White Paper

Writing and Enforcing

Your SOPs for GxP
Compliance Success
By David R. Dills,
Quality & Compliance Advisor
 White Paper

“Say what you do, do what you say, and be able to prove it.”

This paper addresses the fundamentals of writing and enforcing your SOPs
not only for compliance and in accordance with internal company policies and
requirements but certainly ensuring compliance with FDA requirements.

Typical definitions include the “procedures” and processes that you use and
“operate” under that have been “standardized” to ensure they are done the same
way each time. A “clearly written description of how specific tasks are to be done.”
Or, another definition is “detailed written instructions to achieve uniformity of the
performance of a specific function.”

If you are a medical device or pharmaceutical manufacturer, this is no surprise

with FDA because “establish” means to define, to document (in writing or
electronically) and to implement. The goal and emphasis with FDA is simple.

Proof of “Establish”
• Is the firm doing what regulation says?
• Is the firm doing what their procedure says?

There are innumerable examples of FD-483s and Warning Letter cites regarding
procedures (or the lack thereof) that take place within life science manufacturing
facilities throughout the global landscape. Recent observations reflects that
the company failed to establish and maintain procedures for implementing
corrective and preventive action, including requirements for analyzing complaints.
The company also failed to establish and maintain procedures to address
the identification, documentation, evaluation, segregation, disposition and
investigation of nonconforming product.

Company failed to establish procedures for quality audits, as required by 21 CFR.

820.22
For example, your firm does not have any quality audit procedures in place to
assure that the quality system is in compliance with the established quality
system requirements and to determine the effectiveness of the quality system. To
date no audits have taken place.

If you take a commonsense approach and look at what is necessary to maintain

control of your operations, and then add in the extra requirements to ensure
compliance, you will have a well-documented system that can be controlled and
maintained with a minimum of paperwork.

Drafting SOPs that are too restrictive and hard to follow or document is asking
for trouble. At the same time, what is amazing and ironic, is that many companies
have “decent” procedures that are deployed and have been implemented within
their quality management system;
1. First, determine what SOPs are necessary.
2. If possible, have the employee responsible for the SOPs draft them.

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3. Make sure the SOPs are understandable.

4. Make sure the SOPs match the procedure.
5. Keep the SOPs succinct where possible.
6. Train the staff to the SOPs.
7. Audit the SOPs to make sure they are being implemented correctly.
8. When making changes to the document, make sure that it has the correct
revision.
9. Remove all out of date SOPs, including ones in employee desks.
10. If your SOP has written notes, it is not a good SOP.

Plan for Results

Standard operating procedures work best when they are designed to achieve
specific results. Decide what business goals will be achieved through better
management with SOPs and how those goals will be measured. Many benchmarks
exist in the industry to help measure quality and efficiency in specific areas.

Produce First Draft

Select a format for the procedure. If you choose to use simple steps, hierarchical
steps, or the graphic format, first make a detailed list of the steps in the order that
they are done. A simple way to get started is to observe someone performing the
process as it now exists and write down everything that the person does. This list
is now a draft of the procedure.

If the procedure needs to appear as a flowchart, start with the most reasonable
beginning point. Draw the decisions that a worker will need to make and the
actions that follow each decision. Don’t try to be perfect with the first draft,
because it is very likely that you will need to make many revisions.

Conduct Internal Review

Provide each worker who performs the procedure with a copy of the draft SOP.
Ask the workers to review and suggest changes that will make the procedure
easier to understand or more accurate or will improve performance. Assure the
workers that their input is important and will be used. People are much more likely
to accept and use an SOP if they feel a sense of ownership in it.

Another reason to involve the workers is that they are likely to have good ideas.
Highly successful managers actively engage their work teams in a continual quest
to become more efficient, increase cost-effectiveness, and improve quality.

Conduct External Review

Managers increasingly rely on advisers outside their own organizations. The
SOP writing process is an excellent way to tap the expertise of your advisers.
Provide them with a copy of the SOP draft. Ask them to suggest any changes that
will make it clearer and more effective. Revise the procedure as necessary to
incorporate their input.

