Hi everybody, I am Sean and this is Everyday Quality, a podcast
about quality management with a bad tagline.
So it's been a while since the last one, but one exciting
moment is providing the topic for today's entry.
My wife came home the other day and said my boss needs to write
a bunch of SO. PS I'm a simple person and this
this instantly piqued my interest.
Oh, I asked. She said there's a lot of
documentation that needs to be kept, but there's no process for
keeping that documentation. Sometimes I'm I'm described as a
golden retriever esque person. And if at that moment I did
indeed have a tail, I would have instantly given away my joy in
in that moment. So tell me more, I said.
So we we talked about the new requirements in place at at her
workplace. Now I have implemented managed
and grown quality systems in the medical device, aerospace,
defense, automotive, and raw material sectors.
So I've I've had the added bonus of people being generally aware
of what a quality system is. My wife doesn't work in any of
those sectors. I cannot tell you how much our
conversation stressed me right out.
So I offered to write up a control documents procedure and
the records of tangential procedure for for her place to
use as just a baseline to to format it to better fit their
needs. Starting from nothing in terms
of controlled documents is is difficult.
That's that's really the nicest way to put it.
So today we are going to talk about what controlled documents
are, what they help with and how to get started.
So let's start at the beginning. What is a controlled document
now? I really like the ISO 9001
requirements. It states the organization shall
include documented information determined by the organization
as being necessary for the effectiveness of the quality
management system. Now it's pretty broad, but it
gives a really good starting point.
The organization knows they need documented information for
anything necessary for the effectiveness of the QMS. So
what is what is necessary for effectiveness though?
Well, having a documented having documented information related
to how to make, control, and provide other documented
information is a pretty good thing.
So that's a good good starting point.
I once had to start Aqms from absolutely nothing for a little
little flavour text on what that process is like.
I I did not have Gray hair when I started that job and now I get
served at Taco Bell. So it's it's a real taxing
process. I was I was not sure where to
start when when I took on the gig, but it quickly became
apparent that starting with a dock control procedure was what
the organization needed. Having a defined process for the
review and approval of documented information helps
remove all the the guesswork. So it helps unify it helps speed
up the process of document review.
I observed a a pretty natural inclination to have supervisors
review documents prior to release to the, the general
population of the company, but there was no repeatability in
that process In, in this place where I had to start from
scratch, there were constantly questions about like, how do I
get this to the people that need it?
So what if, what if something changes in this?
How do I know that they've read the document?
Just tons, tons of questions. And so starting Aqms with a
defined dot control process is a pretty good way to help solve
those problems. It shows the efficacy of the
quality program and shows that quality is indeed there to help.
Plus, the moment we have a repeatable process documented,
we can start auditing and that is pretty Ding Ding Fung.
So all right, back on track here.
Document structures, let's talk about that.
So I like the four tier pyramid approach to document structures.
Company should have a general quality manual at the the top of
the pyramid. Now ISO 9001 doesn't require
that manual, but it really helps a lot of customers are still
looking for it. A lot of organizations can
benefit from a quality manual and ITF in 1345, they they
absolutely require that manual now that needs to be available.
And odds are if you're listening to this, you're serving multiple
industry types. So right up that manual, which
is a good way to ask like what goes into a quality manual?
Well, that's that's really another half hour conversation.
So we'll do that that later. The the finer details.
But in general, a quality manual should be the 30,000 foot view
of the company, have the quality policy, the interaction of
processes, the organizational structure, not an org chart.
So the org structure is just here's our leadership team and
all of these groups reported to them.
All of these groups reported to them, not an org chart.
You don't want to put names on that.
The big stuff is, is what can be thrown in front of a customer or
auditor to answer some really important questions.
Emmanuel should be able to tell the reader how the organization
views itself and views its processes.
For the ISO nerds, the the manual should function as a one
stop shop for answering all of the section 4-5 and six stuff.
That's if you write your manual, well, you throw that in front of
the, the auditor, they can knock out those whole sections during
your audit underneath the the quality manual.
And then next tier down you have your SO PS, your standard
operating procedures. Now these detail procedures of
the processes outlined in the manual.
So your manual at that 30,000 foot view should include like
here's my product design process and here's my quality process,
here's my safety process. This is how they all interact.
SO PS detail the procedures that all of those high level
processes do. So when when you're working on a
a manual or a system in a hole, listen to the Scipoc episode.
But I like to include Scipoc diagrams in the quality manual
to show what SO PS are expected of a department store big P
capital P process. An operations department would
have an SOP for the planning process.
Quality department has an SOP for the corrected action
process. SO PS tell operators what to do
with inputs, what procedures are employed to create outputs and
where their outputs go in in a big Broadway.
SO PS will reference the the next tier down.
Work instructions, work instructions.
Those are going to be real specific details on how to
complete a task, a work instruction for how to build a
parts, how to create a presentation, how to conduct a
root cause corrective action in accordance with company
practices. That sort of specificity.
It's how to do something, not when to do something, which is
what SO PS do. SO PS are the when they give you
the the structure or constructions are the how.
Finally, at the the bottom of the pyramid, there are forms and
templates. Forms are filled out with
information which will become a record.
