Technical Writing › ...• PharmOut holds ISO 9001:2015 certification from LQRA. Our Quality...
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Technical Writing Presented by: Maria Mylonas
Transcript of Technical Writing › ...• PharmOut holds ISO 9001:2015 certification from LQRA. Our Quality...
Technical Writing
Presented by: Maria Mylonas
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About PharmOut
• PharmOut is a rapidly growing international consultancy offering GMP compliance, qualification & validation, TGA regulatory, engineering and architectural consulting services to the pharmaceutical, blood & tissue, pesticides and veterinary and medical device manufacturers, as well as related hospital and pharmacy operations.
• PharmOut holds ISO 9001:2015 certification from LQRA. Our Quality Management System is certified to the ISO 9001:2015 standard for the provision of architectural design and consultancy services.
"Regulatory Knowledge, Practically Applied"
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Our Services
• GxP compliance consulting
• GxP contracting
• GxP training
• Qualification and Validation
• Quality Management Systems
• Project management
• Regulatory submissions
• Continuous improvement consulting
• Temperature mapping
• Architecture
• Engineering
• Master & Strategic planning
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Activity - introductions
• Who are you? Introduce yourself.• What is your position?• What did you want to get out of
today’s session?
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Online GMP Training - Demo
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Online GMP Training - Demo
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Online GMP Training - Demo
Course Title
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Online GMP Training - Demo
Various documents
Presentation
EvaluationAssessment
Course Title
Course Information
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Course Assessment – Online GMP
At the end of the training you will complete an online assessment throughwww.onlinegmptraining.com:
• You have 60 days access to complete the assessment and evaluation and download materials.
• The assessment is ‘open book’
• The assessment will take Approximately 10 minutes and you will get your certificate
© PharmOut 2018
Guidelines
Please contribute
Please stop me to ask a question
Please relax and enjoy yourself
Please place your phone on silent mode
Please no recording this training session
01 Introduction
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Introduction to Quality Management Systems (QMS) and document management
Information types
Using templates
Features of good documentation (usability and readability)
Using plain language
Process mapping
Where to start
Tips for technical writers
What we will cover today
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Who will benefit from this training?
• This training is targeted at all people who write and review business documents.
• The focus of the training is writing procedures and instructions.
• The principles of this training can be applied to all business writing including emails and customer/client facing communications.
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What do you write?
What types of documents do you write as part of your current (or past) employment?
B/P
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Activity 1. Your perspective
• What are some of the challenges you face when writing and/or reading business documents?
• What works well (or not so well) with procedures and instructions for companies you have worked at?
02. Introduction to Quality Management Systems (QMS) and document management
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Quality Management System (QMS)
A Quality Management System (QMS) is the set of policies, processes and procedures required for planning and execution of activities.
Documents within a QMS include:• Policies• Procedures• Instructions• Forms• Check-lists, etc.
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Why do we document our QMS?
• It is a regulatory requirement• It is an essential part of the quality assurance system and
key to operating in compliance with GMP requirements• To establish, control, monitor and record all activities which
directly or indirectly impact on all aspects of the quality of medicinal products
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What makes a QMS successful?
Strong management
Centralise common processes
One document for common processes
Business process mapping
Usability
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QMS document hierarchy (typical)
Policies/ processes
Standard Operating
Procedures (SOPs)
Operational Instruction (OIs)
OR Work Instructions
(WIs)
Templates Checklists Forms Logbooks
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QMS document hierarchy (example)
Competence Development
SOP
Creating a Personal Development Plan (Work Instruction)
Booking a classroom training
course (Work Instruction)
Training Matrix template
Training Attendance Records
Training travel approval form
Classroom training approval form
Completing Online learning
(Work instruction)
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Foundations of a good QMS
q Determine which document types need to controlledq Develop templates for all document typesq Define numbering conventionsq Define naming conventions for both electronic file and documentsq Agree business writing styleq Agree approval process – who needs to review and who needs to
sign?q Define verification/checking processq Determine how users will access the documents - controlled copies
available hard and/or soft copies?q Determine how distribution of copies be managedq Control of originals - secure storage both electronic and hardcopyq Define record management requirementsq Define retention, archival and destruction rules
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Planning your QMS document numberingTo ensure your numbers are unique and controlled you will need:
Document the numbering convention
Establish registers to
prevent duplication
Centralise and restrict
management of registers
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QMS document numbers
• Document numbers are used to uniquely identify a document
• You should not ‘reset’ or ‘re-use’ a document number
• Consider the size of the company and number of documents in the QMS before locking in the numbering system
• What are some good examples that you’ve seen/used?
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QMS document numbers
• Intelligent numbering systems are helpful to users – if they understand the format they have instant knowledge about the document.
• Format example:
Doc type Department Unique number
Version number
SOP HR 001 01
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Document titles
Document titles should be:• Meaningful• Unambiguous• Easy to find/search• Refer to your document control procedure for
requirements
The document management procedure should include naming conventions to ensure all authors follow a standard approach.
03. Information types
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What document do I need to write?
