Guidance on Writing in Plain English

insect warfare

QA=Question Authority
Trusted Information Resource
#1
Anyone ever run into this document before? Of particular importance to me is Part B, which has a lot of good guidance on writing clear and concise work method statements, but this information is still just as applicable to those writing management system procedures (work instructions, procedures, etc.). I naturally employ a lot of these rules when creating my work so it is as tight as possible, by minimizing or eliminating duplication, and reducing wordiness to an acceptable level.

Thought I would share with the rest of you....

Brian :rolleyes:
 
Elsmar Forum Sponsor
#2
Not seen it before (probably because it's Australian) and it seems OK. I don't like the format of the "proforma" they use. It appears to be too bureaucratic to me.
 

Wes Bucey

Prophet of Profit
#4
Thanks for bringing this to our attention.

I am so pleased to see "write in the active voice."

For some reason (perhaps using old and obsolete materials to learn), English as a Second Language (ESL) folks seem especially prone to use passive voice sentence constructions.

The second most frequent obstacle folks encounter is the use of the third person (he/she/they) versus the second person [implied.]

Thus, instead of writing
"The operator must first turn on the machine."
use
"Turn on the machine." (the "you" is implied as if we wrote
"You turn on the machine.")

In the 80s and 90s, the majority of big honkin' Quality Manuals were written in the third person impersonal:
"The company turns on the machine."
 
P

PaulJSmith

#5
In the 80s and 90s, the majority of big honkin' Quality Manuals were written in the third person impersonal:
"The company turns on the machine."
Active voice writing seems to have become a lost art during my generation ("GenX"). I always tell people, "Write it you would speak it."

Sadly, for some people, this may not be the best advice either.
 
F

Frankie11

#6
When I saw the title of this thread I immediately thought of that document. It was a big help to me when I started writing procedures. (I tend to get incredibly formal when I write).

And the best advice I've had in avoiding the passive voice- if you can add the words 'by zombies' after the verb, you're doing it wrong.

e.g.
The machine is turned on (by zombies)

Paperwork should then be filed (by zombies)

Forklift key must be removed (by zombies) when not in use.
 

Wes Bucey

Prophet of Profit
#8
Equally important is the ability to use simple words
Not so much "simple' as "appropriate" words. Don't dumb it down to "boy/girl; dog/cat" simple, and if you MUST use an acronym ("ASAP") immediately break it down ("As Soon As Possible")

No one likes being treated as if he were a child or an idiot, incapable of understanding a polysyllabic (words of more than one syllable) word when used in context. If the jargon is used to familiarize with what one might encounter in the workplace, then define it the first time it appears in print.
 
