Lessons Learned from the 5 MFRPS Pilot States Oregon Wednesday, March 11, 2015 8:45 AM – 9:45 AM...

Lessons Learned from the 5 MFRPS Pilot States Oregon

Wednesday, March 11, 20158:45 AM – 9:45 AM

San Diego, CA

Oregon Department of Agriculture Food Safety Program

Gesinee TolmanMFRPS Technical Coordinator & HACCP Specialist

Stephanie Page Food Safety & Animal Health Program Director

Frank BarcellosFood Program Manager

Monica DurazoField Operations Manager

Terry HillField Operations Manager

Gesinee TolmanTechnical Coordinator & HACCP Specialist

Jingyun DuanCompliance and Recall Coordinator

Susan KendrickEducation Specialist

ODA MFRPS

Team Members

John BurrManufacturing Specialist

Eric EdmundsProgram AnalystSarah Schwab

IT Liaison

History Audits– Quick

Recaps Lessons Learned

Overview

Overview

Back in September 2010 at the WAFDO Educational Conference

Ellen Buchanan

HistoryEnrolled with MFRPS as one of the pilot

states in 2007First audit by T. Ravelli: 2008 Consultation audit by E. Laymon: 2011Consultation audit by A. Kohl: 201236-month PAVA by T. Ravelli: 2012Awarded MFRPS Grant since August 201260-month PAVA by I. Bevill: 2014

ODA’s MFRPS Implementation Progress Standard 1: Regulatory Foundation

Standard 1 Regulatory Foundation

2008 1st Audit

by T. Ravelli

Team

2011 Consultatio

n Audit by

E. Laymon

2012 ODA’s Self-

Assessment as Submitted for

Contract Amendment 2011-12 FY

2012 Consultation

Audit by

A. Kohl

2012 36-Month

PAVA by

T. Ravelli Team

2014 60-Month

PAVA by

I. Bevill Team

Self-Assessment

Complete Incomplete ☐




Complete Incomplete☐


Implementation Full Partial ☐

Full Partial ☐

Full Partial ☐

Full Partial ☐

Full Partial ☐

Full ☐Partial *

Conformance P

* Oregon does not adopt FD&D Act by reference and has not performed a legal review to to determine if State laws are equivalent in effect to the current Federal laws. => ODA is working with Oregon Dept. of Justice to get the legal review done by the end of July, 2015.

* Partial--In 2012, 1) Not everyone had attended FDA150, FDA151, and FDA170 or completed all of the ORA U courses. This item was included on the strategic plan. 2) Basic food inspection field training was not conducted within 18 months of start date.3) ODA did not have any current sign-offs on joint inspections for new staff based on staffing levels since 07-1-2011.

Standard 2 Training Program

2008 1st Audit

by T. Ravelli

Team

2011 Consultation

Audit by

E. Laymon

2012 ODA’s Self-



2012 Consultation

Audit by

A. Kohl

2012 36-Month

PAVA by

T. Ravelli Team

2014 60-Month

PAVA by

I. Bevill Team

Self-Assessment







Implementation Full ☐Partial

Full ☐Partial

Full ☐Partial

Full ☐

Partial *Full Partial ☐

Full Partial ☐Conformance Yes

ODA’s MFRPS Implementation Progress Standard 2: Training Program

ODA’s MFRPS Implementation Progress Standard 3: Inspection Program

Standard 3 Inspection Program

2008 1st Audit

by T. Ravelli

Team

2011 Consultation

Audit by

E. Laymon

2012 ODA’s Self-



2012 Consultation

Audit by

A. Kohl

2012 36-Month

PAVA by

T. Ravelli Team

2014 60-Month

PAVA by

I. Bevill Team

Self-Assessment





Complete Incomplete☐



Full Partial ☐

Full Partial ☐

Full ☐

Partial *

Full ☐

Partial **

Full Partial ☐Conformance P***

* 1) ODA did not have written policies & procedures for inspecting food plants (the 22 items). 2) ODA did not have written procedures for identifying and maintaining records about recall info. 3) ODA did not have a records retention policy/schedule for personnel records.** Personnel were conducting juice HACCP inspections without advanced food inspection training.*** High risk firms are not always inspected at the frequency identified – due to limited resources

