This draft, November 2000, prepared by EH-53, has not been approved and is

subject to modification. Project No. MGMT-0004

TS

NOT MEASUREMENT
SENSITIVE

DOE-STD-XXXX-YR
PROPOSED

DOE STANDARD
PRINCIPLES FOR PROCEDURE SYSTEM
MANAGEMENT

U.S. Department of Energy

Washington, D.C. 20585

AREA MGMT

DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited.

This document has been reproduced from the best available copy.
Available to DOE and DOE contractors from ES&H Technical Information
Services, U.S. Department of Energy, (800) 473-4375, fax: (301) 903-9823.
Available to the public from the U.S. Department of Commerce, Technology
Administration, National Technical Information Service, Springfield, VA 22161;
(703) 605-6000.

Principles for Procedure System Management

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Intentionally Blank

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Table of Contents
Topic

Page

Table of Contents ............................................................................................................................. i

Foreword ........................................................................................................................................iii
Purpose ............................................................................................................................................ 1
Applicability.................................................................................................................................... 2
Part I: Description of Procedures and Procedure Systems.............................................................. 3
Procedures support different types of work .................................................................................... 6
Part II: Principles for Procedures .................................................................................................... 8
Procedure System Principles........................................................................................................ 9
Principle 1: The procedure system is an integral component of the Integrated Safety
Management System ....................................................................................................................... 9
Evidence that the Principle is fulfilled .............................................................................. 10
Principle 2: The management of procedures is established through policy................................. 10
The function of the Procedure System .............................................................................. 10
Evidence that the Principle is fulfilled .............................................................................. 10
Principle 3: The organization directs when and how procedures are to be used. ........................ 10
Determining when and how procedures are to be used..................................................... 11
Evidence that the Principle is fulfilled .............................................................................. 11
Principle 4: Authority and accountability for the procedure system and for individual procedures
are defined. .................................................................................................................................... 11
Procedure system accountability....................................................................................... 11
Process accountability....................................................................................................... 12
Evidence that the Principle is fulfilled .............................................................................. 13
Procedure Process Principles ..................................................................................................... 13
Principle 5: The procedure process begins with identifying the need for procedures. ................ 14
Evidence that the Principle has been fulfilled................................................................... 14
Principle 6: The procedure bases are identified and documented................................................ 14
Standards basis .................................................................................................................. 15
Management control basis................................................................................................. 15
Technical Basis ................................................................................................................. 15
Design and Authorization Bases ............................................................................ 16
Human Performance Basis ...................................................................................... 16
Work Process Definition .......................................................................................... 16
Operating Experience........................................................................................................ 16
Procedure Interfaces.......................................................................................................... 17
Documenting the Procedure Bases.................................................................................... 17
Evidence that the Principle is fulfilled .............................................................................. 17
Principle 7: Standards are defined for procedure development and design ................................. 17
Multi-discipline skills and knowledge guidelines............................................................. 17
Development guides.......................................................................................................... 18

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Procedure Design guides................................................................................................... 18

Evidence that the Principle is fulfilled .............................................................................. 19
Principle 8: Affected organizations conduct formal reviews of procedures. ............................... 19
Defining the review focus ................................................................................................. 19
Evidence that the Principle is fulfilled .............................................................................. 20
Principle 9: Procedure verification and validation are required prior to use. .............................. 20
Verification addresses technical accuracy......................................................................... 20
Validation addresses procedure usability.......................................................................... 20
First use of a procedure ..................................................................................................... 21
Infrequent use of a procedure............................................................................................ 21
Evidence that the Principle is fulfilled .............................................................................. 22
Principle 10: Procedure authorization attests to procedure usability and readiness to implement.
....................................................................................................................................................... 22
Evidence that the Principle is fulfilled .............................................................................. 22
Principle 11: Change control is established for procedures. ........................................................ 23
Focused review process..................................................................................................... 23
Expedited revisions ........................................................................................................... 23
Periodic review and cancellation....................................................................................... 23
Evidence that the Principle is fulfilled .............................................................................. 24
Procedure Process Principles ..................................................................................................... 24
Principle 12: A document control and delivery system ensures that the correct and current
versions of procedures are available for use. ................................................................................ 24
Procedure index................................................................................................................ 24
Delivery control system ................................................................................................... 25
Evidence that the Principle is fulfilled ............................................................................. 25
Principle 13: Procedure records are accessible and retrievable ................................................... 25
Evidence that the Principle is fulfilled ............................................................................. 26
Principle 14: Information management resources support the procedure system........................ 26
Evidence that the Principle is fulfilled ............................................................................. 27
Principle 15: An effective training and qualification program supports the procedure system... 27
Managers training ........................................................................................................... 27
Procedure users training.................................................................................................. 28
Procedure developers training......................................................................................... 28
Qualification..................................................................................................................... 28
Evidence that the Principle is fulfilled ............................................................................. 28

