Seed Program Quality System Procedure - Official Crop Inspector Certification Procedures

4.0 OUTLINE

The Canadian Food Inspection Agency provides a variety of mandated and non- mandated crop inspection activities. Mandated crop inspection activities include:

• pedigreed seed crop inspection;
• reinspection of pedigreed seed crops;
• Breeder, Select, Foundation and probation plot inspection;
• land use inspection;
• inspections of seed crops conducted as part of the Authorized Crop Inspection Service program (surveillance audits);
• pre-variety germplasm inspections;
• post-harvest verification of isolation corrective actions;
• inspection of confined field trials and post-harvest land use to verify compliance with Part V of the Seeds Regulations.

Non-mandated crop inspection activities include:

• industrial hemp crop inspections on behalf of Health Canada;
• "additional requirements" inspections.

5.0 GENERAL REQUIREMENTS

5.1 Roles and Responsibilities

5.1.1 Programs

Seed Section

• develops quality systems documentation used in the performance of crop inspection activities other than industrial hemp and Plant Biosafety activities. In addition, the role of Seed Section in developing quality systems procedures for additional inspection services and certification standards will be determined on a case by case basis;
• develops written and practical evaluations of crop inspectors other than for industrial hemp and Plant Biosafety Office activities;
• provides consistent guidance on the assessment of written and practical evaluations to Area Network Specialists;
• receives the documents pertaining to assessment of personnel and retains them in a confidential manner;
• for candidates meeting the standards of the certification level sought, certifies the candidate;
• suspends, cancels and reinstates the certification of crop inspectors as appropriate;
• recommends to Health Canada the designation of inspectors under the Controlled Drugs and Substances Act as per QSP 144.1;
• classifies unclassified non-conformances;
• maintains the list of inspectors certified to conduct crop inspections;
• provides to CSGA the list of inspectors certified to conduct crop inspection.

Plant Biosafety Office

• develops quality systems documentation used in the performance of Plant Biosafety activities;
• develops written evaluations for the certification of inspectors for the Plant Biosafety specialization;
• provides guidance on the consistent assessment of written evaluations to Area Network Specialists;
• notifies Seed Section of evaluation results;
• receives documents pertaining to assessment of personnel and retains them in a confidential manner;
• for candidates meeting the standards of the Advanced level for Plant Biosafety activities, certifies the candidate;
• suspends, cancels and reinstates the certification of Plant Biosafety inspectors as appropriate;
• classifies previously unclassified non-conformances related to Plant Biosafety activities.

Area Network Specialists

• facilitate training of Operations staff, ensuring national consistency;
• assess written evaluations of candidates ensuring consistency of assessment within and between regions and over time;
• participate in program monitoring as appropriate;
• communicate with Operations staff regarding changes to certification or inspection procedures.

5.1.2 Operations Branch

• arranges for the training and evaluation of appropriate staff at the appropriate level;
• delivers training in a nationally consistent manner;
• arranges for appropriate training on related activities outside the certification process, including all required occupational health and safety training and administrative matters such as expense claims;
• maintains an appropriate number of staff certified at the appropriate level to address the operational requirements;
• reviews Reports of Seed Crop Inspection and related documentation and conducts monitoring visits;
• only assigns staff certified to perform the specific required task; where staff are not certified to perform the required task, they will be accompanied by certified staff under whose direct supervision they will conduct the activity;
• conducts practical evaluations;
• provides results of practical evaluations to Seed Section on a timely basis;
• upon request, provides verbal feedback to candidates following practical evaluation on areas of weakness;
• provides to CSGA annually the list of lead inspectors for each district.

