Foundations of an Outcome-based Approach
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
- What do you like about the outcome-based approach?
- What are you concerns, and how might they be addressed?
- 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.
- Date modified: