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Document Sample
The
GMP
Labeling
System TM
Regulatory Compliance Newsletter
Spring 2007
SOPs Relay
In FDA and ISO environments, the concept of
quality is made tangible by the information
and processes captured in SOPs, and correct
implementation helps ensure quality.
Knowledge
By Cindy Fazzi
To facilitate cross-training of employ-
F
rom manufacturers to hospitals to I that “written operating procedures shall
the military, most organizations ees on tasks they do not normally per- be maintained and shall include all steps
need standard operating proce- form, such as when they need to to be followed in the collection, process-
dures (SOPs) for a variety of reasons. An substitute for vacationing or sick co- ing, compatibility testing, storage, and
workers
SOP describes a procedure and tells an distribution of blood and blood compo-
operator how to perform it. SOPs are
I To reduce safety risks and other haz- nents for transfusion and further manu-
ards by specifying how to avoid and
helpful in most workplace settings, but facturing purposes” (Section 606.100b).
prevent them
they are particularly critical for organi- The Quality System Regulation (21
I To have a basis for evaluation and
zations with process-oriented opera- CFR Part 820) for medical devices sim-
improvement of processes
tions, such as life sciences and other ilarly requires SOPs and documented in-
manufacturing companies.
I To comply with regulations and
structions that define and control the
quality standards.
SOPs, in conjunction with personnel manner of production (Section 820.70).
training, help relay knowledge from one Regulations and Standards Manufacturers and other organi-
department to another. In a medical de- ¾
The last reason compliance with zations that adhere to quality standards
vice firm, for example, research and de-
v e l o p m e n t s c ie n t is ts pa s s the ir
¾
regulations and quality standards is a developed by the International Organi-
zation for Standardization (ISO) face
key factor that drives many organiza-
knowledge about a product they inno- tions to establish and maintain SOPs. In similar requirements.
vated to the manufacturing department FDA and ISO environments, the concept ISO 9001: 2000 and ISO 13485:
through SOPs. of quality is made tangible by the infor- 2003, widely used throughout the world,
Manufacturers with global operations mation and processes captured in SOPs, require companies to document their
also rely on SOPs to standardize pro- and correct implementation of those procedures, describe how those pro-
cesses in all of their facilities. For exam- SOPs helps ensure quality. cesses interact and develop documents
ple, a Japanese automotive company will FDA’s Current Good Manufacturing for implementation of the quality sys-
train its personnel in the United States on Practice (CGMP) regulations for fin- tem. Compliance with ISO standards is
key manufacturing processes and then ished pharmaceuticals (21 CFR Parts voluntary, although certain countries re-
use SOPs to make sure that high quality 210-211) require written procedures for quire ISO certification and many cus-
is reflected in every car sold by the com- production and process control to ensure tomers prefer vendors and suppliers that
pany, regardless of where it was assem- that products have the identity, strength, are ISO-certified.
bled. quality and purity they purport to possess
There are many other reasons why or- (Section 211.100). These written proce- Types of SOPs
ganizations use SOPs, including: dures, including any changes, must be SOP formats are as varied as business
I To ensure consistent, repeatable reviewed and approved by the quality operations. An SOP may come in the
processes control unit. form of a checklist, a linear flowchart or
I To facilitate training by giving train-
CGMP regulations for blood and some other type of flowchart, hierarchi-
ees a point of reference blood components (21 CFR 606) state cal steps or annotated photos.
We hope this newsletter includes infor- Businesses regulated by the FDA and/or
mation that you can use. Our goal is to pe- are ISO 9000 registered will find GMP
riodically publish articles, written by quality Labeling products helpful in maintaining
Message from professionals, that are timely and informa- compliance. More than 5000 facilities in
tive to the companies in our marketplace.
GMP Labeling Of course, along the way, we also hope to
the U.S., Canada and Europe use GMP
Labeling products on a daily basis.
reinforce our image as a valuable resource
to our customers.