Templates exist ultimately to make life easier and not
recreate the tool every single time.
I'm sure there's a better definition out there somewhere,
but but forms become records. That's that's really the key.
So quality manual. SO PS work instructions and then
the base of the pyramid holding everything together, forms and
templates. Those are the four key document
types. Now do know documented
information does not require something to be written down.
Audio and visual tools can be documented information as well.
You at the company get to determine how the controls are
applied. Now, quick little aside, I love
video work instructions. They're engaging.
They transcend language barriers.
Very easy to put together. But if you have a cell phone,
you have a video studio. I'm an iPhone user, so iMovie is
the way to go for me. Android folks, you could use
something like Movavi. I think that's how you say it.
That is a free version for your phone.
I have a paid version on my desktop that's incredibly easy
to use. But if you record a video and
bring it to your laptop, you can download Davinci Resolve.
It's a video editor app that's incredibly easy, free to use.
The the dashboard is intuitive beyond belief.
So the the trick is to take videos, make them available,
usable, and easy to update through your system.
So that's where the controls come into play.
In ISO, you need to give it a title and some kind of revision
date or number, and that's really the backbone of all of
it. So all right, all right, back,
back on track here. So we have the four tiers of
documents. More than likely you are working
in an existing system. Even if there's no quality
system in place, there's a system in place.
So I highly recommend starting with documentation of those
standard operating procedures, how people get their work done.
Even in a, a four month old start up, there's going to be a
cadence to how things move. You're going to get a real idea
of what the the culture is and culture builds processes.
So even if there's no quality system in place, there's a
system, be on the lookout for it.
Watch how people take inputs and create outputs.
What happens to those outputs? That's that's really where you
want to go? Where where are we going from
there? I got distracted by start-ups.
So, so let's, let's keep in mind that.
All right, yeah, everything in quality is a controversy.
So I'll add a disclaimer here and that this is how I've made
document control work in the past.
Get with process owners and figure out what they think their
process looks like, then write that down.
I don't like highly detailed, SO.
PS If the quality manual has a 30,000 foot view of the
organization, the SOP is getting everybody for a landing at
10,000 feet. Things become a bit more clear.
They become a bit more accessible.
You know, we're through the clouds and can see some patches
of trees, but there's really no need to start naming each tree
at this point. An SOP lets people who work with
the process know what steps they're going to take to make an
to take an input and make an output.
So let's use a corrective action SOP as an example.
At the SOP level, the document is going to say things like when
a non conformance is discovered, the organization's designated
corrective action team members will determine if a full
corrective action is necessary or if another course of action
is needed. Please don't let that actually
be your practice document all you can, if necessary, just just
stop the and and contain the issue.
That's, that's all, all you need to do.
It would continue with. If a corrective action is to be
initiated, the corrective action team will open a corrective
action in the organization's corrective action system.
Use acronyms all over the place. Way, way easier.
That lets the team. That wording lets the team know
that there's a system. It assigns responsibility, but
doesn't tie everyone down into specifics.
This is a sort of procedure that can be replicated across
industries and the steps can remain the same regardless of
what system is used. It's going to be generic, but
it's going to allow you guidance and that's what the SOP should
should be doing. Now, I don't know about you, but
in most places that I've been at, the corrective action system
is kind of treated like a TikTok trend.
There's a new one every week. So keeping the bones of the
process, the written is as kind of generic, just a point A,
point B, Point C kind of thing. That's not going to change.
So just just document the bones in an SOP.
Don't write the muscle into that document.
Leave the cartilage for some place else entirely.
The SO PS are what you're going to show your auditors uses
training guides or new hires and a reference when somebody says,
what if we missed a step? Then you can just slap out that
SOP, just bam, or pull up the video for how the process should
work and you'll be able to say, OK, we did A, we did B, we
missed step C, OK, how do we do step C?
And that's where you can get the work instruction because those
fine details, they are in the work instruction.
These should be where the real real mate, this is where you put
the muscle. That's where this can be found.
This is video details. This is screenshots from the
system placed and replaced in Word documents.
This is where people who read the SOP go to when they need a
reminder of how to close out the corrective action in the current
system. These will be updated often and
hopefully for the better. Getting into the really fine
matters in these sorts of documents.
That's what you want to do. You want to get into the fine
details like to the level of how a person doing the work should
position their hands during the process.
Standard operating procedures give you the the, the basic
structure. They're the framing of the
house. This is the drywall, right?
This gives you the the architectural oomph to to really
make something. The word construction should be
your standard work. And if you are aiming for
standard work, you know, include safety elements, reclude
required materials, put in cycle times if known best practices,
the the actual sequence of events, what tools you need, I
guess that's kind of required materials, but all that sort of
stuff. So, so there are no questions
about how to get the work done to the best method known right
now. Standard work should always be
changing go seek that inputs and now it I know it sounds like a
contradiction that standard work is changing, but getting better
all the time is really the name of the game with standard work.
There's that saying and I do not know who to attribute it to
Apologies to the quote originator and and thanks, but
the saying is there can be no improvement without a standard
taichi. Oh no, that sounds right.