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Test
For procedures to be effective, they must perform in the workplace. There is only
one way to be absolutely certain that a procedure is well written and performs as
expected. Have someone test the procedure by performing each step exactly as it
is described while the procedure writer watches. Have a person not familiar with
the work follow the procedure. Any steps that cause confusion or hesitation for
the test worker should be revised.

Post
Make a final draft of the procedure and post it in the appropriate locations. The
workplace is one essential location. A master SOP file should be kept in a central
location so workers can review little-used SOPs when necessary. It is essential to
keep SOPs up to date.

Train
One of the last steps in the SOP writing process is often the most neglected.
Train or retrain everyone as necessary to follow the procedure exactly. Even with
very detailed steps, it is necessary to train all workers. Otherwise, individuals will
interpret the meaning of procedures in different ways, leading to inconsistency in
work routines and performance.

An effective SOP training program first will make the worker aware of what
training activities will take place and what the trainee will be able to do when
training is complete. The trainer will explain and demonstrate both why and how
each step in the SOP is performed and then gives the learner a chance to practice.

The trainer will provide positive feedback as the learner masters parts of the
procedure and patiently revisits those parts that need improvement.

Audit
An audit will show whether the procedure is being adhered to and whether the
objectives are being met. It can also help identify areas where improvements can
be made.

Each SOP should be audited about three months after implementation and
thereafter at least annually but this is discretionary and determined by the
company and also based on your compliance history. This varies for obvious
reasons. In addition, the SOP should be audited when dispensing errors or “near
misses” occur, to identify ways of preventing their recurrence.

Developing and using operating procedures is a way of life. Well-written,

organized, and controlled procedures can help ease internal confusion, avoid
product liability actions, and reduce recalls. Think of your customers, patients and
end-users. What if something occurs that results in a serious injury or adverse
health consequence (or worse)? What if it occurs because a procedure was not
followed? Mitigate your compliance and legal exposure by following and enforcing
all policies and procedures.

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It is important to have a defined and deployed system to manage process and

documentation changes and assisting in maintaining control within both the
quality system and the organization as a whole. Therefore, firms must “establish
and maintain” procedures. To do so, companies should define, document (either on
paper or electronically), and implement standard operating procedures (SOPs).

Companies must then follow up, review, and revise these documents as needed.
The intent here is simple: Companies must ensure that their organization develops
and manages operationally sound procedures that are compliant with the law, i.e.,
FDA and with other enforcement bodies as necessary. Furthermore, how about
complying with your company’s corporate policies as set forth by the executive
management group?

During past and certainly recent FDA inspections, the agency commonly observed
that companies failed to keep accurate records and that they neglected to
establish and maintain procedures. This is a recurring theme based on indicators.

SOPs (and the method by which process change is managed) serve as a

fundamental means of communication for all levels of the organization. Not only
do they involve employees departmentally, but they also allow management and
employees to gain a cross-functional view of the organization.

This approach encourages employees to think about how process change may
affect other functional areas. A good change-control system forces managers
to think through processes and examine how changes might affect product,
personnel, production, and equipment.

Procedures provide an opportunity to clarify processes to ensure that personnel

understand the procedure and are trained appropriately. Having well-organized
and detail-oriented documentation ensures consistency on execution, which is
especially important when more than one person is responsible for executing a
process.

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All companies experience change, especially in personnel. Employees leave and

are replaced. Business processes and strategies evolve. However, documentation
can remain a stable tool as long as employees are taught to use consistent rules
when developing and modifying company documentation. Writing procedures and
subsequently maintaining them removes ambiguity from interpretation and helps
clarify the story of a document for future reviewers.

One of the most common mistakes that regulated entities make when writing
procedures is copying the regulation word for word, resulting in a procedure that
does not provide employees any instruction or tools for performing tasks.

