Mc w Sop Management

8/11/2019 Mc w Sop Management

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COMPLIANCE ACCELERATED

White Paper:SOP Management as aCompliance Tool in FDA andISO Environments

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White PaperCOMPLIANCE ACCELERATED

OP Management as a Compliance Tool

Introduction

From manufacturers to hospitals to the military, most organizations need standard operating procedures (SOPs) for

a variety of reasons. An SOP may be as simple as a description of how to sanitize milk pails in a dairy factory, or as

complex as the process of chemical isolation and purication of an active pharmaceutical ingredient in a chemicalmanufacturing company.

An SOP describes a procedure and tells an operator how to perform it. SOPs are helpful in most workplace settings,

but they are especially critical for organizations with process-oriented operations, such as life sciences and other

manufacturing companies. SOPs, in conjunction with personnel training, help relay knowledge from one department to

another. In a medical device rm, for example, R&D scientists pass their knowledge about a product they innovated to the

manufacturing department through SOPs.

Manufacturers with global operations also rely on SOPs to standardize processes in all of their facilities. For example, a

Japanese automotive company will train its personnel in the United States on key manufacturing processes and then use

SOPs to make sure that high quality is reected in every car sold by the company regardless of where it was assembled.

There are many other reasons why organizations use SOPs, including:

To ensure consistent, repeatable processes;

To facilitate training by giving trainees a point of reference;

To facilitate cross-training of employees on tasks they dont normally perform, such as when they need to

substitute vacationing or sick co-workers.

To reduce safety risks and other hazards by specifying how to avoid and prevent them;

To have a basis for evaluation and improvement of processes; and

To comply with regulations and/or quality standards.

Regulations and Standards

The last reason compliance with regulations and quality standards is a key factor that drives many organizations to

establish and maintain SOPs. In FDA and ISO environments, the concept of quality is made tangible by the information

and processes captured in SOPs, and proper implementation of those SOPs helps ensure quality.

FDAs Current Good Manufacturing Practice (CGMP) regulations for nished pharmaceuticals (21 CFR Parts 210-211)

require written procedures for production and process control to ensure that products have the identity, strength, quality,and purity they purport to possess (Section 211.100). These written procedures, including any changes, must be reviewed

and approved by the quality control unit.

CGMP regulations for blood and blood components (21 CFR 606) state that written operating procedures shall be

maintained and shall include all steps to be followed in the collection, processing, compatibility testing, storage, and

distribution of blood and blood components for transfusion and further manufacturing purposes (Section 606.100b).

The Quality System Regulation (21 CFR Part 820) for medical devices similarly requires SOPs and documented

instructions that dene and control the manner of production (Section 820.70).


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Manufacturers and other organizations that adhere to quality standards developed by the International Organization for

Standardization (ISO) face similar requirements.

MasterControls suite automates, and effectively integrates SOP management with change control, training control,

audits, corrective/preventive action (CAPA), and customer complaint processes, under a single Web-based platform.

ISO 9001:2008 and ISO 13485:2003, widely used throughout the world, require companies to document their procedures

describe how those processes interact, and develop documents for implementation of the quality system. Compliance with

ISO standards is voluntary, although certain countries require ISO certication and many customers prefer vendors and

suppliers that are ISO-certied.

Types of SOPs

SOP formats are as varied as business operations. An SOP may come in the form of a checklist, or a linear ow chart (or

some other type of owchart), or hierarchical steps, or annotated photos.

Neither the FDA nor ISO require any specic SOP formats. In general, however, SOPs in regulated environments are

expected to be consistent and traceable. They should provide document identication and facilitate control.

To be effective, an SOP should include company name, a descriptive SOP title, identication and control numbers,

purpose, scope, responsibilities involved (specic tasks, whos performing what, certication and qualication

requirements, etc.), and step-by-step procedure. Depending on the nature of the process being described, the SOP may

include calculations for data handling.


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SOPs are usually categorized by procedure type, such as design, manufacturing, quality assurance, etc. Categories help

determine the right format for each SOP and also facilitate appropriate review and approval for the document.

