Standard 4 Breakout Session
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Standard 4 Breakout Session Inspection Audit Program. Peter Haase Director, Bureau of Food Safety and Inspection Wisconsin Department of Agriculture, Trade and Consumer Protection. Patrick Kennelly Chief, Food Safety Section California Department of Public Health. Angela Kohls

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Standard 4 Breakout Session Inspection Audit Program

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Standard 4 breakout session inspection audit program

Standard 4 Breakout Session

Inspection Audit Program

Peter Haase

Director, Bureau of Food Safety and Inspection

Wisconsin Department of Agriculture, Trade and Consumer Protection

Patrick Kennelly

Chief, Food Safety Section

California Department of Public Health

Angela Kohls

Standards Implementation Staff

FDA ORA, Office of Partnerships

Russell Lilly

Manager, Manufactured Food Program

Missouri Department of Health and Senior Services

Skya Murphy

Program and Policy Analyst

Wisconsin Department of Agriculture, Trade and Consumer Protection

Wednesday, March 12, 2014

8:00 – 10:00

Elm Fork I


Standard 4 breakout session inspection audit program

AgendaStrengthening Compliance and Enforcement

  • Welcome and Introductions

  • Current Status of Standard 4 Implementation

  • Presentations on Implementing Standard 4

  • Q & A/Group Discussion

  • Summary and Challenge


Housekeeping

Housekeeping

  • Honor time schedule

  • Stay on topic

  • Get input from everyone

  • Be willing to share

  • Respect different program cultures

  • Do not reference specific audits

  • Be creative, ask questions – parking lot

  • Facilitators – responsible for process

  • Participants – responsible for content


Session objectives

Session Objectives

Generate a list of resources, best practices, lessons learned and challenges/recommendations for developing, implementing and monitoring an inspection protocol.

(Group Exercise Instructions)

Listen to presentations

Discuss and list suggestions on flip charts

Share your group’s suggestions with room


Standard four

Standard Four


Standard four1

Standard Four


Breakout session focus

Breakout Session Focus

  • Elements 4.2b &c, 4.3b & c, and 4.4b & c Implementation of the 3 Types of Audits

    • Field Inspection

    • Inspection Report

    • Sampling


Standard 4 breakout session inspection audit program

Standard 4: Field Inspection Audits

Patrick Kennelly, Chief

Food Safety Section

California Department of Public Health

March 12, 2014


Field inspection audits

Field Inspection Audits

  • Quality assurance review to assess the effectiveness of its inspection program.

    • 2 audits of each inspector every 36 months

    • Conducted by a qualified auditor

    • Documented on Audit form that is equivalent to the FDA Contract Audit form

    • Need an 80% audit rating to be considered a successful audit


Field inspection audits1

Field Inspection Audits

  • Then and Now

    • Better Defined Process

    • Uniform Documentation

    • Ability to Compare Ratings Across the Program


Field inspection audits2

Field Inspection Audits


Field inspection audits3

Field Inspection Audits


Field inspection audits4

Field Inspection Audits

  • Things to Consider

    • How do you select facilities for staff audits?

    • What constitutes a “qualified auditor”?

    • Do you want to vary or alternate auditors for each staff?

    • How do you address individual “Needs Improvement” Ratings?


Field inspection audits5

Field Inspection Audits

  • Scoring across the spreadsheet identifies areas of “Needs Improvement” ratings within a rated category.

    • Need 80% “Acceptable” ratings within each rated category across the program to be in conformance.

    • How do you address Non-Conformance

      ratings?


Field inspection audits6

Field Inspection Audits

  • Benefits

    • More Knowledgeable Workforce

    • Improved Inspection Procedures

    • Identifying Training Gaps

    • Findings Drive Quality Improvement


Standard 4 breakout session inspection audit program

Contact Information

Patrick Kennelly, Chief

Food Safety Section

California Department of Public Health

(916) 650-6598

[email protected]


Standard 4 breakout session inspection audit program

Inspection Report Audits

Russell Lilly

Manufactured food program manager

Missouri Department of Health

March 12, 2014

8:00 AM


Because

Because…

  • I had three inspectors and reviewed every inspection report

  • It is wildly prescriptive

    • At least half of the widgets don’t apply

      • If the shoe doesn’t fit it is uncomfortable


Our situation changed

Our situation changed

  • 18% of 22 inspectors

  • A quality assurance program becomes necessary and valuable


We took the money

We took the money…

  • We owe an honest effort to comply with the standard


We did it

We did it…

  • My best advice

    • Hire someone smart and assign it to them


Was it worth it

Was it worth it?

