ARCHIVED - Audit of the Management Process for Corrective Action Requests - Report

This page has been archived

Information identified as archived is provided for reference, research or record-keeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.

March 2013

Table of Contents


1.0 Executive Summary

Introduction

The Canadian Food Inspection Agency (CFIA, the Agency) plays a key role in maintaining Canada's food safety system. The method in which food is produced and distributed has undergone fundamental changes in recent years. The CFIA is reacting to these changes by implementing an aggressive change agenda.

A key initiative is Inspection Modernization. The Government of Canada's 2011 Budget committed $100 million over five years for the CFIA to modernize its food inspection system. This includes resources to improve inspection delivery, training and tools for inspection staff, scientific capacity in food laboratories, and information management and technology.

As part of this modernization initiative, the Agency has committed to develop an improved food inspection model. The model proposes applying a single compliance and enforcement strategy based on the principle that industry is responsible for producing safe food that complies with regulatory requirements. When non-compliance is found, industry would be responsible for taking appropriate action to correct the situation. The model aims to make compliance and enforcement transparent, predictable and appropriate to the level of non-compliance.

The focus of this audit was the process for managing Corrective Action Requests (CARs), which is the primary inspection tool to manage inspection compliance and enforcement activities. The Meat and Feed Programs, use the Compliance Verification System (CVS) inspection tool, were the two CFIA programs reviewed. Under CVS, if a situation of non-compliance is identified, an Inspection Report – Corrective Action Request (CAR) - is issued. The CAR identifies the area of non-compliance and requires the operator to implement corrective measures by a specific date. Operators respond by providing an acceptable corrective action plan (CAP) and effectively implementing the CAP by that date. The CAR is closed once corrective action has been deemed acceptable after a follow-up inspection by the Agency. In the event of continued non-compliance, the file may be escalated for further enforcement activity.

As the new proposed inspection model is similar to the CVS inspection tool, the findings from this audit can help inform the shift to a more consistent and risk-based approach to delivering programs under Inspection Modernization. A key aspect of the proposed model is the reliance on information for making risk-based decisions and the Agency's ability to direct compliance efforts based on risk assessments of historical data.

It is critical that compliance and enforcement decisions be based on accurate and sufficient data analysis. Inspectors and Inspection Managers require efficient, real-time access to the information they need for decision-making. A significant finding of this audit relates to the management of the overall compliance history of a regulated party.

Also under the Agency's change agenda, a suite of transparency and service related initiatives are being advanced. The CFIA has recently begun several activities to enhance transparency, improve engagement with stakeholders and increase accountability. One such activity is the posting of enforcement and compliance information on the CFIA's website. This further emphasizes the need for accurate, complete and real-time information.

Audit Objective and Scope

The objective of the audit was to provide assurance that the governance, risk management and control framework for the management of Corrective Action Requests (CARs) is adequate.

The scope was limited to CARs issued under the CVS inspection tool in the Meat Program (Food Business Line) and Feed Program (Animal Business Line). The audit scope included CARs issued in fiscal years 2010-11 and 2011-12 as of September 30, 2011.

Key Findings and Conclusion

Key Findings

The audit found that components of the control framework for managing the CAR process are in place. However, opportunities exist to strengthen key aspects of the overall process, including information for decision making, managerial oversight, and record keeping.

The CFIA's Compliance and Enforcement Operational Policy and the Enforcement Manuals in the Meat and Feed Programs, state that the compliance history of a regulated party be considered when making enforcement decisions. This includes reviewing previous instances of non-compliance and the seriousness of past non-compliance. While most components of the compliance history of regulated parties are available in various forms within the CFIA, this information is not readily available in a comprehensive format to allow inspection staff efficient and real-time access when making compliance and enforcement decisions.