5.2 Outline of Training and Evaluation for Crop Inspectors

5.2.1 Training and Evaluation of Basic and Intermediate Crop Inspectors

Training	Certification
Basic	Crop inspection of fields of commonly grown species producing Certified/ Registered crops
Training/Orientation
Work with inspector to learn skills - crops/varieties of easy to moderate level of difficulty including open pollinated corn
Administrative issues associated with crop inspection
Accompany Intermediate inspector on crop inspection of moderately difficult crops
Crop inspection of fields of commonly grown species producing Certified/ Registered seed
Intermediate	Crop inspection of Certified/ Registered crops of moderate difficulty including hybrid corn, hybrid alfalfa, industrial hemp and field beans
Refresher/ review
Crop inspection Certified/ Registered crops of moderate difficulty including hybrid corn
Accompany Advanced inspector for plots and crops of new species	Land use inspection Inspection for Recertification of crops
Training on identity preservation/recertification/land use
Introduction to plant biotechnology and Plant Biosafety issues
Expand ID skills, e.g. trickier varieties of previously inspected kind
Crop inspection of Foundation crops of commonly grown species	Crop inspection of Foundation crops of commonly grown species
Breeder, Select, Foundation and probation plots inspection	Plot inspections

5.2.2 Training and Evaluation of Advanced Crop Inspectors

Advanced level certification is divided into three certification specializations:

• Industrial Hemp - cultivation inspection and sampling on behalf of Health Canada
• Plant Biosafety - current year inspections - post harvest land use inspection
• Licensed Inspector Monitoring - monitoring of licensed inspectors.

In all cases, successful completion of Intermediate crop inspector certification is a prerequisite to the specialised Advanced level certification. An inspector need only become certified to perform the specific required duties.

6.0 CERTIFICATION REQUIREMENTS

Members of the original Certification Development Team are deemed to be certified at the Advanced level and competent to assess practical evaluations. Subsequent members will be assessed on a case by case basis.

Training and evaluation activities will be coordinated by the appropriate Area Seed Network Specialist in cooperation with the Area Training Officer.

Evaluations will measure knowledge and practical ability in pedigreed seed crop inspection and related activities. These evaluations will not include components outside the certification process such as occupational health and safety. The evaluations will be based on the established performance objectives described in the technical competencies for crop inspectors (Appendices I-III). The evaluations need not be administered together, however, the written evaluation would normally be administered first.

6.1 Written Evaluation

Written evaluations for official crop inspectors assess the theory and some practical components of the certifiable competencies at the certification level in question.

The written evaluations will be open book in order to assess comprehension, application and recall knowledge. A candidate who achieves a mark of at least 80% will be considered to have met the standards.

Written evaluations will be assessed by the Area Network Specialist. These evaluations may be administered in conjunction with a formal training program or separately following independent study of the course material.

During the written evaluation, the candidate will be permitted to consult the documents that would normally be available to a crop inspector in the performance of seed crop inspection (Appendix V). All questions will be based on those references. Candidates may not communicate with one another or with individuals other than the invigilator during the written evaluation.

The Seed Section and Plant Biosafety Office shall develop and maintain written evaluations that are approved by the National Manager, Seed Section/Plant Biosafety Office. Sample questions can be found in Appendix VI Sample Written Evaluation Questions.

The Seed Section and Plant Biosafety Office shall maintain administrative control over the written evaluations and will put in place a method to receive feedback and to incorporate improvements as required. The bank of evaluation questions shall be updated as amendments are made to crop inspection reference documents, or seed program policies and procedures. The Seed Section and Plant Biosafety Office will document atypical answers and the marking of these answers in order to provide consistency of assessment and interpretation over time. The marking of evaluations is not influenced by regional inconsistencies in training.

Written evaluations must be invigilated by the Area Network Specialist, a Crop Inspection Evaluator, an Operations supervisor, or an Operations program officer. The invigilator is responsible for contacting the Seed Section or Plant Biosafety Office to arrange for the delivery of a written evaluation. In order to maintain the integrity of the certification process, the invigilator must retain control of the written evaluations at all times. They must not be copied or distributed and may only be provided to a candidate at the location, time and date, and for the duration, established for the evaluation. Copies of written evaluations will not be provided for study purposes. Invigilators will be required to complete and submit the Record of Invigilation Form (Appendix VIII).

It is the responsibility of the invigilator to arrange a location for the written evaluation that has suitable lighting and is free from distractions. The invigilator must review the documents listed in Appendix V and ensure they are the only ones being referred to by a candidate during the written evaluation.

Where the invigilator is not the Area Network Specialist, the invigilator will forward completed evaluations immediately to the Area Network Specialist for assessment. Evaluations must be forwarded in a secure manner, such as by courier.