The type of information you need to write defines the:• type of document to be written• template you select• language you use• level of detail needed.
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Information typesInformation can be grouped according to types:
Information Type Definition
Process Who, what, when….a series of stages performed in order over time, often by different people.
Instruction How…a series of detailed steps performed in order, usually by one person at one time.
Structure Describes what a physical object looks like.
Concept Describes what something is – object, relationship, theory, etc.
Rule Describes what should or should not be done.
Fact Statement that is assumed to be true – specifications, data, formula, validated equipment settings, etc.
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What information goes where?
Different information typically appears in specific document types:
When information describes… then consider using a…
Concept, rule Policy
Fact Report, Specification
Process (what, who, when, purpose) Procedure
Instruction (how) Work instruction, protocol, test method
Structure Manual
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Activity 2: Applying information typesApply information types in your workbook:1. Read through the description.2. List which information type is being described.3. Suggest what type of document you might locate this information.
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Example answers
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Activity 3: Analysing existing documents
In pairs:
• Review the Happy Pharma ‘Short dated stock policy’ extract in your training handbook.
• Identify information types. • Record anything else of note.
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Example answers
Happy Pharma Work Instruction SOP 1234 Version 03
Short dated stock policy Why: To provide rules on how to manage Happy Pharma’s short-dated stock. Who: All staff who handle short dated stock. When: When finished product have a shelf life of less than six months of their shelf life. 1. No batch can be allocated to a customer if the shelf life is less than three months. 2. At least monthly run a report showing all finished product with shef life less than six months. Appendix 1
1. Log onto ERP and run the expiryt query using the LXP transaction code and your password.
Type 1 into the Command field. Type 2 into the Option filed. Tab twice. Press F7.
Rules
Instructions
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Procedures vs. instructions
• Often blurred as to what information goes into a procedure vs. what information goes into an instruction
• Generally:
Procedure InstructionAn overview of a number of tasks or events
A set of detailed instructions to help someone achieve a specific outcome
What, Why, Who, When, Where
How
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Procedures
• Describes what, who, where, when, purpose.• Includes a series of stages describing the sequence
of tasks to be performed.• Takes place over a period of time (hours, days,
weeks).• Usually involves more than one person or groups of
people.• Has an overall goal that is achieved through
completing a number of specific outcomes.
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Activity 4: Procedure exercise
How do you get to this course?
Remember: A procedure tells you ‘what’ not ‘how’.
Stage Description
1 Turn off alarm
2
3
…
… Sit down
WB:1 / 7 mins
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Instructions
• Should be supported by an over-riding procedure (remember the document hierarchy).
• Describes ‘how’ to do something.• Includes sets of steps.• Each set of steps (part) takes place at one time.• Generally has a specific outcome e.g. ‘ordering
consumables’.• Intends to be used ‘on the job’.
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Activity 5: Instructions exercise
Write the instructions on how to ‘brush your teeth’.Remember: An instruction tells you ‘how’ not what’.
Step Instruction
1 Pick up toothbrush.
2
3
4
5
6
7
…
WB:2 / 7 mins
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Sample answer
Step Instruction
1 Pick up toothbrush and toothpaste.2 Squeeze 1.5 cm of toothpaste on to the bristles of the toothbrush.
3Turn on the cold water tap and run water gently over the toothbrush bristles and paste.Note: Do not wash tooth paste off.
4Brush your teeth for two minutes using a:• circular motion over the outside of your teeth• back to forward motion across the bite of your teethNote: Spit out foam.
5 Rinse your mouth with water to flush all residue of tooth paste from your mouth and spit out water.
6 Rinse your toothbrush and put in the toothbrush holder.
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Guidelines when using procedures and instructions• You can have procedure without related instructions• Procedures can stand alone (e.g. don’t need a policy)• Instructions should always have a parent procedure• Forms, checklists, datasheets etc. must always have a parent• Include related instructions for several sections of the same
process within the same instruction. • Don’t split out into multiple instructions when one will do for
the same user (e.g. setup and use an instrument). • Instructions must be more than one page of instructions –
otherwise include the instructions in the procedure.
Length and level of detail needs to be balanced… too long or too short a document becomes less usable.
04. Using templates
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Why do we need standardised templates?
Build standard requirements into the documents (unique identifiers, page numbers, version numbers, title, purpose, scope etc.)
Guide writers into a consistent writing style and format.
Create a professional image for your organisation.
1
2
3
Templates help an organisation to:
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Templates are controlled documents too
• Templates should be available for all document types• Templates should be subject to the same document
management controls as other documents including:ü change controlü version controlü unique numberingü distribution management.
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Using templates and styles
Styles• A set of formatting instructions
that you can apply to text in your document to quickly change its appearance:ü headingsü bodyü table contentsü headers/footers.