The CFIA has a Quality Management System (QMS) in place whereby quality verifications are carried out on completed inspection files, which include CAR activities. The QMS contributes to the overall quality of program delivery, but it is insufficient as a sole monitoring and oversight tool for CARs. For example, specific oversight is required to ensure that high risk and open CARs are adequately monitored. The strengthening of performance reporting and roles and responsibilities will facilitate appropriate monitoring.

Limited transactional information on CARs and their status is recorded in two databases. The National Inspection Division (NID), Operations Branch has a Data Quality Assurance Program in place to ensure a high level of data integrity. Recent improvements were noted in the timeliness of performance reports; however, further improvements are required to ensure that the necessary information is being recorded and available for decision-making at all levels of management in a timely manner.

Our review of 96 inspection files containing CARs indicated that 79% of the files were not sufficiently documented to fully support the CAR process. While it is recognized that inspection staff are required to apply some degree of professional judgment and expertise in their work, an adequate record or file is necessary to support the Agency's due diligence and provide evidence to support possible investigation or prosecution activities.

Conclusion

In conclusion, while a control framework for managing CARs issued under the CVS inspection tool exists, improvements are required in the areas of information management and reporting, monitoring and oversight, and file documentation.

The report includes four recommendations to address areas where improvements are required. Management agrees with the recommendations and its response indicates its commitment to take action. Further, the findings and recommendations will be considered as the Agency progresses with its change agenda, specifically in the areas of inspection modernization and transparency.

2.0 Introduction

2.1 Background

The Canadian Food Inspection Agency (the CFIA or the Agency) is the largest science-based regulator in Canada, with approximately 7,200 employees located in the National Capital Region and four operational Areas (Atlantic, Quebec, Ontario and the West). The Agency is responsible for administering and/or enforcing 13 federal statutes and 38 sets of associated regulations, which govern the safety, nutritional quality and labelling of food sold in Canada and that support a sustainable plant and animal resource base.

The CFIA works with its partners to implement food safety measures, to manage food/ animal/ plant risks and emergencies, as well as to promote the development of food safety and disease control systems. The objective of which is to maintain the safety of Canada's high-quality agriculture, aquaculture/fisheries and agri-food products.

The CFIA takes a three-tiered approach to compliance and enforcement management. The first approach is outlined in the CFIA Compliance and Enforcement Operational Policy. It describes the Agency's approach to compliance management activities, ranging from assisting regulated parties in understanding their obligations to comply with legislative requirements, and extends to monitoring compliance, performing inspection activities, to the various tools available to the CFIA to respond to non-compliance. The second approach is program specific enforcement strategies, and the third approach involves procedures detailing enforcement-related information for each individual program.

It is the responsibility of regulated parties to comply with all relevant Acts and Regulations. Should non-compliance be identified, the consequences are to be clearly identified, predictable and consistently applied.

The Policy and Programs Branch is responsible for establishing program-specific policies and procedural documents based on regulatory requirements. The Operations Branch monitors and assesses industry's compliance with legislation through a variety of compliance management activities, including inspections. When conducting inspections, inspection staff exercise authorities designated in Acts and Regulations, which include the authority to enter and inspect, open containers, examine regulated products or documents, conduct tests, take samples or seize and detain products. Inspectors must verify that regulatory requirements are met in order to determine whether or not the entity is compliant.

The Compliance Verification System (CVS) is an inspecton tool used by CFIA staff to verify regulated party compliance to regulations. The first program to adopt CVS was Meat Hygiene; it was implemented in all meat facilities across the country in 2008. The Feed Program began conducting inspections using the CVS approach at commercial feed mills, on-farm feed mills, retail feed outlets and rendering plants effective April 2009. The CVS was further rolled-out into the Humane Transport Program and the Livestock Identification and Traceability Program in November 2011.

The CVS consists of a number of verification tasks that are linked to specific regulatory requirements. These verification tasks contain detailed procedures for inspection staff to follow when determing compliance. The CVS includes guidance for assigning levels of compliance, as well as reporting tools that allow data to be captured and analyzed. Inspectors conduct CVS verification tasks according to the prescribed frequency described in the establishment profiles. Inspectors document the task results on CVS verification worksheets, and submit these worksheets for data capture on a weekly basis.