For Basic and Intermediate evaluations, candidates who complete the written evaluation outside the crop inspection season but have not completed the practical evaluation will be notified by Seed Section of their results only if they are unsuccessful. Otherwise, the candidate will be informed of the final mark by the Seed Section upon completion of both the written and the practical evaluations.

6.2 Practical Evaluation

Practical evaluations may be administered in conjunction with a formal training program or separately. It is strongly encouraged that candidates with no prior experience in crop inspection receive practical training and mentoring before attempting the practical evaluation.

The practical evaluation will be administered by a member of the certification development team or a certified inspector who has assisted in three practical evaluations at the certification level in question.

Practical evaluations involving crop inspections will be undertaken with the evaluator(s) accompanying each candidate individually. A crop of a species that is representative of the region will be assigned to the candidate(s). The crop must be preselected by the evaluator as being appropriate for use as an evaluation mechanism at the certification level in question. It should not be randomly selected. To the extent practical, candidates at each certification level should be presented with crop with equal levels of difficulty.

The candidates should not be allowed to communicate inspection observations among themselves. The candidates will not be allowed to ask questions of the evaluator(s) during the course of the evaluation, other than to request clarification.

The candidates will be observed directly by the evaluator(s) and will be assessed on their actions during the crop inspection including their conduct of the crop inspection and the quality of the Report of Seed Crop Inspection. Candidates will have access to any written materials that would normally be available to an inspector during crop inspection. The evaluator will provide a description of the variety being inspected to the candidate along with the Application for Crop Inspection and relevant maps.

The practical evaluation will not be terminated upon observation of a critical non- conformance. Complete evaluation will allow for full assessment and will allow for effective remedial training. The evaluation must assess all portions of the practical evaluation using the instructions provided with the evaluation. Failure to do so may result in the need for a candidate to repeat the evaluation.

Practical evaluations involving role plays will be administered by two evaluators, one of whom will participate in the role play and one of whom will observe the role play.

A negative marking scheme will be used for the evaluation. The candidate will begin the evaluation with a mark of 100%. Marks will be deducted for non-conformances. Partially incorrect activities will be deducted part marks. The classification of non- conformances will be consistent with that used during monitoring (Appendix IV). The evaluation will ensure that basic technical competencies are addressed. Points will be deducted for incorrect or incomplete answers or improper use of procedures, equipment, etc. The candidate must have a final mark of at least 80% to successfully meet the standard. Candidates will not have access to the marking scheme during the practical evaluation (Appendix VII).

Evaluation results will be forwarded to the Chief of the Seed Design and Delivery Office, Seed Section.

6.3 Evaluation Results Communication

The crop inspection evaluator will provide verbal feedback following the practical evaluation on areas of weakness only. No indication will be provided at that time on whether the candidate met the standards. For all certifications except the Plant Biosafety specialization, Seed Section will, upon completion of the written and practical evaluation, inform the candidate in writing, the marks obtained and the certification results. Where candidates complete the written evaluation outside the crop inspection season and have not completed the practical evaluation, Seed Section will notify the candidate of their results only if the candidate is unsuccessful. The Plant Biosafety Office will communicate with candidates for the Plant Biosafety specialization. Written feedback on areas of weakness on the written or practical evaluations:

• will not be provided to candidates achieving a mark of 95% or higher;
• will be provided if requested in writing to candidates achieving a mark 80-94%;
• will be provided in all cases where the candidate does not meet the standard;
• will be provided by the National Manager, Seed Section/Plant Biosafety Office.

Inspection managers/supervisors and area training officers will be informed whether the candidate meets/does not meet the standards. Where a candidate has not met the standards, the inspection manager/supervisor will arrange for the candidate to receive additional training on a timely basis.

Evaluation results are considered confidential information. Distribution of information regarding the evaluations shall be governed by the confidentiality guidelines regarding personal information established in the Privacy Act.

6.4 Evaluation Reassessment

Candidates receiving a final mark of 85% or less may request in writing the assessment of their evaluation. The assessment may result in raising or lowering the final mark.

6.5 Re-evaluation

An unsuccessful candidate will require training. The candidate may retake a written and/or practical evaluation at their request, subject to the availability of rewrite evaluations and invigilators or evaluators.

