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Hi everybody, I am Sean and this
is Everyday Quality, a podcast 

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about quality management with a 
bad tagline. 

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So it's been a while since the 
last one, but one exciting 

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moment is providing the topic 
for today's entry. 

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My wife came home the other day 
and said my boss needs to write 

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a bunch of SO. 
PS I'm a simple person and this 

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this instantly piqued my 
interest. 

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Oh, I asked. 
She said there's a lot of 

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documentation that needs to be 
kept, but there's no process for

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keeping that documentation. 
Sometimes I'm I'm described as a

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golden retriever esque person. 
And if at that moment I did 

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indeed have a tail, I would have
instantly given away my joy in 

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in that moment. 
So tell me more, I said. 

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So we we talked about the new 
requirements in place at at her 

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workplace. 
Now I have implemented managed 

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and grown quality systems in the
medical device, aerospace, 

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defense, automotive, and raw 
material sectors. 

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So I've I've had the added bonus
of people being generally aware 

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of what a quality system is. 
My wife doesn't work in any of 

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those sectors. 
I cannot tell you how much our 

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conversation stressed me right 
out. 

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So I offered to write up a 
control documents procedure and 

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the records of tangential 
procedure for for her place to 

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use as just a baseline to to 
format it to better fit their 

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needs. 
Starting from nothing in terms 

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of controlled documents is is 
difficult. 

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That's that's really the nicest 
way to put it. 

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So today we are going to talk 
about what controlled documents 

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are, what they help with and how
to get started. 

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So let's start at the beginning.
What is a controlled document 

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now? 
I really like the ISO 9001 

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requirements. 
It states the organization shall

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include documented information 
determined by the organization 

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as being necessary for the 
effectiveness of the quality 

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management system. 
Now it's pretty broad, but it 

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gives a really good starting 
point. 

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The organization knows they need
documented information for 

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anything necessary for the 
effectiveness of the QMS. So 

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what is what is necessary for 
effectiveness though? 

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Well, having a documented having
documented information related 

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to how to make, control, and 
provide other documented 

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information is a pretty good 
thing. 

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So that's a good good starting 
point. 

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I once had to start Aqms from 
absolutely nothing for a little 

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little flavour text on what that
process is like. 

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I I did not have Gray hair when 
I started that job and now I get

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served at Taco Bell. 
So it's it's a real taxing 

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process. 
I was I was not sure where to 

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start when when I took on the 
gig, but it quickly became 

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apparent that starting with a 
dock control procedure was what 

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the organization needed. 
Having a defined process for the

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review and approval of 
documented information helps 

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remove all the the guesswork. 
So it helps unify it helps speed

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up the process of document 
review. 

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I observed a a pretty natural 
inclination to have supervisors 

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review documents prior to 
release to the, the general 

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population of the company, but 
there was no repeatability in 

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that process In, in this place 
where I had to start from 

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scratch, there were constantly 
questions about like, how do I 

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get this to the people that need
it? 

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So what if, what if something 
changes in this? 

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How do I know that they've read 
the document? 

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Just tons, tons of questions. 
And so starting Aqms with a 

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defined dot control process is a
pretty good way to help solve 

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those problems. 
It shows the efficacy of the 

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quality program and shows that 
quality is indeed there to help.

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Plus, the moment we have a 
repeatable process documented, 

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we can start auditing and that 
is pretty Ding Ding Fung. 

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So all right, back on track 
here. 

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Document structures, let's talk 
about that. 

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So I like the four tier pyramid 
approach to document structures.

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Company should have a general 
quality manual at the the top of

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the pyramid. 
Now ISO 9001 doesn't require 

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that manual, but it really helps
a lot of customers are still 

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looking for it. 
A lot of organizations can 

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benefit from a quality manual 
and ITF in 1345, they they 

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absolutely require that manual 
now that needs to be available. 

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And odds are if you're listening
to this, you're serving multiple

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industry types. 
So right up that manual, which 

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is a good way to ask like what 
goes into a quality manual? 