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Foreword
1. This Department of Energy standard is approved for use by all DOE Components and
their contractors.
2. Beneficial comments (recommendations, additions, deletions) and any pertinent data
that may improve this document should be sent to the Office of Nuclear Safety Policy and
Standards (EH-53), U.S. Department of Energy, Washington, D.C. 20585, by letter or by using
the self-addressed Document Improvement Proposal form (DOE F 1300.3) appearing at the
end of this document.
3. DOE Technical Standards, such as this standard, do not establish requirements.
However, all or part of the provisions in a DOE standard can become requirements under the
following circumstances:
(1) they are explicitly stated to be requirements in a DOE requirements document; or
(2) the organization makes a commitment to meet a standard in a contract or in an
implementation plan or program plan required by a DOE requirements document.
Throughout this standard, the word "shall" is used to denote actions which must be performed if
the objectives of this standard are to be met. If the provisions in this standard are made
requirements through one of the two ways discussed above, then the "shall" statements would
become requirements. It is not appropriate to consider that "should" statements would
automatically be converted to "shall" statements as this action would violate the consensus
process used to approve this standard.
This Standard was prepared by the DOE Technical Standards Procedure Topical Committee. Members
include: Maggie Sturdivant - EH, Earl Carnes - EH, Charles Billups - SC, Joe King - DP, John Tseng EM, John Psaras - EM, Fred Carlson, consultant, Dick Nolan, DOE LBNL, Joyce Sylvester PWI, OR,
Peery Schaffer - Bechtel Jacobs, OR, Dan Plung - WSRC, Jacquie Lewis - BWXT INNEL, Steve Greene
UC, LANL, Susanne Guleke BWXT, PANTEX. The team wishes to acknowledge the assistance of
Dr. Daryl Grider and Mr. Bill Mullins for their assistance in the preparation of this Standard.

iii

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Purpose
This Technical Standard (Standard) provides principles derived from lessons learned and best practices
from within the Department and industry for integrating management and technical knowledge,
requirements and standards into procedures that effectively support the missions of the Department of
Energy (DOE). These missions include scientific research and development, energy supply, nuclear
weapons stockpile stewardship, and cleanup of the environmental legacy from weapons production. This
Standard relies on principles rather than on prescription, and promotes reasoned adaptability in
recognition of the diversity of work, hazards, work environments, technical complexity, risks, knowledge,
and experience associated with accomplishing DOEs missions. Reliance on principle offers two
important benefits to providing a critical level of consistency in addressing this very diversity. First,
reliance on principle is intended and essential to retaining a consistent and recognized level of proven
performance excellence throughout DOE when it comes to codifying proven historical work practices and
newly developed work practices into approved procedures. Second, reliance on principle ensures the
direction is equally applicable to support all types of mission work: scientific, technical , operational,
maintenance, environmental, management and administrative work such as finance and personnel.

Introduction:
Over the past decade changes in DOEs missions have placed heightened attention on DOEs methods for
performing work. The result of this focus has been progress in matching work methods to missions. For
work where risk is understood, much collective experience has been codified. For work with
unconventional risks, good practices are being systematically and continuously learned by those working
at the edge of technology to develop standards and procedures for dealing prudently with the
unconventional.
Mission changes prompted the Department to establish a tailored standards-based approach for all DOE
work. This standards-based approach was developed in response to several factors: DOEs highly
specialized and experienced work force was aging and retiring; because of changing social expectations
new methods were needed to allow more open disclosure and discussion of how DOE work is performed;
new missions posed challenges that are on the edge of current knowledge. The government as a whole
was moving toward a system of regulation based on performance accountability. The Department of
Energy has responded by developing a body of performance-based policies, contracts, rules and
directives.
The standards-based approach is expressed in the DOE Safety Management System Policy, which
requires work in accordance with an Integrated Safety Management System (ISMS). This establishes a
formal framework to: (1) define work, (2) analyze hazards, (3) develop controls, (4) perform work and (5)
use feedback for correction and continuous improvement. These five functions are guided by seven
principles which address (1) line management responsibility for safety, (2) roles and responsibilities, (3)
personnel competence, (4) balanced priorities, (5) standards and requirements, (6) tailored hazards
controls, and (7) authorization of work. This framework is intended to apply in a tailored way to
technical work as well as the management and administrative work necessary to accomplish assigned
missions.
The ISM Policy is expressed through a hierarchy of agreements that take the form of mission, program,
and project descriptions and a variety of local work controls that individuals use to produce the outcomes
expected of their work. Work controls, particularly procedures, provide detailed expression of
management expectations for completing work tasks.

