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Transcript of ifpti - Houstonhouston.afdo.org/uploads/1/5/9/4/15948626/1230-skya-murphy... · “Corrections...
IFPTI Fellowship Cohort V:
Research Presentation
Priya Nair
2015-2016
IFPTI Fellowship Cohort VI:
Research Presentation
Skya Murphy, MSci
2016-2017
ifpti.org
Slide 2“Corrections after FDA and Wisconsin Manufactured Food Inspections
Show Comparable Compliance Rates”
Funding for this program was made possible, in part, by the Food and Drug Administration through grant 1U18FD005964-01; views expressed in
written materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and
Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States
Government.
Corrections after FDA and Wisconsin
Manufactured Food Inspections Show
Comparable Compliance Rates
Skya Murphy, MSci
IFPTI 2016-2017 Cohort VI
Department of Agriculture, Trade, and
Consumer Protection, Wisconsin
Slide 3“Corrections after FDA and Wisconsin Manufactured Food Inspections
Show Comparable Compliance Rates”
IFSS
Program
Standards
Federal Programs
State
Programs
• The Integrated Food Safety System (IFSS) concept
asserts that by meeting program standards, state and
federal regulatory programs can rely on each other to
more effectively and efficiently achieve compliance
outcomes and protect public health.
Background
Slide 4“Corrections after FDA and Wisconsin Manufactured Food Inspections
Show Comparable Compliance Rates”
Background (continued)
Wisconsin Department of Agriculture,
Trade and Consumer Protection
(WDATCP) was found in full
conformance with the Manufactured
Food Regulatory Standards in 2014
Images source: Courtesy of WDATCP
WDATCP began counting FDA
inspections toward its workload in
2014, and currently work planning
together
Slide 5“Corrections after FDA and Wisconsin Manufactured Food Inspections
Show Comparable Compliance Rates”
• Inspection key similarities:
– Verbally communicate findings and expectation that firm
corrects all violations
– Written reports and follow-up on previous inspection findings
• Inspection key differences:
– Inspection duration
– Terminology for violations
– Provision of written inspectional observations to firm
– Timeframe for firm receipt of inspection report
– Reinspections
Background (continued)
Slide 6“Corrections after FDA and Wisconsin Manufactured Food Inspections
Show Comparable Compliance Rates”
The effect of a regulatory inspection on a firm’s future
compliance with the law may be different depending on
whether FDA or WDATCP does the inspection.
Problem statement
Image source: Courtesy of WDATCP
Slide 7“Corrections after FDA and Wisconsin Manufactured Food Inspections
Show Comparable Compliance Rates”
1. Do FDA and WDATCP regulatory inspections achieve
the same degree of compliance at manufactured food
firms in Wisconsin?
Research Question
Image source: Courtesy of WDATCP Image source: FDA/flickr
Slide 8“Corrections after FDA and Wisconsin Manufactured Food Inspections
Show Comparable Compliance Rates”
• Analyze inspection reports written by both agencies,
where at least one violation of commonly-enforced
regulations is noted.
• Measure degree of compliance as % violations
corrected between inspections.
• Estimate average degree of compliance achieved
between inspections:
– WDATCP followed by WDATCP
– FDA followed by WDATCP
Methodology
Slide 9“Corrections after FDA and Wisconsin Manufactured Food Inspections
Show Comparable Compliance Rates”
• Randomly-selected 2 sets of 40 pairs of inspections
conducted in 2014-2016:
Methodology (continued)
WDATCP inspection
Followed by an WDATCP inspection
FDA inspection
Followed by an WDATCP or
FDA inspection
Slide 10“Corrections after FDA and Wisconsin Manufactured Food Inspections
Show Comparable Compliance Rates”
• Analyzed:
– Initial inspection: How many violations were recorded?
– Subsequent inspection: How many violations were observed
again (uncorrected)?
• Violations were counted as corrected, if they were not
documented in the subsequent report
• Calculated:
– Average compliance rates as number of corrected / number of
observed violations.
• Performed:
– A statistical comparison (paired t-test).
