I deficiencies The compliance level required is 100%. Compliance level less than 100% CORRECTIVE ACTION TIME FRAME When a Category I deficiency is identified during an inspection, the inspector must evaluate product safety immediately and require the establishment to implement corrective action immediately or as soon as possible, depending on the circumstances. An inspection must be initiated, following the steps below. Determine the potential cause of the deficiency. Determine when the deficiency first appeared. Evaluate the safety of the product. 16
Determine appropriate corrective action and ensure it is implemented immediately, if required. Where an inspector believes on reasonable grounds that the Act or the regulations have been contravened, the inspector may seize and detain any agricultural product or other thing by means of or in relation to which the inspector believes on reasonable grounds the contravention occurred; or that the inspector believes on reasonable grounds will afford evidence in respect of a contravention of the Act or the regulations. Recall should be considered if the products are on the retail market and if it poses a risk to human health. If the cause of the deficiency cannot be determined immediately or if product safety cannot be evaluated, consider stopping production of the affected product until satisfactory corrective action is established and implemented. 17
ACTION PLAN SUBMISSION TIME FRAME If corrective action is not required immediately, ensure that the establishment submits an action plan in writing within 24 hours and implements corrective action. The corrective action must meet the program requirements. DIRECTED INSPECTION TIME FRAME Further directed inspections, if required, will then be carried out to ensure that all deficiencies or non-conformances are corrected. The procedures described in the program guidelines must be used for follow-ups on seized and recalled products. If the establishment does not properly implement its corrective action plan, the procedure indicated in section 3.7, Suspension of Registration, must be followed. 2.3.2 Follow-up for Category II deficiencies The compliance level required is 75% or more. Compliance level equal to or greater than 75% ACTION PLAN SUBMISSION TIME FRAME The establishment must submit an action plan at the time of inspection or within a month of the closing meeting date of the inspection (see section 2.2.16). CORRECTIVE ACTION TIME FRAME The establishment must implement corrective action within two months of the closing meeting date of the inspection (as outlined in the above Table I) or within a longer delay in accordance with the action plan, in such a way that the program requirements are met. DIRECTED INSPECTION TIME FRAME The decision to conduct a directed plant inspection for all Category II deficiencies is at the inspector s discretion (with the agreement of his or her supervisor). Compliance level less than 75% 18
ACTION PLAN SUBMISSION TIME FRAME The establishment must submit an action plan at the time of inspection or within a month of the closing meeting date of the inspection (see section 2.2.16). 19
CORRECTIVE ACTION TIME FRAME When an inspection reveals a compliance level of less than 75%, the inspector must immediately evaluate product safety and require the establishment to take appropriate corrective action. Nature of associated deficiencies having a cumulative effect on potential product safety/ contamination (e.g. calibration problems, equipment sanitation, equipment maintenance). Actual Category II compliance level. Overall situation, e.g. plant history, readiness to implement corrective action, Category III deficiencies relating to Category II deficiencies. DIRECTED INSPECTION TIME FRAME A directed plant inspection must be performed for all Category II deficiencies within 30 days of the closing meeting date of the inspection or in accordance with the date indicated in the action plan. Follow-up could be a priority the following season for sugar bush establishments operating late in the season. If the establishment does not properly implement its corrective action plan, the inspector must follow the guidelines in section 3.7, Suspension of Registration, or section 3.8, Cancellation of Registration, as appropriate. 2.3.3 Follow-up for Category III deficiencies The compliance level required is 65% or more. Compliance level equal to or greater than 65% CORRECTIVE ACTION TIME FRAME The establishment must submit an action plan at the time of inspection or within a month of the closing meeting date of the inspection (see section 2.2.16). ACTION PLAN SUBMISSION TIME FRAME The company must implement corrective action within a year of the closing meeting date of the inspection (as outlined in the above Table I) or within a longer delay in accordance with the 20
action plan, in such a way that the program requirements are met. Low-risk deficiencies may require product assessment for quality or adulteration (refer to the Maple Products Inspection Manual for procedures). DIRECTED INSPECTION TIME FRAME Category III deficiencies will be followed up through directed inspections at the inspector s discretion (with the agreement of his or her supervisor). Compliance level less than 65% CORRECTIVE ACTION TIME FRAME The establishment must submit an action plan at the time of inspection or within a month of the closing meeting date of the inspection (see section 2.2.16). ACTION PLAN SUBMISSION TIME FRAME The company must implement corrective action within a year of the closing meeting date of the inspection (as outlined in the above Table I). Low-risk deficiencies may require product assessment for quality or adulteration (refer to the Maple Products Inspection Manual for procedures). DIRECTED INSPECTION TIME FRAME A directed plant inspection must be performed to determine compliance with the action plan within a year of the closing meeting date of the inspection or in accordance with the date indicated in the action plan. Follow-up could be a priority the following season for sugar bush establishments operating late in the season. If the establishment does not properly implement its corrective action plan, the inspector must follow the guidelines in section 3.8, Cancellation of Registration. 2.3.4 Follow-up for Category II and III deficiencies 21
