Writing Effective Standard Operating Procedures and Other Process Documents

This is a course for people who must write process documents required by the binding regulations. Process documents in sum create a procedural infrastructure that delineates the company’s activities. These documents include Standard Operating Procedures (SOPs); policies; work instructions; laboratory methods; emergency action, chemical hygiene, animal husbandry and other plans; and quality manuals. This course is valuable for pharmaceutical, medical device, and biotech professionals in drug discovery, product development, quality assurance, clinical testing, information technology, and regulatory affairs. It is also helpful for senior and middle management executives who want to familiarize themselves with the regulations that mandate procedures and the industry standards for writing them, putting them in place, and remaining compliant.

Learning Objectives

Upon completion of this course, you will:

• Understand the mandates for clearly delineated processes set forth by the Food and Drug Administration (FDA), International Conference on Harmonization (ICH), Occupational Safety and Health Administration (OSHA), the International Organization for Standardization (ISO), and other governing bodies
• Have increased understanding of the role of written procedures in maintaining effective and compliant business activities
• Understand the importance of document integrity and established controls
• Understand how to prevent overlaps, contradictions, and disconnects in documents
• Have increased confidence in planning and writing various process documents
• Understand how English tenses work and how they serve to make process documents clear and logical
• Understand how to write in the third person, use the imperative voice, and pare the passive
• Be able to control the language so that every word counts and messages are clear to readers
• Know the answers to your questions about language anomalies
• Understand the industry standards for procedure writing, including typical components of documents, and using document templates
• Know how to review and revise documents
• Understand the full life cycle of SOPs and other documents
• Understand how training is integral to document approval
• Know how to build a non-binding style guide to support the writing process

Course Description

This course presents a comprehensive overview of process writing that the binding regulations require. There’s a tenet among regulatory bodies: “If you didn’t write it down, it didn’t happen,” and while the regulations tell companies what they need to do and document, they don’t tell them how. Determining how systems work and how processes occur and documenting them is up to companies to determine. This course presents process writing within the “big picture” of controlled documentation and gives industry standards for delivering information. Effectively prepared process documents keep companies on track and compliant. Participants will learn how to write them so that they ensure consistency in operations. A workshop in process writing gives participants the opportunity to actually write about a process and then assess the results.

The course also addresses problematic areas of the English language and affords participants the chance to voice their questions. Participants will learn how to tighten and refine the language to produce clear and comprehensive documents.

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COURSE AGENDA

DAY ONE

Systems and Controls

• Introductions
• Document integrity and control
• Regulatory requirements and good business practices
• Determining which process documents to put in place
• Documents for overall systems and specific activities
• Process documents and their relationship to other documents
• Preventing overlaps, contradictions, and disconnects

Tense and Voice in Process Documents

• Identifying the audience
• Using verbs to control action
• Using the active voice
• Paring the passive
• Writing in the third person
• Using the imperative voice

Writing Effective Policies, Procedures, Instructions, and Methods

• Components of Standard Operating Procedures, instructions, and methods
• Controlling sequence of actions
• Choosing the correct voice
• Using the present tense
• Writing about conditions
• Avoiding ambiguity and redundancy
• Using parallel structure
• Being consistent from document to document

Procedure Writing Workshop

• Writing a procedure
• Assessing the process
• Refining it on paper

DAY TWO

Manuals and Plans

• Know your audience
• Components of quality manuals
• Components of Chemical Hygiene and other plans
• Identifying responsibilities
• Explaining systems and activities
• Controlling voice
• Writing section by section
• Controlling sentences

Refining Style

• Precision – making every word count
• Identifying false language rules
• Participants’ grammar concerns
• Language bugbears and how to avoid them
• Punctuating for clarity
• Establishing a non-binding style guide

Reviewing and Revising

• Finalizing the document for review
• Peer review
• Formal review – author and reviewer roles
• Making sure the components are in place
• Refining the purpose and scope
• Assessing and improving the flow
• Making comments on review documents

Remaining Compliant

• Periodic review cycles
• Building document histories
• Revisions and impact on other documents
• Setting reasonable timeframes from planning to active document
• Training on procedural documents
• Remaining compliant