ODA’s MFRPS Implementation Progress Standard 4: Inspection Audit Program

Standard 4 Inspection Audit

Program

2008 1st Audit

by T. Ravelli

Team

2011 Consultation

Audit by

E. Laymon

2012 ODA’s Self-



2012 Consultation

Audit by

A. Kohl

2012 36-Month

PAVA by

T. Ravelli Team

2014 60-Month

PAVA by

I. Bevill Team

Self-Assessment Complete Incomplete ☐







Full ☐Partial

Full ☐Partial

Full Partial ☐

Full Partial ☐

Full Partial ☐

Conformance P*

* Questions removed from Worksheet 4.4 and Appendix 4.7. Added “Not Applicable” to Appendix 4.5, 4.6 and 4.7. - All appendix and worksheets were corrected after the 60-month PAVA and are equivalent to FDA forms.

ODA’s MFRPS Implementation Progress Standard 5: Food-related Illness and Outbreaks, and Response

Standard 5 Food-related Illness and

Outbreaks, and Response

2008 1st Audit

by T. Ravelli

Team

2011 Consultation

Audit by

E. Laymon

2012 ODA’s Self-



2012 Consultation

Audit by

A. Kohl

2012 36-Month

PAVA by

T. Ravelli Team

2014 60-Month

PAVA by

I. Bevill Team








Full Partial ☐

Full Partial ☐

Full ☐

Partial *

Full ☐

Partial *

Full ☐

Partial *Conformance P

* ODA does not have a MOU that encompasses all elements of Standard 5. (5.3) - ODA is continuing to work with Oregon Health Authority to update and complete the MOU through future meetings.

ODA’s MFRPS Implementation ProgressStandard 6: Compliance and Enforcement

Standard 6 Compliance

and Enforcement

2008 1st Audit

by T. Ravelli

Team

2011 Consultation

Audit by

E. Laymon

2012 ODA’s Self-



2012 Consultation

Audit by

A. Kohl

2012 36-Month

PAVA by

T. Ravelli Team

2014 60-Month

PAVA by

I. Bevill Team

Self-Assessment








Full ☐Partial

Full ☐Partial

Full ☐


Full ☐

Partial **Conformance P

* 1) ODA did not run a report on the critical and chronic violators. 2) ODA had some timelines established, but not for all enforcement actions. 3) ODA had not conducted a performance review of all enforcement actions.** ODA is not meeting all timelines delineated in our policies for follow-up inspections for enforcement actions – due to limited resources

ODA’s MFRPS Implementation ProgressStandard 7: Industry and Community Relations

Standard 7 Industry and Community Relations

2008 1st Audit

by T. Ravelli

Team

2011 Consultation

Audit by

E. Laymon

2012 ODA’s Self-



2012 Consultation

Audit by

A. Kohl

2012 36-Month

PAVA by

T. Ravelli Team

2014 60-Month

PAVA by

I. Bevill Team

Self-Assessment








Full Partial ☐

Full Partial ☐

Full ☐


Full Partial ☐Conformance Yes

* ODA’s outreach form did not address the evaluation and critique sections of Appendix 7.

ODA’s MFRPS Implementation ProgressStandard 8: Program Resources

Standard 8 Program

Resources

2008 1st Audit

by T. Ravelli

Team

2011 Consultation

Audit by

E. Laymon

2012 ODA’s Self-



2012 Consultation

Audit by

A. Kohl

2012 36-Month

PAVA by

T. Ravelli Team

2014 60-Month

PAVA by

I. Bevill Team








Full Partial ☐

Full ☐Partial

Full ☐


Full Partial ☐

Conformance P**

* 1) ODA had a calculation for the number of field staff for the whole program, but had not calculated the field staff for just the manufactured foods. 2) ODA did not include the MIG thermometer and pasteurization kits calibration procedures. This info was listed in the training plan, but the language should be strengthened. ** ODA does not have a procedure for calibration of thermometers – Corrected after the 60-month PAVA