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Throughout DOE the maintained, written documents describing work performance may be referred to by
terms such as management controls, work instructions, operations aids, checklists, protocols,
administrative controls and standard operating procedures. This diversity of terminology has emerged
over time as part of the culture of individual DOE operations. Regardless of the terms used, local level
task work controls are considered the domain of procedures. Procedures serve to carry forward the
organizations collective knowledge of how to perform work, maintain design integrity, protect the health
and safety of people and the environment, and convey the management expectations for the degree of
autonomy of decisions and actions available to individual work performers. The value of procedures in
promoting the mutual goals of safety and quality is widely recognized by regulatory bodies and
professional associations such as the Occupational Safety and Health Agency, the Nuclear Regulatory
Commission, the Environmental Protection Agency, the Institute of Nuclear Power Operations, the
International Atomic Energy Agency, the Center for Chemical Process Safety, the American Society for
Quality and the International Organization for Standards. Just as these bodies do not all mandate the same
detailed methods for documenting procedures, so the set of Principles set forth in this Standard is
intended to accommodate a wide range of very different work realities.
What the agencies mentioned above do require is procedures that produce consistently high levels of safe,
efficient work results. The set of Principles established in this Standard also requires that work performed
according to written procedures achieve similar consistently high levels of safety and efficiency. In the
past, the Department of Energy has invested extensive effort and significant resources on procedures,
with uneven results. Procedures continue to be identified as principal causal factors in DOE accidents,
operating events, and lessons learned. Event reviews often specify a lack of management attention to
procedure development and procedure system management. To support implementation of Integrated
Safety Management at the task work control level, a DOE Procedures Topical Committee was chartered
as part of the DOE Technical Standards Program. The intent of this committee is to address procedures
from an enterprise view, that is, in a way applicable to all of the Departments work.
The members of the Topical Committee are managers, workers, operators, scientists, engineers and
technical specialists from both DOE and contractor organizations who have years of experience with
procedures and management systems. To support the ISM goal of doing work safely, the Committee has
focused attention on how procedures promote safe, efficient performance. The Committee has worked to
foster appropriate procedures that reduce the potential for human error. Members are mindful that
imposing inappropriate models of procedures would be counterproductive. The need to avoid the onesize fits all approach to procedures was felt to be an essential aspect of providing guidance that would be
productive, supported and used.
A comprehensive set of Principles for procedure system management and procedure development was
determined to provide the appropriate level of guidance. Establishing such a set of Principles was
deemed to be consistent with both the DOE need for an enterprise approach that respects the diversity of
DOE work and the management needs to communicate expectations and maintain awareness of procedure
systems and development activities. The guiding concept for these Principles is that the work, the hazards,
the environment in which the work occurs, and the skills, knowledge and experience that the work
demands give rise to the type of procedures to be used and how procedures will be used to aid in
performing work.

Applicability
This Standard can be applied to any DOE mission work. Contractors may use this Standard to tailor their specific
methods for managing the development, review, approval, distribution, use, maintenance and retirement of

DOE-STD-XXXX-YR

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procedures. This Standard is consistent with and supports requirements and guidance found in 10 CFR Part 830
"Nuclear Safety Management," DOE Order 414.1A "Quality Assurance," DOE G 414.1-2 "Quality Assurance
Management System Guide," DOE Order 5480.19 "Conduct of Operations Requirements for DOE Facilities," and
DOE Order 440.1A "Worker Protection Management for DOE Federal and Contractor Employees."

Part I: Description of Procedures and Procedure Systems

This section describes the role of procedures, the concept of a procedure system, typical
types of procedures, and the relationship of procedures to other management controls.
The Department of Energy has made a commitment that work will be done consistent
with contractual agreements, laws and regulations and the principles and functions of
ISM. This commitment is to ensure that work is planned, performed, and appropriately
documented to protect the environment and the safety and health of the public and
workers. This approach to doing work is intended to:

Increase safety and effectiveness of work

Support safe and effective human performance
Allow for good judgment in planning work
Create consistency and stability in expectations and accountability
Maintain protection, while establishing a balance between costs and benefits
Encourage decision making at the appropriate level

Procedures are components of Integrated Safety Management

The procedure system is the broad administrative program that encompasses the
development, review, approval, distribution, use, maintenance and retirement of
procedures.
Procedures play an essential role in implementing the components of ISM (Figure 1) by:

Capturing agreements - Capturing the agreements and requirements for performing

work as expressed in the approved contract and the ISM System description. DOE
and contractors establish up-front agreements on basic approaches to doing
institutional, facility and activity work, for example, the acceptable degree of risk
associated with particular work. These agreements are established in the contracts,
the ISM System Description and associated authorization documents. Procedures
integrate these agreements into directions for performing the work.
Implementing controls - Procedures implement the administrative, design, operating
and quality controls.
Implementing standards - Procedures provide work instructions that implement
standards and requirements.
Supporting human performance - Procedures provide accurate and authorized
information and direction to enable individuals to perform assigned tasks safely and
effectively.

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Hierarchy of Components
Safety Management

Objective

Safety Management

Increasing level of detail

Principles

Safety Management

Functions

Safety Management

Mechanisms

Safety Management

Responsibilities

Safety Management

Implementation

Figure 1

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For most DOE work, implementation of work design, expectations, requirements and
standards are communicated through a set of interrelated documents. Depending upon the
work involved, risk, or safety implications, a document hierarchy may be needed to
express and achieve full implementation, for example, to communicate policy and
direction, support effective human performance, provide necessary information, establish
an organization's written intent to comply with applicable regulations and commitments,
and to direct task activities.
Figure 2 provides an example of a document hierarchy for capturing and implementing
expectations, requirements, commitments and direction.

Document Hierarchy
Source Documents
Laws, Regulations, Contract,
DOE Directives, Safety
Management System
Descriptions, Corporate Policy,
Corporate Standards
Bases Documents
Technical Bases, Design and
Authorization Bases,
Management Bases, Human
Performance Bases,
System/Program Descriptions
Work Instructions
Management Control
Procedures, Technical
Procedures, Emergency
Procedures
Supporting Documents
Lists, Guides, Templates

Figure 2

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As illustrated in Figure 2, work control is the jurisdiction of procedures. Within the

control document types, only procedures establish task direction for how administrative,
technical, and emergency activities are to be accomplished. Procedures, in other words,
constitute the document type by which work is actually accomplished.
To ensure procedures represent a commitment to doing work safely and effectively,
procedures are products of professional collaboration and integration of the knowledge
and experience from multiple disciplines. Line management, subject matter experts and
workers are responsible for ensuring that procedures are correct and usable. That is, they
are responsible for ensuring that procedures:

Support work accomplishment in the safest, most effective way

Fully implement the standards and commitments
Are compatible with related procedures, programs, and initiatives
Are as easy to comprehend and as easy to perform as possible
Are consistent with the guiding principles and core functions of ISM

Procedures support different types of work

Procedures are tailored to precisely and effectively support the levels of work:
institutional, facility and activity. Because work activities and situations require different
means for communicating effectively to personnel performing the work, different
procedure types may be needed. These procedure types differ in level of detail and
format consistent with their intended application and the bases used for their
development.

