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Developing Written Documentation

Effective Compliance Programs DEVELOPING WRITTEN DOCUMENTATION According to the US Dept. of Health & Human Services Office of Inspector General (OIG) there are 7 fundamental elements of an effective compliance program. The first element focuses on implementing written policies, procedures and standards of conduct to develop a culture of ethical and compliant behavior. → #1 The 7 Implementing written policies, procedures and standards of conduct Fundamental #2 Designating a compliance officer and compliance committee Elements #3 Conducting effective training and education of an Effective # 4 Developing effective lines of communication Compliance Program #5 Conducting internal auditing and monitoring #6 Enforcing standards through well-publicized disciplinary guidelines #7 Responding promptly to detected offenses and undertaking corrective action DOCUMENTATION NUMBERS TO KNOW Since 2009, the OIG has entered into Corporate Integrity Agreements (CIAS) with over 20 pharmaceutical manufacturers and counting. Accompanying these CIAS were monetary penalties ranging from several million dollars to multi-billion dollar settlements. 00000000080 0000000000 9 10 11 12 13 14 15 16 17 18 19 20 100% of those CIAS require Policies and Procedures Every CIA surveyed requires implementation of a Code of Conduct, covering 4-6 minimum areas of organizational and employee behavior. Additionally, each CIA not only requires policies and procedures, but mandates they cover a minimum number of topic areas. >20 S10 3 All CIAS require distribution of mandatory Out of the 21 CIAS CIAS surveyed, more than two-thirds require 10-14 CIAS CIAS policies and procedures to employees within an policies and procedures on 15 or more areas. 15-19 established timeframe, typically 120 days from the CIA effective date. CIAS POLICY & PROCEDURE AREAS DOCUMENTATION FRAMEWORK DOCUMENTATION is critical to ensure consistent behavior and business practices across the organization. Each document type serves a unique purpose in the overall framework. Traditionally, policies, procedures and standards of conduct are considered mandatory while guidance documents are not. Here is a best-practices approach to strategically organizing your documentation structure: CODE OF CONDUCT POLICIES are the highest level of the document hierarchy. They provide principles and rules for conducting activity within an organization. PROCEDURES often referred to as Standard Operating Procedures or SOPS, define how something must be done, including by who, when, and other details relevant to a business activity. Procedures follow the rules and principles outlined in your oganization's policie s. STANDARDS OF CONDUCT often referred to simply as sta ndards or citeda documents, provide specific limits, ranges or other acceptable parameters or boundaries. GUIDANCE DOCUMENTS while not included by the OIG as part of effective co mpliance programs, guidan ce do cuments support policies, procedures, and standards of conduct. Guida nce documents may provide suggestions, best practices, or tips, and include checklists, forms, user guides, FAQS and more. DEVELOPMENT ROADMAP Creating documentation should not be a piece meal process. The roadmap below identifies key steps for how to create and develop effective compliance documentation. DOCUMENTATION FRAMEWORK PLANNING DRAFTING Develop a systematic approach for con sistent planning & development. This includes defining document types, creating templates, and establishing the critena and process for creating new documents. Th is is the most important and often over looked phase. Identify a need for documentation, allocate individuals & reso urces, and determine timelines, docu ment review & approval, and implementation Gather information from subject matter experts (SMES) and relevant stakeholders and organize the information according to your document template. strategies. MAINTENANCE IMPLEMENTATION REVIEW & APPROVAL Update docu ments based on changes to business practices. Establishing regu lar re-review cycles en ables documents to reflect current business cycles. Determine document storage and a ccessibility needs and develop a communication and training strategy, as necessary. Relevant individuals must be informed of new and revised policies, procedu es, Seek review and approval to ensure the document is accurate, complete and relevant. Levels of review and approval should be defined within the docu mentation framework. and standards of conduct to establish awareness and ensure compliance. KEY QUESTIONS TO ASK The process for creating effective documentation may vary greatly from one organization to another. Below are some helpful questions to consider to ensure a smooth process. DOCUMENTATION FRAMEWORK o O DRAFTING PLANNING O Q: Is your framework defined and understood by those in the organization? Q: Who is coordinating document development? Q: What is the document type, purpose, and scope? Q: Are document templates stored in an accessible lo cation? Q: What resources must be invo ved? Q: Were the necessary stakeholders consulted? Q: What is the timeline for completion? Q: Are responsibility and accountability clearly defined? MAINTENANCE O IMPLEMENTATI ON REVIEW & APPROVAL Q: How often are documents reviewed or audited for accuracy? Q: Where is the document stored? Who is responsible? Q: What are the minimum levels of required review? Q: Who is responsible for updating do cuments requiring revision? Q: Who is the intended audience and how will we communicate to them? Q: Who has authority to approve different types and levels of documents? Q: Does the new documentation need to be read and understood or requie training? KEY QUESTIONS TO ANSWER Policies, procedures and standards of conduct should ultiamtely provide the reader with the WHAT, WHO, WHEN, and HOW. WHAT WHO WHEN HOW How do I follow the policy? Who does the rule apply to? Who is doing the action? What is the rule, action When does the rule apply? When is the action required? or criteria? How do I complete the process? How do I know if my criteria fit acceptable limits? Who fits the criteria? When do I fit the criteria? For more information, visit us at or contact us at [email protected] PotomacRiver SOURCES: PART NERS US Dent. of HHS OIG Compliance Program Guida nce for Phamace utical Manufacturers US Dept. of HHS OIG Coporate Integity Agreements homepage

Developing Written Documentation

shared by atoakley on Oct 30
Highlights US Dept. of HSS OIG documentation guidance and CIA requirements as well as provides a recommended documentation framework and development process.


Meredith Swartz


Adam Oakley


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