• Paragraph styles affect the entire paragraph
• Character styles affect the text within a paragraph
What to expect in procedure template
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Procedure template (example)
• Mandatory front and back sections for abbreviations, references and change history table
• Tabulated roles and responsibilities
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Procedure template (example)
• Purpose• Scope • Out of scope• Roles and responsibilities• Section description table/contents • Content (i.e. the process)
• Any appendices• Definitions and abbreviations• References• Change history
‘Front matter’
‘Back matter’
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Purpose
Section Requirements
Purpose • Summarises the overall purpose of the procedure• Should be short and concise• May reference to a policy document or legislation
reference • Does not include process or scope information
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Scope
Section RequirementsScope • Summarises ‘who’ and ‘when’ the procedure should be
usedOut of scope • Out of scope is just as informative as in scope
• Use a bulleted list of the areas or processes that are out of scope and provide a reference to the appropriate document
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Roles and responsibilitiesSection RequirementsRoles and responsibilities
• Include each role mentioned within the text of the procedure – do not include extra roles
• Briefly summarise the main responsibilities for each role
• Do not include process or instruction
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Section description/table of contentsSection Requirements
Section description table/table of contents
• First level headings used to describe the process• Does not include second level headings or page
numbers• Complete this section as part of the process
mapping before you write, so that the document follows the process order
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Definitions and abbreviationsSection Requirements
Definitions and abbreviations
• Include definitions and all abbreviations used within the text
• Do not include additional terms or abbreviations
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ReferencesSection Requirements
References • Only include references used within the text• Do not use additional, ‘nice to have’ references – the
document should not be used as a bibliography or reading list
• You can separate internal and external references• Order according to document ID and document type
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Change historySection RequirementsChange history • Very brief summary of changes made to each version
of the document• Detailed changes are captured within the referenced
change control• Used to see ‘at a glance’ the history of the document• If you are using an electronic document management
system, you may not need this in the document
What to expect in an instruction template
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Instructiontemplate (example)
• Link to parent reference
• Section/description table/table of contents
• OHS section – specific safety requirements only
• No scope or roles and responsibilities sections as this is in the procedure
• Uses step/action tables to document step-by-step instructions
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Instruction template (example)
• Purpose• Health and safety• Section description table/contents • Instructions
• Any appendices• References• Change history
‘Front matter’
‘Back matter’
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Purpose
Section Requirements
Purpose • Summarises the overall purpose of the document• Should be short and concise• Should reference the parent procedure• May include scope information if not addressed by purpose
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Safety
Section RequirementsSafety • Briefly lists any safety equipment or requirements
needed while executing the instruction• May reference to an MSDS if product-specific• References other documents detailing further
information
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Section description/table of contentsSection Requirements
Section description table
• First level headings used to describe the instructions• Does not include second level headings or page
numbers• Complete this section as part of the process mapping
and before you write so that the document follows the process order
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Definitions and abbreviations
Section Requirements
Definitions & abbreviations
• Include definitions and all abbreviations used within the text
• Do not include additional terms or abbreviations
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References
Section Requirements
References • Only include references used within the text• Do not use additional, ‘nice to have’ references – the
document should not be used as a bibliography or reading list
• Separate internal and external references• Order according to document ID and document type
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Change history
Section Requirements
Change history • Very brief summary of changes made to each version of the document
• Detailed changes are captured within the referenced change control
• Used to see ‘at a glance’ the history of the document• If you are using an electronic document management
system, you may not need this in the document
05. Features of good documentation
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Activity 6. Finding information
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Features of good documentation
Useful• informative• helpful• detailed• relevant
Usable• structured• well laid out• readable
Reliable• accessible• maintainable• up to date
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Examples
How much information should you include?Examples:
• If you only need to refer to the information once, then don’t include it every time e.g. locations “…start the mixer machine in the processing room.”
• If the information is likely to be referred to frequently, or different from step to step, then include it every time e.g. “…set the mixer speed to 300 rpm.”
• Include critical information including time, temperature, quantity; anything that may affect quality
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Readability
• Readability is defined as reading ease - how easy is it for the reader to read the document?
• Research has shown that easy-reading text improves comprehension, retention, and reading speed.
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line length (<12 words per line)
word length (shorter is
better)
sentence length (shorter is
better)
space between lines - white
space
http://www.online-utility.org/english/readability test and improve.jsp
How do you improve readability?
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Activity 7: Readability test article A
Read the article A, consider:• line length• word length• sentence length• formatting• which paragraphs could you improve?
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Readability test
A fog index of 12 requires the reading level of a U.S. high school senior (around 18 years old).
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Readability test
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Activity 7: Readability test article B
Read the article B, consider:• line length• word length• sentence length• formatting• which paragraphs could you improve?
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Usefulness and usability
Usefulness: What does the reader need to know in order to achieve their goal?
Usability: Is the reader able to follow the document to achieve their goal?
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Usability tests
A simple way to test the usability of your document is to watch someone perform the task using your instructions
Note where your user has trouble or gets stuck
If they are continually having to ask questions or getting stuck, this indicates there is a problem with the usability of your document
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Activity 8: The challenge
Who likes puzzles?