Candidates who are unsuccessful in the written evaluation at the Basic, Intermediate or Advanced level will be required to rewrite the entire evaluation.

Candidates who are unsuccessful in the practical evaluation at the Basic level will be required to reattempt the entire evaluation. At the Intermediate and Advanced specialization in industrial hemp, an unsuccessful candidate will only be required to reattempt the portion of the practical evaluation where he/she did not meet the standard. For example, if the candidate was unsuccessful on the plot inspection portion of the Intermediate practical exam but was successful in the role play on land use, the candidate would only be re-assessed on the plot section of the evaluation.

7.0 CERTIFICATION

Both the written and practical evaluations for a specific level must be successfully completed by the end of the subsequent crop inspection season from which the initial evaluation was started. For example, if a candidate took Basic level training and successfully completed the written exam in February of 2008, the candidate would have until the end of the 2009 crop inspection season to successfully complete the Basic level practical exam.

A candidate may be evaluated for more than one level in a single year. However, an inspector must meet the standards for the lower certification level before being certified at the higher level.

Upon successful completion of written and practical evaluations for crop inspection, the Chief, Seed Design and Delivery, Seed Section:

• will assign the inspector an inspection number, where appropriate;
• inform the candidate and the inspection manager/supervisor and Area training officer of the certification of the inspector;
• enter the inspector's name, inspector number and certification level in the List of Crop Inspectors;
• inform the Canadian Seed Growers' Association of certification and level.
• issue an Official Crop Inspector Certificate (Appendix IX).

In order to perform industrial hemp inspections on behalf of Health Canada, an inspector must also be designated by Health Canada under the Controlled Drugs and Substances Act.

8.0 MONITORING CROP INSPECTORS

The on-going verification of conformance with standards is a critical component to quality systems.

Monitoring performance allows for the:

• timely identification of non-conformances;
• feedback to the inspector;
• clarification of training;
• correction of performance.

The classification of non-conformances allows for nationally consistent interpretation of the non-conformance and appropriate response times to facilitate fair and consistent actions. This section provides information on remedial activities within the context of an ISO based quality system. Appendix X provides a sample record that may be used in annual monitoring of crop inspectors. Appendix XI provides a monitoring record for individual staff, this record assists in recording the monitoring frequency for the subsequent year.

8.1 Monitoring Basic Crop Inspectors

In the first field season, the lead inspector will:

• review all crop inspection reports submitted by the inspector;
• conduct crop visits emphasizing inspections of species not previously encountered by the inspector.

If less than five minor non-conformances and no major or critical non-conformances are identified during the first field season following certification, the monitoring frequency will be:

• 2 - 3 field visits would be conducted. Additional monitoring would be performed only if three or more minor or any major or critical non- conformances are identified during the initial field trial visits;
• 10% of Reports of Seed Crop Inspection would be reviewed.

8.2 Monitoring Intermediate Crop Inspectors

In the first field season following certification, the lead inspector will:

• review all Reports of Seed Crop Inspection pertaining to Foundation crops and plots, and crops/varieties of moderate difficulty;
• review 10% of all Reports of Seed Crop Inspection related to Basic level activities;
• conduct a minimum of three and a maximum of six field visits of inspections including at least one of each of Foundation crops, plots, land use, crops/ varieties of moderate difficulty and, where appropriate, recertification. Additional field visits would be performed only if three or more minor non-conformances or any major or critical non-conformances are identified during the initial field visits.

If less than four minor non-conformances and no major or critical non-conformances are identified during the first field season following Intermediate certification, the monitoring frequency will be:

• 10% of all Reports of Seed Crop Inspection pertaining to Intermediate level activities;
• 2-3 field visits pertaining to Intermediate level activities would be conducted. Additional monitoring would be performed only if three or more minor and any major or critical non-conformances are identified the initial field visits.

If there is a gap in the seasons of employment, the inspector would be monitored in the first year of re-employment at the same level as in the first year of Intermediate certification.

8.3 Monitoring Advanced Crop Inspectors

For Plant Biosafety activities, the Plant Biosafety Office will review all inspection reports submitted by the inspector. When the Plant Biosafety Office identifies that information in reports is missing, incorrect or presented in an inconsistent manner, they will classify the non-conformance according to Appendix IV, complete an action request form and contact the inspector and/or inspection supervisor. When the Plant Biosafety Office identifies the need for additional monitoring, field visits will be performed by the Area Network Specialist.