For example, the maintenance department of a dairy factory may need a simple checklist of materials needed for cleaningmilk pails, but the manufacturing department of a chemical company that produces active pharmaceutical ingredients may

require a combination of hierarchical steps and a linear owchart for its SOPs. A document categorized as maintenance

SOP for cleaning milk pails clearly does not need to be routed to the legal department. But an SOP identifying hazardous

materials throughout the facility may very well need to go to the legal department or regulatory affairs for review because

it may have some impact on compliance with Environmental Protection Agency regulations.

SOP Management: Challenges

Despite the much ballyhooed information age and computer revolution, most companies continue to rely on paper-

based processes. Typically, SOPs are created using Microsoft Word, printed out, and stored in three-ring binders.

The binders are then routed physically from one approver to the next. Once approved, the contents of the binder are

photocopied so every affected department will have one binder handy.

For a small organization, this process may be just ne. But for most companies, a manual system poses many challenges,

including:

Inefciency The process of routing, reviewing, and approving an SOP can be slow and inefcient. This is

especially true if an organization generates hundreds or thousands of SOPs and the people who need to review and

approve them are in different locations or out of the ofce. It is likely that SOPs may get lost while being routed,

either buried in someones messy desk or computer in box (if routed via e-mail). Search and retrieval of SOPs

would entail sorting through voluminous paper work. Updating SOPs would be equally slow. In addition to going

through the same routing and approval process during revision, obsolete paper documents must be disposed of.

Poor Communication In a manual system, quality processes are not connected, making it hard for people who

operate those processes to communicate. To speed up the approval of an SOP, the originator needs to make phone

calls, send e-mail messages, or remind approvers in person and thats just one SOP. Multiply the number of

phone, e-mail, and personal reminders a dozen times for an employee responsible for a dozen SOPs. In a fast-

paced organization (i.e., a company with 24/7 operations in multiple facilities all over the world), SOPs are likely

to change constantly, but people affected by the changes may not be notied in a timely manner.

Lack of Training Its bad enough that employees are not notied about new (or newly revised) SOPs in a

timely manner, but its worse when they dont get the appropriate training on the new SOPs. This failure to keep

up with training on new SOPs is inherent in a manual system thats not connected to the training control process.

So, employees may be using new SOPs but they may be doing it poorly without the appropriate training.

Ineffective Documentation Effective implementation of SOPs has a direct impact on product quality, and that

is why its critical for organizations to capture accurate and up-to-date information in SOPs. But it takes a lot

of time and effort to manually update SOPs, so employees may sit on updates, jeopardizing conformance. It is

equally difcult to rely on employees to always remember to document any changes in an SOP, including who

made the change, why, and when.

Poor Revision Control Companies that rely on a manual system often complain that it is difcult to get rid

of obsolete documents. Even after SOPs have been revised and approved, old documents may resurface on the

shop oor. Another problem is that employees may use documents that have not been approved simply because

they are able to grab that binder sitting on someones desk. In both cases, using uncontrolled SOPs could lead to

nonconformance.


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Poor Collaboration Creating and updating SOPs usually require collaboration. For organizations that

use manual processes, collaboration would entail face-to-face meetings and passing around a document that

employees take turns editing. This manual process works when there are few collaborators who are based in the

same facility and whose schedules are similar. But collaboration among employees with varied schedules andresponsibilities and who are based in different facilities will be practically impossible.

Lack of Visibility Paper-based processes are not connected, making it difcult for management to monitor

the effectiveness of SOPs and make timely decisions. For example, if the customer complaint process is

not connected to either corrective/preventive action (CAPA) or change control, it may take a while before

management realizes that a certain complaint should have been escalated to CAPA and should have resulted in a

change in a manufacturing SOP, perhaps preventing a product recall.

MasterControl Solution

The MasterControl quality management suite consists of congurable, easy-to-use, and integrated applications for

automating, streamlining, and effectively managing SOPs and other documents, change control, training control, audits,

corrective/preventive action (CAPA), customer complaints, and other forms-based quality and business processes under a

single Web-based platform.

Hundreds of companies worldwide use MasterControl to facilitate compliance with FDA regulations and ISO quality

standards. Heres how MasterControl can address the challenges discussed earlier.