I'll look it up. All right, So finally that that
work instruction is supported then by that forms and templates
category. These are the the real
workhorses of this system. Forms and templates exist to
facilitate record collection in a standard way.
So your forms and templates are in place to make sure
information can be conveyed to users with ease and data is
recorded at a repeatable manner. So every single time, every
every time somebody goes to read that data, it isn't a real pain
of the keister. Templates really help speed up
processes like a common PowerPoint templates or a work
construction template or just a standard report template,
management review templates. My goodness, have that.
That's a a pretty key one. It's a great resource to to just
have that in a template that you can plug and play all your data
in every three months or so. But having that one accepted
method for complete conveying information, that's what your
template is there to do. So those are the the the four
tiers a system really should have.
There's nothing wrong with other types of forms, but before
making a controlled document system large and having specific
things in there ask that really benefits your users.
Maybe of a projects oriented organization and charters are
part of the the day-to-day. The charter should be a
template, but what do you do with that filled out version
that that needs to be reviewed and approved and all of that?
How does that get into your system?
What sort of approval structure does it need?
Does the charter need to be controlled at all That there's
those are all the questions that we will ultimately be company
specific answers. So let's let's talk about
approval structures. What makes a controlled document
system really helpful is that the documentation within the
system should be reviewed by people accountable for the
process outputs. So it's leads, managers, process
owners, whatever you want to call them.
The people accountable for the results need to be reviewing the
information being distributed to their teams and the people
executing the work. Let's go to the very top, the
quality manual that should be reviewed and approved by the top
management of the organization or if it's site specific, just
the site top management. SO PS I say should be process
owners, quality leaders and one or two other key leaders, making
sure that there's, there's real clarity on what the role of that
SOP is trying to fulfill or constructions should be reviewed
and approved by the process owners and quality leaders.
And this I mentioned qualities, controversy forms and templates
should just be controlled by the process owners.
I suggest making other anything. Everything other than forms and
templates revision level controlled.
So that's here's your revision 1, revision 2, revision 3 goes
through that full approval process.
However, you distribute that for approval and then forms and
templates should be revision date controlled.
So your process center can go in there, make the changes, change
the Rev date, bam, and deploy it.
Now you really want to make sure that old forms and templates are
removed from potential access. All of this though is is really
organization specific. So your your culture, your way
of doing things is going to dictate how you're going to
interact with these 4 tiers and how that approval structure
goes. In a highly controlled
environments where you don't have a lot of wiggle room at the
process level to make changes, your forms and templates
probably go through a more stringent review process.
Med device probably can't get away with just a single point of
approval just for for risk mitigation if nothing else.
So the structure though, the four, four systems, 4 levels,
tiers, whatever word we're using and it makes life easy and is if
you just have those four things, you can quickly establish
expectations and expectations of the the process.
Let's go back to that, that project charter example though.
Now that's a filled out form that will guide future work.
It's owned by a project team and will impact multiple
stakeholders. That's a weird way to say
stakeholders, multiple stakeholders.
A charter should not be revised once it's approved though, but
you do need to make sure that everyone has access to the
approved charter since that's a key function of the charter.
So this instance sits outside of SO PS work instructions, forms,
and should probably get its own category as just a record.
Approvals will come from the project launch meeting and an
SOP will guide what that project process looks like, while if
your constructions will provide specific direction.
The charter is ultimately an output of the process and will
serve as an input for the rest of the project.
So we have a spot on the template that has sign offs from
various impacted stakeholders and then store the charter as a
record. Best recommendation to get you
started, but again, I cannot can all stress this enough, each
organization is going to be wildly different in how these
documents are handled. Now I've worked in large
aerospace, small medical, medium sized fence, and small raw
materials book publishing even. Not one of them treated
documents in the same way. And even the ones where I
created the document control structure, they were created in
a way that ensured the users of the documents were going to
actually use the documents in a regulated environments.
Documents are essential survival tools and an ISO environments.
There's there's a vibe that the docs there are are just there to
survive an audit. Remind folks that the only way
we can really get better is to know how to do the task in the
1st place. So write it down, make newbies
follow the process and then you'll find areas where the
process can be improved quickly. That's that's that's what having
that standard in place does. It allows your new entrance,
your rookies to really see how to do it, try to execute it and
then fix it and get better over time.
So that's, you know, this, this has been a, a really long rant
on a topic that's that's very essential to every system.
But I'll, I'll stop talking now and we'll talk more about it
later. And in the meantime, come check
out COQ ms.com, where Colorado quality systems.
This, this little company of ours offers a lot of templates
and forms to get you started. You can follow a QikLink to to
download QMS Notion templates. And there's a a fully editable
quality tools suite of HTML and JavaScript programs.
So there's a CPK calculator, Fishbone diagram tool that works
great on a virtual root cause meeting and more.
And they're all available for free download.
And of course, if you need some help with your QMS, reach out to
coqualitysystems@gmail.com or to the podcast directly everyday
qualitypodcast@gmail.com and we'll chat about neat stuff.
So all right, that will do it for this entry.
Reach out with any questions. We'd love to hear from you.
Thanks for your time. Bye.