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Issue Number: Council II 036

Title

Risk-Based Inspection Form-Marking

Issue you would like the Conference to consider

REMOVE THE RESTRICTION FROM THE AUDIT MANUAL THAT THE FORM NOT BE PRE-POPULATED WITH ITEMS MARKED "IN"

Public Health Significance

THE RECOMMENDED RISK-BASED INSPECTION FORM CONTAINS "IN/ OUT / NA / AND NO" CATEGORIES FOR 54 GROUPS OF VIOLATIONS. USE OF THIS FORM IS NECESSARY TO MEET AT LEAST 3 SEPARATE Retail Food Regulatory Program STANDARDS. REQUIRING EACH OF THE 54 GROUPS TO EACH BE MARKED EVERY INSPECTION IS REQUIRED TO ELIMINATE ALLEGED POTENTIAL BIAS THAT MAY BE PRESENT IF THE FORM IS PRE-POPULATED WITH ITEMS MARKED "IN".

REASONS THIS REQUIREMENT SHOULD BE ELIMINATED INCLUDE:

  • THERE IS NO STATISTICALLY VALID RESEARCH THAT SHOWS SUCH BIAS WOULD OCCUR. FORCING INDIVIDUALS TO ROUTINELY MARK 50+ ITEMS ON A FORM EACH INSPECTION WOULD JUST AS LIKELY PROMOTE "DRY LAB" BEHAVIOR TO JUST GET THROUGH THE FORM AND INCREASE GENERAL HUMAN ERROR. LETTING PROFESSIONALS JUST MARK THE ITEMS THAT HAVE MEANING FOR THAT INSPECTION (OUT,NA/NO) WOULD BE FAR MORE MEANINGFUL.
  • THE CONSISTENT APPROACH OF CFP HAS BEEN TO STATE OUTCOMES, NOT TO PRESCRIBE SPECIFIC SOLUTIONS. THIS ALLOWS INDUSTRY TO USE AN IMPLEMENTATION SYSTEM THAT MEETS THEIR NEEDS AND FLEX THAT SYSTEM TO UTILIZE CURRENT TECHNOLOGY AND TRAINING METHODS. THAT SAME PHILOSOPHY SHOULD BE USED FOR THE REGULATORY AGENCIES. QUALITY CONTROL SYSTEM SPECIFICS OVER THE INSPECTION WRITING PROCESS SHOULD BE DETERMINED BY EACH AGENCY. FOR EXAMPLE, WITH THE INSPECTION FORM, QUALITY CONTROL CAN BE MAINTAINED THROUGH INITIAL AND ONGOING TRAINING WITH A STANDARDIZED TRAINER, SUPERVISORY REVIEW, REPORTS OF MARKING PATTERNS USED BY STAFF IF THE FORM IS MAINTAINED IN AN ELECTRONIC DATABASE, ETC.
  • RESOURCE STRAPPED STATE AND LOCAL AGENCIES CANNOT AFFORD THE EXTRA TIME NEEDED TO ROUTINELY MARK "IN" ON A FORM OVER 50 TIMES PER INSPECTION. FOR EXAMPLE AT AN EXTRA 5 MINUTES PER INSPECTION TO MARK EACH OF THE ITEMS "IN", USE OF THIS FORM STATEWIDE IN MICHIGAN WOULD CAUSE A 5.4 FTE STAFF REDUCTION IN TIME (101,682 INSPECTIONS X 5 MINUTES= 508,410 MINUTES/60=8474 HOURS/1550 HOURS/FTE=5.4 FTE'S). THIS REPRESENTS A 2.2% REDUCTION IN STAFFING STATEWIDE.
  • INFLEXIBLE, COMMAND AND CONTROL REQUIREMENTS SUCH AS THIS WILL BE A DETERRENT TO AGENCIES ENROLLING AND OR WORKING TO PROGRESS TO MEET THE STANDARDS.

Recommended Solution: The Conference recommends...

that a letter be sent to the FDA requesting removal of the Audit Manual restriction that the risk-based retail inspections form fields not be pre-populated as "in."

Attachments

Submitter Information

Name Sean Dunleavy
Organization Great Lakes Conference on Food Protection
Address P.O. Box 16082
Lansing, MI 48901
Telephone (517) 243-8895
Fax (517) 373-3333
Email dunleavys@michigan.gov
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