Management Control Procedures

Management control procedures, most typically associated with institutional-level

activities, provide formal direction for accomplishing interactions, maintaining
communications, and ensuring consistency of operations. Management control
procedures define the processes (methods) required to ensure that the goals and
objectives of the organization's programs are implemented. They are sometimes referred
to as administrative procedures, program descriptions or management system
descriptions. Unlike technical procedures, management control procedures are not
directly used to operate or maintain facilities or equipment. Collectively, management
control procedures describe a comprehensive set of controls, interactions, and
communications deemed essential by management for the safe and efficient operation of
the entire organization. One way of thinking about Management Control procedures is
that they translate policy into action. They are based less on quantitative analyses and
design standards than on the managements philosophy of operation, and agreements on
how operations will be accomplished. In some ways, they represent much of the culture
of the organization. For instance, one company might require plan of the day meetings to
transmit lessons learned; another might opt for classroom training to communicate
recently learned lessons; while a third company might choose required reading; and a
fourth company might employ all of these options. The method is tailored to meet the
managements strategy for meeting its corporate goals and commitments.

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Examples of activities most typically administered by management control procedures

include:

Quality assurance
Configuration management
Personnel management
Emergency management
Fire protection
Human performance
Work planning
Safeguards and security
Lessons learned

Technical Procedures

Technical procedures focus primarily on accomplishing facility and activity level

activities. They are based upon design controls (specifications, drawings), operational
controls (documented safety analysis reports, technical specifications), management
controls (industrial safety, training) and experience (lessons learned programs).
Technical procedures provide direction and information on how to accomplish the
technical tasks associated with the full life cycle of performing work, including:

conducting research
design
construction
testing,
starting up,
operating,
periodically surveilling the equipment, facilities, and processes,
maintaining,
shutting down,
transitioning to new missions
deactivation and decommissioning

Alarm Response and Emergency Procedures

Alarm response and emergency procedures delineate the steps to take when an abnormal
condition exists. Alarm response procedures signal when operations approach
established safety margins, allowing appropriate intervention prior to encountering
conditions that are more serious. Emergency procedures detail the responses when safety
margins have been breached or seriously jeopardized. Both alarm response and
emergency procedures are based upon systems design specifications, safety analyses,
hazards analyses, process flow diagrams, and vulnerability studies.

Summary
Procedures communicate direction for performing work when the consequences of that
work are important to safety, quality and regulatory compliance. For many types of
work, the use of procedures is required by regulation or corporate policy. To support
effective safe work, procedures must be based on the work to be done, hazards or
business vulnerabilities associated with that work, appropriate requirements, standards
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DOE-STD-XXXX-YR
and expectations. The purpose of a procedures management system is to control the
development and maintenance of procedures so that individual procedures and the
collective set of procedures support effective, safe work throughout the organization.

Part II: Principles for Procedures

Part II contains (1) principles on which a comprehensive procedure system is based, (2)
principles by which procedures are developed and (3) principles for supporting the
procedure system though the organization's infrastructure. Within the framework of
these principles, specific criteria and system elements can be developed based on the
work to be performed. Each principle is followed by an explanation of why the principle
is significant, what it entails, and how it is fulfilled. In some instances, there is overlap
among explanations. This overlap is intentional and warranted not only to support the
different types of users, but also to afford each principle sufficient depth so that it can be
understood both as an independent principle and as one part of an integrated system.
Fifteen principles are identified for developing, reviewing, approving, distributing, using,
maintaining and retiring procedures and managing these procedure functions. To promote
a clearer understanding of the interrelationships among the principles, they are organized
into three categories.
Procedure system principles. These principles establish the necessary management
controls for a procedures system to support the principles and functions of ISM.
Principle 1: The procedure system is an integral component of the Integrated
Management System.
Principle 2: The management of procedures is established through policy.
Principle 3: The organization directs when and how procedures are to be used.
Principle 4: Authority and accountability for the procedure system and for
individual procedures are defined.
Procedure process principles. These principles establish the necessary controls for the
identification, development, review, approval, maintenance, continuous improvement,
and evaluation of procedures.
Principle 5: The procedure process begins with identifying the need for
procedures.
Principle 6: The procedure bases are identified and documented.
Principle 7: Standards are defined for procedure development and design
Principle 8: Affected organizations conduct formal reviews of procedures.
Principle 9: Procedure verification and validation are required prior to use.

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Principle 10: Procedure authorization attests to procedure usability and readiness

to implement.
Procedure system support principles. These principles address the interrelated programs
needed to ensure the procedure system functions effectively and maintains procedures
over time.
Principle 11: Change control is established for procedures.
Principle 12: A document control and delivery system ensures that the correct
and current versions of procedures are available for use.
Principle 13: Procedure records are accessible and retrievable
Principle 14: Information management resources support the procedure system.
Principle 15: An effective training and qualification program supports the
procedure system.

Procedure System Principles

An effective procedure system produces work-focused, accurate and usable procedures,
integrates input for performance of work communicated from other management control
systems, and incorporates ISM principles and functions for performing work at all
working levels.

A Procedure System is established for developing, reviewing, approving, distributing,

using, maintaining and retiring procedures
Procedure management and use are established through policy
Responsibilities and accountabilities are assigned for the procedure system and the
procedures
Mechanisms are identified for integrating work inputs communicated through other
management control systems

Principle 1: The procedure system is an integral component of the Integrated

Safety Management System
The ISM Principles and Core Functions are codified through contracts, the ISM System
Description and associated documents that collectively comprise an organization's
management controls. The procedure system is a mechanism that supports institutional,
facility and activity work consistent with requirements, standards, management, technical
and performance bases, agreements and commitments. The organization's hierarchy of
documents should clearly describe the procedures system and how the guiding principles
and core functions of ISM are used within the procedures system.
Evidence that the Principle is fulfilled
To fulfill this principle, an organization should describe how it controls the development
and maintenance of procedures. Descriptions may be documented at the institutional,

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facility or activity level. Descriptions include the organization's overall policy on

procedures, the organizational roles and responsibilities for procedure development and
maintenance, and the management controls that inter-relate to perform procedure
management functions.

Principle 2: The management of procedures is established through policy.

An organization's policy on procedures is derived from the nature of the work, i.e., the
levels of complexity and uncertainty involved and the hazards associated with that work.
The appropriate degree of formality of procedures and documentation should be tailored
to the work and hazards. Policy on procedure system management should be conveyed
using the appropriate levels of the organization's document hierarchy such as the Safety
Management System Description, formal policy statements, program descriptions or
standards.
The function of the Procedure System
Policy should set the management expectations for developing, reviewing, approving,
distributing, using, maintaining and retiring procedures.
Evidence that the Principle is fulfilled
To fulfill this principle, establish policy for:

The procedure management system

The functional purposes and limitations of procedures

Principle 3: The organization directs when and how procedures are to be

used.
All activities associated with defining the procedure system, developing the procedure
process, and ensuring suitable support and integration are aimed at making procedures
available to increase safety, maintain quality objectives, and enhance human
performance. Clear and unambiguous direction should stipulate when to use, how to use
and who should use the procedures once approved and issued. To support a clear and
consistent use of procedures, requirements are established on use, documentation of use
and verification of use. The organization should identify circumstances in which formal,
written procedures will be required to promote and support the safe and effective
performance of work. At the same time, the organization should define work where
controls other than written procedures are more appropriate to accomplishing work safely
and efficiently. Procedures may not always be the best vehicle to solve process,
performance, integration, and safety problems. Boundaries should be established on the
work situations requiring formal written procedures, and those situations in which work
plans or verbal instructions combined with worker qualifications and experience provide
sufficient assurance that work can be performed safely.

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Determining when and how procedures are to be used

Identify the types of procedures that the organization intends to use

Establish the criteria for determining which steps in a procedure are to be
documented as they are completed, and which are to be independently verified.
Establish who is responsible for using procedures
Establish how to use procedures, i.e., reference only, in-hand, or verbatim
compliance
Establish how procedure use will be verified and documented
Establish what to do during actual use of a procedure if something unanticipated
occurs, if an emergency situation arises, or if steps delineated in a procedure cannot
be followed as written.
Determine the levels of training, experience and qualification associated with
procedures and their use

when training must include formalized testing and qualification

what allowances to make for skills associated with craft competency

Evidence that the Principle is fulfilled

To fulfill this principle, establish direction on when to use, how to use, who will use
procedures and how procedure performance is documented.

Principle 4: Authority and accountability for the procedure system and for
individual procedures are defined.
The procedure system includes development, review, approval, distribution, use,
maintenance and retirement of procedures. Authority and accountability should be
defined for each of these elements of the procedure system. In addition, authority and
accountability should be assigned for individual procedures to ensure procedure quality
and to promote procedure ownership. The organization should formally assign authority
for performing tasks associated with the procedure system and individual procedures.
Accountability is assigned to individuals deemed capable by experience, knowledge and
training to perform certain functions for an organization. They have demonstrated they
can perform assigned functions and that the organization and the individual(s) have
agreed that assigned functions will be performed as expected.
In some instances, authority and accountability may be assigned to different individuals
or organizations for each of the procedure types. This separation may be warranted
because of the differences in the development and administrative processes for the
procedure types, to afford greater attention on each type of procedure, or to support
organizational structures (e.g., assigning responsibility for technical procedures to an
operating division and management control procedures to an administrative function).
Procedure system accountability
Authority and accountability should be established for the procedure system. Although
the overall procedure system may have distributed elements, authority and accountability
should be clearly described. Assignment of authority and accountability is also important

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to assure availability of resources - personnel, data management, technical expertise

(subject matter experts, technical and safety reviews), and associated production
resources.

Process accountability
No single individual or organization can ensure that all needed procedures are generated
or that all procedures remain current, accurate, and complete. Management must ensure
that procedure-related operating experience information is directed into the procedure
system so that necessary revisions or improvements may be made. Collectively, all
designated procedure owners are held accountable for ensuring that procedures within
their purview are developed as necessary and updated:

When work changes,

When requirements change,
When Authorization bases change,
When feedback identifies opportunities to improve a procedure,
When procedure deficiencies (errors, omissions) are identified,
When Unreviewed Safety Questions are identified.

