Standard 4 – Inspection Audit Program

Amir JavedMFRPS Program SpecialistCalifornia Department of

Public Health

Tuesday March 10, 2015

Julie LoeraFood Safety Officer

Texas Department of State Health Services

MAKING STANDARD 4 WORK FOR YOUCalifornia and Texas Programs

Not One Size Fits All

• Discussion within program on key elements

• Discussion with other states similar to yours

• Development of a written procedure• Updating the procedure

Not One Size Fits All• Discussion within program on key

elements – Different approaches to meeting all elements– Breakdown elements of this standard – Identify key staff to work on different components– Assess your states needs and identify goals• What is already established • What needs to be created

– Set timelines

Not One Size Fits All

• Discussion of FDA Contract Auditing• Discussion with other states similar to

yours– Reach out to other states– Get their input– Inquire about their hurdles and what worked well

for them

Not One Size Fits All

• Development of a written procedure– Establish a protocol for written procedure– Assign out different components of the procedure to

identified staff for completion– Identify reviewers

• E.g. 1st, 2nd, final

– Set timeline– In CA & TX – we converted worksheets 4.2, 4.3, 4.4 in

excel documents for easier compilation and evaluation of audit findings

Not One Size Fits All

• Updating the procedure– Make updates as necessary– Never set parameters so stringent that you have

difficulty meeting them– Keep change logs for all updates

The Standard Elements• Field audit component• Inspection reports audit• Samples report audits• Compilation of results annually • Evaluation of results annually to determine

program improvement needs• Development of Correction Action plans for

performance factors with ratings below 80%

The Standard Elements• Field audit component– Done through out the year as defined in you procedure– Audit Tools (FDA form 3610 or equivalent)– Compiling audit finding – worksheet 4.2 or equivalent– Evaluation of results

• Calculating performance ratings

– Corrective Action Plans (rating<80%)• Performance factors vs. individual audits

– Use of FDA Contract Audits

The Standard Elements• Inspection reports audit component– Done through out the year as defined in you procedure– Reports selection process

• 75 vs. CA (3/Inspector) & TX (2/Inspector)

– Audit Tools (Appendix 4.3 or equivalent)– Compiling audit finding – worksheet 4.3 or equivalent– Evaluation of results

• Calculating performance ratings (excel docs CA & TX)

– Corrective Action Plans (rating<80%)• Performance factors vs. individual report audits

The Standard Elements• Sample reports audit component– Done through out the year as defined in you procedure– Reports selection process

• Randomly selected 75 reports/year

– Audit Tools (Appendix 4.4 or equivalent)– Compiling audit finding – worksheet 4.4 or equivalent– Evaluation of results

• Calculating performance ratings (excel docs CA & TX)

– Corrective Action Plans (rating<80%)• Performance factors vs. individual report audits

Written Procedures to define• roles and responsibilities– Who is going to collect, compile, and evaluate

• qualifications for auditors– E.g. FMD 76 trained, 5 years of experience, etc.

• timeframes for field audits– 2/36months

• timeframes and selection process for report audits– When is it done (CA vs. TX)– 75 vs. #of reports/inspector

Written Procedures to define• timeframes and selection process for

sample audits– When is it done (CA vs. TX)– 75 randomly selected

• compiling audit findings• reviewing audit findings• how to address corrective actions• how to address individual remediation

MEETING THE STANDARD BUT IN DIFFERENT WAYS

California and Texas Programs

Audit Element

• Roles and Responsibilities– Auditor– Inspector– Manager/Supervisor

• Qualification of Auditors– Background– Classroom training– Clearing the Auditor

Audit Element

• Timeframes for field audits–How often– Facilities selected–Use of FDA Contract Audits to meet

Standard

Audit Element

• Timeframes for report and sample audits– Time frame–How Selected• 7%• Across Inspectors

Compilation Element

–Compilation of Audit Findings•Who is responsible•When is it done•Master audit summary forms from

Standards• State Developed Forms

Evaluating Element

–Evaluating Audit Findings•Who is responsible•When is it done• Excel as a tool

Corrective Action Element

• Individual Inspection Audit Ratings–Remediation to address performance issues–Remediation to address individual audits–Who is responsible–Documentation

Corrective Action Element

• Overall Audit and Performance Factor Ratings–Development of Corrective Action Plans– Tracking Completion of Plans

Closing Thoughts

Contact Information

Julie Loera

Food Safety Officer

Texas Department of State Health Services

Julie Loera@dshs.state.tx.us

Contact Information

Amir Javed

MFRPS Program Specialist

California Department of Public Health

Amir.Javed@cdph.ca.gov