Spelling Errors in User Manual (IFU) for Medical Device

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Haisoj Lesleh

Hi all,

We have an odd problem at my company. Our senior engineer modified the user's manual for our medical device. However, he misspelled a few words, and some of them are misspelled in such a way that could cause significant confusion to a first time user of our medical device. Unfortunately, the proof of the document was sent over to a couple of managers (both busy people) who glanced over the proof and signed off. The proof which went to the printers had the errors in it. We can't blame the printers for this problem - it's all on us. When the shipment arrived, another set of eyes finally discovered the typos.

Now I am working to fix this mess from a Quality perspective. We can't do a Non-Conforming Product report because the product conforms perfectly to the proof we sent to the printers. A Corrective & Preventative Action plan might be appropriate, but it is difficult to identify the root cause. Do we say that the senior engineer needs more training on how to use the spell check feature in his design program? We could do remedial training and document it. Or should we create a whole new SOP for writing technical documents which will have stricter rules in place for all documents? Or do we just say, "Hey, we all make mistakes sometimes. Try to spell it right next time." The only problem with the last option is that I don't know where the ISO 13485 form is for that... :rolleyes:

Thanks in advance for any help.
 

pkost

Trusted Information Resource
Re: Spelling Errors in User Manual for Medical Device

I hope none of the manuals made it into the market place? that would change the whole level of the problem.

Assuming they didn't then your CAPA procedure would appear to be the right way forward for me; you've got a number of issues here that need addressing.

1. The engineer didn't use spell check...has this happened before? was it a one off? if it is a one off, perhaps an email (which can be included as evidence of action) reminding him/her of the importance of spell checking and the consequences of not doing so

2. Document review and approval...It managed to get through this because the people doing the actual review didn't review it before approving!...Can either be an isolated incident which could be addressed as above, or it sounds more systemic in that there is inadequate resource i.e. they don't have time to check documents they are reviewing. The solution to this would be to either impress upon them the importance of adequately checking documents and ensuring they do it, or getting another person in to review documents..


The "hey, we all make mistakes sometimes" is not really acceptable - certainly one person can make a mistake but that should be caught by the reviewer!
 

somashekar

Leader
Admin
Re: Spelling Errors in User Manual for Medical Device

Hi all,

We have an odd problem at my company. Our senior engineer modified the user's manual for our medical device. However, he misspelled a few words, and some of them are misspelled in such a way that could cause significant confusion to a first time user of our medical device. Unfortunately, the proof of the document was sent over to a couple of managers (both busy people) who glanced over the proof and signed off. The proof which went to the printers had the errors in it. We can't blame the printers for this problem - it's all on us. When the shipment arrived, another set of eyes finally discovered the typos.

Now I am working to fix this mess from a Quality perspective. We can't do a Non-Conforming Product report because the product conforms perfectly to the proof we sent to the printers. A Corrective & Preventative Action plan might be appropriate, but it is difficult to identify the root cause. Do we say that the senior engineer needs more training on how to use the spell check feature in his design program? We could do remedial training and document it. Or should we create a whole new SOP for writing technical documents which will have stricter rules in place for all documents? Or do we just say, "Hey, we all make mistakes sometimes. Try to spell it right next time." The only problem with the last option is that I don't know where the ISO 13485 form is for that... :rolleyes:

Thanks in advance for any help.
User manual is a very important design output for medical device and must have undergone all the required review and verification and controlled by an identifier. Somewhere here is the lapse and must be identified as your root cause and CA worked out.
Our senior engineer modified the user's manual for our medical device
Is this a part of his authority as defined and documented under your 5.5.1 of ISo13485 ? If so, please also address it accordingly in your root cause and corrective action steps. If not, then what has your senior engineer got to do with modifying the user manual artwork ? He must have brought it to the notice of the first approver.
As far as the form is concerned this can be addressed in your corrective action form with the detected problem (non conformance) found during inspection of supplied parts. The detected problem after analysis could drive an internal corrective action.
 