If an inspector identifies a situation of non-compliance, an Inspection Report – Corrective Action Request (CAR) - is issued. In the meat program, a CAR will identify areas of non-compliance with regulatory or policy requirements in the areas of food safety, non-food safety, export, HACCP design, animal welfare and sampling. In the feed program, the tasks have been designed to emphasize industry accountability. Inspectors issue CARs based on verification activities which identify non-compliance to Feeds Act and Regulations and/or the Health of Animals Act and Regulations.

Operators respond by providing an acceptable corrective action plan (CAP) and effectively implementing the CAP by a specified date. The CAR is closed once corrective action has been deemed acceptable after a follow-up inspection by the Agency. In the event of continued non-compliance, the file may be escalated for further enforcement activity.

Based on the data provided to the audit team by the National Inspection Division (NID), there were 2,405 CARs issued to 486 registered meat establishments during the 18 month scope period of the audit. During the same period, there were 3,403 CARs issued to 1,039 feed/rendering mills.

2.2 Objective

The objective of the audit was to provide assurance that the governance, risk management and control framework for the management of Corrective Action Requests (CARs) is adequate.

2.3 Scope

The scope was limited to CARs issued under the CVS inspection tool in the Meat Program (Food Business Line) and Feed Program (Animal Business Line). The audit scope included CARs issued in fiscal years 2010-11 and 2011-12 as of September 30, 2011.

For the purpose of this audit, the lifespan of a CAR begins at the point when an inspector has determined non-compliance of a task and issues a CAR, until the closure or escalation of that CAR. Resolution of non-compliance through the Enforcement and Investigation Services (EIS) Division was outside of the scope of this audit.

The audit did not assess the IT systems or system controls used to manage CAR data; however data from the systems was reviewed and analyzed in support of management decision making information.

2.4 Methodology and Approach

Audit criteria (see Appendix A) were developed to serve as standards against which our assessment was made and form the basis for the conduct of the audit. The criteria were derived from a risk and control assessment of CAR processes outlined in Chapters 14 and 18 of the Meat Hygiene Manual of Procedures, the Feed Compliance Verification System Procedural Manual and the Feed Compliance Verification System Enforcement Procedures. These audit criteria support the audit objective and scope. A correlation table between the criteria and the audit findings is presented in Appendix B.

The fieldwork for this audit was substantially completed on June 29, 2012.

A detailed file review was conducted to gather evidence in support of audit observations. A sample of 96 inspection files containing CARs was selected using professional judgment.

The 96 files reviewed are as follows:

Area Meat Feed Total
Ontario 1 4 5
Quebec 24 16 40
Western 23 28 51
Total 48 48 96

The selection of files recognizes the logistical challenges of obtaining the required documentation from a decentralized environment and also that inspection files in the Meat Program are not maintained on CFIA property. The audit team conducted site visits to registered establishments in order to access original inspection files held at these off-site locations. File documentation relating to CAR activities were assessed and analyzed using checklists developed and tested during the planning phase of the audit.

2.5 Statement of Assurance

The audit was conducted in accordance with the Internal Auditing Standards for the Government of Canada as required under the Treasury Board Policy on Internal Audit and has examined sufficient, relevant evidence and obtained sufficient information and explanations to provide a high level of assurance in support of the audit conclusion.

3.0 Findings and Recommendations

3.1 Compliance History Management

The compliance history of regulated parties is not captured or recorded in a comprehensive manner.

We expected that the compliance history of a regulated party would be complete, comprehensive, recorded and readily available to Agency officials making compliance and enforcement decisions.