ODA’s MFRPS Implementation ProgressStandard 9: Program Assessment

Standard 9 Program

Assessment

2008 1st Audit

by T. Ravelli

Team

2011 Consultation

Audit by

E. Laymon

2012 ODA’s Self-



2012 Consultation

Audit by

A. Kohl

2012 36-Month

PAVA by

T. Ravelli Team

2014 60-Month

PAVA by

I. Bevill Team

Self-Assessment








Full ☐Partial

Full Partial ☐

Full Partial ☐

Full ☐

Partial *Full Partial ☐Conformance Yes

* In the strategic plan, projected completion dates for each task were not identified.

ODA’s MFRPS Implementation ProgressStandard 10: Laboratory Support

Standard 10 Laboratory

Support

2008 1st Audit

by T. Ravelli Team

2011 Consultation

Audit by

E. Laymon

2012 ODA’s Self-



2012 Consultation

Audit by

A. Kohl

2012 36-Month

PAVA by

T. Ravelli Team

2014 60-Month

PAVA by

I. Bevill Team








Full ☐Partial

Full ☐Partial

Full ☐

Partial *Full ☐

Partial *

Full ☐

Partial *Conformance P

* ODALS is not ISO 17025 accredited - ODALS is working towards the accreditation using FDA ISO CAP funds.

Current ODA’s Overall Self-Assessment- 2015

Standard 1 Standard 2 Standard 3 Standard 4 Standard 5







Full Partial ☐

Full Partial ☐

Full Partial ☐

Full ☐Partial

Standard 6 Standard 7 Standard 8* Standard 9 Standard 10







Full Partial ☐

Full ☐Partial

Full Partial ☐

Full ☐Partial

* ODA’s Self-Assessment is different from the 60-month PAVA result (Full).

Lessons LearnedLessons learned is a pretty big category.

ODA were doing many good things before the standards.

**********************************************************

Here are the three (3) highlights;1. Documenting what we do and, therefore; we

have been able to identify gaps in our program. 2. Reviving a lot of items that were fading away

over time in our program.3. Creating and adopting new things that we didn’t have before.

Appendix 2.2-6: Staff Specialties for Inspections and Qualified Trainers

1. Documenting What We Do- We have been able to identify gaps in our programs i.e. “Training Program” --has allowed us to make modifications that in the end provide a more comprehensive program- Our inspectors are better trained than they were 10 years ago. This has also helped us towards our goal of consistency among inspectors.

Food Sampling SOPs

2. Reviving the Old and the Fades

- Review and revised the current P&P of all our enforcement actions.- Established a separate P&P of timeline for EAs Follow-up.

2. Reviving the Old and

the Fades

Reasons for Recall:2013Pathogens (5): Hepatitis A, Cryptosporidium, L. monocytogenes Under-processed (9)Meat products without USDA inspection (1)Adulteration (2)Plastic inclusion (1)2014Pathogens (9) Campylobacter, Salmonella, L. monocytogenes Undeclared allergens (7)Product spoilage (2)Lower level of nutrients (1)

3. Creating and Adopting New Items

3. Creating and Adopting New Items

** Outreach time was not tracked in 2009 and 2010.

* Types of outreach activities have been tracked since 2009.3. Creating and Adopting New Items

Lessons LearnedThe biggest negative is resources; All of the standards take a tremendous

amount of time and staff hours to administer.

Meeting time with FDA, audit time and reporting time have been required.

Once the grant money runs out - although these tasks keep us accountable, they take a lot of time and staff hours.

25

Stephanie P.

Frank B.

Monica D.

Terry H.

Jingyun D.

Susan K.

John B. Eric E. Sarah S.

Gesinee T.

Contact Information

Gesinee TolmanMFRPS Technical Coordinator & HACCP Specialist

Oregon Department of Agriculture Food Safety Program

Email: [email protected]

Lessons Learned from the 5 MFRPS Pilot States Oregon Wednesday, March 11, 2015 8:45 AM – 9:45 AM...

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