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Wes Bucey

Prophet of Profit
Re: Spelling Errors in User Manual for Medical Device

My suggestion - bite the bullet, admit the manual is in error and proceed to create a new revision (following document change procedures in your organization) without the spelling errors. There is an expense, but pointing fingers is wasting time. The "approvers" who didn't do the job were your last line of defense - they erred - this is NOT life threatening unless the documents get to end users, so start NOW to make the revision.

Further delay means you can't ship product without correct manuals - that is probably a bigger expense than revising and reprinting.

Chalk this up to "lesson learned" - i.e. a chain is only as strong as its weakest link, which means no one can have the attitude of "let George do it" or he becomes the weakest link.
 

yodon

Leader
Super Moderator
Re: Spelling Errors in User Manual for Medical Device

Having a hard time letting go of this one. I don't disagree with all the responses so far. I particularly agree with the point Wes made about not assessing blame. The only remaining concern is what will you do to prevent a future occurrence? Here's where your root cause analysis may be quite helpful. If the last line of defense is too busy or just doesn't care, then you need a change. Telling them to "do better" is probably a bit weak. Maybe consider having an independent review for formatting and spelling (not necessarily for content but someone with language skills).

Spell checkers may never understand context ("their" -v- "there") so a human review is still probably a good idea.
 
T

treesei

:2cents:

1. Word processing software's built in tools may not be adequate for spell/grammar check, especially if the text is highly technical with scientific terms.

2. Managers are not the best proofreaders. They likely do not have the time or the patience. And they are too expensive to be used as proofreaders.

3 (oops, penny #3 :)). Many engineers are poor writers. That is why there is a job called technical writer.
 
M

MIREGMGR

Many engineers are poor writers. That is why there is a job called technical writer.

Yes, absolutely.

And most engineers and other technical/scientific people, and even some professional writers, are imperfect editors and proofreaders. That is why there are still editors and proofreaders at those companies for which it's important not to accidentally make an impression of low quality.
 
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Haisoj Lesleh

Good points all around. We have initiated a CAPA and so far, so good. We definitely will not try to pin blame on a particular person because that's just not helpful. Our main concern is to identify the root cause and fix it, and many of you have good points about that above. I agree that a technical writer would be a useful resource for our company (engineers being engineers and managers being managers), so we'll have to think about hiring someone with those qualifications sometime soon.

Thank you all for your help!
 

Wes Bucey

Prophet of Profit
Good points all around. We have initiated a CAPA and so far, so good. We definitely will not try to pin blame on a particular person because that's just not helpful. Our main concern is to identify the root cause and fix it, and many of you have good points about that above. I agree that a technical writer would be a useful resource for our company (engineers being engineers and managers being managers), so we'll have to think about hiring someone with those qualifications sometime soon.

Thank you all for your help!
Hiring technical writers on a contract or on a temporary basis is usually acceptable for most companies. Be sure, though, YOUR people have input and review of the product. Do not shove the entire job off to an outsider - you are buying expertise in crafting your company's ideas into a finished product, not someone to make your rules. Think of this person as a professional editor/proofreader of your work, not as an original author.

I often run across instructions drafted by folks with an imperfect sense of American English grammar and spelling, even if they are native born in the USA. Most times, the errors do not detract from the sense of the document, but sometimes they do. Whether the error is life-threatening or just merely holds the company up to ridicule, the negative effect can cause financial harm to the company. When I come across such errors, I have a lingering suspicion the inattention to quality in the document is indicative of inattention to quality in the product and hesitate to make new purchases from such companies.
 

Jim Wynne

Leader
Admin
Hiring technical writers on a contract or on a temporary basis is usually acceptable for most companies. Be sure, though, YOUR people have input and review of the product. Do not shove the entire job off to an outsider - you are buying expertise in crafting your company's ideas into a finished product, not someone to make your rules. Think of this person as a professional editor/proofreader of your work, not as an original author.

There are two different disciplines--proofreading and technical writing. The former should be qualified to find and correct or highlight errors in spelling, grammar, punctuation usage, but might not know anything about style or whether the work is technically correct.

A technical writer, on the other hand, is a person who should be able to (a) understand what she's writing about--the technical end of things, which is why that word is in the job title--and (b) write good :tg: in the appropriate style. The work of technical writers should be properly "proofed."
 
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