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Well, that's that's really 
another half hour conversation. 

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So we'll do that that later. 
The the finer details. 

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But in general, a quality manual
should be the 30,000 foot view 

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of the company, have the quality
policy, the interaction of 

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processes, the organizational 
structure, not an org chart. 

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So the org structure is just 
here's our leadership team and 

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all of these groups reported to 
them. 

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All of these groups reported to 
them, not an org chart. 

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You don't want to put names on 
that. 

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The big stuff is, is what can be
thrown in front of a customer or

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auditor to answer some really 
important questions. 

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Emmanuel should be able to tell 
the reader how the organization 

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views itself and views its 
processes. 

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For the ISO nerds, the the 
manual should function as a one 

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stop shop for answering all of 
the section 4-5 and six stuff. 

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That's if you write your manual,
well, you throw that in front of

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the, the auditor, they can knock
out those whole sections during 

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your audit underneath the the 
quality manual. 

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And then next tier down you have
your SO PS, your standard 

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operating procedures. 
Now these detail procedures of 

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the processes outlined in the 
manual. 

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So your manual at that 30,000 
foot view should include like 

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here's my product design process
and here's my quality process, 

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here's my safety process. 
This is how they all interact. 

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SO PS detail the procedures that
all of those high level 

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processes do. 
So when when you're working on a

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a manual or a system in a hole, 
listen to the Scipoc episode. 

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But I like to include Scipoc 
diagrams in the quality manual 

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to show what SO PS are expected 
of a department store big P 

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capital P process. 
An operations department would 

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have an SOP for the planning 
process. 

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Quality department has an SOP 
for the corrected action 

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process. 
SO PS tell operators what to do 

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with inputs, what procedures are
employed to create outputs and 

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where their outputs go in in a 
big Broadway. 

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SO PS will reference the the 
next tier down. 

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Work instructions, work 
instructions. 

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Those are going to be real 
specific details on how to 

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complete a task, a work 
instruction for how to build a 

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parts, how to create a 
presentation, how to conduct a 

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root cause corrective action in 
accordance with company 

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practices. 
That sort of specificity. 

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It's how to do something, not 
when to do something, which is 

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what SO PS do. 
SO PS are the when they give you

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the the structure or 
constructions are the how. 

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Finally, at the the bottom of 
the pyramid, there are forms and

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templates. 
Forms are filled out with 

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information which will become a 
record. 

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Templates exist ultimately to 
make life easier and not 

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recreate the tool every single 
time. 

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I'm sure there's a better 
definition out there somewhere, 

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but but forms become records. 
That's that's really the key. 

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So quality manual. 
SO PS work instructions and then

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the base of the pyramid holding 
everything together, forms and 

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templates. 
Those are the four key document 

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types. 
Now do know documented 

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information does not require 
something to be written down. 

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Audio and visual tools can be 
documented information as well. 

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You at the company get to 
determine how the controls are 

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applied. 
Now, quick little aside, I love 

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video work instructions. 
They're engaging. 

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They transcend language 
barriers. 

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Very easy to put together. 
But if you have a cell phone, 

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you have a video studio. 
I'm an iPhone user, so iMovie is

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the way to go for me. 
Android folks, you could use 

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something like Movavi. 
I think that's how you say it. 

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That is a free version for your 
phone. 

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I have a paid version on my 
desktop that's incredibly easy 

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to use. 
But if you record a video and 

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bring it to your laptop, you can
download Davinci Resolve. 

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It's a video editor app that's 
incredibly easy, free to use. 

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The the dashboard is intuitive 
beyond belief. 

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So the the trick is to take 
videos, make them available, 

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usable, and easy to update 
through your system. 

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So that's where the controls 
come into play. 

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In ISO, you need to give it a 
title and some kind of revision 

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date or number, and that's 
really the backbone of all of 

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it. 
So all right, all right, back, 

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back on track here. 
So we have the four tiers of 

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documents. 
More than likely you are working

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in an existing system. 
Even if there's no quality 

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system in place, there's a 
system in place. 

