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Innovation in the development of SOPs

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 1 COGNITIVE PROCEDURES

In corporate and government bureaucracies the usual method for developing a

procedure is to copy and amend the old, or find a stock procedure that can be used
to echo regulations. Even if actual users are involved in the development of a written
procedure, most often a controlling function will intercede, which results in an output
consisting of a list of points organized in a consistent stylized fashion.
This methodology produces documents which initially demonstrate compliance,
however typically these are neither welcome, nor of value to their target audiences
‘the users’, and do not provide continued compliance.

A standard operating procedure is defined as:

“Standard Operating Procedures (SOPs): Detailed, written instructions

to achieve uniformity of the performance of a specific function.”
ICH E6 §1.55

To be in compliance with this requirement a standard operating procedure needs

to be, at least, a set of instructions having the force of a directive, which includes
those features or operations that lend themselves to a definite or standardized
procedure without loss of effectiveness. However, SOPs which lack clarity of business
value or recognition of users needs and desires can quickly become an administrative
burden prone to stagnation, a process which itself leads directly to ‘non compliance’.

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 If SOPs are allowed to be dynamic and cognitive, they can be very effective catalysts
which drive performance improvement and organizational results.
Unfortunately, it is uncommon for SOPs to be amended outside of their typical review
schedule, and sadly common for them to remain unchanged for years. Users may not
be provided with opportunities to either facilitate changes outside of this schedule,
or to suggest changes for consideration during the next cycle.
Assuming continued compliance, this indicates that processes remain largely
unchanged and therefore do not experience improvements in business value.
To be a valuable component in business process and to maintain compliance SOPs
must be both accessible and stimulating.

“Good grief, did I just say SOP and stimulating in the same sentence.”
— Dan Burgess, “Innovation in the development of SOPs”

Stimulating procedures, which I’d prefer to refer to as cognitive procedures, have

the potential to stimulate thought and therefore innovation, both through their
development and in day-to-day use. Cognitive procedures provide a service and value
to the organization far in excess of the essential regulatory requirements and rules.

Cognitive SOPs: SOPs which provide a compliant backbone while developing

a greater process understanding and stimulating innovative thought.

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 2 THE RELATIONSHIP BETWEEN TRAINING AND SOPs
For SOPs to be truly effective they need to be both used, and supplemented with
education, training and experience.

“Each individual involved in conducting a trial should be qualified by

education, training, and experience to perform his or her respective task(s).”
ICH E6 §2.8

SOPs provide uniformity in the performance of a specific function, and are not
intended to be fully comprehensive in detail for untrained users. This highlights
that the relationship between SOPs and training is critical, and that training must
answer the questions that SOPs stimulate.
This is seen as a positive factor in an environment of improvement as it is hoped
that users do question why things are done the way they are.

“If you think of standardization as the best that you know today,
but which is to be improved tomorrow; you get somewhere.”
—Henry Ford

An effective SOP must provide rational standardization, be supported by knowledge,

but remain open to improvement. Without these elements, non-compliance or
stagnation will occur.

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 “I have an
allegorical map from the
early 1900’s on my office wall.
This map highlights the issues to
avoid in achieving success without
specifying any detail on how to avoid the
issues. Like a good SOP it sets out a journey
to achieve a result. It demonstrates the
path to take, providing standardization
by highlighting actions to avoid. With
appropriate training to generate an
understanding of how to avoid the
pitfalls identified, this map contains
many of the elements of
a good SOP.”
— Dan Burgess

yes

success no

“Be a yardstick of quality.

Some people aren’t used
to an environment where
excellence is expected.”
— Steve Jobs

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 3 REGULATIONS, PROCEDURES, SOPs AND COMPLIANCE

As mentioned earlier, SOPs are required under GCP to achieve uniformity

of the performance of a specific function and in GMP, GLP and Medical Device
Regulations, specific areas to be covered by procedures and SOPs are defined.
But nowhere can a standard be found to define how SOPs are constructed
or employed.

Within the US GMP environment 21 CFR 210/211 establishes standards for procedures
related to, “production and process control designed to assure that products have the
identity, strength, quality and purity they purport or are represented to possess.”

In US GLP environment 21 CFR 58 states “A testing facility shall have

standard operating procedures in writing, setting forth nonclinical laboratory
study methods that management is satisfied are adequate to insure the quality
and integrity of the data generated in the course of a study.”

Within the US medical device environment 21 CFR 820 states that companies
must have documented procedures for “methods used in, and the facilities
and controls used for, the design, manufacture, packaging, labeling, storage,
installation and servicing of all finished devices for human use.”

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 Within the US GxP environment for computerized systems 21 CFR 11 refers to
“The establishment of, and adherence to, written policies that hold individuals
accountable and responsible for actions initiated under their electronic signatures,
in order to deter record and signature falsification.”

In the UK GLP environment, SI 1999 No 3106, Part VII, 1 states “A test

facility should have written standard operating procedures approved by test
facility management that are intended to ensure the quality and integrity
of the data generated by the test facility. Revisions to standard operating
procedures should be approved by test facility management.”

In Japanese GLP environment, GLP Ordinance 21, Chapter 4, Article 11,

states “The management shall prepare the SOP for the method and work
flow of the items as follows:” (a list of fourteen areas follows this statement)

In the international GLP environment, OECD Principles of Good Laboratory

Practice, Section 7.1 (2) states “Each separate laboratory unit should have
immediately available Standard Operating Procedures relevant to the activities
being performed therein. Published text books, articles and manuals may be
used as supplements to these Standard Operating Procedures.”

In the international GCP environment ICH E6 Systems Section 2.13 states “Systems with
procedures that assure the quality of every aspect of the trial should be implemented.”

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 Regulations do exist regarding approval of SOPs and version control while providing
‘good business practice’.
Additionally, a number of factors should be considered to address the common
regulatory questions:

Purpose: a clear descriptive statement expressing the intent of the procedure, this
can additionally define regulatory requirements that are met,

Scope: describes the functions and if necessary roles to which an SOP applies,

Definitions: provide standard terminology across SOPs. The provision of

standardization across definitions is an enormous asset when SOPs are used
across different regulatory regions or when SOPs begin to interact with each other,

References: should only include documents referenced from within the SOP itself
which are fundamental to its understanding, attachments and appendices can be
dealt with in the same way as references, and

Document history: provides access to previous versions of procedures for use in

reconstructing events.

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 Purpose, scope, definitions and document history are not required in the SOPs
themselves, though are considerations in development, as long as they are elements
within the SOPs system (Index or Glossary). The use of an electronic access system
prevents unnecessary inclusion of definitions and references not utilized within the
SOPs and may be more efficient if these items are not allowed to become ‘clutter’
affecting understanding of the procedure.

As long as the following elements are included

THERE ARE NO RULES REGARDING FORMAT:

Who: relates to a specific group or function within the scope of the

SOP to allow proper accountability for what is being described,

What: describes each step in the process in a clear and concise manner,

When: is included if timelines are a factor for standardization,

Where: if the process is to be conducted at a standardized location, and

How and Why: a task is performed may be covered through

training and need not be included in the SOP itself.

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 Care should be taken to ensure that whatever format is chosen for the SOP that the
process is not described twice in different ways, this avoids increasing the potential
for inconsistency and non-compliance.

SOPs address what is to be done and training can address how it is to be done.
Describing the HOW in detail may be more effectively managed through training if
the WHAT is enough to achieve uniformity of the performance of a specific function.
A strong understanding of WHY a task is performed will increase the efficacy of the
procedure, compliance with it, and the quality of the work output.

Though these factors should be considered in SOP development, factoring them

into overall SOP access and simplifying the SOPs themselves may dramatically
improve use and compliance through the reduction of clutter superfluous to the
user experience. The first question a regulator will ask in relation to any finding
is “are SOPs being actively used?” If they were in use the SOP in question will
perhaps need amendment, but if not, the finding highlights a weakness in the SOP
system itself and will likely generate further ‘unwanted’ investigation.

“Sweet songs never last too

long on broken radios.”
— John Prine

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 4 TOP SOP DEVELOPMENT TIPS

1. Results Orientated: The best SOPs achieve specific results, they orientate tasks
towards results which enable the establishment of measures and benchmarking. An
SOPs ability to achieve results is a direct indicator of its efficacy. This may result
in splitting longer SOPs into measurable tasks.

2. Don’t create unnecessary rules: The SOP is there to achieve uniformity of the
performance of a specific function, not to provide uniformity and stifle innovation. Many
courses exist which will tell you how to format SOPs and one of the first questions
asked is “does a standardized format really increase effectiveness?” The answer is,
it may or may not depending on the environment within which the SOP is used.

3. SOPs are part of the process: When SOPs are not utilized and explored for process
improvement they may become a bureaucratic burden. When they are utilized
day-to-day they provide scope for continuous improvement.

4. SOPs and Training need to be conjoined: You cannot effectively train on SOPs
unless the process is already understood. Training on the process includes the ‘why’,
or the rationale the SOP probably lacks and develops a greater understanding of the
SOP while providing a compliant backbone for uniformity of performance. We
understand that each individual should be qualified by education, training, and
experience to perform his or her respective task(s), and that this involves more than
reading and following SOPs. SOPs and training can be viewed together as two parts
of a whole, though the proportion that each part plays can vary.
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 5. Balance SOP and Training: A careful balance of proportions.
More detail may be necessary in an SOP when:
• The process is not well understood regardless of education, training
and experience,
• The process is simple and can easily be understood through review,
• There is less opportunity to practice, and
• The process is infrequently used.
And more in the training when:
• The WHY is critical to fully understanding the process,
• Practice is essential to utilization, and
• The process is commonly used.

6. Indexing is critical: The index is a critical element in accessing SOPs and its
role needs to be given attention in the overall SOP system. The index may contain
elements which make more sense in this context, such as title, purpose, scope and
revision history which are all tools in the identification of the SOP to be accessed.

7. Flowcharts may aid understanding: Visual thinking may help in the rationalization
of SOPs however their use in SOPs themselves may not always aid understanding.

8. The SOP development process is a cycle: Changes to SOPs do not have to be made
according to a schedule. Though if it helps to do so, there should be a mechanism
to capture and review suggestions to change or recommended process improvement
provided at any time. Critical changes of course should not wait until the next
scheduled review.
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 THANK YOU.
Written by Dan Burgess, Alexion Pharmaceuticals

Produced by karlssonwilker, Inc. for CQA, Alexion Pharmaceuticals

Thanks to Denise Romero, Alexion Pharmaceuticals

CQA Training 00062009.

© MMIX Alexion Pharmaceuticals