Procedures should be made up of several sections, which at a minimum can

include purpose, scope, definitions, background, associated and reference
documents, responsibilities, revision history, and the actual steps of the procedure.

Procedures should begin with a purpose section, which defines what the
procedure is going to describe (process, assembly, etc.). The purpose can
additionally define the requirements being met by the particular procedure.

The scope of the procedure should describe to whom or to what the procedure
applies. The scope of a document can be specific so that it includes only a subset
of the employee population or process, or it can be general and include the entire
organization, location, or process.

A definition section is typically considered optional; however, it can be helpful

with complex or technical documentation. Definitions are exactly as you would
expect them to be: a dictionary or glossary of terms that are mentioned within the
procedure. The background section, also considered optional, is a good place to
tie in the quality and regulatory reasons or associations for the existence of the
procedure.

The responsibilities section of the procedure defines who is responsible for

the execution of the process both directly and indirectly. There can be several
responsible parties associated with one procedure.

Both individuals (e.g., training coordinator) and groups of people (e.g.,

management, the quality assurance department) can be responsible for a
procedure. Do not call out specific employee names. It is better to address the
responsible job title or function (e.g., document administrator).

Revision history allows an organization to review earlier versions of a procedure.

The organization can also revisit methods and programs previously employed.
Such tools enable firms to avoid duplicating mistakes or having to recreate
processes.

Avoiding duplication and limiting the number of mistakes an organization makes

can ultimately save money and time and reduce employee frustration. When

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developing the procedure section, describe how to execute the process in the
same order that the tasks are performed.

Using flowcharts is a great way to explain process direction and is acceptable for
communicating internal processes. Flowcharts should be used in conjunction with
a textual description. The procedure section should give instructions for correctly
completing (i.e., filling in blanks) the supporting forms and reference attachments.
Include sufficient detail to ensure consistent execution of the task.

Developing SOP Skills

Writing and developing solid operational procedures is a skill that develops
over time. Procedures are usually fairly technical and often describe complex
subjects. These procedures are reviewed by subject-matter experts, as well as by
internal and external auditors and by employees at all levels of the organization.
Therefore, it is important to consider the language used when communicating an
idea.

Terms like must, shall, and will indicate steps within a procedure that must be
adhered to exactly with each execution. Avoid words that cause ambiguity. Words
such as periodically, generally, may, should, and can typically indicate a preference
and do not enforce consistent execution.

Conversely, document format and organization of your procedures and forms

can lead to ease of use in the maintenance of records, which results in greater
accuracy. Procedures should always follow a predetermined format. Encourage
employees to use templates by making them available and easily accessible.

Nonetheless, in order to have a robust and healthy SOP system, several key
elements are involved in creating a document change control system. A good
system ensures that the correct people review and approve documents (approvals
should be defined by document category and level of personnel, as well as being
cross-functional and departmental).

It also ensures that change occurs when needed, and not on a periodic basis
(unless required procedurally or driven through other standards). Control of
distribution and retrieval ensures that only the current, approved versions of
documents are available for use.

“It can’t be so detailed that if you make any process changes at all, you’re
completely out of compliance.”
Another way companies write themselves out of compliance is by not having the
resources to implement an SOP. “I often find companies don’t focus on resources,”
adding that part of the drafting and approval process is to ensure the necessary
resources are available. Not following existing SOPs may be viewed as worse than
not having written SOPs.

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Therefore, your benefits should be quite apparent.

Benefits:
• Compliance
• Consistency
• Continuity
• Quality Assurance
• Responsibility
• Control
• Confidence
• Empowerment –Personnel

Ten Reasons to Have SOPs

1. Because they help people to focus on specific activities that lead toward goal
achievement.
2. Because they improve communication and teamwork among workers,
management, and advisors.
3. Perpetuation of “best practices.”
4. Because variation can be very costly.
5. Because you can’t make changes until you have control of the system.
6. Because training is much easier with SOPs than without.
7. Because it’s tough to give good feedback when it’s not clear what you want.
8. Because many workers today have previous (differing) experience from past
employers.
9. Because many workers today don’t have previous experience.
10. Because they help temporary workers and contractors to do the job right.