If the plant does not achieve the compliance levels for both Category II (75%) and Category III (65%), the inspector must follow the guidelines applicable to Category II deficiencies (section 2.3.2) and to Category III deficiencies (section 2.3.3). 2.3.5 Critical health and safety implications An unsatisfactory evaluation for any Risk Category I or II items or direct contamination of the product can have health and safety implications. In such a situation, the establishment takes immediately or promptly the necessary corrective action to isolate the affected products while the problem is still present. If the establishment has not demonstrated to the inspector that the product is under control or safe, an inspector may seize, any agricultural product or other thing by means of or in relation to which the inspector believes on reasonable grounds that the Act or the regulations have been contravened; or that the inspector believes on reasonable grounds will afford evidence in respect of a contravention of the Act or the regulations. Laboratory analysis of the affected lots may be necessary to determine the product s safety. If a product potentially poses a risk to human health and has been distributed, the inspector must immediately contact his or her supervisor and provide the relevant details, in order to determine if a product recall is necessary as per the recall protocol. Seizure of the equipment must be considered and implemented if by means of or in relation to which the inspector believes on reasonable grounds that the Act or the regulations have been contravened; or that the inspector believes on reasonable grounds will afford evidence in respect of a contravention of the Act or the regulations. Suspension of the establishment s registration must be considered and implemented if necessary (refer to Chapter 3 for more details). 2.3.6 Repetitive deficiencies There may be occasions when an establishment repeatedly fails to submit its action plan or to carry out the necessary corrective action. Depending on the circumstances, the inspector can determine with his or her supervisor (in consultation with the programs) that the establishment does not meet the minimum requirements of the program. For example, in the case of repetitive Category III deficiencies, follow-up may not be necessary. If discussion and monitoring have not enabled the establishment to achieve the desired compliance level, an Area meeting should be arranged with the appropriate establishment manager to explain the deficiencies in detail and the reasons why they must be corrected. The meeting should end with the development of a mutually agreed upon action plan and a commitment for its implementation. 22
If subsequent directed inspections do not indicate satisfactory corrective action and it is felt that compliance will not be forthcoming, the procedure for suspending or cancelling registration must be initiated in consultation with a program specialist (refer to Chapter 3 for more details). 2.4 Safe work practices during an establishment inspection All inspection staff must be aware of the hazards present in their working environment. Pre-operational checks of the work area are essential to identify unsafe conditions or situations. If such conditions or situations are identified, they must be corrected before the inspection or testing activities begin. The inspection staff should not begin work at third-party premises until unsafe conditions and situations are corrected. Safe work practices combined with on-the-job training will help reduce the risk of injury to inspectors. The following safe work practices are to be observed when performing the inspection or testing tasks outlined in this manual. 2.4.1 Manual material handling At the establishment, inspectors must plan their visit and notify the operator, as explained in section 2.2. They can ask to have an operator representative assigned to assist them at all times while selecting samples as per subsection 21(3) of the Canada Agricultural Products Act. The proper lifting techniques when loading and unloading samples are as follows: Size up the load before lifting. Ensure that the travel way is clear of obstructions. Keep your feet at least a foot apart to provide a stable base. With a straight back, bend your knees to lift the load. Keep the load as close to your body as possible. Turn by pivoting at the feet, not by twisting at the waist. Use a dolly. Below are more guidelines for manual material handling (Canadian Centre for Occupational Health and Safety): Plan your lift. Reduce the size of the load. Reduce the distance a load is carried. Make multiple trips with smaller load sizes. 23
Assign more people to lift extra heavy loads. Use more than one person or a mechanical device to move the load. Before beginning an inspection at a workstation in the establishment, inspectors must ensure that the table height is adequate for performing the inspection, lighting is at least 540 lux and a chair is available. 2.4.2 Moving vehicles Inspectors must watch for all moving vehicles (tow motors, forklifts, trucks, etc.) while travelling around and within the operator s establishment. Designated walkways must be used when possible. It is important to bear in mind that pedestrians do not necessarily have the right of way. Inspectors must try to remain visible to vehicle operators and be aware of the dangers associated with vehicle exhaust fumes. 2.4.3 Personal protective equipment Inspectors must wear and be trained in the use, care and maintenance of personal protective equipment, in accordance with their scales of entitlement. Personal protective equipment requirements and safety measures are often recommended and listed on products or substances encountered in the workplace. The Workplace Hazardous Materials Information System (WHMIS) is a nationwide system designed to provide information on hazardous materials used in the workplace. There are three key elements to WHMIS: labels, material safety data sheets (MSDS) and worker education. The WHMIS label and, in its absence, the product label are sources of information on the relative toxicity (flammability, corrosivity, etc.) of a substance, the first-aid measures that should be taken if and when exposure does occur, recommended personal protective equipment that should be worn and a referral to the product MSDS. A system of symbols and risk phrases indicates the toxicity of the substance. The MSDS has more specific information about the product or substance and should be consulted if it is available at the site. Under the Protective Clothing heading, section 2.2.7 contains a list of the items that should be included as personal protective equipment. 24