We found that a complete compliance history of a regulated party is not captured or recorded in a single, comprehensive information system. Although many components of compliance information on an individual regulated party are available in many cases, the information is scattered throughout the Agency in various forms. As such, CFIA officials responsible for compliance decisions are not afforded the benefit of a real-time complete picture of a regulated party's history to make clear and consistent decisions supported by adequate evidence and appropriate documentation.

When determining a response to non-compliance, the nature and severity of the consequences are to be proportionate with the nature of the non-compliance. The full assessment should take into consideration the seriousness of harm, history and intent. The compliance history of the regulated party is to be considered with respect to the existence of previous instances of non-compliance and the seriousness of past non-compliance. This consideration is important when determining appropriate inspection enforcement action. CFIA's inspection and enforcement policies dictate that the compliance history of a regulated party must be considered when:

  • Making compliance / enforcement recommendations and decisions;
  • Responding to non-compliance;
  • Hazard Analysis Critical Control Point (HACCP)Footnote 1 system design audits / inspections;
  • Determining task frequency in the context of the risk based strategy; and
  • Conducting enforcement investigations.

In addition to previous instances of non-compliance, the following information would aid in contributing to a comprehensive compliance history:

  • License suspensions or cancellations;
  • Results of Management Review Team (MRT) decisions / outcomes;
  • Recalls and recall investigations;
  • Linking of a CAR to previous similar instances to identify root causes;
  • Final Notices of Non-Compliance;
  • Previous fines / Administrative Monetary Penalties (AMPs);
  • Decisions on Request for Reviews by operators;
  • CARs forwarded to EIS;
  • CARs forwarded to other regulators (e.g. Health Canada); and
  • Similar CFIA enforcement decisions for similar non-compliances in other Areas.

Interviews indicated that the undocumented recollection of the inspector is relied upon when gathering historical compliance information. This poses a significant risk where new or less experienced inspection staff is in place as well as in regions where staff are regularly rotated between facilities.

Recommendation 1.0:
It is recommended that the Agency identify essential information that would constitute a complete compliance history and ensure this information is readily accessible to individuals making compliance and enforcement decisions.

3.2 Active Monitoring and Oversight

Demonstrated active monitoring and oversight of CARs could be strengthened.

We expected that active monitoring and oversight of CARs was being carried out to confirm that CARs are being closed as prescribed to ensure industry compliance.

We found that there is limited active monitoring or oversight of CAR activity to demonstrate that compliance and enforcement activities are sufficiently controlled.

Structured supervisory and managerial monitoring through the Quality Management System (QMS) is established. Verifications are carried out on completed inspection files by Operations Branch staff in an effort to implement continuous improvements to the consistency and overall quality of the regulatory, service and incident management activities.

The QMS activities are conducted with a focus on detecting and resolving identified quality loss issues. Quality Verifications (QVs) are reactive in nature as they are carried out on completed inspection files after the fact. Although QMS results contribute to the overall quality of program delivery, monitoring and oversight needs to extend further than the current level to ensure that compliance and enforcement activities are effectively managed.

There is no common tool in place for the day-to-day monitoring of CAR activities including the management of overdue CARs, extensions to action plan submission dates and/or implementation date extensions. Some Areas are performing limited active monitoring for CARs. In the absence of a formal monitoring strategy, individual customized tools, with varying levels of sophistication, have been developed and are being used throughout the Agency.

It is the expectation of the Operations Strategy and Delivery (OSD) Division within the Operations Branch that Inspection Managers, specifically in situations of non-compliance, support the activities carried out by the inspectors and inspection supervisors. In particular, they should be responsible for monitoring the status of outstanding CARs to ensure the regulated party is not prolonging or avoiding compliance.

In addition, there was no specific oversight of CARs issued for high risk tasks. CVS tasks are determined to be high risk through the Risk Based Strategy in the Meat Program and are imbedded in the Procedures Manual for the Feed Program. The frequency of the tasks is based on the level of risk assigned. The higher the risk, the more frequent the task.

