Content, Format and Style Requirements for Controlled...

Document Number: WI-DOC-01-01Version Number: 1.0

Effective Date: 00 January 0000

Document Owner: Chief Quality Officer Page: 1 of 19

Title: Controlled Document Content, Format and Style Requirements

1.0 PURPOSEThe purpose of this Work Instruction (WI) is to provide an instructional tool that facilitates consistent creation and review of controlled documents by describing the standards for the content, formatting and style of controlled documents.

2.0 SCOPEThis WI applies to Policies, Manuals, Standard Operating Procedures, Work Instructions and Supporting Documents (e.g. controlled documents) that are governed by the TQMS quality management system (QMS).

3.0 INTRODUCTIONIt is intended that this WI should be used in conjunction with the Level 1 – Level 5 controlled document templates. The templates provide pre-formatted styles and detailed instruction to assist users with creating Level 1 – Level 5 quality system documents (i.e. Policy, Manual, Standard Operating Procedure, Work Instruction, and Supporting Documents)

4.0 ROLES AND RESPONSIBILITIES4.1 Document Manager

Provide support to document authors during the development of new documents

4.2 Document Authors

Create documents that accurately reflect current practice or the practice that is intended to be followed.

Form ControlTMP-DOC-01-01-04 v 1.0Effective: 00 January 0000

Copyright © Ticalion Quality Management Services, LLC. All rights reserved. The contents of this document are proprietary to Ticalion Quality Management Services, LLC Unauthorized use, disclosure and reproduction are strictly prohibited. Non-transferable, single entity use license provided to purchaser. Proof of purchase required.





Create and format documents according to this procedure and the applicable template.







4.3 Document Owner/Supervisor

Provide assistance to document authors during the development of documents to assure that documents meet business needs.

Participate in the review of draft documents under their area of responsibility to assure technical accuracy.

Approval authority for controlled documents under their area of responsibility

4.4 Quality Assurance

Provide support to the document author during the new procedure planning phase to help address the necessity, purpose, and scope of the new procedure.

Provide assistance to the document author to assure that controlled documents are drafted in compliance with quality management system requirements.

Approval authority for all controlled documents

5.0 RELATED DOCUMENTS

Document Number Document Title

SOP-DOC-01 Document Control Process

WI-DOC-01-02 Controlled Document Collaboration, Review and Approval







SOP-EDM-01 Electronic Document Management System General Use

6.0 SUPPORTING DOCUMENTS

Document Number Document Title

TMP-DOC-01-01-01 Policy (POL) Template

TMP-DOC-01-01-02 Manual (MAN) Template

TMP-DOC-01-01-03 Standard Operating Procedure (SOP) Template

TMP-DOC-01-01-04 Work Instruction (WI) Template

TMP-DOC-01-01-05 Supporting Document (FRM) Template

7.0 DEFINITIONS AND ACRONYMS

Acronym/Term Definition







Approved The status of an item (e.g., controlled document, controlled record) that has been reviewed, found acceptable and documented as acceptable by all approvers.

Archive: 1.) A collection, usually of records, that is stored and maintained for historic reference. 2.) A lasting collection of system data or other records that are in long term storage.

Change Control The process of identifying, documenting, verifying, reviewing and approving changes before their implementation.

Controlled Document A document that is reviewed and approved prior to use, version controlled, and has a life cycle.

Document Control System

The processes that govern the controlled document lifecycle.

Quality System Controlled Document (aka Quality System Document)

Controlled documents whose existence is mandated by the quality management system requirements. Typically quality system controlled documents consist of policies, manuals, plans, standard operating procedures, work instructions, forms and templates .







Record (aka Quality Record)

Any written or electronic documentation providing evidence that activities were performed and their results. Records include original documents, accurate reproductions of original documents, electronic data and files. Records do not exist until the activity has been performed.

Record Management The policies and procedures that govern systematic control of all records from their creation, or receipt, through their processing, distribution, organization, storage, retrieval, retention and ultimate disposition.







8.0 WORK INSTRUCTION8.1 When is this work instruction used?

This work instruction is used by document authors when creating policies, plans, manuals, standard operating procedures, work instructions and supporting documents.

