Audit Preparation: View from a Pilot State

Skya MurphyProgram and Policy Analyst

Wisconsin Department of Agriculture, Trade and Consumer Protection

Audit Preparation: Table of Contents Approach-Outline

• Table of Contents Concept and mechanics– How to create a linked table of

contents– Why it’s useful

• Other audit prep tips and tricks • Be an anthropologist and a cheerleader • There is always room for improvement

– A successful audit finds it• Embrace the audit as additional quality

assurance and improvement: Yay! Documentation! Yay! Feedback

• Practice: sister states, OP-SIS, your own staff.

• Intro presentation at outset

WI Audit Preparation Recipe: The Table of Contents

Focus of talk

is only possible if thishas happened first

WRITE IT DOWN

Resulted in a fast, informative audit

Recipe for an unsuccessful audit?

“One of these is the current version….”

Table of Contents: Linking Offers easy navigation to up-to-date policies despite nested files and many obsolete versions

DOCUMENT CONTROL Current and Fit For Use

How-To: Table of Contents

• Start with a Word document listing all the performance elements, documentation and deliverables that you will be required to create, update and maintain: a good starting point would be the FDA-provided Audit checklist

Table of contentsRight click on the element requirement and hyperlink it to the documentation of your conformance or gap: here, we will link to the Standard 1 self-assessment

Table of contents• Links will turn blue! And can be checked off the list of

documents to gather. Further color coding helps focus on items that will be linked before the audit but aren’t yet

Table of contents Color Coding Suggestions • Informational headings are black – Black headings are also used to indicate hard copies: “example,

hard copy training certificates, filed by name” • Links to completed documentation are blue • Red headings preface links to the strategic plan showing

forthcoming documents and gaps that have been identified for example, – Standard 9, “Exit Strategy of Sustainment” see strategic plan

For easy navigation and reference, under each standard add links to the current standards, the baseline assessment for the

standard, and subsequent self-assessments

To highlight progress, include links to super-contract and cooperative agreement deliverables for each year:

In the .5 section of each standard, link to required documentation including each documented performance

element

Table of Contents: Efficiency of Links• Links to the same document can be

located throughout the table of contents as needed. For example:– Each element that is not met could

state “gap identified on strategic improvement plan” and be a link to the current strategic improvement plan.

– Link to same documentation in each standard element it refers to, i.e. Recall information in standards 3 and 5

Table of Contents Translation tool

Table of Contents is Versatile

• Tool for showcasing program strengths improvement projects, during an audit, a presentation to sister states, and your own program staff

Audit Preparation Table of Contents Ongoing Strategy

• Maintaining it over time means your documentation is always at your fingertips: you are aware of current progress and ready for an audit at any time

Examine the Artifacts

Other tips and tricks: Be a cheerleader and an anthropologist

Ask lots of questions

Be a cheerleader and an anthropologist

Create the Records

Our program is awesome! Audit

preparation is fun!

Be a cheerleader and an anthropologist Documenting the oral tradition

• Wisconsin enrolled as pilot state in 2007• I began helping with audit preparation in 2012;

Documenting the oral tradition began much earlier: – Circa 1998: Policy teams to put inspection procedures down in

writing and codify best practices, motivated by realization that every region of Wisconsin doing things differently

– By 2000 policy teams for food processor, retail food, dairy and farm inspection policies and forms

…and is what made successful audit preparation possible

Low-tech way to distribute and update policies began 2002 and still going

Tips and tricks: Set the stage, rehearse the players• Schedule subject matter experts/standards

leads to be available to talk through each standard

• Prepare slides for each summarizing program strengths and areas that need improvement to conform within each standard.

• Begin auditor’s visit with presentation including agency overview. Each standard lead presents one to three standards.

• Embrace the audit as additional quality assurance

• There is always room for improvement• A successful audit

finds it• Practice: sister states,

OP-SIS, your own staff. • Intro presentation at

outset

Yay! Documentation! Yay!

Feedback!

• Communication with auditing team and guidance from Standards Implementation Staff set clear expectations

• “Table of Contents” with hyperlinks increased efficiency, organized documents, easily navigated to without leaving the room.

• Team approach: subject matter experts ready to take the lead through each standard and accompanying documentation

• Yay, feedback! Yay, documentation

Conclusions: there is no finish line