It is noted that in the event of non-compliance to food safety regulations, control is immediately implemented to eliminate all food safety deviations. In cases where further action is required to gain full compliance, such as the training of plant employees, the operator must implement temporary measures to fully manage food safety issues until such a time as the CAR can be closed.

There are no specific monitoring activities being conducted to ensure that CARs issued against high risk tasks are being flagged, tracked and managed in an effective manner. For example, during the period covered by the audit, there were 127 CARs issued against daily tasks (i.e., high risk tasks) in the Meat Program. Audit analysis determined that these high risk CARs were open for an average of 65 days, with one daily task CAR being open for a total of 379 days.

Although the maximum timelines for submission of an action plan and the completion of corrective measures are intended as a guide in the program specific manuals of procedure, the date specified by the inspector for completion of corrective measures must reflect the seriousness of the non-compliance. The maximum guideline for the submission of an action plan is 14 calendar days, and 60 days is the guideline for the implementation of corrective measures. There was no evidence demonstrating that open CARs are afforded adequate monitoring and oversight to ensure timely resolution.

In both programs there are specific tasks that trigger subsequent tasks to be conducted when a CAR is issued. There was also no demonstrated flagging or tracking of these high risk tasks to ensure this was being carried out as prescribed in the procedures manuals.

Individual roles and responsibilities pertaining to CAR related activities are outlined in the program specific manuals and enforcement procedures. Auditors found that the Roles and Responsibilities sections of both MOPs and Enforcement Procedures Manuals need to be clarified. For example, Inspection Managers are not prescribed any specific duties in either the Feed or Meat MOP Roles and Responsibilities sections. Although their role is mentioned in the generic Roles and Responsibilities sections, the responsibilities are not fully articulated. Job descriptions for Inspection Managers did not encompass specific compliance oversight responsibilities. The Management Review Team (MRT), for which the Inspection Manager is responsible, is a key control in the process as this is the management body which provides support, guidance and recommendations to the designated CFIA official responsible to take action in the course of inspection enforcement activities. The audit found that the manuals were not all-encompassing for the role of this oversight body.

Without management monitoring and oversight, the Agency cannot demonstrate that the resolution of CARs is effectively managed and that high risk and open CARs are addressed in a timely manner.

Recommendation 2.0:
A risk-based approach to monitoring and oversight should be developed outlining specific roles and responsibilities to ensure CARs are being effectively managed.

3.3 Performance Information for Decision Making

CAR information for decision making is not fully defined or provided to the appropriate levels of management in a timely manner.

We expected that all levels of management receive the required information for decision making.

We found that the reporting of CAR information is not targeted to all levels of management, specifically the Inspection Manager and Inspection Supervisor levels, and the information requirements are not defined.

In the Meat Program there are quarterly and annual reports issued to the Regional Directors, Area Executive Directors, and the Vice President of the Operations Branch. The main purpose of these reports is to provide information on the delivery rates of inspection activities. There is limited information contained in these reports on CARs performance. For example, reports for the Vice President and Executive Director only contain one table identifying establishments that have never been issued a CAR. The Regional Director reports have three tables highlighting the following CAR activity:

  • the number of tasks rated "U"Footnote 2 (i.e.: CAR) by establishment;
  • the number of high risk Listeria sampling tasks that have been rated “U”; and
  • CARs past due, by establishment, with the number of days overdue.

Although the reports are useful, sufficient CAR information is not being provided to the appropriate levels of management within the organization. The Agency has not conducted a needs analysis to determine the level, type or frequency of CAR information required at each level of management for decision making purposes.

Until recently, these reports were being distributed to senior management up to four months after the end of the reporting period. Reports are now being issued six weeks post quarter.

These reports are not being delivered directly to Inspection Managers or Inspection Supervisors. It is the intention that these reports, once received in the Regions, be shared with inspection staff; however many inspection staff interviewed indicated that they did not receive this information.