This work instruction is used by the peer-review group to guide the initial review and revision of draft documents.

Refer to flowchart FLW Document Control Process Flowchart for an overview of the document control process.

8.2 New Document Planning

8.2.1 The document author will discuss the need for a new document with their supervisor and appropriate SMEs. QA should be consulted, as necessary, when planning a new document.

8.2.2 In considering the proposal for a new document, the group should review existing, similar controlled documents to determine whether a new document is necessary or whether an existing document can be modified to satisfy the subject matter of the proposed new document. The group should also assess the likely impact of the proposed document on any current controlled document by discussing the proposed content with other potential stakeholders.

8.2.3 If all parties agree with the proposal to create a new document, the author will obtain the appropriate template for the new document from the approved controlled document library.







Refer to the document SOP Electronic Document Management System (EDMS) General use for instructions to locate and retrieve released controlled documents using the EDMS.

8.3 Structure and Organization of the Draft Document

8.3.1 Controlled documents are created in a consistent format according to the relevant approved template and the requirements of this work instruction.

8.3.2 Use the controlled document templates listed in the Supporting Documents section of this WI for document templates that provide pre-formatted styles and detailed instruction to assist users with creating Level 1 – Level 5 quality system documents (i.e. Policy, Manual, Standard Operating Procedure, Work Instruction, and Supporting Documents)

8.3.3 The templates include the required sections for the controlled document. At the discretion of the document author and QA, additional sections may be added to controlled documents in order to improve organization, readability, and user-friendliness of the document.

8.3.4 In the absence of a specific template for the type of controlled document to be prepared, the structure and organization of the controlled document may be based on an existing, approved document template and tailored to the purpose and scope of the specific document.

8.4 Content Requirements

8.4.1 The author will create a draft of the document based upon the content and format requirements in the applicable template and the style requirements documented in this procedure.







8.4.2 The author should consult with necessary personnel (e.g., SME’s, supervisors, document owners, document manager, QA) to prepare a complete preliminary draft of the document.

8.4.3 The author will provide content that is complete to the level that there is no ambiguity about the sequence of operations.

8.4.4 Where flexibility is needed in order to allow the user to make a choice or a decision, the procedure will provide adequate instruction to guide the decision making process and or keep the choice options within a bounded framework.

8.4.5 When writing the document it is important for the author to think about the audience and address the document to the audience. The author should consider that the document is not only written for personnel that may already understand the activity, but it is also written so that other personnel (e.g., customer, new employee, personnel from a different department, auditor) can understand how the activity is performed.

8.4.6 Explain the actual process at a level of detail that enables a qualified employee that may be new to the task, such as a new hire, to follow the process. Detail shall be to a level that multiple qualified people would perform the procedure in the same manner and achieve the same results. The peer-review group, based upon their knowledge of the subject and the target audience, will determine the appropriate level of detail.

8.4.7 The document author will take into consideration the title, purpose, scope, and content of existing controlled documents when preparing a new or revised draft document so that the draft document does not adversely impact any other controlled document.

8.4.8 If the new controlled document does have an impact on an existing controlled document, then the existing controlled document is likely to require revision in parallel with the new draft document. The document author shall work with the owner of the impacted procedure, or their designee to make necessary changes to the impacted procedure.







8.5 Document Format Standards

8.5.1 It is strongly preferred that authors use the document templates to write consistently formatted documents. Documents may be created without using an approved template only when there is not an approved template that is suitable to the required content and structure of the proposed document. QA has final authority over document format standards.

8.5.2 When using approved templates, it is required that authors obtain a template from the controlled document library in the EDMS each time they write a new procedure to avoid use of an incorrect, obsolete or corrupted template.

8.5.3 The general format requirements for documents are pre-formatted in templates that include all of the standard sections for each document and include formatted Microsoft Word Styles. The following Microsoft Word Styles are built in to the templates, and will be used when creating new procedures. The document author may modify the indent on these sections to facilitate readability.

