All the bad PDS behaviour that would of course never happen at your shop

This week, a slightly tongue in cheek look at all the naughty things that people do when it comes to PDSs. Not at your company of course!

Here are my top 8. Let me know how many you’ve seen. And of course if I’ve missed any, please add them in the comments.

I’ll review it after everyone else has

My personal favourite. I know why people say this, it’s because they are absolutely snowed under with work and are hoping to just review the final version. The problem of course, is that when everyone does this, then you never get to a final version!

I’m not signing a verification certificate

Yep, we’ve seen this. I think it’s because of the following idea about PDSs…

It’s not my job

If you think that PDSs are ‘just’ a compliance requirement (and you’re not in compliance), then of course you’re not going to want to spend any time reading/thinking about PDSs. Unfortunately however, PDSs are not ‘just’ a compliance requirement. And further to that, compliance should be checking not doing. In my mind anyway!

I’m just going to rewrite this section (that has nothing to do with me)

Everyone’s a wordsmith. Which would be fine, except that the section you’re rewriting may well have been carefully crafted by the subject matter expert, who is now not thrilled that they have to spend time discussing why their original wording was just fine thanks.

I need to change something otherwise I’m not ‘adding value’

Everyone knows this person. Sometimes it’s me! It’s a bad habit, borne out of insecurity. It really is OK to say ‘I have read this and I don’t have any changes’.

Only doing a cursory once over

Naughty naughty. And a quick way to build in problems that future-you is going to have to deal with.

Sub-par evidence for verification Another one that might just bite you later.

Referring to a previous PDS or marketing material does NOT a source make! If you’re not sure, imagine standing in front of a judge and explaining why you thought that this document was sufficient evidence. If the idea of that makes you feel sick, find some better evidence. And don’t forget to ask for help* if you’re stuck.

Forgetting that the PDS must match the way the product actually works (as well as meet the legal requirements)

You have a lovely legal opinion saying your PDS meets the requirements, so everything is good right? Er, not quite. Your PDS also has to accurately portray the way the product works. This is an easy trap to fall into, but one that high quality evidence will protect against.

*‘Don’t bring me problems, bring me solutions’ has a lot to answer for in my opinion. It really is OK to say I have a problem and I don’t know how to fix it. Well at least it should be OK.