SOP record keeping includes one-time activities and recurring activities. The major record keeping burden of SOPs results from the one-time activity of creating them¹. Most efforts to improve this focus on document routing times or converting from paper to electronic document management. However, a significant portion of SOP record keeping costs continues to result from the inefficient use of labor during their creation.

Once an organization has identified and agreed to create a necessary SOP, the creation process generally consists of seven steps. These are:

1. Initiating the document control process.
2. Researching and drafting content.
3. Formatting content.
4. Routing the draft document for review.
5. Revising the draft based on reviewer comments.
6. Routing the revised document for approval.
7. Closing out the document control process.

The chart below shows the percentage of effort required during each step of creating a typical SOP.

SOP Creation Process
Step	Description	%
1	Initiating document control process	3
2	Research & draft content	45
3	Format content (fonts, images, tables, etc)	15
4	Route draft document for review	20
5	Revise draft based on reviewer comments	10
6	Route revised document for approval	5
7	Closeout document control process	3

Real costs

The amount of labor spent during the creation of a SOP directly affects the cost. The real cost of creating SOPs depends on several variables:

• Work hours per SOP
• Cost per work hour
• Pages per SOP
• Total number of SOPs

Let's look at these in detail:

Hours per SOP: According to Executive Order 12866¹, the FDA must examine the economic implications of proposed changes to 21CFR. A figure often cited by the FDA in the Federal Register is that each SOP requires 20 hours to create ¹. The table below represents the work hours spent on each step of the SOP creation process.

Cost per Hour: A typical employee pay rate for FDA-regulated industries is $20.00 per hour², not including benefits. Assuming benefits and other operating overheads are roughly equal to the hourly pay rate³, employee-written SOPs cost $40.00 per hour to create. Involving high-level employees (Directors, VPs, etc) or consultants can easily double the cost per hour. Given these cost per hour estimates, a single SOP costs between $800 and $1600 to create.

Pages per SOP: An evaluation of 260 SOPs from various FDA-regulated organizations resulted in a total count of 1,541 pages, a calculated average of 6 pages per SOP, and a range of 2 to 40 pages per SOP ³. Based on the calculate average of 6 pages per SOP, each page requires 3 and 1/3 hours of labor and $133 to $266 to create.

Total Number of SOPs: A survey of seven pharmaceutical organizations found that the average number of SOPs per organization is 1250, with a range of 500 to 1810⁴. Based on the average SOP count of 1250 and the FDA’s estimate of 20 work hours per SOP, each of these organizations has a SOP creation investment of 25,000 work hours, equaling $1,000,000 to $2,000,000.

Recreating content - unnecessarily

More than a third of GxP document content is used repeatedly. Yet authors in most organizations re-create it for every document. When authors re-create content that already exists, their unnecessary effort increases labor costs and produces inconsistencies that decrease accuracy and reader comprehension.

GxP DOCUMENT COMPOSITION BY PARAGRAPH

An analysis of 700+ documents from a medical device company found that less than 50% of paragraphs were identified as totally unique. Of the remaining paragraphs, base paragraphs (15%) were recorded as content appearing for the first time, but found elsewhere in the documents either as exact matches (9%), or in some close variation (28%)⁵.

Reusing content

Reusing and harmonizing content makes creating SOPs far more efficient. Costs are reduced and document quality is improved. Content reuse involves taking content from one document and using it in other documents. The scale of content reuse ranges from reusing single sentences to reusing entire documents, such as those supplied by equipment & instrument manufacturers. Content harmonization involves identifying content that is shared between multiple documents and removing any inconsistencies caused by authors “recreating” the content for each document. Whether they are used together or separately, content reuse and content harmonization streamline the SOP creation process.

A streamlined SOP creation process delivers tangible benefits, including:

• Labor optimization
• Cost reduction
• Improvement in document quality
• Improvement in 21CFR compliance

Let's go over these in more depth:

Optimize Labor: With content reuse, there is no duplication of creative effort--everything made for one document can be used in others. This very efficient process allows people to spend less time on unnecessary activities and more time on contributing to better quality systems.