A / 20 mins
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Activity 8: The Challenge
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How to help users
STEP BY STEP INSTRUCTIONS
1. Attach the hat (A) to the head (B),
2. the head(B) to the torso (C), 3. the torso(C) to the legs (D)
A
B
C
D
EXPLODED VIEW
LABELED PARTS LISTS
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How to help users
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How to help users
• Labelled diagram • Detailed step by step instructions
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How to help users
• Work flow diagram
• Full process overview
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How to help users
Labelled postersDress code requirements: Change rooms – non-sterile
Hair net P2 face mask Non sterile overcoat Non sterile latex gloves Non-sterile over boots When entering the change room: wash your hands as per WI XYZ: Hand washing techniques.
· Fit the face mask
· Fit the hair net ensuring all hair is covered
· Sit on the step over and fit covershoes, ensure…
Diagrammatic techniques
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Pick the usability & readability issues…
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Know your reader
Will they do this task often?
What will they be doing/wearing and where will they be when reading the document?
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Audience analysis
Your audience can vary in a number of ways:• job responsibilities• expertise• attitude• education• age• language and culture• environment• frequency of use
The results will affect:• language you use• level of detail you include• structure of the document• content of the document• method of delivery.
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Activity 9: Memory test
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Memory tests
• How many words did you remember during the first test?
• How many words did you remember during the second test?
• Did you remember more words during the second test?
• If yes why do you think that you remembered more?
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Helping your audience learn
Short term memory• stores things for a little while
and then sends them to your long term memory or forgets them
• stores 7±2 items (comprehension limit)
• stores chunks of information better than unrelated elements.
Long term memory• stores information in chunks
and patterns• stores images more easily
than text or abstract ideas (usually).
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Helping your audience learn
• You can help your audience learn and store things in their memory by:• limiting procedures, lists and instructions to between 5
and 9 items• not overloading them with information• grouping relevant information by using headings• dealing with one concept at a time• using images.
7 2±
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Activity 10: Apply the 7 + 2 rule
Review example text:• how would the 7±2 tool apply?• where could you insert a natural breaks to improve
usability? • suggest sub headings that may help to break up the
process. Example…
Section Description
1 Prepare for assembly (Steps 1-3)
2 Set-up…
3
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Example answer
Section Description1 Prepare for assembly (Steps 1-3)2 Set-up the wheels (Steps 4-7)3 Set-up the brakes (Steps 8-12)4 Attach the pedals (Step 13-17)5 Pump up the tyres (Step 18-20)
6 Set-up seat and handle bar heights (Step 21-25)
06. Using plain language
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Clear as…
This is a multipurpose passenger vehicle which will handle and manoeuvre differently from an ordinary passenger car, in driving conditions which may occur on streets and highways and off road. As with other vehicles of this type, if you make sharp turns or abrupt manoeuvres, the vehicle may roll over or may go out of control and crash. You should read driving guidelines and instructions in the Owner's Manual, and WEAR YOUR SEAT BELTS AT ALL TIMES.
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Foundation of technical writing
• Plain language is a communication style that focuses on considering the needs of the audience when writing.
• It also provides guidance on how to standardize technical writing.
• Structured approach including:• Information types• Document types• Language usage• Formatting • User analysis
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It’s government policy…
• ‘At the level of structure, plain language drafters try to organise information in a clear and meaningful way.
• The sequencing of provisions is based on chronological order, logical order, or combination of principles that is likely to make sense to the reader. Equally important, the structure of the statute is clearly revealed to the reader through use of headings and sub-headings…
• Plain language drafters also draw on the research and insights of experts in document design. They pay as much attention to fonts and white space as they do to choice of words. They try to devise methods of presenting material visually that will assist the reader to use the … book effectively, and with minimum effort.’
http://www.opc.gov.au/plain/docs.htmThe Australian Office of Parliamentary Council (OPC)
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It’s the law…
• President Obama signed the Plain Writing Act of 2010 on October 13, 2010.
• The law requires that federal agencies use "clear Government communication that the public can understand and use."
• On January 18, 2011, he issued a new Executive Order, "E.O. 13563 - Improving Regulation and Regulatory Review." It states that "[our regulatory system] must ensure that regulations are accessible, consistent, written in plain language, and easy to understand.“
http://www.plainlanguage.gov/http://www.plainlanguage.gov/examples/before_after/index.cfm
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Plain language in action
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Plain language in action: Medicare Fraud Letter
The Medicare Beneficiary Services receives a lot of Medicare fraud correspondence every year. To reach their customers more effectively, they took an already short letter and made it even shorter and to the point. Before
Investigators at the contractor will review the facts in your case and decide the most appropriate course of action. The first step taken with most Medicare health care providers is to reeducate them about Medicare regulations and policies. If the practice continues, the contractor may conduct special audits of the providers medical records. Often, the contractor recovers overpayments to health care providers this way. If there is sufficient evidence to show that the provider is consistently violating Medicare policies, the contractor will document the violations and ask the Office of the Inspector General to prosecute the case. This can lead to expulsion from the Medicare program, civil monetary penalties, and imprisonment.