Examples of accountability and authority that should be assigned include:

Line managers are designated to ensure that procedures:

Are consistent with contract provisions,

Are in keeping with the approved ISMS,

Correctly interface with other procedures,

Complement and are consistent with the administrative controls of the procedures
system ,

Are routinely assessed,

Are used as directed by organizational policy.

Procedure developers (subject matter experts, workers and others as designated by

management) are capable of and responsible for developing technically correct
procedures that:

are work focused,

are based on the established design, operating and administrative controls;

implement the standards, recognize the operating environment and conditions,
and consider the knowledge obtained through lessons learned and related work
experience;

are designed to optimize human performance,

reflect, as in the case of many Management Control procedures, the expectations
and philosophy of management;

adhere to writers guides and basic tenets of procedure design.

Procedure users share responsibilities for ensuring that work experience is

appropriately considered, including ensuring that finished procedures can be
effectively used in the field under the prevailing work conditions.

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Technical reviewers share the responsibility for making sure that all elements of
procedures are true and accurate representations of the work, hazards, workplace, the
requirements, and work experience.

Cross-disciplinary experts share the responsibility to identify and evaluate

supporting, affected, and related initiatives and programs when developing or
revising procedures.

Validation personnel are responsible for ensuring procedures, in final form, are
usable in the actual environment where the work is to be accomplished.

The owning organization is responsible for the content, usability and final review.
The owning organization confirms that the procedure remains responsive to the
original purposes and to the requirements and standards being implemented.

Evidence that the Principle is fulfilled

To fulfill this principle, define accountability and authority for the procedure system,
including:

Designate the line management accountability for the procedure system.

Designate accountability and authority for development, review, approval,
distribution, use, maintenance and retirement of procedures.
Identify responsibilities for organizational interfaces.
Identify accountabilities for routine assessment of the procedures.

Procedure Process Principles

The procedure development process is designed to ensure that procedures are accurate
and usable and they are consistent with the as-is equipment, work environment,
organizational structure, established business agreements and processes, and approved
ISM concepts. A comprehensive procedure development process includes the following
elements:

Identification of needed procedures,

Identification of the bases to support procedure development,
Qualified, responsible procedure developers,
Use of established standards for procedure development,
Interfaces with other procedures,
Verification through formal interdisciplinary reviews,
Validation through walk-throughs or similar methods,
Formal procedure approval to establish accountability,
Revision and performance evaluation requirements,
Maintenance of procedures and supporting documentation,
A method of feedback for continuing improvement.

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Principle 5: The procedure process begins with identifying the need for
procedures.
Not all work requires procedures, nor do procedures add value to the performance of all
work. Training or day-to-day supervision, for example, may be more appropriate and
effective for many work activities. Therefore, the first task in a procedure process is to
determine which activities need or would benefit from a procedure and to determine the
most efficient form of the procedure (for example, traditional 8 x 11 step-by-step, or
electronic procedures, job aids, operator aids, decision aids, checklists). This
determination is made considering such factors as risk, work experience, lessons learned,
informed judgments, capability and constraints (for example, available technology).

Procedures are warranted when any one of the following criteria is met:

TO REDUCE RISK: When work entails risk to the worker, public, environment or
the organization. This criterion is important when any of the following conditions
exist:
-

Authorization bases require procedure use

Infrequent performance of the operation
A complex operation
Conditions that entail significant uncertainty
A high consequence of error
High personnel turnover on the operation
Frequent change in information or methods

In addition, procedures may be warranted for reducing significant business risks, e.g.,
financial or legal liability, intellectual property loss, loss of company-sensitive
information.

TO ENSURE CONSISTENCY: to prescribe a specific way of doing work where

consistency is important to safety, quality, human performance or reliability; or
where consistency is essential to maintaining compliance with laws, regulations, and
commitments.

Evidence that the Principle has been fulfilled

To fulfill this principle, establish guidelines for determining when procedures are needed.

Principle 6: The procedure bases are identified and documented.

The bases documentation, the referenceable collection of documents and information
from which the procedures are developed, is the library that affords a high level of
confidence that the procedures in use are complete, appropriate, usable, technically
correct and promote effective human performance. The traceability between the
procedures and the bases documentation must be identified and be clear and consistent.
All procedures, whether management control, technical or emergency should have an

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identifiable basis. However, the bases documents vary. For technical procedures,
documents such as hazards analyses and design specifications are principal information
sources. For management control procedures bases documents tend to be regulations,
standards, and best practices.
An essential step in the procedure process is to pull together or identify the need for
current, accurate, complete bases from which to write procedures. The bases may contain
any or all of the following based on the work:

Standards basis
Management control basis
Technical Basis
Design and Authorization bases
Work Process definition
Human Performance basis
Operating Experience
Procedure Interfaces
Standards basis
A goal of ISM is to have all DOE activities governed by sufficient sets of standards to
provide protection during the accomplishment of work. Standards bases are included in
approved ISM System Descriptions and listed by contract in Lists A and B. Contracts
typically identify requirements and standards that are important for management control,
technical and emergency procedures. The standards basis is derived from the work and
the hazards (or vulnerabilities) and furnishes essential input from which to develop
procedures.

Management control basis

Included in the management control basis for procedures are documents that address
commitments to meeting contractual and regulatory obligations, and organizational
policy through:

Administrative programs,
Operational programs,
Technical support programs,
Contracts,
Memoranda of Agreement/Understanding.

Technical Basis
The technical basis for procedures includes the documents that establish the boundaries
within which normal and emergency operations can be performed safely. The Technical
Basis includes the design and authorization bases, work process definition, and operating
experience.