NID has recently started distributing new reports for the Meat Program directly from the CVS database to Regional Directors, Area Operations Coordinators and the Area CVS Coordinators with the intent that this information be shared with inspection staff. These reports are disseminated monthly and report on open CARs past due over 30 days. Distribution of the reports is timely as they are sent out one or two days after the end of the month.

Compliance information for CARs in the Meat Program is captured and managed in the CVS Database, and in the Feed Program an Access database is used. The capability of the current databases is limited in that once the data has been submitted, there is no mechanism to update milestone information, e.g. revised due dates when extensions are granted.

The audit determined that the NID has a Data Quality Assurance Program in place and as such there was a high level of data integrity, less than a 2% error rate. Although the data contained in the two databases is accurate, it does not provide for a complete compliance history. The databases currently do not have the capability to capture key transactional information such as revised due dates, date and results of follow-up activities, MRT decisions, and final notices of non-compliance. The following CAR information is captured:

Meat Database Feed Database
Area Area
Region Region
Sub-District Facility Name
Establishment Number CAR Number
CAR Number Task Number
Task Number Facility Number
Act or Regulation Contravened Type
CAR Issue Date Feed Assure
Date of Corrective Action of Corrective Measures Risk Category
CAR Closed Date Date CAR Issued
CAR Issued by (Inspector) Written Corrective Action Plan Attached
Due Date
Action Plan Submission Date
Date CAR Closed
Inspectors Name

As crucial performance data is not being provided to the required levels of management, there is a risk that CARs may remain open longer than necessary and high risk CARs may not be effectively closed.

Recommendation 3.0:
It is recommended that timely information be disseminated to the appropriate levels of management to support effective decision making.

3.4 Record Keeping and File Documentation

Sufficient supporting documentation to substantiate compliance decisions was not evident in all cases.

We expected that inspection files would contain sufficient supporting documentation to substantiate compliance and enforcement decisions.

We found that the level and quality of supporting documentation on the inspection files did not always support compliance or enforcement decisions.

The procedural manuals for both programs contain a section on file maintenance. The meat MOP is not prescriptive with respect to required documentation to substantiate CAR activities as it does not itemize specific documents to support compliance activities. The Procedural Manual for the Feed Program is more robust as it itemizes all applicable documents required to support the inspection.

The audit team reviewed 96 inspection files containing CARs to determine the adequacy of documentation to support compliance activities. Overall 79% of the files were not sufficiently documented. The results of the file review were as follows:

Meat Files Feed Files Total
Files tested 48 48 96
Files with errors or omissions 36 40 76
% 75% 83% 79%

Some of the deficiencies noted relate to:

  1. Missing documentation;
    • Notice of Unacceptable Action Plans, and/or
    • Enforcement Tracking Forms.
  2. CARs were not always written in accordance with Manual of Procedures;
    • Insufficient detail on granted extensions for action plans,
    • No indication of previous CARs for same task (linking), and/or
    • Some CARs include non-compliances relating to multiple CVS tasks.
  3. The CAR process was not always followed in accordance with Manual of Procedures;
    • Follow-up not conducted within required time frame,
    • Unacceptable Actions Plan forms not being issued, and/or
    • No action plan received.
  4. There was insufficient documentation to support some MRT decisions;
    • Actions, decisions and recommendations not recorded, and/or
    • Enforcement Tracking Forms (ETFs) were incomplete.

Similar issues were found in a March 2012 report issued by the Quebec Area outlining the results of their Harmonization Project. This project evaluated CVS inspection files completed by meat processing inspectors in the Quebec Area in order to verify their quality and uniformity level.

When a situation of non-compliance has not been corrected by the operator and the CAR remains open, the inspector may submit a request for review. In this case, an MRT is formed by the Inspection Manager to ensure that the CAR is addressed in a timely manner and a course of action is determined and implemented. The process of documenting MRT actions, recommendations and decisions needs to be strengthened. This is critical information used for tracking enforcement decisions as well as contributing to the regulated party's overall compliance history.