After
We will take two steps to look at this matter:
• We will find out if it was an error or fraud.
• We will let you know the result.
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Keep it simple
Complicated… Simple…ResideTerminateUtilisation ofOptimumAt this point in timeOn the other hand
LiveEnd
UseBest
Now
Alternatively
?
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Be direct
Lengthy… Concise…
Reverse backwards
Repeat again
In actual fact
End results
Aims to ensure that
Don’t use unnecessary words:
ReverseRepeat
In fact
Results
Aims to
?
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Break it down
Example:‘This regulation governs disaster assistance for services to prevent hardship caused by fire, flood, or acts of nature that are not provided by FEMA or the Red Cross.’
This regulation covers disaster assistance that: a) Includes services to prevent hardship caused by fire,
flood, or acts of nature.b) Is not covered by FEMA or the Red Cross.
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Activity 11: Keep it simple
Re-write the following paragraph using concise language
‘Your continued efforts and commitment to meeting these challenges ensuring we deliver on the revised dates are sought by management. If you encounter any issues that are inhibiting you from achieving your individual tasks then please raise these with your team leader promptly and, if need be, escalate the situations with myself if you believe they are of such significance or causing you significant frustration.’
Hint: What are the two key messages they are sending?
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What did you come up with?
Sample answer:
‘We ask for your continued commitment to ensure that the revised dates are met. If you have any problems, please contact your team leader, or raise significant issues with me.’
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Be specific
• Use specific language to say what you mean.• If you are being vague then you may need to do
some more research!• Often your reader will not know that you are using
non-specific language, it will just mean that they will understand less.
Examples of non-specific languageA few GenerallyA couple MostlySeveral Some
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Be specific
Non-specific:1. Set-up and start the mixer.
Specific:To start the mixer:1. Move the handle to ‘Closed’.2. Set the timer to 60 minutes.3. Press the ON button.
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Inclusive language
Avoid:• reference to gender (male nurse,
female CEO)• gender specific pronouns (he, she).
It is illegal to discriminate on the grounds of race, nationality, gender, appearance, physical or mental capabilities.
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Avoid jargon and clichés
• Consider your audience before you use technical language or acronyms – will they understand?
• Is the audience permanent, casual or volunteer?
• Does the department experience a high employee turn over?
• Consider using a glossary to explain terms
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Acronyms
• Always write acronyms out in full the first time you use them:• Laugh out loud (LOL)• I love you (ILY)• Shaking my head (SMH).
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How acronyms can cause confusion……
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Register
• Register is the complexity of the language used:• formal• standard• informal.
• Parallel to dress code:• formal – dinner suit, ball gown• smart casual – pants, shirt, skirt• informal – shorts, t-shirt, sandals.
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Tone
• Tone is the emotional colour of writing:• unfriendly• neutral• friendly.
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Combining register and tone
Friendly Neutral Unfriendly
Formal
Standard
Informal
AIM
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Consider the tone
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When more is less
• Within a larger body of text, a piece of italics does not stand out much. It signifies a context difference while the text is being read.
• By contrast bold attracts the human eye and is good when you need readers to scan for a word.
Overemphasising does nothing but annoy a reader. Underlining, using bold and
italics lead to poor readability.
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Active voice
Passive… Active…For each business unit a training matrix must be maintainedThe screen can be wiped using a tissueAll criteria from the Protocol must be assessed
Use active voice when writing procedures and instructions.
Maintain a training matrix for each business unitWipe the screen using a tissue
Assess all criteria for the protocol
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Active voice
Make the following sentences active:1. All quotes for services are to be forwarded to the finance
department for review.
Forward all quotes for services to the finance department for review.
2. These should be printed and signed instead of saving electronically.
Print these and sign instead of saving electronically.
?
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Active voice
Step Instruction123
Slabs of text are easier to read when stepped out.
The pink copy must be filed with the invoice. The green copy must be given to the client. The original referral should be filed with the client’s master file.
File the pink copy with the invoice.Give the green copy to the client.File the original referral in the client’s master file.
?
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Activity 12: Writing in active voice
Rewrite the sentences in Activity 12 in your workbook in the active voice.
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Parallel structure
Parallel structure means that the components:• match each other• address the same topic• have the same form.
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Parallel structure
Set-up includes:
1. Installing the machine2. Ask Engineering to set the machine parameters3. Running the machine4. Clean5. Maintaining the machine
Set-up includes:
1. Installing the machine.2. Setting the machine parameters.3. Running the machine.4. Cleaning the machine.5. Maintaining the machine.
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Parallel structure
How could the following list be re-written using parallel structure?
• The organisation is interested in:• promoting staff• An increase in salaries• wants to help staff reach their potential.
• The organisation is interested in:• promoting staff• increasing salaries• helping staff reach their potential.
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Consistency
Consistency can help guide your reader:
Inconsistent… Consistent…Type your nameClick OKKey in the dateHit the Enter keyPut in you license numberSelect OK!
Enter your nameClick OK
Enter the dateClick OKEnter your license numberClick OK
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How could we improve this slab?