Ten Reasons for Not Having SOPs

1. The “Blame Game”
2. Too much time
3. Too much trouble
4. We can’t agree
5. No accountability
6. Creativity is more fun
7. My way is best
8. We can all have our own special processes
9. More flexibility in performance reviews
10. If you have them, you have to follow them

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How Much Detail

• The minimal amount of detail should include:
• Critical “what’s”
• Critical “how’s”
• The “who’s” if more than one person is involved. Remember, not all SOPs in an
organization need the same level of detail.

Does your procedure involve many decisions and steps? This chart will help
determine a suitable and ideal format.

Many Decisions? More Than 10 Steps? Best SOP Format

NO NO Simple Steps.

NO YES Hierarchial

YES NO Flowchart

YES NO Flowchart

How do you Handle Overcoming Resistance

• “We’ve done it just fine the way we’ve always done it before!”
• “This is no benefit to me, just extra work!”
• “The boss wants to micro-manage everything we do.”

Problems:
• Fear of change
• WIIFM (What’s In It For Me)
• Lack of empowerment.

Solutions:
• Explain need for change and listen to concerns. Communication!
• Share mission and values of the business. Explain how improvement benefits
everyone.
• Encourage people to take an active role in shaping change and improving quality.
• FDA/LAW and Injury/Death Associated with Product SOPs must be a true
reflection of what is actually being done. If not, change the process or change

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the SOP. Often the failure of an SOP or a collection of SOPs originates from the
technical shortcomings of the SOPs and the following depressing list shows
why staff might resist using SOPs:

• The required SOP is difficult to locate in the total collection of SOPs

• The SOP is written in foreign language
• The SOP is written in language difficult to follow
• Instructions and general information are mixed
• The procedure is described in an unfamiliar way
• The user knows another (better) method, or can do the procedure in ‘his/her
sleep’

Most companies have a wide variety of SOPs that describe how to do different
tasks. In many companies technicians and operators are trained in how to follow
individual SOPs and their training record specifies which SOPs they are trained on
and are authorized to use.

There is no federally approved format for a SOP but there are expectations within
the industry, i.e., FDA regulated industry, on how a SOP should be written.

Therefore, the SOP is written in imperative sentences rather than a narrative

style. A cookbook format is used and sentences should start with a task specific
verb that tells what to do. The instructions are numbered in the order that
they will be followed. Writing detailed procedures and developing document
management systems seem tedious and, for many, are not core competencies.

Procedures are the cornerstone of a strong quality system; they provide

infrastructure and are the backbone of Quality Management System. Inspectors
will audit processes against approved procedures. The development and use of
SOPs are an integral part of a successful quality system. They provide information
to perform a job properly and correctly, and consistently in order to achieve a pre-
determined specification and quality end-result.

Creating appropriate procedures eliminates the need for interpretation by

employees and ensures that procedures are being followed as intended. They
allow for consistency of business process execution, thus limiting inspectional
findings, product liability, and recalls. Manufacturers should use good judgment
when developing their quality system and apply those sections of the QS
regulation or even 21 CFR 210/211 that are applicable to their specific products
and operations.

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Same rationale applies to how you develop, execute and enforce your SOPs.
In most cases, it is left to the manufacturer to determine the best methods to
attain quality objectives. In most cases, it is left to the manufacturer to determine
the best methods to attain quality objectives. In some cases, however, the
QS regulation does specify the particular type of method to be used, such as
written procedures or written instructions. This does not mean, however, that
manufacturers cannot vary from the method specified if the intent of the GMP
requirement can be met by another method.