An ETF is generated to document the actions, decisions and recommendations proposed by the MRT. This form is then forwarded through the chain of management for approval. The audit team reviewed 11 ETFs in detail and found that only one demonstrated a complete and thorough account of the Agency's actions to address the non-compliance. This is a key control in the process as this Team is the final step in the inspection setting to secure compliance before being referred to investigative bodies for enforcement.

Inspection staff interviewed during the audit stated that, though there are gaps in documentation, the adequacy of CAR documentation on inspection files has been improving since the implementation of CVS. This progress should be aided by the results of the Harmonization Project conducted by the Quebec Area, and the planned Agency-wide Uniformity Project, being led by the Operations Strategy and Delivery (OSD) and the NID of the Operations Branch. The goal of the planned Uniformity Project, which is anticipated to be completed by March 2013, is to improve the consistency of inspection delivery across the four Areas.

The impact of insufficient CAR documentation can be significant if the file is escalated to Enforcement and Investigation Services (EIS). When inspection files are referred to EIS, they have the potential to become evidence for EIS investigators. An incomplete file could result in regulatory decisions being overturned by the courts, prosecution not being pursued, and/or significant resources being invested by EIS to gather sufficient evidence.

Recommendation 4.0:
It is recommended that policy guidance be developed to specify the required CAR documentation necessary to complete an inspection file to support compliance and enforcement decisions.

Appendix A: Audit Criteria

  1. Roles and responsibilities for the management, oversight and conduct of the CAR process are clearly defined and communicated:
    1. The relevant inspection and enforcement manuals clearly describe the roles and responsibilities for CAR activities; and
    2. Roles and responsibilities are communicated.
  2. There is effective and demonstrated oversight of the CAR process:
    1. Inspection Supervisors track and monitor CARs; and
    2. Inspection Managers consult Management Review Teams (meat) and Issues Analysis Teams (feed) prior to making enforcement decisions.
  3. Higher risk CARs are identified and an effective monitoring and reporting process is in place to mitigate the related risks:
    1. Higher risk CARs (i.e., food safety tasks, high risk sampling in meat, and CARs that trigger subsequent task completion in feed) are identified, reported and monitored; and
    2. CARs issued for similar or repeated deviations are linked and monitored.
  4. Higher risk regulated parties are identified and monitored:
    1. The compliance history of a regulated party is determined with respect to previous instances of non-compliance and the seriousness of past non-compliance; and
    2. The compliance history of a regulated party is documented and monitored.
  5. CAR information is timely, accurate, and relevant and reports are provided to the appropriate level of management:
    1. The reliability and accuracy of data is addressed through Quality Assurance activities; and
    2. Information for decision making is timely and relevant.
  6. There is sufficient file documentation to support compliance activities:
    1. The CAR process is followed and decisions are sufficiently documented in accordance with established procedures; and
    2. Oversight of the inspection files is demonstrated.

Appendix B: Findings to Criteria Crosswalk

Criteria Findings 1. The compliance histories of regulated parties is not captured or recorded in a comprehensive manner Findings 2. Demonstrated active monitoring and oversight of CARs could be strengthened Findings 3. CAR information for decision making is not fully defined or provided to the appropriate level of management in a timely manner Findings 4. Sufficient supporting documentation to substantiate compliance decisions was not evident in all cases
1. Roles and responsibilities for the management, oversight and conduct of the CAR process are clearly defined and communicated X
2. There is effective and demonstrated oversight of the CAR process X X X
3. Higher risk CARs are identified and an effective monitoring and reporting process is in place to mitigate the related risks X X
4. Higher risk regulated parties are identified and monitored X
5. CAR information is timely, accurate, and relevant and reports are provided to the appropriate level of management X X
6. There is sufficient file documentation to support compliance activities X X
Date modified: