Standard Operating Procedure

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The key takeaways are that an SOP is a document outlining step-by-step procedures and it is important to involve stakeholders, use simple language, and ensure clarity.

The different formats for writing an SOP are a simple steps format, a hierarchical steps format, and a flowchart format.

The factors to consider for the audience are their prior knowledge, language abilities, and the size of the audience.

Standard Operating Procedure (SOPs)

A Standard Operating Procedure (SOP) is a document consisting of step-by-step information


on how to execute a task. An existing SOP may need to just be modified and updated, or you
may be in a scenario where you have to write one from scratch. It sounds daunting, but it's
really just a very, very, very thorough checklist.

Formatting Your SOP


1. Choose your format. There is no right or wrong way to write an SOP. However, your
company probably has a number of SOPs you can refer to for formatting guidelines,
outlining how they prefer it done. If that's the case, use the pre-existing SOPs as a
template. If not, you have a few options:
o A simple steps format. This is for routine procedures that are short, have few
possible outcomes, and are fairly to the point. Apart from the necessary
documentation and safety guidelines, it's really just a bullet list of simple
sentences telling the reader what to do.
o A hierarchical steps format. This is usually for long procedures -- ones with
more than ten steps, involving a few decisions to make, clarification and
terminology. This is usually a list of main steps all with sub-steps in a very
particular order.
o A flowchart format. If the procedure is more like a map with an almost infinite
number of possible outcomes, a flowchart may be your best bet. This is the
format you should opt for when results aren't always predictable.
2. Consider your audience. There are three main factors to take into account before
writing your SOP:
o Your audience's prior knowledge. Are they familiar with your organization
and its procedures? Do they know the terminology? Your language needs to
match the knowledge and investment of the reader.
o Your audience's language abilities. Is there any chance people who don't
speak your language will be "reading" your SOP? If this is an issue, it's a good
idea to include lots of annotated pictures and diagrams.
o The size of your audience. If multiple people at once are reading your SOP
(those in different roles), you should format the document more like a
conversation in a play: user 1 completes an action, followed by user 2, and so
on and so forth. That way, each reader can see how he or she is an integral cog
in the well-oiled machine.
3. Consider your knowledge. What it boils down to is this: Are you the best person to
be writing this? Do you know what the process entails? How it could go wrong? How
to make it safe? If not, you may be better off handing it over to someone else. A
poorly-written -- or, what's more, inaccurate -- SOP will not only reduce productivity
and lead to organizational failures, but it can also be unsafe and have adverse impacts
on anything from your team to the environment. In short, it's not a risk you should
take.
o If this is a project you've been assigned that you feel compelled (or obligated)
to complete, don't shy away from asking those who complete the procedure on
a daily basis for help. Conducting interviews is a normal part of any SOPcreating process.

4. Decide between a short or long-form SOP. If you're writing or updating an SOP for
a group of individuals that are familiar with protocol, terminology, etc., and just
would benefit from a short and snappy SOP that's more like a checklist, you could just
write it in short-form.
o Apart from basic purpose and relevant information (date, author, ID#, etc.), it's
really just a short list of steps. When no details or clarification are needed, this
is the way to go.
5. Keep your SOP purpose in mind. What's obvious is that you have a procedure
within your organization that keeps on getting repeated over and over and over. But is
there a specific reason why this SOP is particularly useful? Does it need to stress
safety? Compliance measures? Is it used for training or on a day-to-day basis? Here
are a few reasons why your SOP is necessary to the success of your team:
o To ensure compliance standards are met
o To maximize production requirements
o To ensure the procedure has no adverse impact on environment
o To ensure safety
o To ensure everything goes according to schedule
o To prevent failures in manufacturing
o To be used as training document
If you know what your SOP should emphasize, it'll be easier to
structure your writing around those points. It's also easier to see just
how important your SOP is.

Writing Your SOP


1. Cover the necessary material. In general, technical SOPs will consist of four
elements apart from the procedure itself:
o Title page. This includes 1) the title of the procedure, 2) an SOP identification
number, 3) date of issue or revision, 4) the name of the agency/division/branch
the SOP applies to, and 5) the signatures of those who prepared and approved
of the SOP. This can be formatted however you like, as long as the
information is clear.
o Table of Contents. This is only necessary if your SOP is quite long, allowing
for ease of reference. A simple standard outline is what you'd find here.
o Quality Assurance/Quality Control. A procedure is not a good procedure if it
cannot be checked. Have the necessary materials and details provided so the
reader can make sure they've obtained the desired results. This may or may not
include other documents, like performance evaluation samples.
o Reference. Be sure to list all cited or significant references. If you reference
other SOPs, be sure to attach the necessary information in the appendix.
Your organization may have different protocol than this. If there are
already pre-existing SOPs you can refer to, abandon this structure and
adhere to what's already in place.
2. For the procedure itself, make sure you cover the following:
o Scope and applicability. In other words, describe the purpose of the process,
its limits, and how it's used. Include standards, regulatory requirements, roles
and responsibilities, and inputs and outputs.
o Methodology and procedures. The meat of the issue -- list all the steps with
necessary details, including what equipment needed. Cover sequential

3.