Neither the FDA nor ISO require any Search and retrieval of SOPs entails nected to the training control process.
specific SOP formats. In general, how- sorting through voluminous paper- So, employees may be using new
ever, SOPs in regulated environments work. Updating SOPs is equally slow. SOPs, but they may be doing it poorly
are expected to be consistent and trace- In addition to going through the same without the appropriate training.
routing and approval process during I Ineffective documentation. Effective
able. They should provide document
revision, obsolete paper documents implementation of SOPs has a direct
identification and facilitate control. must be purged. impact on product quality; that is why
To be effective, an SOP should in- I Poor communication. In a manual it is critical for organizations to cap-
clude company name, a descriptive SOP system, quality processes are not con- ture accurate and up-to-date informa-
title, identification and control numbers, nected, making it hard for people who tion in SOPs. But it takes a lot of time
purpose, scope, responsibilities in -
¾
operate those processes to communi- and effort to manually update SOPs,
volved specific tasks, who is perform- cate. To speed up the approval of an so employees may sit on updates,
ing what, certification and qualification SOP, the originator needs to make jeopardizing conformance. It is
¾
requirements and step-by-step proce-
¾
phone calls, send e-mails or remind
approvers in person and that is just
equally difficult to rely on employees
to always remember to document any
dures. Depending on the nature of the
one SOP. Multiply the number of changes in an SOP, including who
process being described, the SOP may made the change, why and when.
phone, e-mail and personal reminders
include calculations for data handling. a dozen times for an employee re- I Poor revision control. Companies
SOPs are usually categorized by pro- sponsible for a dozen SOPs. In a that rely on a manual system often
cedure type, such as design, manufactur- fast-paced organization, SOPs are complain that it is difficult to get rid
ing or quality assurance. Categories help likely to change constantly, but peo- of obsolete documents. Even after
determine the correct format for each ple affected by the changes may not SOPs have been revised and ap-
SOP and also facilitate appropriate re- be notified in a timely manner. proved, old documents may resurface
view and approval for the document. I Lack of training. It is bad enough on the shop floor. Another problem is
that employees are not notified about that employees may use documents
Challenges
new or revised SOPs in a timely man- that have not been approved simply
Despite the much ballyhooed “infor- because they are able to grab that
ner, but it is worse when they do not
mation age” and “computer revolution,” get the appropriate training on the binder sitting on someone’s desk. In
most companies continue to rely on pa- new SOPs. This failure to keep up both cases, using uncontrolled SOPs
per-based processes. Typically, SOPs with training on new SOPs is inherent could lead to nonconformance.
are created using Microsoft Word, in a manual system that is not con-
printed out and stored in three-ring bind-
ers. The binders are then routed physi-
cally from one approver to the next.
After approval, the contents of the binder
are photocopied so every affected de-
partment will have one binder handy.
For a small organization, this process
may be just fine. But for most compa-
nies, a manual system poses many chal-
lenges, including:
I Inefficiency. The process of routing,
reviewing and approving an SOP can
be slow and inefficient. This is partic-
ularly true if an organization gener-
ates hundreds or thousands of SOPs,
and the people who need to review
and approve them are in different lo-
cations or out of the office. It is likely
that SOPs may get lost while being
routed, either buried in someone’s
messy desk or computer inbox.
I Poor collaboration. Creating and up- ENG
INEERING / TECH. SER
VIC
dating SOPs usually requires collabo- LYTICS – REPORTING ES
G ANA
TIN
ration. For organizations that use TES Integrated MA
NU
manual processes, collaboration AL F
IC Quality Management
IN
AC
would entail face-to-face meetings
CL
TU
and passing around a document that
RI
Department-
NG
Specific
employees take turns editing. This
T
EN
Documents
manual process works when there are
PM
Audit Document
REG
Control
ELO
few collaborators who are based in
ULAT
the same facility and whose schedules
RESEARCH & DEV
Non-
are similar. But collaboration among conformances
Change
ORY AFFAIRS
Control
employees with varied schedules and
Quality Control Risk
responsibilities and who are based in Issues Assessment
different facilities is practically im- CAPA
possible. Customer
Complaints
I Lack of visibility. Paper-based pro-
cesses are not connected, making it Training
Sarbanes-Oxley
Control
difficult for management to monitor (SOX)
New Employee
SA
the effectiveness of SOPs and make Role/Job Change
LE
Annual Training
timely decisions. For example, if the
S
NS
/M
customer complaint process is not
O
AR
TI
KE A
connected to either corrective and TI
NG ER
OP
preventive action (CAPA) or change
control, it may take a while before
management realizes that a certain FINANCE
complaint should have been escalated An effective system integrates SOP management with change control, training con-
to CAPA and should have resulted in trol, audits, corrective and preventive action, and customer complaint processes.
a change in a manufacturing SOP, Source: MasterControl Inc.
perhaps preventing a product recall.
may allow offsite or traveling em- ally anywhere. There is no need for
Solutions ployees to participate in the review employees to remember to document
A quality management suite should and approval process through the changes because the system provides
consist of easy-to-use and integrated ap- Internet. Even suppliers, consultants a time-stamped audit trail that cap-
plications for automating, streamlining and other third parties may be given tures the identity of anyone who
and effectively managing SOPs and limited access to the system so they creates, views or changes an elec-
other documents, change control, train- can be immediately notified upon ap- tronic record, when the action oc-
ing control, audits, CAPA, customer proval of changes to SOPs that affect curred, and the changes made. Along
them. As an alternative, external links with the stamp, users are asked to en-
complaints and other forms-based qual-
can be created to make selected docu- ter a reason for every change.
ity and business processes under a single ments and processes available with-
Web-based platform.