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So I highly recommend starting 
with documentation of those 

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standard operating procedures, 
how people get their work done. 

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Even in a, a four month old 
start up, there's going to be a 

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cadence to how things move. 
You're going to get a real idea 

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of what the the culture is and 
culture builds processes. 

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So even if there's no quality 
system in place, there's a 

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system, be on the lookout for 
it. 

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Watch how people take inputs and
create outputs. 

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What happens to those outputs? 
That's that's really where you 

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want to go? 
Where where are we going from 

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there? 
I got distracted by start-ups. 

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So, so let's, let's keep in mind
that. 

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All right, yeah, everything in 
quality is a controversy. 

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So I'll add a disclaimer here 
and that this is how I've made 

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document control work in the 
past. 

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Get with process owners and 
figure out what they think their

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process looks like, then write 
that down. 

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I don't like highly detailed, 
SO. 

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PS If the quality manual has a 
30,000 foot view of the 

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organization, the SOP is getting
everybody for a landing at 

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10,000 feet. 
Things become a bit more clear. 

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They become a bit more 
accessible. 

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You know, we're through the 
clouds and can see some patches 

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of trees, but there's really no 
need to start naming each tree 

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at this point. 
An SOP lets people who work with

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the process know what steps 
they're going to take to make an

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to take an input and make an 
output. 

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So let's use a corrective action
SOP as an example. 

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At the SOP level, the document 
is going to say things like when

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a non conformance is discovered,
the organization's designated 

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corrective action team members 
will determine if a full 

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corrective action is necessary 
or if another course of action 

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is needed. 
Please don't let that actually 

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be your practice document all 
you can, if necessary, just just

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stop the and and contain the 
issue. 

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That's, that's all, all you need
to do. 

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It would continue with. 
If a corrective action is to be 

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initiated, the corrective action
team will open a corrective 

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action in the organization's 
corrective action system. 

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Use acronyms all over the place.
Way, way easier. 

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That lets the team. 
That wording lets the team know 

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that there's a system. 
It assigns responsibility, but 

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doesn't tie everyone down into 
specifics. 

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This is a sort of procedure that
can be replicated across 

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industries and the steps can 
remain the same regardless of 

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what system is used. 
It's going to be generic, but 

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it's going to allow you guidance
and that's what the SOP should 

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should be doing. 
Now, I don't know about you, but

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in most places that I've been 
at, the corrective action system

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is kind of treated like a TikTok
trend. 

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There's a new one every week. 
So keeping the bones of the 

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process, the written is as kind 
of generic, just a point A, 

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point B, Point C kind of thing. 
That's not going to change. 

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So just just document the bones 
in an SOP. 

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Don't write the muscle into that
document. 

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Leave the cartilage for some 
place else entirely. 

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The SO PS are what you're going 
to show your auditors uses 

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training guides or new hires and
a reference when somebody says, 

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what if we missed a step? 
Then you can just slap out that 

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SOP, just bam, or pull up the 
video for how the process should

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work and you'll be able to say, 
OK, we did A, we did B, we 

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missed step C, OK, how do we do 
step C? 

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And that's where you can get the
work instruction because those 

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fine details, they are in the 
work instruction. 

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These should be where the real 
real mate, this is where you put

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the muscle. 
That's where this can be found. 

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This is video details. 
This is screenshots from the 

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system placed and replaced in 
Word documents. 

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This is where people who read 
the SOP go to when they need a 

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reminder of how to close out the
corrective action in the current

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system. 
These will be updated often and 

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hopefully for the better. 
Getting into the really fine 

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matters in these sorts of 
documents. 

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That's what you want to do. 
You want to get into the fine 

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details like to the level of how
a person doing the work should 

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position their hands during the 
process. 

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Standard operating procedures 
give you the the, the basic 

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structure. 
They're the framing of the 

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house. 
This is the drywall, right? 