Efcient System MasterControl automates routing, delivery, and storage of SOPs, greatly increasing the

efciency of SOP management. The system provides a secure, centralized repository that makes search and

retrieval easy. SOPs will not get lost because the system can track every documents exact location.

Effective Communication With MasterControl, follow-up is automatic. The system will continue to send

notications until the person acts on an SOP. It incorporates escalation, so if the person is unavailable for a periodof time, the SOP will move to the next person authorized to approve it. A Web-based platform allows even off-

site or traveling employees to participate in the review and approval process through the Internet. Even suppliers,

consultants, and other third parties may be given limited access to the system so they can be immediately notied

upon approval of changes to SOPs that affect them. As an alternative, external links can be created to make

selected documents and processes available without giving them system access.

Integrated Training By integrating training control with SOP management and other quality processes, all

employees affected by new or revised SOPs will be automatically sent training tasks. MasterControl automates

assignment, monitoring, and verication of training tasks. The system also automates grading of online exams. It

allows implementation of a progressive training program by sequencing training courses. Once a prerequisite is

completed, the next course is automatically launched.

Effective Documentation MasterControl makes it easier to keep SOPs accurate and current. To update or

revise documents, there is only one place to make a change because all SOPs will be stored in a centralized,

Web-based repository that can be accessed by authorized users from virtually anywhere. There is no need for

employees to remember to document changes because the system provides a time-stamped audit trail that captures

the identity of anyone who creates, views, or changes an electronic record, when the action occurred, and the

changes made. Along with the stamp, users are asked to enter a reason for every change.

Automatic Revision Control Employees will no longer use uncontrolled SOPs because only approved

documents will be released and made available to them. Obsolete SOPs will not re-surface. With MasterControl,

when an SOP is revised, the original version is automatically archived upon approval and release of the revision.


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Also, setting an expiration date will make an SOP obsolete on that date and it will automatically be archived.

Automatic revision control will ensure that when an SOP is being revised, it will not be available for check out

until approval of the revision.

Improved Collaboration A virtual collaboration workspace allows individuals to participate at their

convenience. They can review, comment on, revise, or approve an SOP without having to be physically present

with the rest of the team. Redlines will be visible to all team members so there wont be duplication of efforts.

A Web-based platform allows even off-site or traveling employees to collaborate.

Increased Visibility MasterControl makes the entire quality system visible by integrating different processes

and connecting different departments. Management will be able to monitor the effectiveness of SOPs in a

single, integrated system better than in separate processes. For example, a serious customer complaint will be

automatically escalated to CAPA, which in turn will trigger a change in all relevant SOPs. Advanced analytics

and reporting capability will also help management get a real-time view of the quality system to continuously

improve it.

Conclusion

For FDA-regulated and ISO-certied companies, SOPs are more than just a tool of operation. SOPs directly affect product

quality, and therefore, compliance. Development of effective SOPs and implementing them properly require commitment

from the entire organization. Choosing the right software solution that will facilitate and improve SOP management

should be a part of this commitment. Once established, an efcient and effective SOP management system will serve as a

foundation for an organizations sustainable compliance and long-term success in the market.

Related Videos

Why companies Choose MasterControl

Using MasterControl for FDA Compliance

Using MasterControl for ISO Compliance

About MasterControl Inc.

MasterControl produces software solutions that enable regulated companies to get their products to market faster,

while reducing overall costs and increasing internal efciency. MasterControl securely manages a companys critical

information throughout the entire product lifecycle. Our software is known for being easy to implement, easy to validate

and easy to use. MasterControl QMS and QEM solutions include quality management, document management/documentcontrol,product lifecycle management, audit management, training management,bill of materials, supplier management,

submissions management, and more. Supported by a comprehensive array of services based on industry best practices,

MasterControl provides our customers with a complete information management solution across the entire enterprise. For

more information about MasterControl, visit www.mastercontrol.com, or call: 1.800.825.9117 (U.S.);

+44 (0) 1256 325 949 (Europe); or +81 (3) 5422 6665 (Japan).

2012 MasterControl Inc. All rights reserved.

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