I Automatic revision control. Em-
out giving them system access. ployees will no longer use uncon-
To address manual-based challenges, I Integrated training. By integrating trolled SOPs because only approved
an automated system can provide a vari- training control with SOP manage- documents will be released and made
ety of solutions including: ment and other quality processes, all available to them. Obsolete SOPs will
I Efficient system. A Web-based sys- employees affected by new or revised not resurface. With an automated sys-
tem can automate routing, delivery SOPs will be automatically sent train- tem, when an SOP is revised, the
and storage of SOPs, thereby increas- ing tasks. Some systems automate as- original version is automatically ar-
ing the efficiency of SOP manage- signment, monitoring and verification chived on approval and release of the
ment. The system provides a secure, of training tasks. The system also revision. Also, setting an expiration
centralized repository that makes may automate grading of online ex- date will make an SOP obsolete on
search and retrieval easy. SOPs will ams. It allows implementation of a that date and it will automatically be
not get lost because the system can progressive training program by se- archived. Automatic revision control
track every document’s exact loca- quencing training courses. After a will ensure that when an SOP is being
tion. prerequisite is completed, the next revised, it will not be available for
I Effective communication. Auto- course is automatically launched. check out until approval of the revi-
matic follow-up helps improve effi- I Effective documentation. An auto- sion.
ciency. The system will continue to mated system makes it easier to keep I Improved collaboration. A virtual
send notifications until the person SOPs accurate and current. To update collaboration workspace allows indi-
acts on an SOP. It incorporates esca- or revise documents, there is only one viduals to participate at their conve-
lation, so if the person is unavailable place to make a change because all nience. They can review, comment
for a period of time, the SOP will SOPs will be stored in a centralized, on, revise or approve an SOP without
move to the next person authorized to Web-based repository that can be ac- having to be physically present with
approve it. A Web-based platform cessed by authorized users from virtu- the rest of the team. A Web-based
I platform allows even off-site or trav- product quality, and therefore, com- About the Author
eling employees to collaborate. pliance. Development of effective Cindy Fazzi is a marketing communi-
I Increased visibility. An automated SOPs and implementing them cor- cations specialist for MasterControl
system can make the entire quality rectly require commitment from the Inc. (Salt Lake City). For more infor-
system visible by integrating different entire organization. Choosing the mation, call (800) 825-9117, e-mail
processes and connecting different right software solution that will facili- cfazzi@mastercontrol.com or visit
departments. Management will be tate and improve SOP management www.mastercontrol.com.
able to monitor the effectiveness of should be a part of this commitment.
SOPs in a single, integrated system Once established, an efficient and ef-
better than in separate processes. For fective SOP management system will This article has been reprinted with
FDA-regulated and ISO-certified serve as a foundation for an organiza- permission from Quality Magazine,
companies, SOPs are more than just a tion’s sustainable compliance and copyright February 2007.
tool of operation. SOPs directly affect long-term success in the market.
Tech Tips
• SOPs, in conjunction with personnel training, help • In FDA and ISO environments, the concept of quality
relay knowledge from one department to another. is made tangible by the information and processes
• Manufacturers with global operations also rely on captured in SOPs, and correct implementation of
SOPs to standardize processes in all of their facilities. those SOPs helps ensure quality.
• Compliance with regulations and quality standards is a • An SOP may come in the form of a checklist, a linear
key factor that drives many organizations to establish flowchart or some other type of flowchart, hierarchical
and maintain SOPs. steps or annotated photos.
20 th
Anniversary
GMP Labeling®
Compliance products
for the
health care
industry
1987
2007
Additional copies of this issue may be obtained by calling GMP Labeling at 800-637-4487.
To access an archive of Regulatory Compliance Newsletters visit www.gmplabeling.com. Presorted Standard
Fax to 408-522-3212 to be added to our mailing list for future issues of this newsletter.
U.S. Postage
PAID
San Jose, CA
GMP Labeling®, Inc. Permit No. 125
525 West Remington Drive
Sunnyvale, CA 94087
Phone 800-637-4487
408-522-3200
Fax 408-522-3212
E-mail sales@gmplabeling.com
Web www.gmplabeling.com
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