Thread starter Similar threads Forum Replies Date
A Guidance on Writing a Procedure Document Control Systems, Procedures, Forms and Templates 19
S Any guidance on writing business proposals and tenders? Book, Video, Blog and Web Site Reviews and Recommendations 14
dgrainger Informational MDCG 2021-24 - Guidance on classification of medical devices EU Medical Device Regulations 0
J Can we register non-device clinical decision support software under draft guidance? Other US Medical Device Regulations 5
S In Need of GIDEP Guidance AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
A Can anyone explain UKRP guidance relating to Northern Ireland? UK Medical Device Regulations 0
Ajit Basrur Any ISO standard or guidance documents on barcode and scanning? Other Medical Device Related Standards 1
B What is the difference btw RUO vs IUO for IVD in FDA guidance ? US Food and Drug Administration (FDA) 12
D FDA Guidance on Computer Software Assurance versus 21 CFR Part 11 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
G Does FDA allows remote approvals of quality documentation. Is there any specific guidance on signing any quality records remotely? Document Control Systems, Procedures, Forms and Templates 1
N Guidance - Cost of Good Quality Misc. Quality Assurance and Business Systems Related Topics 2
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance document to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Sidney Vianna Release of ISO 10013:2021, Quality management systems – Guidance for documented information Other ISO and International Standards and European Regulations 0
M Labelling - Is there a guidance or regulations that specifically defines the 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Guidance for health institutions on in-house manufacture and use UK Medical Device Regulations 1
S Need guidance on project ISO 13485:2016 - Medical Device Quality Management Systems 2
dgrainger Informational MHRA guidance on CE UKNI - Article 5.5 - 2021-02 EU Medical Device Regulations 0
R Quality System Functional Safety Checklist / Guidance IATF 16949 - Automotive Quality Systems Standard 0
K Looking for guidance to write an SOP on Statistical Methodologies? Statistical Analysis Tools, Techniques and SPC 7
A 21 CFR 820 - Risk Management - Looking for some guidance US Food and Drug Administration (FDA) 3
A Which guidance do you use for guiding the requirements of IFU for 510(k) submission? Medical Device and FDA Regulations and Standards News 5
M Minimum sample size - Guidance and statistical rationale Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
A FDA guidance on non-sterile Medical Device Packaging Medical Device and FDA Regulations and Standards News 7
Aymaneh AAMI TIR45 guidance wanted IEC 62304 - Medical Device Software Life Cycle Processes 4
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0
D GMDN code update - Canada - Do you know if there is guidance? Canada Medical Device Regulations 0
D Where to find Guidance Class II Amendment Canada Medical Device Regulations 1
dgrainger Informational UK guidance on Device regulation from Jan 2021 published UK Medical Device Regulations 19
shimonv FDA News FDA guidance on Multiple Function Device Products (8/2020) Other US Medical Device Regulations 1
K FDA Premarket Cybersecurity Guidance - 4 questions Other US Medical Device Regulations 5
B EU MDR Perscription product guidance EU Medical Device Regulations 1
John Broomfield Guidance on Safe Working During Covid-19 Pandemic Misc. Quality Assurance and Business Systems Related Topics 5
dgrainger Informational UK guidance on FSNs - May 2020 EU Medical Device Regulations 1
dgrainger Informational UK guidance on FSNs - Published 20 May 2020 UK Medical Device Regulations 1
W Seeking Guidance Verification Test Strategy for Class B Medical Devices IEC 62304 - Medical Device Software Life Cycle Processes 1
S What is considered a "core algorithm"? (From an FDA guidance document) Medical Information Technology, Medical Software and Health Informatics 4
Stoic Are any medical device companies using the 2011 FDA process validation guidance instead of GHTF/SG3/N99-10:2004? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Guidance on manufacturing non-surgical face masks US Food and Drug Administration (FDA) 3
dgrainger Informational MHRA guidance update on withdrawal of Notified Bodies Medical Device and FDA Regulations and Standards News 0
M Advertising medical devices in the U.S - Advertising regulations or guidance documents Other US Medical Device Regulations 3
dgrainger Informational MHRA updated guidance: Clinical investigations of medical devices – guidance for manufacturers Medical Device and FDA Regulations and Standards News 0
rob73 MDCG guidance on class 1 devices and MDR EU Medical Device Regulations 0
U Product Lifecycle Procedure Guidance Design and Development of Products and Processes 7
J CEN/TR 17223:2018 Guidance on the relationship between13485 and MDR.. worth the money?? ISO 13485:2016 - Medical Device Quality Management Systems 3
M Informational EU – Ongoing Guidance development within MDCG Subgroups Medical Device and FDA Regulations and Standards News 1
M Informational US FDA Draft Guidance – Breast Implants – Certain Labeling Recommendations to Improve Patient Communication Medical Device and FDA Regulations and Standards News 0
M Informational EU – EMA revised guidance – Questions & Answers on Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 201 Medical Device and FDA Regulations and Standards News 2
D Performance Qualification per GHTF Guidance Other Medical Device Related Standards 12
M Informational EU – Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR Medical Device and FDA Regulations and Standards News 2
dgrainger Informational MDCG 2019-11: Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR Medical Device and FDA Regulations and Standards News 0

Similar threads

Top Bottom