innovation in the development of sops

8/9/2019 Innovation in the Development of SOPs

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Innovation in the development o SOPs

WELCOME TO

ENJOY


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COGNITIVE PROCEDURES

In corporate and government bureaucracies the usual method or developing a

procedure is to copy and amend the old, or nd a stock procedure that can be usedto echo regulations. Even i actual users are involved in the development o a written

procedure, most oten a controlling unction will intercede, which results in an output

consisting o a list o points organized in a consistent stylized ashion.

This methodology produces documents which initially demonstrate compliance,

however typically these are neither welcome, nor o value to their target audiences

the users, and do not provide continued compliance.

A standard operating procedure is dened as:

Standard Operating Procedures (SOPs): Detailed, written instructions

to achieve uniormity o the perormance o a specic unction.

ICH E6 1.55

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

to be, at least, a set o instructions having the orce o a directive, which includes

those eatures or operations that lend themselves to a denite or standardized

procedure without loss o eectiveness. However, SOPs which lack clarity o business

value or recognition o users needs and desires can quickly become an administrative

burden prone to stagnation, a process which itsel leads directly to non compliance.

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I SOPs are allowed to be dynamic and cognitive, they can be very eective catalysts

which drive perormance improvement and organizational results.

Unortunately, it is uncommon or SOPs to be amended outside o their typical review

schedule, and sadly common or them to remain unchanged or years. Users may not

be provided with opportunities to either acilitate changes outside o this schedule,

or to suggest changes or consideration during the next cycle.

Assuming continued compliance, this indicates that processes remain largely

unchanged and thereore 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 grie, did I just say SOP and stimulating in the same sentence.

Dan Burgess, Innovation in the development o SOPs

Stimulating procedures, which Id preer to reer to as cognitive procedures, have

the potential to stimulate thought and thereore innovation, both through theirdevelopment and in day-to-day use. Cognitive procedures provide a service and value

to the organization ar in excess o 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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THE RELATIONSHIP BETWEEN TRAINING AND SOPs

For SOPs to be truly eective they need to be both used, and supplemented with

education, training and experience.

Each individual involved in conducting a trial should be qualied by

education, training, and experience to perorm his or her respective task(s).

ICH E6 .8

SOPs provide uniormity in the perormance o a specic unction, and are not

intended to be ully comprehensive in detail or 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 actor in an environment o improvement as it is hoped

that users do question why things are done the way they are.

I you think o standardization as the best that you know today,

but which is to be improved tomorrow; you get somewhere.Henry Ford

An eective 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 anallegorical map rom the

early 1900s on my oce wall.This map highlights the issues to

avoid in achieving success withoutspeciying any detail on how to avoid the

issues. Like a good SOP it sets out a journeyto achieve a result. It demonstrates thepath to take, providing standardizationby highlighting actions to avoid. Withappropriate training to generate anunderstanding o how to avoid thepitalls identied, this map contains

many o the elements oa good SOP. Dan Burgess

success

yes

no

Be a yardstick o quality.

Some people arent used

to an environment where

excellence is expected.

Steve Jobs


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REGULATIONS, PROCEDURES, SOPs AND COMPLIANCE

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

o the perormance o a specic unction and in GMP, GLP and Medical DeviceRegulations, specic areas to be covered by procedures and SOPs are dened.

But nowhere can a standard be ound to dene how SOPs are constructed

or employed.

Within the US GMP environment 1 CFR 10/11 establishes standards or procedures

related to, production and process control designed to assure that products have theidentity, strength, quality and purity they purport or are represented to possess.

In US GLP environment 1 CFR 58 states A testing acility shall have

standard operating procedures in writing, setting orth nonclinical laboratory

study methods that management is satised are adequate to insure the quality

and integrity o the data generated in the course o a study.

Within the US medical device environment 1 CFR 80 states that companies

must have documented procedures or methods used in, and the acilities

and controls used or, the design, manuacture, packaging, labeling, storage,

installation and servicing o all nished devices or human use.

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Within the US GxP environment or computerized systems 1 CFR 11 reers to

The establishment o, and adherence to, written policies that hold individuals

accountable and responsible or actions initiated under their electronic signatures,

in order to deter record and signature alsication.

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

acility should have written standard operating procedures approved by test

acility management that are intended to ensure the quality and integrity

o the data generated by the test acility. Revisions to standard operating

procedures should be approved by test acility management.

