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Standard 4 – Inspection Audit Program
Amir Javed MFRPS Program Specialist California Department of Public Health Julie Loera Food Safety Officer Texas Department of State Health Services Tuesday March 10, 2015
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Making Standard 4 Work for You
California and Texas Programs Making Standard 4 Work for You
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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
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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
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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
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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
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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
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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%
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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
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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
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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
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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
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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
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Meeting the Standard but in different ways
California and Texas Programs Meeting the Standard but in different ways
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Audit Element Roles and Responsibilities Qualification of Auditors
Inspector Manager/Supervisor Qualification of Auditors Background Classroom training Clearing the Auditor
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Audit Element Timeframes for field audits How often
Facilities selected Use of FDA Contract Audits to meet Standard
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Audit Element Timeframes for report and sample audits Time frame
How Selected 7% Across Inspectors
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Compilation Element Compilation of Audit Findings Who is responsible
When is it done Master audit summary forms from Standards State Developed Forms
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Evaluating Element Evaluating Audit Findings Who is responsible
When is it done Excel as a tool
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Corrective Action Element
Individual Inspection Audit Ratings Remediation to address performance issues Remediation to address individual audits Who is responsible Documentation
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Corrective Action Element
Overall Audit and Performance Factor Ratings Development of Corrective Action Plans Tracking Completion of Plans
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Closing Thoughts
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Contact Information Contact Information Julie Loera Food Safety Officer Texas Department of State Health Services Julie Amir Javed MFRPS Program Specialist California Department of Public Health
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