4.

5.

6.

procedures and decision factors. Address the "what ifs" and the possible
interferences or safety considerations.
o Clarification of terminology. Identify acronyms, abbreviations, and all
phrases that aren't in common parlance.
o Health and safety warnings. To be listed in its own section and alongside the
steps where it is an issue. Do not gloss over this section.
o Equipment and supplies. Complete list of what is needed and when, where to
find equipment, standards of equipment, etc.
o Cautions and interferences. Basically, a troubleshooting section. Cover what
could go wrong, what to look out for, and what may interfere with the final,
ideal product.
Give each of these topics their own section (usually denoted by
numbers or letters) to keep your SOP from being wordy and confusing
and to allow for easy reference.
This is by no means an exhaustive list; this is just the tip of the
procedural iceberg. Your organization may specify other aspects that
require attention.
Make your writing concise and easy to read. Odds are your audience isn't choosing
to read this for fun. You want to keep it short and clear -- otherwise their attention
will stray or they'll find the document formidable and hard to grasp. In general, keep
your sentences as short as possible.
o Here's a bad example: Make sure that you clean out all of the dust from the
air shafts before you begin using them.
o Here's a good example: Remove all dust from air shafts before use.
o In general, don't use "you." It should be implied. Speak in the active voice and
start your sentences with command verbs.
If necessary, interview the personnel involved in the process on how they execute
the task. The last thing you want to do is write an SOP that is just plain inaccurate.
You're compromising the safety of your team, their efficacy, their time, and you're
taking an established process and not paying it any mind -- something your teammates
may find a little offensive. If you need to, ask questions! You want to get this right.
o Of course, if you don't know, ask multiple sources, covering all roles and
responsibilities. One team member may not follow standard operating
procedure or another may only be involved in a portion of the deed.
Break up large chunks of text with diagrams and flowcharts. If you have a step or
two that are particularly intimidating, make it easy on your readers with some sort of
chart or diagram. It makes it easier to read and gives the mind a brief hiatus from
trying to make sense of it all. And it'll be appear more complete and well-written for
you.
o Don't include these just to bulk up your SOP; only do this if necessary or if
trying to bridge a language gap.
Make sure each page has control document notation. Your SOP is probably one of
many SOPS -- because of this, hopefully your organization has some type of larger
database cataloguing everything within a certain reference system. Your SOP is part
of this reference system, and therefore needs some type of code in order to be found.
That's where the notation comes in.
o Each page should have a short title or ID #, a revision number, date, and "page
# of #" in the upper right hand corner (for most formats). You may or may not
need a footnote (or have these in the footnote), depending on your
organization's preferences.

Ensuring Success and Accuracy


1. Test the procedure. If you don't want to test your procedure, you probably haven't
written it well enough. Have someone with a limited knowledge of the process (or a
person representative of the normal reader) use your SOP to guide them. What issues
did they run across? If any, address them and make the necessary improvements.
o It's best to have a handful of people test your SOP. Different individuals will
have different issues, allowing for a wide variety of (hopefully useful)
responses
o Be sure to test the procedure on someone who's never done it before. Anyone
with prior knowledge will be relying on their knowledge to get them through
and not your work, thus defeating the purpose.
2. Have the SOP reviewed by those who actually do the procedure. At the end of the
day, it doesn't really matter what your bosses think of the SOP. It's those who actually
do the work that it matters to. So before you submit your work to the higher ups, show
your stuff to those that'll be doing (or that do) the job. What do they think?
o Allowing them to get involved and feel like they're part of the process will
make them more likely to accept this SOP you're working on. And they'll
inevitably have some great ideas!
3. Have the SOP reviewed by your advisors and the Quality Assurance team. Once
the team gives you the go ahead, send it to your advisors. They'll probably have less
input on the actual content itself, but they'll let you know if it meets formatting
requirements, if there's anything you missed, and the protocol for making it all official
and input into the system.
o Route the SOP for approvals using document management systems to ensure
audit trails of the approvals. This will vary from organization to organization.
Basically, you want everything to meet guidelines and regulations.
o Signatures will be necessary and most organizations nowadays have no
problem accepting electronic signatures.
4. Once approved, start implementing your SOP. This may involve executing a
formal training for the affect personnel (e.g. classroom training, computer-based
training, etc.) or it may mean your paper is hung up in the bathroom. Whatever it is,
get your work out there! You worked for it. Time for recognition!
o Be sure your SOP remains current. If it ever gets outdated, update it, get the
updates re-approved and documented, and redistribute the SOP as necessary.
Your team's safety, productivity, and success matter on it.

Tips

Remember to involve the stakeholders whenever possible, so that the documented


process is the actual process.
Use simple English to explain the steps.
Use flowcharts and pictorial representations so that the reader is clear about the
process.
Ensure document history is documented for every version change.
Check if an old version of the SOP exists before you write yours. You may just be
able to make a few quick changes. Make sure you still document them, though!

Check for clarity. Make sure there aren't multiple interpretations. Show the procedure
to someone unfamiliar with the process and have them tell you what they think it
says; you may be surprised.
Get people to review your document before getting approval.

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