Maintenance activity includes chemicals, power supplies, fire protection systems, security systems, HVAC, water and gas supplies.
Maintenance activity includes:• chemicals• power supplies• fire protection systems• security systems• HVAC • water and gas supplies.
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Bullets and numbering
• Use bullet points when sequence is not important.• Use numbers when sequence is important.
Bullet points… Numbers…Please buy the following items: To make the cake you need to:• apples 1. Turn on the oven.• oranges 2. Add the eggs and flour.• milk 3. Stir for 60 seconds.• bread 4. Pour into the cake tin.• chocolate. 5. Bake in the oven for 30 minutes.
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Indented numbering – avoid
2.1 I suspect it comes from academic papers but indented numbering is the nemesis of well formatted SOPs.
2.1.1 When incorrectly formatted, indents creep across the page and steals line length making documents disjointed and difficult to read.
2.1.1.1 By using tables and numbered bullets you can achieve the same quick reference result.
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Bullets and numbering
How many actions must be completed in this paragraph?
When completing the contractor induction form include your name and address on the first line and write the client's address on the second line, make sure you enter your security pass number in the security field, and submit the completed package to the receptionist.
Follow the guidelines below to complete the contractor induction form:1. Write your name and address on the first line.2. Write the client's address on the second line.3. Write your security pass number in the ‘Security’ field. 4. Submit the completed package to the receptionist.
?
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Activity 13: Using tables, bullets and numbersReformat the text in Activity 13 in your workbook, use active voice, bullets and numbers to make the instruction clear and concise.
Tip: To help identify the different stages in the instruction use your pen to mark each new instruction before attempting to re-write into active language.
Step InstructionX Apply the following guidelines when writing a procedure:
• include a clear scope on the first page• write the process in sequence• ensure you update the change history table on the last page.
X Forward completed documents for final approval by the:1. Preparer.2. Verifier.3. Approver.
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Tables
• Tables are a good way to communicate information clearly.
• Tables separate information, but also show how it relates.
• If you are presenting a lot of information, consider using a table.
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Tables
No. Consideration1 Every column should have a heading.2 Information within each column should be parallel.3 Punctuation must be consistent through out the table.4 If you only have one column it is not a table.5 If a table runs over two pages, repeat the header.
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Page breaks
Step Instruction1 Fill the saucepan with water.2 Place the saucepan on the stove and turn the stove onto medium heat.
3 Wait for water in saucepan to boil.
Page break
Step Instruction4 Remove egg from fridge.
5Place egg onto tablespoon and lower slowly into boiling water. Gently remove the tablespoon leaving the egg in the water.Note: Dropping the egg against the saucepan will cause the egg shell to split.
Continued…
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Using the role column
You can use a role column if the responsibility changes often in a table.
Step Role Description1 QC Xx2 QC Xx3 QC Xx4 QC Xx5 QC Xx
Step Description1 QC must:
• Xx• Xx• Xx
2 The Initiator must:• Xx• Xx
3 QC must forward all documentation to QA. For final review.
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Using tables – in action
1. Click on the CONTACT PERSON tab and fill the Last name and the First name. For Country Type fill ‘UE’. After you have filled the First name click on FURTHER DATA. A new screen will appear.
2. Fill only the First four fields (Profession, Position, Nationality and Age Group) then press ENTER. Then go to the Last name and double click. Add the details of Gender & Marital status. At the bottom of the page add the Person and Communication details. Once that is done click on back. Then go to SALES AREA DATA. Under SALES fill the CUSTOMER GROUP number: 07(wholesale)/01(retail).
3. Under PARTNER FUNCTION fill in the NUMBER column with the number of the Employee - E.g.107335 (employee number for NahiAzzi). ENTER
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Tables in action
Step Instruction1 Select [CONTACT PERSON] tab.
2 Enter the Last name and the First name.
3 Enter UE for Country Type.
4 Select [FURTHER DATA].Result. A new screen will appear.
5 Enter the first four fields (Profession, Position, Nationality and Age Group) then select [ENTER].
6 Go to the Last name field and double click. Enter Gender and Marital status.
7 At the bottom of the page enter the Person and Communication details.
8 Select [BACK].
9Go to SALES AREA DATA and enter the CUSTOMER GROUP number:• 07 – wholesale• 01 – retail
10 Under PARTNER FUNCTION enter the NUMBER column with the number of the Employee.Example: 107337
11 Select [ENTER].
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Group effort
The [Contact person tab] must be selected. The last name of the customer must be entered in the Name field. [Further Data tab] must be selected when the customer details are entered including- gender, marital details and number of children. Click on the [Submit] tab to save the entry.
Step Instruction
1
2
3
4
?
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Example answer
Step Instruction
1 Select the [Contact person tab].
2 Enter the last name of the customer in the Name field.
3Select [Further Data tab] and enter:• gender• marital status• number of children.
4 Select the [Submit tab] to save the entry.
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Step Action1 Determine the number of copies to be issued.