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Design and Authorization Bases

The design and authorization bases for procedures include design and
construction criteria, materials, design engineering drawings and specifications,
hazards analyses, documented safety analysis reports, unidentified safety
questions (USQ) documents and vendor information. The Authorization Basis
may also include facility permits, emergency plans, waste management plans,
pollution prevention plans, quality management plans, conduct of operations
plans and, in cases of multiple user facilities, tenant agreements.

Work Process Definition

A significant part of developing the procedure is analysis of the work process,

activity, or task represented in the procedure. These analyses examine work
sequences: what initiates the action, the steps to be followed in response to that
action, and the results from completing those steps. The analyses include
potential hazards, vulnerabilities or the areas that increase the probability of
errors, and the consequence of these errors. The intent of such analyses is to
produce a set of directions and information to be addressed in the procedure, to
identify human performance issues, indicate the appropriate warnings and
cautions, and determine qualification or training necessary for persons who will
carry out the procedure. In Management Control procedures work process
analyses focus on maximizing efficiency, cost effectiveness, productivity, and
communication.

Operating Experience

The purpose of collecting and evaluating operating experience is to avoid

repeating errors, to continually improve and to learn from others. Operating
experience includes experience from within a given organization and from other
external organizations that perform similar work. Each DOE contractor
organization has a number of systems and processes intended to capture
operating experience, analyze causes, identify corrective actions and identify
opportunities for continuing improvement. The organization must ensure that
these operating experience systems and processes examine and identify causes
and corrective actions related to procedures. At the same time, a healthy focus on
continuous improvement will encourage identification of opportunities for
improved work process flows, introduction of new technologies, automation, and
elimination of unnecessary or redundant procedure steps.

Human Performance Basis

The process, activity, task, workplace and organizational factors that affect human
performance should be addressed during the procedure development process. Human
error is often attributable to management practices, organizational weaknesses,
unnecessary or excessive organizational interfaces, equipment deficiencies, adverse
environmental conditions or circumstances involving high degrees of uncertainty. In
addition, lessons learned during previous or similar work performance should be
evaluated to identify potential for error and common types of human error associated
with given work or procedures.

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Procedure Interfaces
A new procedure or a change to an existing procedure may impact related procedures.
The development process should include identifying interfaces with existing procedures
and a means to determine if changes are needed to existing procedures to ensure that the
collective set of procedures is integrated.

Documenting the Procedure Bases

The bases for procedures should be identified and documented to support development
and review of procedures and be maintained as part of procedure history records.
Information supporting the justification for the procedure, how procedure bases were
developed, and assumptions and informed judgments used to integrate requirements into
procedures is maintained with records of the corresponding procedure so that this
information may be retrieved. Procedure developers use basis documentation to establish
the foundation for procedures. Sets of related procedures might be developed from one
group of bases; it is not necessary to have a unique group of bases for each procedure.
However, every procedure is tied to the appropriate bases information.

Evidence that the Principle is fulfilled

To fulfill this principle, the procedure process description should describe how procedure
development integrates and documents contributing information:

Management controls basis,

Standards basis,
Technical basis,
Human performance basis,
Interfaces with related procedures,
Operating history and lessons learned programs.

Principle 7: Standards are defined for procedure development and design

The organization should define standards for developing and designing procedures.
These standards may take the form of institution, facility, or activity documents.
Developing procedures consistent with the organization's standards ensures that
individual procedures are sound, that the procedure process is coherent, and that
documents are controlled and retrievable. The standards should address how all
necessary skills, expertise, and experience are captured in the procedure development and
review, and the processes for developing and revising procedures. Such standards are
often referred to as Procedure Guides.

Multi-discipline skills and knowledge guidelines

Effective procedure development demands full knowledge of the bases and work
experience related to a procedure. The organization should develop guidelines for how

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the procedure development process will ensure participation of all those needed to
provide a thorough knowledge of the work and its hazards and those to perform work and
human performance task analyses. This expertise must also involve those involved in the
performance and outcome of the work addressed by the procedure. In addition to
ensuring this primary expertise, the process must also ensure the development process
includes persons knowledgeable about the ISM system, the procedure system, the
development and use of bases, and the organization's documentation standards. Further,
guidelines should address how participants will be qualified on these related topics.

Development guides
The DOE has issued a DOE Technical Standard for developing technical procedures,
DOE-STD-1029-92 "Writers Guide for Technical Procedures." DOE and contractor
organizations can use this standard or tailor guides for their specific circumstances.
While the Writers Guide is oriented to technical procedures, the basic concepts presented
are useful for developing other types of procedures as long as the application of the
concepts is based on the nature of the work involved and the skills, knowledge and
experience of those who will perform the work. Tailored development guides should
define a procedure process, describe guidelines for presenting procedures (content,
format, and style) and include a plan for managing the records generated.

Procedure Design guides

The purpose of procedure design is to optimize human performance: (1) by presenting
information in ways that are most readily understood by the user, and (2) by presenting
information in a manner that reduces or eliminates those errors commonly made during
the use of procedures. Procedure design offers methods for eliminating common errors
of commission and omission. Design issues include:

Document Structure
- Document layout (how to structure the document presentation to increase
comprehension and usability)
- Page layout (how to use headings, white space and typographic techniques to
increase performance and quality)
- Language (how to use terminology, reading levels and sentence structure to
enhance understanding and usability)
- Common error types (knowledge of common errors made when using procedures
and strategies for preventing these)
Use of alternative media to present procedures (e.g., electronic media, paper hard
copies),
Graphical presentations (the use of non-narrative formats such as tables, figures,
graphs, and forms) to better articulate required actions and documentation,
Alternative presentation structures (such as job performance aids) to optimize human
performance.