In summary, both developing procedures and controlling them force managers

and management in general to think about how change might affect production,
materials, supplier, equipment, and validation, and certainly the patient and
end-user. MasterControl produces software solutions that enable regulated
companies to get their products to market faster, while reducing overall costs
and increasing internal efficiency. The solutions securely manage your company’s
critical information and the documentation process throughout the entire product
lifecycle.

About the Author

David R. Dills, Quality & Compliance Advisor
David R. Dills is a Quality & Compliance Advisor at MasterControl and an
independent Regulatory & Compliance Consultant with an accomplished record.
Dills has more than 22 years of hands-on experience with emphasis on Class I/II/
III medical devices, In Vitro diagnostics, and pharmaceuticals in the areas of QA,
Regulatory Affairs and Compliance. Since 2000, Dills has provided consultative
services on behalf of manufacturers, has subcontracted by third-party
consultancies and has provided services involving all key stages of the product
development, submissions, commercialization process, inspection readiness
preparation, GxP compliance, audits/assessments, remediation/regulatory
strategies, postmarketing surveillance and vigilance reporting, clinical affairs,
deployment and remediation, Quality Management, documentation systems,
software validation, ISO 13485, CE Mark, and multi-country product registrations.
He has been previously employed by medical device firms and consultancies,
including a globally recognized CRO.

Dills manages quality, regulatory, and compliance projects with multiple

competing priorities that have various direct impacts on site operations and/or
commercial opportunities. Dills develops strategies for governmental approval
to introduce new products to market, provides guidance/direction on regulatory
requirements and constructs/reviews submissions (e.g, 510(k), PMA, NDA),
including dossiers and technical files, and registrations for the Pacific Rim, the
Americas and EU. Dills is also responsible for establishing and remediating QMS
systems with emphasis on preventing the design, manufacture and shipment of
defective products.

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Dills manages QS and regulatory problems (e.g, AEs, MDRs, enforcement,

investigations and complaints) related to development, manufacturing,
commercialization, and in addition, recommends action(s) to senior leadership
to ensure effective resolution for manufacturers to achieve sustainable and
best-practice compliant systems. Dills’ background encompasses broad
capabilities in quality systems, GxPs, RA, and interfaces with FDA and other
governmental agencies on the global regulatory landscape, MDD/IVDD Directives,
ISO 14971/13485, and demonstrates credible experience to optimize business
performance through proactive strategies to mitigate compliance exposure. Dills
also develops strategies for manufacturers by providing strategic and tactical
solutions that facilitate the achievement of regulatory and quality milestones and
on minimizing delays due to noncompliance.

Dills has served on the Faculty Advisory Board for the Pharmaceutical Training
Institute and currently serves on the Editorial Advisory Boards for Software
Quality Professional and the Institute of Validation Technology (IVT), publisher
of the Journal of GXP Compliance and Journal of Validation Technology and on
the Readers’ Board for Medical Device & Diagnostic Industry and Medical
Product Manufacturing News and was accepted for inclusion into the 2005-
2006 Strathmore’s “Who’s Who” of Professionals. Dills has published validation,
regulatory and compliance-related articles and is an accomplished global
industry presenter. Mr. Dills’ academic degrees include studies in Environmental
Science and Biology. He is a former Chair and Co-Chair of ASQ’s Section 1506 and
an active member of the Biomedical Division, RAPS, PDA, ISPE, and other industry
working groups.

About MasterControl
MasterControl Inc. creates software solutions that enable life science
and other regulated companies to deliver life-improving products to more
people sooner. MasterControl’s integrated solutions accelerate ROI and
increase efficiencies by automating and securely managing critical business
processes throughout the entire product lifecycle. More than 1,000 companies
worldwide, ranging in size from five employees to tens of thousands, rely
on MasterControl cloud solutions to automate processes for new product
development, clinical, regulatory, quality management, supplier management,
manufacturing and postmarket surveillance. MasterControl solutions are well-
known for being scalable, easy to implement, easy to validate and easy to use.
For more information, visit www.mastercontrol.com.

© 2019 MasterControl Inc. All rights reserved.

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