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This gives you the the 
architectural oomph to to really

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make something. 
The word construction should be 

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your standard work. 
And if you are aiming for 

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standard work, you know, include
safety elements, reclude 

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required materials, put in cycle
times if known best practices, 

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the the actual sequence of 
events, what tools you need, I 

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guess that's kind of required 
materials, but all that sort of 

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stuff. 
So, so there are no questions 

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about how to get the work done 
to the best method known right 

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now. 
Standard work should always be 

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changing go seek that inputs and
now it I know it sounds like a 

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contradiction that standard work
is changing, but getting better 

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all the time is really the name 
of the game with standard work. 

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There's that saying and I do not
know who to attribute it to 

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Apologies to the quote 
originator and and thanks, but 

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the saying is there can be no 
improvement without a standard 

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taichi. 
Oh no, that sounds right. 

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00:17:03,000 --> 00:17:09,720
I'll look it up. 
All right, So finally that that 

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work instruction is supported 
then by that forms and templates

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00:17:14,040 --> 00:17:16,520
category. 
These are the the real 

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workhorses of this system. 
Forms and templates exist to 

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facilitate record collection in 
a standard way. 

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So your forms and templates are 
in place to make sure 

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information can be conveyed to 
users with ease and data is 

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recorded at a repeatable manner.
So every single time, every 

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every time somebody goes to read
that data, it isn't a real pain 

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of the keister. 
Templates really help speed up 

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processes like a common 
PowerPoint templates or a work 

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00:17:46,960 --> 00:17:49,840
construction template or just a 
standard report template, 

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management review templates. 
My goodness, have that. 

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That's a a pretty key one. 
It's a great resource to to just

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have that in a template that you
can plug and play all your data 

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00:18:01,440 --> 00:18:07,680
in every three months or so. 
But having that one accepted 

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00:18:07,680 --> 00:18:11,800
method for complete conveying 
information, that's what your 

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00:18:11,800 --> 00:18:18,960
template is there to do. 
So those are the the the four 

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tiers a system really should 
have. 

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00:18:21,480 --> 00:18:26,200
There's nothing wrong with other
types of forms, but before 

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00:18:26,200 --> 00:18:29,920
making a controlled document 
system large and having specific

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00:18:30,040 --> 00:18:34,320
things in there ask that really 
benefits your users. 

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Maybe of a projects oriented 
organization and charters are 

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part of the the day-to-day. 
The charter should be a 

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00:18:42,240 --> 00:18:44,480
template, but what do you do 
with that filled out version 

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00:18:44,960 --> 00:18:47,800
that that needs to be reviewed 
and approved and all of that? 

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How does that get into your 
system? 

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00:18:49,720 --> 00:18:52,360
What sort of approval structure 
does it need? 

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00:18:52,360 --> 00:18:55,800
Does the charter need to be 
controlled at all That there's 

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00:18:55,800 --> 00:18:59,200
those are all the questions that
we will ultimately be company 

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00:18:59,400 --> 00:19:03,000
specific answers. 
So let's let's talk about 

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approval structures. 
What makes a controlled document

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00:19:07,000 --> 00:19:10,880
system really helpful is that 
the documentation within the 

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system should be reviewed by 
people accountable for the 

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00:19:14,560 --> 00:19:18,160
process outputs. 
So it's leads, managers, process

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00:19:18,160 --> 00:19:19,360
owners, whatever you want to 
call them. 

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The people accountable for the 
results need to be reviewing the

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00:19:23,880 --> 00:19:26,800
information being distributed to
their teams and the people 

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00:19:26,800 --> 00:19:32,960
executing the work. 
Let's go to the very top, the 

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00:19:32,960 --> 00:19:36,600
quality manual that should be 
reviewed and approved by the top

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00:19:36,720 --> 00:19:39,960
management of the organization 
or if it's site specific, just 

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the site top management. 
SO PS I say should be process 

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owners, quality leaders and one 
or two other key leaders, making

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00:19:48,560 --> 00:19:51,680
sure that there's, there's real 
clarity on what the role of that

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00:19:51,680 --> 00:19:55,400
SOP is trying to fulfill or 
constructions should be reviewed

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00:19:55,400 --> 00:19:57,800
and approved by the process 
owners and quality leaders. 