2 Make the required number of copies. Ask a documentation controller to sign, date and number each one using red ink or a red stamp.
If the document is at revision…
then ask…
1 • the departmental manager and documentation controller where the document should be issued.
• Documentation controller to record the number of copies to be issued in the document register.
2 or later • refer to the document register to find out how many copies are to be issued.
Using if/then tables
If/then tables are a great way to present step-by-step information. It stops you moving through scenarios without structure, and forces you to think about how a task is done chronologically.
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If… then…
the solution is cloudy add 1.5 kg of X and stir for 20 minutes at 300 rpm.
the solution is clear add 0.5 kg of X and stir for 20 minutes at 150 rpm.
the solution is clear with some particulate matter
add 1 kg of X and stir for 20 minutes at 300 rpm.
Using if/then tables
Avoid repeating words:
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Using if/then tables
If the solution is… then add…
cloudy 1.5 kg of X and stir for 20 minutes at 300 rpm.
clear 0.5 kg of X and stir for 20 minutes at 150 rpm.
clear with some particulate matter 1 kg of X and stir for 20 minutes at 300 rpm.
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Using if/then tables – example
Step Instruction1 Fill the saucepan with water.
2 Place the saucepan on stove and turn stove onto medium heat.
3 Wait for the water in the saucepan to boil.
4 Remove egg from fridge.
5 Place the egg onto a tablespoon and lower slowly into boiling water.
6 Gently remove the tablespoon leaving the egg in the water.Note: Dropping the egg against the saucepan will cause the egg shell to split.
7 Wait for 3 minutes.
8 Turn the stove off.
9 Using the tablespoon lift the egg from the water and place in egg cup.
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Using if/then tables – exampleStep Instruction
1 Fill the saucepan with water.
2 Place the saucepan on stove and turn stove onto medium heat.
3 Wait for the water in the saucepan to boil.
4 Remove egg from fridge.
5 Place the egg onto a tablespoon and lower slowly into boiling water.
6 Gently remove the tablespoon leaving the egg in the water.Note: Dropping the egg against the saucepan will cause the egg shell to split.
7Cook the egg:
8 Turn the stove off.
9 Using the tablespoon lift the egg from the water and place in egg cup.
If the egg is to be… then wait…soft boiled 3 minuteshard boiled 4 minutes
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Using if/then tables - formatting
If the result is… then…
1 notify the Team Supervisor for further instructions.
2 or 3 • insert the probe• record the result
If the result is… then…1 notify the team Supervisor for further instructions.
2 or 3 • insert the probe• record the result
WB 8 Part 1 / 07 mins
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Activity 14: Using if/then tables
If updates have… then…occurred check that the current control DNA samples still include a
positive and negative control for each mix.not occurred · add an extra DNA sample to the existing control
· record the update in the sample logbook.
Check the kit inserts for any updates to the primer mixes.
Reformat the text into an if/then table. Remember to:• avoid repeating words in the stem sentence• use bullets for lists• write in active voice.
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Complex information
Complicated bullet lists are a sign to consider using a table:
• Here is the plan for tonight:• drive to the city
o7:00-7:30pm§ everyone
• go to dinnero7:30-9:00pm§ everyone
• go to movieo9:00-11:00pm§ Mary, Sally and Peter.
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Complex information
Complicated bullet lists are a sign to consider using a table:
Activity Time AttendeesDrive to city 7:00 – 7:30 pm EveryoneGo to dinner 7:30 – 9:00 pm EveryoneGo to movie 9:00 – 11:00 pm Mary, Sally and Peter
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Activity 15: Tabulating complex information Develop a table to help make the information in Activity 15 easier to understand.
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Example answer
WB 8 Part 2/ 07 mins
Internal control band visible
Specific band visible
Interpretation of observed bands
Reaction score
No No Negative 0
Yes No Negative 1
Yes Yes, but very weakProbably a negative reaction but could be a very weak positive reaction
2
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How to unknot existing text
• Sometimes it is easier to write a procedure or instruction from scratch rather than re-write an existing procedure.
• Tips for editing existing text:• transfer information progressively to a clean template• track the information you have transferred so you know it
has been addressed• at the end of the transfer review the information that has
been left to ensure all important elements have been captured.
07. Process mapping
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What is process mapping?
• Mapping refers to stepping out a process from start to finish, in the order that it occurs.
• Mapping is like telling a story - there should always a clear start and end point.
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Process mapping
• Prompts you to review the as-is process (what you do today)
• Helps identify effort duplication and areas of confusion
Why process map?
• Improve the quality of the process and the documentation• Reduce cost and time• Improve productivity
Process mapping goals
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Mapping techniques
Keep it simple!• Identify the process to be mapped.• Identify start and end of the process.• Determine all the roles involved in the process.