2.4.4 Slip and fall prevention The risk of slipping, tripping and falling can be reduced by: wearing CSA- approved protective footwear; keeping footwear tread in good condition, replacing at 30% wear; practising good housekeeping; keeping work areas and walkways free from debris; and following safe work practices. 2.4.5 Establishment premises hazards During product sampling, inspectors must be aware of environmental conditions and any structural concerns (e.g. unprotected transit holes in warehouses) and must inform the manager/supervisor on duty of any hazards. 2.4.6 Climbing Inspectors must not climb up on skids, equipment or materials or stand on platforms being hoisted by a lift truck or on the lift truck forks. They must ask the establishment for assistance to obtain samples or items beyond their reach. 2.4.7 Emergency procedures Inspectors must be familiar with the emergency procedures of the establishment they are working in. They must also: know the emergency plan of the work site they are at; if such a plan does not exist, ensure that they have their own plan of escape if an emergency occurs; be aware of the emergency exits in their immediate work area (these exits must remain unlocked and unobstructed); and refer to appropriate material safety data sheets when dealing with chemical hazards. 2.4.8 Right to refuse 25
Inspectors always have the right to refuse to perform an inspection for occupational safety and health reasons. If they have doubts about they safety or a co-worker s safety, they must notify their supervisor and identify the safety issue. The safety issue must be addressed and resolved before inspectors can begin work. 26
ANNEX I - METHOD FOR CALCULATING COMPLIANCE PERCENTAGES (OVERALL RATING) Method for Calculating the Overall Compliance Rating The overall establishment rating is based on the calculation of the percentage of satisfactory tasks for each of Categories I, II and III. The calculation is performed using the Chapters 4 and 5 calculation tables and the overall compliance table that follows the inspection report. Calculation of compliance for each of Chapters 4 and 5 CALCULATION TABLE For each of chapters 4 and 5 Tasks Category I Category II Category III Unsatisfactory A I A II A III To Be Rated minus (N/A + N/I) B I B II B III 1. For Category I, in cell A I, add the total number of unsatisfactory Category I tasks from Chapter 4 (according to the inspection report) and write the result in A I. Formula: Total Unsatisfactory Cat I = A I 2. For Category I, in cell B I, add the total number of tasks that could be rated Category I. Then subtract from this total the number of tasks that could be rated Category I but were not inspected (N/I) and not applicable (N/A). Write the result in B I. 27
Formula: To Be Rated Cat I minus (N/A Cat I + N/I Cat I) = B I 3. Repeat operations 1 and 2 above for Categories II and III for each of Chapters 4 and 5, and write the results in the cells A II, A III, B II and B III. 28
Calculation of overall compliance rating OVERALL COMPLIANCE CALCULATION TABLE Chapters 4 and 5 combined Establishment Name: Registration No.: Tasks Category I Category II Category III Total unsatisfactory C I C II C III Total to be rated D I D II D III Compliance % = (D! C) / D x 100 E I E II E III 4. For Category I, in cell C I, add the Category I unsatisfactory tasks from Chapters 4 and 5. Write the result in C I. Formula: A I (Chap 4) + A I (Chap 5) = C I 5. For Category I, in cell D I, add the total number of tasks that could be rated Category I from Chapters 4 and 5. Write the result in D I. Formula: B I (Chap 4) + B I (Chap 5) = D I 6. Repeat operations 4 and 5 for the Category II and III tasks respectively, and write the results in the other cells C II, C III, D II and D III. 7. To determine the overall compliance % for Category I, perform the following calculation: (Total Number of Tasks to Be Rated Cat I minus Total Number of Tasks Rated Category I) Total Number of Tasks to Be Rated Cat I x 100. Write the result in E I. 29
Formula: (D I! C I) x 100 = E I D I 8. Repeat operation 7 for Categories II and III respectively. Write the results in E II and E III. 9. The overall establishment rating is E I, E II and E III. 30
ANNEX II - SAMPLE COVERING LETTER Canadian Food Inspection Agency [DATE] [NAME OF ESTABLISHMENT DIRECTOR] [NAME AND ADDRESS OF ESTABLISHMENT] Dear Sir/Madam: Subject: Establishment inspection results Please find enclosed the report on the in-depth inspection of your establishment that [INSPECTOR S NAME] and I conducted on [DATE]. During the exit interview at your establishment, all deficient items observed during the inspection were discussed with you and your staff. Deficient items in Health and Safety categories have resulted in ratings of % in Category I, % in Category II and % in Category III. You are reminded of sections 6 to 6.2 and/or 7 of the Maple Products Regulations under the Canada Agricultural Products Act. [IF NECESSARY, IDENTIFY THE CRITICAL DEFICIENCIES AND REFER TO THE APPROPRIATE SECTION OF THE REGULATIONS.] Attached to the report is a follow-up worksheet that may be used to indicate the dates on which corrective action will be implemented to address those items found unsatisfactory. Please forward your written and signed action plan to this office no later than [DATE: NOT MORE THAN ONE MONTH AFTER THE DATE OF THE INSPECTION]. We would like to thank you and your staff for your cooperation during the inspection. Please do not hesitate to contact me if you have any questions. Yours truly, [INSPECTOR S NAME] Processed Products Inspector 31