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00:19:58,480 --> 00:20:03,720
And this I mentioned qualities, 
controversy forms and templates 

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00:20:03,720 --> 00:20:05,640
should just be controlled by the
process owners. 

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00:20:06,840 --> 00:20:11,160
I suggest making other anything.
Everything other than forms and 

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00:20:11,160 --> 00:20:13,560
templates revision level 
controlled. 

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00:20:13,800 --> 00:20:17,560
So that's here's your revision 
1, revision 2, revision 3 goes 

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through that full approval 
process. 

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00:20:19,800 --> 00:20:23,800
However, you distribute that for
approval and then forms and 

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00:20:23,800 --> 00:20:27,080
templates should be revision 
date controlled. 

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00:20:27,720 --> 00:20:30,680
So your process center can go in
there, make the changes, change 

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00:20:30,680 --> 00:20:33,720
the Rev date, bam, and deploy 
it. 

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00:20:34,320 --> 00:20:36,480
Now you really want to make sure
that old forms and templates are

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00:20:36,480 --> 00:20:41,440
removed from potential access. 
All of this though is is really 

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00:20:41,440 --> 00:20:44,520
organization specific. 
So your your culture, your way 

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00:20:44,520 --> 00:20:47,720
of doing things is going to 
dictate how you're going to 

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00:20:47,720 --> 00:20:50,680
interact with these 4 tiers and 
how that approval structure 

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00:20:50,680 --> 00:20:52,400
goes. 
In a highly controlled 

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00:20:53,040 --> 00:20:56,560
environments where you don't 
have a lot of wiggle room at the

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00:20:56,560 --> 00:21:00,240
process level to make changes, 
your forms and templates 

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00:21:00,240 --> 00:21:02,840
probably go through a more 
stringent review process. 

324
00:21:04,520 --> 00:21:08,720
Med device probably can't get 
away with just a single point of

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00:21:08,720 --> 00:21:14,320
approval just for for risk 
mitigation if nothing else. 

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00:21:16,440 --> 00:21:20,000
So the structure though, the 
four, four systems, 4 levels, 

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00:21:20,520 --> 00:21:27,600
tiers, whatever word we're using
and it makes life easy and is if

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00:21:27,600 --> 00:21:31,280
you just have those four things,
you can quickly establish 

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00:21:31,280 --> 00:21:37,680
expectations and expectations of
the the process. 

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00:21:39,120 --> 00:21:41,520
Let's go back to that, that 
project charter example though. 

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00:21:42,120 --> 00:21:46,520
Now that's a filled out form 
that will guide future work. 

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00:21:47,400 --> 00:21:51,240
It's owned by a project team and
will impact multiple 

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00:21:51,280 --> 00:21:53,680
stakeholders. 
That's a weird way to say 

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00:21:53,680 --> 00:21:55,800
stakeholders, multiple 
stakeholders. 

335
00:21:57,040 --> 00:22:03,400
A charter should not be revised 
once it's approved though, but 

336
00:22:03,400 --> 00:22:05,680
you do need to make sure that 
everyone has access to the 

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00:22:05,680 --> 00:22:11,000
approved charter since that's a 
key function of the charter. 

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00:22:13,000 --> 00:22:19,040
So this instance sits outside of
SO PS work instructions, forms, 

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00:22:19,600 --> 00:22:23,240
and should probably get its own 
category as just a record. 

340
00:22:24,200 --> 00:22:26,760
Approvals will come from the 
project launch meeting and an 

341
00:22:26,760 --> 00:22:30,640
SOP will guide what that project
process looks like, while if 

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00:22:30,640 --> 00:22:34,520
your constructions will provide 
specific direction. 

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00:22:35,720 --> 00:22:39,560
The charter is ultimately an 
output of the process and will 

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00:22:39,560 --> 00:22:42,240
serve as an input for the rest 
of the project. 