8.5.4 Formatting follows the following style guidelines:

Line Spacing –

o Single, 24pt before, 12pt. after for Level 1 Headers

o Single, 6pt before, 12pt after for all other level of headings and for normal text

Font –

o Arial 14pt font for Level 1 Headers







o Arial 11pt font for all other level of headings and for normal text

Outline Numbering – (i.e., 1.0, 1.1., 1.1.1., etc…) Used for major section headings, informational topics, operational steps and operational sub-steps in the procedure. Generally not used for informational sub-topics.

Bullet – Generally used for informational sub-sections such as responsibilities in the Roles and Responsibilities section and general information sections of the procedure.

SOP Footer – Used for all text in the footer.

Font: (Default) Bodoni MT, 9pt, Justified Line spacing: single, Space After: 0pt, Don't adjust space between Latin and Asian text, Don't adjust space between Asian text and numbers, Style: Linked, Quick Style Based on: Normal

SOP Header – Used for all text in the header.

Font: (Default) Bodoni MT, Underline Line spacing: single, Space Before: 3pt After: 3pt

Heading 1 – Used for all major section headers (e.g., purpose, scope, procedure).

Indent: Left: 0" Hanging: 0.3" Line spacing: single, Space Before: 6pt After: 12pt, Level 1, Outline numbered + Level: 1 + Numbering Style: 1, 2, 3… + Start at: 1 + Alignment: Left + Aligned at: 0" + Indent at: 0.3", Style: Linked, Quick Style, Priority: 10 Based on: SOP Header 1 Following style: Normal

Heading 2 – Used for sub-headers. Used in the Roles and Responsibilities section to identify individual roles. Used in the Procedure section to identify the requirements and general information sub-sections.







Font: Bold, Indent: Left: 0" Hanging: 0.4" Line spacing: single, Space Before: 6 pt After: 12pt, Level 2, Outline numbered + Level: 2 + Numbering Style: 1, 2, 3… + Start at: 1 + Alignment: Left + Aligned at: 0" + Indent at: 0.4", Style: Linked, Hide until used, Quick Style, Priority: 10 Based on: Normal Following style: Normal

Normal, Figure and Table – Used for the title of all tables and figures and body text of all sections of the document.

Bullet – List Paragraph – Used for the bulleted (i.e., •, ▪, ○, ♦, etc…) responsibilities in the Roles and Responsibilities section and the body text of requirements and general information sub-sections sections of the procedure.

Indent: Left: 0.38" Hanging: 0.25" Line spacing: single, Space Before: 6 pt After: 12 pt, Bulleted + Level: 1 + Aligned at: 0.25" + Indent at: 0.5", Style: Quick Style, Priority: 35 Based on: Normal

Normal – Number – Used for the outline numbered (i.e., 1.0, 1.1., 1.1.1., etc…) operational sub-sections of the procedure.

Reference (Subtle Reference) – Used to set apart references to external procedures, reference documents and notes.

Font color: Accent 2, Style: Quick Style, Priority: 32 Based on: Default Paragraph Font

Additional styles may be present in the Microsoft Word Styles window; however, the Styles listed above should be the primary styles needed for creating controlled documents.

The standard alignment for procedures is left-justified, Arial 11, unless otherwise specified by the template and the applicable Microsoft Word Style.







8.6 Conventions

The following sub-sections contain a partial list of conventions and appropriate situations in which to use these conventions when writing a controlled document. This list is not inclusive, and should be viewed as a guideline. Font effects (bold, italic, underline) may be used in additional situations to assist with the readability of the document.

Capitalization

o Any reference within the procedure that indicates a specific application, system, person, or item should be capitalized. For example:

Document Control System is capitalized because it is used as a noun to refer to a specific system.

References to the system administrator are not capitalized because there are, or could be, multiple system administrators.

o All major (level 1) headings are formatted to all CAPS (all capitals) according to the template.

o All minor headings and sub-headings are written in Title Case according to the template.

o References to tables, figures, or controlled documents are written in Title Case.

o Job positions (titles) or roles are written in lowercase, except when abbreviated such as “Dr.” or “QA”.

Bold







o Specific actions or inputs to a process including the name of a button or icon to click or specific information to input to a computer system or application are written in bold.

o All headings are written in bold according to the template.

Font - Italics

o References to other resources such as related documents, tables, and figures are formatted in italics.

o Additional information included as notes, are formatted in italics.