Savings With Content Reuse

This chart represents the savings content and document reuse can achieve compared to not employing reuse. The result is a 30% reduction in labor needed to create SOPs with content reuse, and a 45% reduction with document reuse.

Reduce costs: Content reuse lowers costs by reducing the labor needed to create SOPs. A six page SOP that requires 20 work hours to create from scratch can take as few as 14 hours when existing content is reused, or 11 hours when entire documents are reused. This labor reduction directly translates into a cost savings of $240 to $320 per SOP. In terms of an entire SOP library, a $1,000,000 creation investment can be reduced by $300,000 to $450,000.

Improve document quality: Harmonization improves document quality by removing inconsistencies in repeatedly used content. The removal of inconsistencies not only resolves potential conflicts of fact between different versions, it improves reader comprehension by helping readers overcome the physical and mental limitations of reading and comprehending text⁶.

Reading Comprehension And Optical Processing

When reading, the human eye looks for patterns in text. Variations in text patterns tell the brain, “this is new information,” even if the information has already been learned. The brain must then develop multiple eye-recognition patterns for the same information. Reducing unnecessary eye-recognition patterns caused by inconsistent content makes brain resources available for higher-order comprehension⁷.

Improve 21CFR Compliance: The FDA’s systems inspection approach places a premium on consistency of operations and policies⁸. The practices of reuse and harmonization are totally in keeping with this approach. They reduce inconsistency and enable rapid response to changing conditions in the operating and regulatory environment.

Getting Started

Content reuse and harmonization have the potential to completely transform the traditional SOP creation process. What's more, for many organizations, receiving the benefits can begin today by implementing some relatively simple solutions. These are:

• Know the process
• Purchase documents
• Reuse existing content
• Harmonize reusable content

Let's look at these more closely:

Know the Process: Each organization seeking to improve a process must first understand what is happening in that process. Answering the following questions can help you establish a performance baseline for the SOP creation process:

• What are the labor-intensive activities in the creation of SOPs?
• How many hours of labor does each activity require?
• What is the approximate hourly wage of each person involved in those activities?
• What is the approximate hourly operating overhead for the organization?
• How many SOPs does the organization have?
• What is the page count for each SOP? Average? Range?

Once you've answered these questions, the formulas in the table below can help you calculate the costs of the SOP creation process. In addition to the budgeting and planning benefits for individual organizations, record keeping metrics are crucial to regulatory decision-making and can be submitted to FDA during the response period of each proposed rule.

Purchase Documents: Perhaps the quickest, most effective way to significantly reduce the labor of creating SOPs is to purchase them in a pre-written format. Purchasing pre-written GxP documents can all but eliminate the drafting step, nearly cutting in half the labor needed to create a new SOP.

There are a number of sources that can provide SOPs, as well as other GxP documents, including:

• Manufacturers of Instruments & Equipment
• Software Developers
• GxP Document Publishers

Reuse Existing Content: The existing SOPs in an organization’s document library are a prime source of reusable content. Reusable content consists of text, images, tables, and other content, collectively known as content objects. A number of content reuse methods are available.

Copy-and-Paste: The simplest way to reuse content is by copying content from existing SOPs and pasting it into new SOPs during the drafting stage. While the success of this method depends on each author’s knowledge of the existing documents, copy-and-paste is an important first step toward content reuse.

Single Source Document: An advanced version of the copy-and-paste method is to copy reusable content from your existing SOPs and paste it into a master list of content, known as a single source document. Whenever a new SOP is being drafted, the author can find and retrieve reusable content from the single source document instead of having to go to each SOP individually.

Advanced Templates: Another way to reuse content is to develop advanced document templates. Traditionally, FDA-regulated organizations have SOP templates that define a high-level outline of SOP sections (Scope, Purpose, Responsibilities, etc). Instead of simply having an outline, providing additional content that incorporates variable text fields will improve the SOP creation process.