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Mapping techniques
• Determine the process.• Use a post-it note for each step.• Follow the most common scenario - don’t worry
about exceptions to start with.• Go back to exceptions and repeat (if/then).• Use active language to keep ‘task’ focused:
• Take XXXX• Forward XXXX
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Process mapping activity
• Get into groups or work on your own.• Review the procedure you have chosen to bring to this class.• Develop a basic process map for the process (using post-it
notes)• Remember:
• Identify the start and the end of the process• Identify the roles in the process• 7±2 rule
• Comment on improvements required for your chosen procedure. Eg: Needs pictures, add tables, shorten paragraphs etc.
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Using Visio for process mapping
Task/process step
Decision (e.g. yes/no)
Delay
Direction of process
File / Store
End point
Automated process
Document
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To swim lane or not to swim lane?
Swim lanes can be:• used to indicate responsibilities• complicated when recording large and complex processes,
however can be rewarding when you persevere!
08. Where to start
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Where to start?
When reviewing
existing documents
you may find:
• information is duplicated in several documents
• several documents relate to one subject making a user ‘jump’ around to understand the process
• you started out to update one document but need to review and combine several
• procedural and instructional information has been combined and you need to split information into two documents.
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Where to start?
Make an assessment… Can the informationbe added to
an existing doc?
YesYes, but the document
is now toolong or confusing
No
Consider creating a new document
Consider creating a document hierarchy to
understand how associated documents are linked
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When you start writing…
Use the following methodology to write any document:
Analyse Group Sequence Signpost
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A. Analyse
Collect information relating to the topic by:• interviewing Subject Matter Experts (SMEs)• researching books, internet, etc.• reviewing all existing documentation (create a
document hierarchy)• brainstorming.
Establish if you are writing a process (procedure) or instruction (work instruction) – remember information types?
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B. Group
1. Sort and group information – put similar information or tasks together.
2. Identify irrelevant information and duplication.
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C. Sequence (process map)
• Sequence each group of information.• Process map and create an overview of the process
in a table or flow chart.
Remember:ü What does you audience need to know?ü What order do they require the information?ü Is the order logical?ü 7±2 rule
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D. Sign post
• Use the stages of your process as sections headings in your procedure to help the audience:ü find information quicklyü preview what is to comeü understand how ideas relate to one another.
• Ensure that headings are clear and parallel.
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Write the content in plain language
Section Description
1 Determine the type of inspection activity
2 Complete set-up
3 Inspect product
4 Review inspection results
5 Complete reconciliation
6 Transfer packed product to storage
7 Finalise batch documentation
8 Respond to power failures or process incidents
ProcedureFollow the process perform an inspections.
1. Determine the type of…The Packing Operator determines the type of activity…
2. Complete set-upThe Packing Operator completes the following preliminary set-up…
3. Inspect productComplete inspections using 100%...
4. Review inspection resultsAnalysis of product inspection results is based on…
5. Complete reconciliationComplete a 100% reconciliation of all rejects, samples…
09. Tips for technical writers
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Role of a technical writer
• We are not specific on who can author documents.• The focus is on:ü writing style - legible, unambiguous, written in the
imperative, mandatory styleü templates use - designed ‘with care’, laid out in an
orderly fashion, sufficient space.
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Working with subject matter experts
Often the technical writer will not be a subject matter expert (SME) in all areas of the process they are documenting.
Technical writers must work with SMEs to accurately complete the document. When interviewing SMEs ensure that you are prepared (pre-reading, prepare questions to ask).
SMEs can be experts in a particular area of the product, subject or system. You may need to work with many SMEs on one process.
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Review approach: option 1
Reviewer 1
Reviewer 2
Reviewer 3
Draft copy 1
Draft copy 2
Draft copy 3Writer sends out 3 drafts then combines feedback
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Review approach: option 2
Reviewer 1
Reviewer 2
Reviewer 3
Writer sends a notificationdocument ready for review, one document seen by all reviewers
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Communicating reviewer changes
Good practice:• Collate all feedback.• Note the changes that were accepted or rejected.• Provide a reason.• Send feedback to reviewers so they know why their
comments may not appear in the final document.
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Summary and Recommendations
• Ensure standard templates and styles are finalised.
• Map your department processes BEFORE looking at your documents.
• Review your documents to see if they reflect your process.
• Align existing documents to each stage of the process.
• Identify documentation gaps/opportunities to merge.
• Develop a register.• Keep your department process map as a
guide when you need to make future updates.
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Introduction to Quality Management Systems (QMS) and document management
Information types
Using templates
Features of good documentation (usability and readability)
Using plain language
Process mapping
Where to start
Tips for technical writers
What we will cover today
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Thank you for your time.Questions?
Maria Mylonas
Learning & Development Director
www.pharmout.net
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Course Assessment – Online GMP
At the end of the training you will complete an online assessment throughwww.onlinegmptraining.com:
• You have 60 days access to complete the assessment and evaluation and download materials.
• The assessment is ‘open book’
• The assessment will take Approximately 10 minutes and you will get your certificate
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Online GMP Training - Demo
Various documents
Presentation
EvaluationAssessment
Course Title
Course Information
1. Mark Complete
2. Complete Evaluation
3. Complete Test
4. Download Certificate
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Online GMP Training - Demo
1. Mark Complete
