How to Achieve a Zero Deficiency Audit

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www.navexglobal.com © 2015 NAVEX Global, Inc. All Rights Reserved.


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How to Achieve a Zero Deficiency Audit

Lauren Chesnut & Mary Bennett




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P R E S E N T E D B Y

Vice President, Advisory Services

NAVEX Global

Lauren E. Chesnut, H.T. (ASCP)

Quality Assurance Manager,

Department of Pathology,

South Texas Reference Laboratories,

University of Texas Health Science Center at San Antonio

Mary A. Bennett, R.Ph.




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Agenda

• A Story of Taming Paper for Better Audit Results

• Policy Management Benchmark Report Highlights

• Policy Management Tech Solutions

• Q&A




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A STORY OF TAMING PAPER FOR BETTER AUDIT RESULTS

H O W T O A C H I E V E A Z E R O D E F I C I E N C Y A U D I T




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The Story Begins…




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• Documentation of proper review by authorized personnel

• Document revisions are properly tracked and approved

• Archived documents are stored for a defined amount of time according to records retention policy

• Documentation that any revised documents have been reviewed by all applicable personnel

Effective Document Control & Management




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Lack of documentation related to:

• Annual review of all policies and procedures by the current laboratory director and personnel

• Review of revisions made to policies and procedures

• Certification that all personnel are knowledgeable of current policies and procedures

Top 3 Most Common Policy-Related Audit Deficiencies




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Most Valuable Features in a Document Management System

• Ease of implementation, operation and maintenance

• Ability to create multiple department partitions within the same system

• Automatic notification of pending tasks

• Flexibility of template design and properties

• Ability to control levels of accessibility to different areas or individuals

• Ability to demonstrate that personnel are knowledgeable about current policies and procedures

• Variety of reports demonstrating activities within the system by individuals or by documents




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How Technology Resulted in Zero Deficiencies

• Documents are complete and accessible; no missing critical pages due to missing binders

• Automated review functions ensure documents are reviewed on time and by the authorized individual

• New version creation process ensures that a current document is still available for use during revision process

• No time lag between document approval and distribution to all applicable staff

• Ensured periodic review of documents means better adherence to proper procedure

• Documentation that updated documents have been reviewed means staff is knowledgeable of current policy and practice




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• Improved communication and documentation of policy reviews

• Freed up valuable time for managers involved in document management process

• Policies and procedures are in a constant state of compliance

• Capability of linking documents multiple ways

• Increased clarity regarding responsible parties

Other Benefits




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POLICY MANAGEMENT BENCHMARK REPORT HIGHLIGHTS




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• 879 respondents across 18 industries

• Respondents include:

C-Suite (10%)

Senior Managers/VPs (44%)

Managers (29%)

Non-Managers/Other (17%)

• Respondents represent small, medium and large companies (roughly 1/3 of each)

• First and largest report of its kind by an independent resource company

• Collected anonymously

About the Policy Benchmark Report Survey




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1. Training employees

2. Aligning policies with regulations

3. Improving version control, reducing redundancy and inaccuracy

4. Creating and updating documents easily

5. Providing quick and easy access to the most current policies and procedures

KEY FINDING 1:

Top Policy Management Challenges




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• 51% of survey respondents manage between 5 and 250 documents.

• 20% of survey respondents manage more than 750 documents.

• Respondents are managing many kinds of documents: policies, procedures, codes of conduct, job descriptions, applications, I-9s, contracts, etc.

KEY FINDING 2:

Type and Number of Policies Managed




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• Primary Owners

HR 69%

E&C 68%

Legal 67%

• Who pays?

Budgets don’t align with stakeholders

• No budget 24%

• E&C 22%

• HR 19%

• Legal 13%

• Organization 20%

KEY FINDING 3:

Ownership of Policy Management




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• Budget

FSGO expects “adequate resources”

$0 (41%)

<$25K (15%)

• FTEs

Most dedicate 1 or less (43%)

• Budgets likely dedicated to FTEs not systems and controls

KEY FINDING 4:

Resources Assigned to Policy Management




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KEY FINDING 5:

Regional and Language-Specific Policies

• Old practice: One size fits all

• New paradigm: Multiple languages, geographies and cultures

• Best practices should be:

Current policies translated

Localized and respectful




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Key Takeaways

• Policy management is a maturing business function: budgets and FTEs reflect this.

• Respondents with policy management systems are far more likely to rate key aspect of their program as “very good” or “excellent” compared to those without automated software.

• Significant opportunity to educate business leaders on why investment is critical to a successful E&C program—and organizational culture.

• Number of policies and management complexities indicate that manual, siloed management approaches are quickly becoming unsustainable as a viable business or risk mitigation strategy.




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POLICY MANAGEMENT TECH SOLUTIONS




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“Organizations often lack an auditable means of policy maintenance, communication, attestation, and training. To defend itself, the organization must be able to show a detailed history of what policy was in effect, how it was communicated, who read it, who was trained on it, who attested to it, what exceptions were granted, and how policy violation and resolution was monitored and managed.”

Michael Rasmussen GRC pundit and expert on

GRC technology architectures and solutions




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• Regulatory compliance increases in healthcare (audits!)

• High turnover

• Quality of healthcare

• Increased focus on efficiency

• Acquisitions / mergers

• Downsizing of workforce

• Diversity of workforce

Challenges in Healthcare Market




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Policy Management Lifecycle

CREATE

Draft Reviewers Approval

Document owner

Policy draft Subject Matter Experts Approver




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Policy Management Lifecycle

PUBLISH / ARCHIVE CREATE

Draft Reviewers Approval Distribute Certification

Queue for Later Release

Publish

Document owner

Archive

Policy draft Subject Matter Experts Approver

Users




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Global & Scalable

HQ Master Policy

3rd Party/Partners

Variations Based on Locality

Multiple languages

EU Data Privacy

Roll-Up Reporting




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Typical Areas of ROI

Policy Management

• Document creation & editing

• Reviews & approvals

• Audit & accreditations

• Data collection, analysis, and reporting

Increase Oversight / Risk Reductions

• Increased awareness

• Reduced regulatory actions

• Reduced litigation & settlement costs

Current Process Costs

• Searching & retrieval time

• IT cost reductions

Policy Training & Communication

• Management time delivering trainings

• Policy sign-off attestation




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Key Benefits

• Word integration

• Automated management

• Resource reduction

• Faster retrieval

• Enhanced training

• Proven compliance

• Lower redundancy

• Increased productivity

• Heightened quality

• Risk prevention

• Localized copies




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Questions




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Thank You!

Lauren E. Chesnut Quality Assurance Manager [email protected]

Mary A. Bennett VP, Advisory Services [email protected]

mailto:[email protected]

mailto:[email protected]

How to Achieve a Zero Deficiency Audit

Business

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