Example Of Templatized Purpose Statement

This SOP describes the <description of use> of the <manufacturer name> <equipment name>,<equipment model #>.

This is an example of a templatized purpose statement for equipment SOPs. The same can be done for any repeatedly-used content object. Organizations may also find it useful to develop separate templates for each type of SOP, such as Calibration, Operation & Maintenance, Software Administration, and Laboratory Methods.

Single Source Content Database: The most advanced way to reuse content involves a single source content database (SSCD) in which all content is stored as content objects that can be reused in many documents without being recreated. This is similar to the single source document method; however, SSCDs provide additional functionality:

• Import existing documents & content
• Advanced content indexing & searching
• Electronic Records & Electronic Signature compliance
• Version control of content objects and/or whole documents
• Automatic translation (localization)
• Output to many different formats (HTML, Word, Help Files, PDF, etc)

SSCDs should not be confused with electronic document management (EDM) systems, which are primarily used to control whole documents after they are created. SSCDs can supplement or completely replace EDM systems, providing a complete environment for creating, approving, and publishing GxP documents to multiple output formats.

Harmonize Reusable Content: Harmonizing reusable content involves identifying repeatedly-used content, which are categorized as exact matches or near duplicates, and removing the inconsistencies between each variation. This can be accomplished through a well-coordinated manual effort or through the use of software designed specifically for text analysis.

Overcoming the challenges

The challenges of creating SOPs for compliance with 21CFR can be overcome through the practices of content reuse and harmonization. The benefits of these practices include cost reduction and labor optimization, as well as improvements in quality and regulatory compliance. While the full use of these practices will dramatically change the SOP creation from its traditional form, an “incremental steps” approach will ensure a smooth transition for most organizations.

About Chris Whalley

Chris Whalley (chris@doxpub.com) is the publisher and CEO of Doxpub, a digital publishing company based in Seattle, Washington. Whalley has extensive experience in the regulatory compliance, information systems and start-up operations of biotechnology and medical device organizations. He has implemented and supported large-scale electronic document management systems, and participated in the creation, review and approval of hundreds of laboratory, clinical and manufacturing documents.

Learn more about Doxpub at: www.doxpub.com

References:

1. Federal Register (Volume 67, Number 26)
2. Federal Register (Volume 58, Number 190)
3. Federal Register (Volume 69, Number 134)
4. BLS Occupational Outlook, 2004-2005
5. Federal Register (Volume 69, Number 134)
6. Doxpub research survey
7. PDA letter to FDA, Feb 22, 1999, Ref: Docket No. 98N 1110
8. Doxpub paragraph analysis
9. Journal of Advance Composition (JAC), 11.1 (1991), “Readable Writing: The Role of Cohesion and Redundancy,” Alice Horning.
10. Cooke A, Zurif EB, DeVita C, Alsop D, Koenig P, Detre J, Gee J, Pinãngo M, Balogh J, Grossman M. (2001). Neural Basis for Sentence Comprehension: Grammatical and Short-Term Memory Components. Human Brain Mapping, 15: 80-94.
11. FDANews (2002), “Too Many SOPs May Hurt GMP Compliance Efforts,” M. Anisfeld

1. Federal Register (Volume 69, Number 134)
2. BLS Occupational Outlook, 2004-2005
3. Doxpub research survey
4. PDA letter to FDA, Feb 22, 1999, Ref: Docket No. 98N 1110
5. Doxpub paragraph analysis
6. Journal of Advance Composition (JAC), 11.1 (1991), “Readable Writing: The Role of Cohesion and Redundancy,” Alice HorCooke A, Zurif EB, DeVita C, Alsop D, Koenig P, Detre J, Gee J, Pinãngo M, Balogh J, Grossman M. (2001). Neural Basis for Sentence Comprehension: Grammatical and Short-Term Memory Components. Human Brain Mapping, 15: 80-94.ning.