  • I think so

    • We have sent a number of “corrective emails”

      • Mark this here not there

      • Be sure to put your “time out” on the form

      • Turn in your reports on time


I would still like

I would still like

  • To have a quality system designed from the ground up to fit our program


Standard 4 breakout session inspection audit program

Contact Information

Russell Lilly

Manufactured food program manager

Missouri Department of Health

Email: [email protected]


Standard 4 breakout session inspection audit program

Steps to Implementing

Standard 4 Sample Collection Record Audit

Peter Haase

Director, Bureau of Food Safety and Inspection

Skya Murphy

Program and Policy Analyst

Wisconsin Department of Agriculture, Trade and Consumer Protection


Sample collection record audit outline

Sample Collection Record Audit Outline

  • Introduction and Challenges

  • Steps to customization

  • Conclusion

    • Documents on flash drive


Intro wisconsin department of ag trade consumer protection

Intro: Wisconsin Department of AgTrade & Consumer Protection

  • Enrolled in MFRPS in 2007

  • Challenges: Full Standard 4 Implementation Planned for 2015

    • Phase III Contract Audit since 2011

      • Currently Piloting Non-Contract Field Inspection Audit

      • Inspection Report Audit 2013

      • SCR Audit 2014


Intro wisconsin department of ag trade consumer protection1

Intro: Wisconsin Department of AgTrade & Consumer Protection

Current Surveillance Sampling Program for Manufactured Food Establishments

>Sampling at 2,400 establishments annually:

  • 2 product samples

    and

  • 5-10 environmental swabs at each routine inspection


Intro wisconsin department of ag trade consumer protection2

Intro: Wisconsin Department of AgTrade & Consumer Protection

  • Standard 10 Full Conformance

    • ISO Certified since 2007

    • Sampling Policies and Procedures

    • Two Sample Collection Record Forms, Food and Dairy


Challenges of auditing our sample collection records step 1 test drive of appendix 4 7

Challenges of Auditing our Sample Collection Records: Step 1 Test drive of Appendix 4.7.


Standard 4 breakout session inspection audit program

Challenges of Auditing our Sample Collection Record (SCR): Step 1 Results of Test drive of Appendix 4.7.

  • Findings:

    • 4.7 is more easily managed in table format

    • FDA Criteria:

      • Some not applicable or redundant for our reports

      • Very general: guidance specific to our SCRs required


Standard 4 breakout session inspection audit program

Audited against our Policy

Added guidance specific to our Sample Collection Record form

and procedures


Audited against our scrs

Audited against our SCRs


Standard 4 breakout session inspection audit program

Customized 4.7 Form:

Added guidance specific to our Sample Collection Record form

and procedures


Piloted new form and guidance by auditing 71 scr s from calendar 2012

Piloted new form and guidance by auditing 71 SCR’s from Calendar 2012

  • Results:

    • Opportunities for improvement: Use of hash marks and down arrows, form completeness

      • Redundant criteria:

    • SCR and sample always together


Standard 4 breakout session inspection audit program

Challenges of Auditing our Sample Collection Records (SCR): Problem detected but not an audit criterion: Use of Correct Form

Substituted alternate criteria: Use of correct form


Standard 4 breakout session inspection audit program

Challenges of Auditing our Sample Collection Records (SCR): For redundant criteria, combined and substitutedalternate criteria


Sample selection included in sop for standard 4

Sample Selection (included in SOP for Standard 4)

  • 75 SCR’s chosen per calendar year from MF establishments for auditing:

    • at least 1 per sampler,

    • random with regard to date, establishment


Sop for standard 4 cont

SOP for Standard 4 Cont.

  • Entering and tabulating results: Excel Spreadsheet

  • 1 for acceptable,

  • 0 for needs improvement


Sop for standard 4 cont1

SOP for Standard 4 Cont.

  • SCR Audit completed in March for previous calendar year

  • Needs Improvement Factors (<80%) become training topics at staff meetings

  • Other improvements can be made immediately upon discovery:

    • Already identified from SCR 2013 audit: “Foodborne Outbreak” reason for sampling on new Dairy SCR


Conclusion

Conclusion

  • Adapting 4.7 to our Sample Collection Record

    • Meaningful results for quality improvement

  • Documents on AFDO-MFRPA website:

    • Lab SOP #2060-Receipt and Integrity of Samples

    • SCR Policy and Procedures

    • SCR Forms (Food and Dairy)

    • Our Audit Form 4.7 and Data Entry/Calculations Sheet

    • Description of sample selection and procedures for Standard 4 including Sample Collection Record Audits


Standard 4 breakout session inspection audit program

Contact Information

Skya Murphy

Program and Policy Analyst

Wisconsin Department of Agriculture, Trade and Consumer Protection

Email: [email protected]


Standard 4 breakout session inspection audit program

Contact Information

Patrick Kennelly, Chief

Food Safety Section

California Department of Public Health

Email: [email protected]

Russell Lilly

Manufactured Food Program Manager

Missouri Department of Health

Email: [email protected]

Skya Murphy

Program and Policy Analyst

Wisconsin Department of Agriculture, Trade and Consumer Protection

Email: [email protected]

Peter Haase, Director

Bureau of Food Safety and Inspection

Wisconsin Department of Agriculture, Trade and Consumer Protection

Email: [email protected]


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