In Japanese GLP environment, GLP Ordinance 1, Chapter , Article 11,

states The management shall prepare the SOP or the method and work

fow o the items as ollows:(a list o ourteen areas ollows this statement)

In the international GLP environment, OECD Principles o Good Laboratory

Practice, Section .1 () states Each separate laboratory unit should have

immediately available Standard Operating Procedures relevant to the activitiesbeing perormed 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 .13 states Systems with

procedures that assure the quality o every aspect o the trial should be implemented.


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Regulations do exist regarding approval o SOPs and version control while providing

good business practice.

Additionally, a number o actors should be considered to address the common

regulatory questions:

Purpose: a clear descriptive statement expressing the intent o the procedure, this

can additionally dene regulatory requirements that are met,

Scope: describes the unctions and i necessary roles to which an SOP applies,

Denitions: provide standard terminology across SOPs. The provision o

standardization across denitions is an enormous asset when SOPs are used

across dierent regulatory regions or when SOPs begin to interact with each other,

Reerences: should only include documents reerenced rom within the SOP itsel

which are undamental to its understanding, attachments and appendices can bedealt with in the same way as reerences, and

Document history: provides access to previous versions o procedures or use in

reconstructing events.


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Purpose, scope, denitions 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 o an electronic access system

prevents unnecessary inclusion o denitions and reerences not utilized within theSOPs and may be more ecient i these items are not allowed to become clutter

aecting understanding o the procedure.

As long as the ollowing elements are included

THERE ARE NO RULES REGARDING FORMAT:

Who: relates to a specic group or unction within the scope o the

SOP to allow proper accountability or what is being described,

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

When: is included i timelines are a actor or standardization,

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

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

training and need not be included in the SOP itsel.


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Care should be taken to ensure that whatever ormat is chosen or the SOP that the

process is not described twice in dierent ways, this avoids increasing the potential

or 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 eectively managed through training i

the WHAT is enough to achieve uniormity o the perormance o a specic unction.

A strong understanding o WHY a task is perormed will increase the ecacy o the

procedure, compliance with it, and the quality o the work output.

Though these actors should be considered in SOP development, actoring theminto overall SOP access and simpliying the SOPs themselves may dramatically

improve use and compliance through the reduction o clutter superfuous to the

user experience. The rst question a regulator will ask in relation to any nding

is are SOPs being actively used? I they were in use the SOP in question will

perhaps need amendment, but i not, the nding highlights a weakness in the SOP

system itsel and will likely generate urther unwanted investigation.

Sweet songs never last too

long on broken radios.

John Prine


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TOP SOP DEVELOPMENT TIPS

1. Results Orientated: The best SOPs achieve specic results, they orientate tasks

towards results which enable the establishment o measures and benchmarking. AnSOPs ability to achieve results is a direct indicator o its ecacy. This may result

in splitting longer SOPs into measurable tasks.

. Dont create unnecessary rules: The SOP is there to achieve uniormity o the

perormance o a specic unction, not to provide uniormity and stife innovation. Many

courses exist which will tell you how to ormat SOPs and one o the rst questions

asked is does a standardized ormat really increase eectiveness? The answer is,it may or may not depending on the environment within which the SOP is used.

3. SOPs are part o the process: When SOPs are not utilized and explored or process

improvement they may become a bureaucratic burden. When they are utilized

day-to-day they provide scope or continuous improvement.

. SOPs and Training need to be conjoined: You cannot eectively train on SOPsunless the process is already understood. Training on the process includes the why,

or the rationale the SOP probably lacks and develops a greater understanding o the

SOP while providing a compliant backbone or uniormity o perormance. We

understand that each individual should be qualied by education, training, and

experience to perorm his or her respective task(s), and that this involves more than

reading and ollowing SOPs. SOPs and training can be viewed together as two parts

o a whole, though the proportion that each part plays can vary.


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5. Balance SOP and Training:A careul balance o proportions.

More detail may be necessary in an SOP when:

The process is not well understood regardless o 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 inrequently used.

And more in the training when:

The WHY is critical to ully 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 identication o the SOP to be accessed.

. Flowcharts may aid understanding: Visual thinking may help in the rationalizationo 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 i 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 o 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. or CQA, Alexion Pharmaceuticals

Thanks to Denise Romero, Alexion Pharmaceuticals

CQA Training 0006009.

MMIX Alexion Pharmaceuticals

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