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00:22:42,240 --> 00:22:45,920
So we have a spot on the 
template that has sign offs from

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00:22:45,920 --> 00:22:51,760
various impacted stakeholders 
and then store the charter as a 

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00:22:51,760 --> 00:22:54,480
record. 
Best recommendation to get you 

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00:22:54,480 --> 00:22:59,440
started, but again, I cannot can
all stress this enough, each 

349
00:22:59,440 --> 00:23:02,120
organization is going to be 
wildly different in how these 

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00:23:02,120 --> 00:23:05,040
documents are handled. 
Now I've worked in large 

351
00:23:05,040 --> 00:23:08,440
aerospace, small medical, medium
sized fence, and small raw 

352
00:23:08,440 --> 00:23:11,920
materials book publishing even. 
Not one of them treated 

353
00:23:11,920 --> 00:23:13,880
documents in the same way. 
And even the ones where I 

354
00:23:13,880 --> 00:23:19,080
created the document control 
structure, they were created in 

355
00:23:19,080 --> 00:23:21,760
a way that ensured the users of 
the documents were going to 

356
00:23:21,760 --> 00:23:27,640
actually use the documents in a 
regulated environments. 

357
00:23:28,200 --> 00:23:31,680
Documents are essential survival
tools and an ISO environments. 

358
00:23:31,680 --> 00:23:36,360
There's there's a vibe that the 
docs there are are just there to

359
00:23:36,360 --> 00:23:40,720
survive an audit. 
Remind folks that the only way 

360
00:23:40,720 --> 00:23:43,880
we can really get better is to 
know how to do the task in the 

361
00:23:43,880 --> 00:23:47,120
1st place. 
So write it down, make newbies 

362
00:23:47,120 --> 00:23:50,200
follow the process and then 
you'll find areas where the 

363
00:23:50,200 --> 00:23:55,680
process can be improved quickly.
That's that's that's what having

364
00:23:55,680 --> 00:23:59,760
that standard in place does. 
It allows your new entrance, 

365
00:23:59,760 --> 00:24:05,840
your rookies to really see how 
to do it, try to execute it and 

366
00:24:05,840 --> 00:24:09,000
then fix it and get better over 
time. 

367
00:24:09,960 --> 00:24:15,560
So that's, you know, this, this 
has been a, a really long rant 

368
00:24:15,800 --> 00:24:18,720
on a topic that's that's very 
essential to every system. 

369
00:24:19,560 --> 00:24:23,320
But I'll, I'll stop talking now 
and we'll talk more about it 

370
00:24:23,600 --> 00:24:27,200
later. 
And in the meantime, come check 

371
00:24:27,200 --> 00:24:31,080
out COQ ms.com, where Colorado 
quality systems. 

372
00:24:31,720 --> 00:24:36,920
This, this little company of 
ours offers a lot of templates 

373
00:24:36,920 --> 00:24:42,080
and forms to get you started. 
You can follow a QikLink to to 

374
00:24:42,080 --> 00:24:47,680
download QMS Notion templates. 
And there's a a fully editable 

375
00:24:47,680 --> 00:24:50,760
quality tools suite of HTML and 
JavaScript programs. 

376
00:24:50,760 --> 00:24:53,920
So there's a CPK calculator, 
Fishbone diagram tool that works

377
00:24:53,920 --> 00:24:57,960
great on a virtual root cause 
meeting and more. 

378
00:24:57,960 --> 00:24:59,680
And they're all available for 
free download. 

379
00:25:01,200 --> 00:25:04,320
And of course, if you need some 
help with your QMS, reach out to

380
00:25:04,320 --> 00:25:08,360
coqualitysystems@gmail.com or to
the podcast directly everyday 

381
00:25:08,360 --> 00:25:13,440
qualitypodcast@gmail.com and 
we'll chat about neat stuff. 

382
00:25:14,040 --> 00:25:17,760
So all right, that will do it 
for this entry. 

383
00:25:18,120 --> 00:25:20,320
Reach out with any questions. 
We'd love to hear from you. 

384
00:25:20,560 --> 00:25:21,240
Thanks for your time. 
Bye.