8.7 Language Standards

8.7.1 Avoid the use of ambiguous, non-specific words and phrases such as “as soon as possible”, “periodically”, or “appropriate”. Instead, provide a timeframe, frequency or dependency as shown in the following example:

Example: Ambiguous/Unambiguous Language

Ambiguous Unambiguous

As Soon As Possible Within 48 Hours

Periodically Once Per Quarter

As Appropriate When Condition X Is Met

8.7.2 State mandatory requirements using direct language such as “must” or “shall”.







8.7.3 Indirect words such as “should” or “may” shall be used cautiously, and are allowed where the requirement is not mandatory.

8.7.4 Define abbreviations the first time that they are used. Write out the word or phrase the first time that it appears in the text and include the abbreviation in parentheses following the word or phrase. For example, Quality Management System (QMS) is the proper way to define QMS.

8.7.5 Refer to all controlled documents in italics, by document type and name in title case. For Example, this is the appropriate way to refer to WI General Use of the Electronic Document Management System. Red font may be used for emphasis but must be used consistently throughout the document.

8.7.6 All documents referenced in the body of a procedure will be listed in the Related Documents section.

8.7.7 All supporting documents referenced in the body of a procedure will be listed in the Supporting Documents section.







8.8 Commonly misused terms:

8.8.1 Assure / Ensure / Insure

Assure means to make something certain (by verification) or to make certain that something will happen.

Ensure means to make sure, certain or guarantee. The use of the term “ensure” should be minimized because of the legal implications of the guarantee.

Insure means to make sure, certain, or secure. This term is similar to assure; however, it typically refers to financial matters and the insurance industry.

8.8.2 Obtain / Attain

Obtain means to gain possession of a physical object.

Attain means to gain possession of, or achieve, a state or condition.

8.8.3 Use / Usage / Utilize

Use means to employ something for its intended purpose.

Usage means to employ something for its intended purpose over a period of time.

Utilize means to employ something for an action other than its intended purpose.







8.9 Peer-Review and Collaboration of Draft Controlled Documents

8.9.1 Document authors are responsible for identifying peer reviewers and for coordinating the peer review. Document owners and QA personnel may be called upon to assist the process of identifying peer reviewers and coordinating peer reviews.

8.9.2 Personnel identified to perform peer review are responsible for assuring that their review is performed in accordance with WI Review of Controlled Documents.

8.9.3 Peer reviewers are responsible for submitting their review recommendations to the document author by the due date that is provided by the document author/owner or QA.

Refer to the work instruction Controlled Document Collaboration, Review and Approval for the document review procedure.

8.10 Initiation of the Review and Approval

8.10.1 At near final stage the document author emails the document to the document manager for final approval routing. The author will provide the document manager with the following information:

8.10.2 An editable copy of the draft document, typically in Microsoft Word format.

8.10.3 The numbers and titles of parent documents. For example if the draft document is a form, the author will provide the document manager with the name and document number for the parent SOP and parent WI if applicable.

8.10.4 A list of all subordinate documents. For example if the draft document is an SOP, the author will provide the document manager with the name(s) and document number(s) for all subordinate WI(s) and forms, if applicable.







8.10.5 Any other important information related to the draft procedure, such as target approval or target effective date.

8.10.6 The document manager will initiate the Review and Approval task according to the work instruction Controlled Document Collaboration Review and Approval.

9.0 EXCEPTIONSDocuments that are not identified as controlled documents in the quality manual and which are not controlled under the document control system are exempt from the requirements of this procedure. Such documents frequently include but are not limited to documents and records that are created and pertain to company financial information, marketing activities, and business development activities inasmuch as they are not required to be maintained under the quality system for compliance to federal, state, or local law.

10.0 QUALITY RECORDSThe output of this procedure is an unapproved document and peer review recommendations. Unapproved documents and recommendations are not part of the quality record. There are no quality records associated with this procedure.

11.0 VERSION SUMMARYThe Version Summary section contains a summary of all significant changes made in the current version of the WI. This section only addresses changes from the previous version of the WI to the current version. The version summary must indicate if the document replaces and makes obsolete a previously approved document.

Change # Description







1 New procedure. No prior procedure.



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