ARCHIVED - Foundations of an Outcome-based Approach

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This consultation closed 2013-11-30

Purpose

  • Explain the foundations of an outcome-based approach including performance measurement
  • Outline the Agency's thinking around implementing the approach
  • Explore stakeholder views

Context

  • In response to a changing operating environment, the CFIA has embarked on an ambitious transformation agenda with four strategic areas of focus:
    • Stronger food safety rules
    • More effective inspection
    • Commitment to service
    • More information for consumers
  • The outcome-based approach to regulation and inspection contributes to the strategic areas stronger food safety rules and more effective inspection

Outcome-based approach is one of many

The Agency uses three approaches to regulation as appropriate: prescriptive, systems-based, and outcome-based

  • Prescriptive regulation (technology- or standards-based)
    • Process or procedure requirements are defined in regulation
    • Regulated parties have little or no choice regarding how to comply
  • Systems-based regulation (management-based)
    • e.g. Quality Management Plan in fish, HACCP for meat
    • Regulated parties required to develop valid internal risk management plans and the Agency verifies that the plans are properly and effectively implemented
  • Outcome-based regulation (performance-based)
    • Required outcome or level of performance is written into regulation

Foundations of outcome-based regulation

  • Emphasis on specific and measurable outcomes versus prescriptive provisions:
    • Clear definition of the outcomes in regulation (the what), and how compliance will be measured
    • Regulated parties choose method to achieve the outcome (the how)
  • Performance measures (indicators, criteria, tests) used to assess whether an outcome is achieved:
    • Act as the basis to understand compliance obligation
    • May accompany the outcome in regulation
  • Regulated parties validate their compliance approach using performance measures
  • Inspectors use the performance measures to verify that compliance approaches are effective

Key benefit – increased due diligence

  • Proactive/preventive – regulated parties focus on achieving outcomes rather than fulfilling prescribed behaviours
    • No simple checklist for what to do
    • Compliance assurance – need to evaluate whether the outcomes are consistently achieved
  • Reporting on outcomes – Agency could seek performance data from regulated parties to inform:
    • Risk-based prioritization of inspection activities
    • Auditing the integrity of the inspection system
    • Examination of trends

Key benefit – flexibility

  • Provides flexibility for regulated parties to introduce new technologies, processes, procedures that enhance safety and/or reduce costs
  • Allows the regulator to adjust to changing science, technology, and economic conditions more easily
  • Holds promise in establishing comparability with safety regimes in other jurisdictions based on similar outcomes

Practical implementation

  • In many cases, accepted or existing industry practice will achieve the outcomes – easing transition
  • To ensure practical use of the outcome-based approach the Agency will:
    • Maintain safety as paramount consideration
    • Seek input from stakeholders early and often
    • Develop performance measures and guidance material at the same time as the outcomes
    • Work with regulated parties that wish to implement innovative compliance approaches
    • Consider consistency with international standards and major trading partners

Adapting to the approach

  • The Agency will be transparent about use of performance measures
    • Developed in concert with regulation – stakeholder buy-in
    • Written into regulation where appropriate – to provide legal certainty
    • Provide training and guidance for inspectors – consistent interpretation and application
  • Development of model systems for SMEs
    • Non-binding model practices or procedures that facilitate compliance
    • The Agency will explore creating a focal point to develop model systems
  • Comprehensive and targeted guidance documents – compliance promotion

Questions for discussion

  1. What do you like about the outcome-based approach?
  2. What are you concerns, and how might they be addressed?
  3. Given that the Agency aims to increase use of the outcome-based approach where appropriate, what is industry’s readiness to move in this direction?

Feedback

The Agency welcomes your input and feedback on the outcome-based approach. Please send comments or questions:

By email: CFIA-Modernisation-ACIA@inspection.gc.ca

By mail:

Strategic Partnerships Division
1400 Merivale Road, Tower 1
Floor 6, suite 218
Ottawa, ON K1A 0Y9
Canada
Attn: Outcome-based approach

By fax: 613-773-5606

Annex – Transport Canada example

  • Outcome and performance measures are specified in law
  • Sections 104(3) and (4) of Schedule IV of the Motor Vehicle Safety Regulations, which states:
    • (3) Every vehicle shall have a powerdriven windshield wiping system that has at least two frequencies or speeds and that has, irrespective of engine speed and engine load,
    • (a) one frequency or speed of at least 45 cycles per minute
    • (b) a difference of at least 15 cycles per minute between the highest frequency or speed and one of the lower frequencies or speeds, and
    • (c) the lower frequency or speed referred to in paragraph (b) equal to at least 20 cycles per minute
  • Section 104(3) specifies the outcome – every vehicle shall have a powerdriven windshield wiping system, no matter its design, that has at least two speeds
  • Sections 104(3)(a), (b), and (c) are the performance measures to determine if the system meets the outcome regardless of speed or engine load

Annex – Australian example

  • Australian Meat Standard (AS 4696) and the Export Control Orders – specify the outcome in law, and performance measures are in guidance
  • Outcome: the plant and equipment are not a source of contamination to carcasses, meat or meat products
  • Performance indicators:
    • Procedures are in place to ensure that, prior to commencement of operations, plant and equipment that could contact product, either directly or indirectly, are cleaned and sanitised.
    • Other areas of the establishment, including storage areas, amenities and establishment environs are kept in a suitable sanitary state.
  • Guidance has detailed checklists to help use the performance indicators

Annex – Safe Food for Canadian's regulations example

  • Outcome and performance measures are specified in law
  • Requirement for Preventive Control Plan Element 1: Processes and Products – 2(c) Product Coding And Labelling Control
  • Outcome: each food commodity shall be marked with a code mark on the label or container
  • Performance indicators:
    • The code mark shall be applied in a legible and permanent manner.
    • The exact meaning of the code shall be available to the inspector.
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