Methodology (continued)
Slide 11“Corrections after FDA and Wisconsin Manufactured Food Inspections
Show Comparable Compliance Rates”
• Manufactured food establishment inspection reports
written between 2014 and 2016:
– At least 1 violation of 21 CFR 101, 110, 113, 114, 120,123
– WDATCP Initial Inspection followed by WDATCP
– FDA Initial Inspection followed by WDATCP
Study Population
Slide 12“Corrections after FDA and Wisconsin Manufactured Food Inspections
Show Comparable Compliance Rates”
Results
FDA-Initial Rate82.06%
WDATCP-Initial Rate 86.12%
50%
55%
60%
65%
70%
75%
80%
85%
90%
95%
100%
Mean Compliance Rates
Slide 13“Corrections after FDA and Wisconsin Manufactured Food Inspections
Show Comparable Compliance Rates”
Means ± Margin of Error (Confidence Intervals) and
Proportions of Further Compliance
Variable Measured
Initial Inspection Agency
FDA WDATCP
Compliance Rate 0.82 ± .08 0.86 ± .08
Days between inspections 272.1 ± 49.34 471.5 ± 51.84
% with 483 issued (FDA) Reinspection or Follow-Up to Follow
(WDATCP) (as marked on initial inspection)30% 20%
Number of Items included in Verbal Discussion with
Management (FDA) or Non-Critical Violations in Initial
Inspection Report (WDATCP)
3.65 ± 0.8 3.85 ± 1.2
Total Number of violations Initial Inspection 4.5 ± 0.82 4.15 ± 1.32
Number of Corrected Violations as per subsequent Inspection
Report3.65 ± 2.33 3.65 ± 4.00
Uncorrected Violations, as per subsequent inspection report 0.85 ± 1.17 0.5 ± 0.75
Percentage of with new violations detected at subsequent
inspection 85% 85%
Number of new violations 4.43 ± 1.5 4 ± 1.5
Results (continued)
Slide 14“Corrections after FDA and Wisconsin Manufactured Food Inspections
Show Comparable Compliance Rates”
Results (continued)
180
34
146
166
20
146
0 50 100 150 200
Total-Initial Insp
Total Uncorrected
Total Corrected
Violations Comparison
WDATCP-WDATCP FDA-WDATCP
Slide 15“Corrections after FDA and Wisconsin Manufactured Food Inspections
Show Comparable Compliance Rates”
• The results of this study show that there is equivalency
in the compliance outcomes achieved by routine
inspections between the FDA and WDATCP.
Results (continued)
Image source: Courtesy of WDATCP
Slide 16“Corrections after FDA and Wisconsin Manufactured Food Inspections
Show Comparable Compliance Rates”
• Study shows equivalence and room for improvement.
• Results emphasize importance of the exit interview to
communicate inspection findings.
• The majority of reports analyzed did not explicitly
reference the other agency’s report even when the
other agency’s inspection was the most recently-
conducted routine inspection.
Conclusions
Slide 17“Corrections after FDA and Wisconsin Manufactured Food Inspections
Show Comparable Compliance Rates”
1. Continue current practices to maintain equivalent
compliance rates.
2. WDATCP could save resources by accepting more
written documentation of corrections, as FDA
recommends in response to FDA Form 483.
3. Review most recent routine inspection report,
regardless of which agency conducted it.
4. Scheduling inspections: Continued room for
improvement to schedule at least 5 months apart.
Recommendations
Slide 18“Corrections after FDA and Wisconsin Manufactured Food Inspections
Show Comparable Compliance Rates”
• WDATCP: Ronesha Strozier, Peter Haase, Dr. Steve
Ingham, and Troy Sprecker
• FDA: Joel Hustedt, Angela Kohls, and MFRPS CAP
• IFPTI: Fellows, Mentors, and Staff, especially Joe
Corby, Dr. Paul Dezendorf, and Nadina Williams-
Barrett
• Association of Food and Drug Officials (AFDO)
Acknowledgements
Slide 19“Corrections after FDA and Wisconsin Manufactured Food Inspections
Show Comparable Compliance Rates”
Questions?
Skya Murphy, Msci
Slide 21“Corrections after FDA and Wisconsin Manufactured Food Inspections
Show Comparable Compliance Rates”
Additional Supporting Information
Table of Contents
• Background
• Results—Table 3 Uncorrected Violations
• Uncorrected Violations
• Most Common Uncorrected Violations
• Top 13 Uncorrected Violations
• Remaining Uncorrected Violations