For industrial hemp monitoring and sampling activities done on behalf of Health Canada, Health Canada will review all inspection reports submitted by the inspector. When the Office of Controlled Drugs and Substances identifies that information in reports is missing, incorrect or presented in an inconsistent manner, they will classify the non-conformance according to Appendix IV, complete an action request form and contact the inspector and/or inspection supervisor. A copy will be sent to the Seed Design and Delivery Office.

The Office of Controlled Drugs and Substances will track and report annually to the National Industrial Hemp Liaison Officer, Seed Section, the number and types of concerns relating to Industrial Hemp Field Inspection Reports. A summarized report will be routed to the lead inspector through the Area Network Specialist. When Health Canada identifies the need for additional monitoring, this will done by the Area Network Specialist.

For Basic or Intermediate activities performed by an Advanced level inspector, 10% of these reports must be reviewed by the Regional Seed Program Officer. For regions that do not have a Seed Program Officer, reports must be reviewed by an individual or individuals designated by the Region providing at least one individual has been certified at the Advanced level in that region to provide technical guidance.

If no non-conformances of any kind pertaining to Basic and Intermediate activities are identified during monitoring, no monitoring would be conducted for two calendar years. Subsequent monitoring would be done at the previously described frequencies for the Advanced level.

8.4 CSGA Surveillance of Reports of Seed Crop Inspection

When the CSGA identifies information that is missing or inconsistent in Reports of Seed Crop Inspection, the CSGA staff will contact the lead inspector. The lead inspector will determine if the omission/error is a non-conformance and, if so, will classify the non-conformance.

CSGA will track and report annually to the National Manager, Seed Section, the number and types of concerns relating to Reports of Seed Crop Inspection. A summarized report will be routed to the lead inspector through the Area Network Specialist.

8.5 Classification of Non-Conformances

Any non-conformances identified by the lead inspector, the CSGA, the Plant Biosafety Office or the Office of Controlled Drugs and Substances will be classified according to Appendix IV.

8.5.1 Where different minor non-conformances are identified:

• by the lead inspector within one inspection season
• the CSGA, Office of Controlled Drugs and Substances or Plant Biosafety Office during one inspection season,
  
  multiple minor non-conformances will be classified as a major non-conformance as follows

  Basic	5
  Intermediate	4
  Advanced	3

Where the same minor non-conformance has been identified on multiple occasions

• by the lead inspector during the current and/or two previous inspection seasons
• by the CSGA, Office of Controlled Drugs and Substances or Plant Biosafety Office during the current and/or previous two inspection seasons, it is to be classified as a major non-conformance using the table above.

The same principles are to be applied for the elevation of major non-conformances to critical.

Under no circumstances may a corrective action request be issued to an inspector where a non-conformance results from:

• circumstances beyond the inspector's control;
• the need to avoid a hazard to the inspector's health and safety;
• compliance with the direction of his supervisor.

8.6 Responses to Non-Conformances

For minor non-conformances, the lead inspector will communicate verbally with the inspector as to the nature of the non-conformance and will provide a suggested corrective action.

The lead inspector will note the date of this communication and the nature of the non- conformances in his quality systems record.

For a major or critical non-conformance (including elevated minor non-conformance), the lead inspector will complete a standard action request form, discuss the corrective action request with the inspector and agree on a corrective action. Both parties will sign the action request. The lead inspector will retain the document in his quality systems records. In the case of a critical non-conformance, the certification of the inspector is considered to be suspended until the corrective action is taken and verified. The lead inspector will communicate recommendations for suspension of certification to Seed Section on a timely basis.

The inspector must undertake/initiate corrective action within the response time and the corrective action must be verified prior to the closure time to ensure performance standards are met. The maximum allowable response time and maximum time for closure that shall be set for any specific action request are found in the following table:

Non-Conformity Type	Maximum Response Time	Maximum Time for Closure
Minor	10 days*	60 days
Major	4 days	30 days
Critical	1 day	5 days

* calendar days

Where the lead inspector is not the supervisor of the certified inspector, the lead inspector will communicate detailed information to the supervisor regarding the non- conformance. The supervisor will be responsible for communication with the inspector in question, for maintaining all quality systems records and tracking corrective actions.

Where corrective action is not implemented and verified within the maximum time for closure, minor and non-conformances will be elevated one level. Failure to close a critical non-conformance within the closure time will result in recommendation for suspension of certification.

9.0 SUSPENSION/ CANCELLATION OF CERTIFICATION

The suspension/cancellation of certification resulting from a non-conformance related to a competency at the Advanced level will result in a suspension/cancellation of Advanced level specialized certification but retention of Intermediate certification and any other specialized Advanced certification covered by this QSP.

The suspension/cancellation of certification resulting from a non-conformance related to a competency at the Intermediate level will result in suspension/cancellation of Intermediate and, if applicable, any Advanced level certification, but retention of Basic certification.

The suspension/cancellation of certification resulting from a non-conformance related to a competency at the Basic level will result in suspension/cancellation of certification as a crop inspector.

The certification suspension/cancellation must not be recommended where the ability to take corrective actions or to verify corrective actions are beyond the inspector's control.

The certification of a crop inspector will be suspended when a critical non- conformance is identified during a review of Reports of Seed Crop Inspection, other crop inspection report or a field visit and corrective action is not taken within the required closure time. Certification will also be suspended when an inspector leaves the employment of CFIA. This determination will be made each March 30.

The certification of a crop inspector will be cancelled when:

• an inspector no longer has the physical capacity to perform the functions of a crop inspector;
• the certification has been suspended for a period of two years and no corrective action pertaining to the suspension has been taken;
• the inspector provides false or misleading information as part of a Report of Seed Crop Inspection;
• the inspector obtains his certification by inappropriate means;
• an inspector is recommended for suspension for the third time in a six year period;
• an inspector has not been employed by the CFIA for a period of two years.

10.0 REINSTATEMENT OF CERTIFICATION

Where a certification has been suspended, the certification will be reinstated upon successful completion of :

• remedial training or corrective action; or
• a practical evaluation.

Where a certification has been cancelled, the certification will be reinstated upon the successful completion of all evaluations pertaining to the effected cancellations.

In both cases, the monitoring frequency for a reinstated inspector is identical to that of a newly certified inspector.

11.0 IMPLEMENTATION OF CERTIFICATION

As of April 1, 2008, inspection managers and supervisors will only assign Basic and Intermediate level crop inspection and Advanced level Plant Biosafety activities to those inspectors who are certified to perform the specific activity.

Monitoring of crop inspection activities will not be fully implemented until April 1, 2008. Prior to this date, monitoring activities described by this QSP will be undertaken only of inspectors who are certified.

11.1 Records And Administration

Records shall be maintained in support of the official crop inspector certification program. All records shall be maintained in accordance with the confidentiality guidelines regarding personal information established in the Privacy Act.

The following records shall be maintained:

Action Request Forms: shall be retained by the lead inspector with a copy sent to the inspector.

Certificates: a copy of the inspector's certificate shall be retained by the Seed Section.

Evaluation Records: shall be kept in a confidential file by the Seed Section/Plant Biosafety Office.

List of Official Crop Inspectors: the Seed Section shall maintain the list of official crop inspectors. This list shall be provided to the CFIA inspection offices and the CSGA. A name shall be entered on the list after Seed Section receives the required documentation indicating certification standards have been met. Inspection Managers will notify Seed Section of any changes in the employment status of an official crop inspector under their jurisdiction. Seed Section will issue a notification when any changes are made to the official list.

The List of Official Crop Inspectors shall contain the following information:

• name of the certified crop inspector;
• certification status and level;
• certification date;
• date the list was last updated.

Monitoring Records: annual monitoring reports indicating monitoring level, number and classification of non-conformances shall be maintained by the Regional Seed Program Officer or designated individual and must be kept in a confidential file.

Official Crop Inspector Database: the Seed Section shall maintain an Official Crop Inspector Database that contains the following information:

• name of official crop inspector
• inspector number
• date of certification
• certification status
• dates of suspension, cancellation and/or reinstatement
• date record last updated

Training Records: shall be kept on file by a candidate's supervisor and the appropriate Area Training Officer.