These design concepts, much like the management principles that define the procedures
program, are the fundamentals from which the development guides are built.

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Evidence that the Principle is fulfilled

To fulfill this principle, the procedure system must include:

Procedure development standards,

Procedure process standards,
Procedure design standards,
Training and qualification programs for procedure development personnel.

Principle 8: Affected organizations conduct formal reviews of procedures.

Review of procedures by affected organizations (those involved in performing,
supporting, or owning the outcome of the work) is important to ensure every aspect of a
procedure is technically correct and usable. Any procedure may involve and affect many
organizations, each with different responsibilities and expertise. Representatives from
these organizations review the procedures from technical, safety, operational, human
performance, worker and management perspectives. Involving relevant organizations and
individuals for review is equally important for developing new procedures, reviewing
infrequently used procedures or revising existing procedures.

Defining the review focus

Although subject matter experts and procedure users develop the bases for a procedure,
peer review is essential. Peer review means that the same skills, knowledge and
experience mixture is applied to review a procedure as is applied to development of the
procedure. Involvement of reviewers should occur as early as possible in the
development process.
The procedure review process draws on experts (including procedure users and
developers), facilitates the interfaces of the procedure with other activities, and
encourages commitment to the process and product. The type and depth of review
depends on the procedure content, complexity of the activity, levels of uncertainty, the
operational and safety considerations, and the degree of coordination needed among
programs and areas of expertise. For example, a procedure for processing hazardous
waste streams requires a different set of reviewers and reviews than will a management
control procedure on property management.
The procedure process allows for clear definition of which groups review which
procedure, disposition of review comments, and documentation of the review in the
procedure history file.

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Evidence that the Principle is fulfilled

To fulfill this principle, promote the importance of the review process and describe how
the organization:

Develops guidelines to define the review requirements, participants, and

expectations,
Dedicates appropriate resources to support the review effort,
Provides training for review personnel.

Principle 9: Procedure verification and validation are required prior to use.

A final assessment of the completed procedure is performed by the organization that
owns the procedure to ensure the procedure is technically correct, is consistent with
operating practices, fulfills the original need for the procedure, and is useable by the
intended work force in the intended work environment.

Verification addresses technical accuracy

The line manager responsible for performance of the procedure is responsible for
verification. Verification is not intended to replicate the development or review process;
verification substantiates the procedure's technical accuracy. To the degree possible,
verification is incorporated into the technical review process, but additional actions may
be required to ensure that each procedure is of highest quality.
The verification process is intended to ensure:
The procedure is technically accurate,
The development and review processes have been conducted consistent with the
applicable management controls,
The procedure is consistent with existing related procedures and consistent with
ongoing initiatives,
The development and review processes have not inadvertently introduced
requirements for actions that are inconsistent with contracts and approved operating
practices.

Validation addresses procedure usability

A validation is conducted prior to authorization to ensure the procedure can be used as
written. This validation focuses on use, a factor that should have already been
incorporated in the development phase by subject/technical experts, but which needs
reassessment prior to approval. Specifically, the validation allows independent
assessment after resolution of review comments to demonstrate that the procedure can be
used as written and in the environment where the actual task is to be performed.
For management control procedures affecting general plant or administrative systems, the
validation is part of the technical and interdisciplinary reviews conducted of the
procedure.

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For technical procedures, some level of simulation of the actual practice is used. At the
highest level of confidence validation involves use of a mock up or simulator in which
the actual steps are practiced. At the next confidence level is a walkdown, in which
personnel take the procedure to the location where the task is to be done and, without
actually performing the task, ensure that each step is correct and readily useable as
written. At the lowest level of confidence, validation is an analytical review that does not
simulate actual operation, but validates the procedure based on the knowledge and
experience of the reviewers.
Whereas all procedures are validated, the level of confidence needed differs with several
factors:

Type of procedure (management controls, technical procedures or emergency

procedures),
Types of work and the degree of hazard,
Operating experience or the degree of familiarity with the operation (for example, a
small change to a well documented and mature process as contrasted with work
involving minimally characterized hazards, high uncertainty or high complexity),
Successful work experience, including lessons learned materials and other supporting
documentation.

First use of a procedure

Irrespective of the validation method used, no procedure is truly validated until it has
been used. The procedure system should contain special provisions for first use of
procedures based on the risk associated with the work. Procedures that warrant mockups, simulator validation or walkdowns should be identified within the procedure system
as needing special attention for first use. Such procedures, when authorized after the
validation, are identified to let the user know that no one has ever used the procedure
before. Therefore, when using a procedure so identified careful scrutiny (possibly
including additional observers) is warranted when the procedure is first used.

Infrequent use of a procedure

Infrequently performed work is a major source of accident or injury potential. If a
particular work activity has not been performed for some time, the procedure for
performing that activity should be reviewed, verified and validated with the same level of
rigor as required for a new procedure. During the intervening period of procedure use a
number of changes may have occurred. Examples include facility modifications,
introduction of new materials in the facility or process, development of new hazards
reduction techniques, change in the skills, knowledge and experience of workers or
changes in formality of work. These type changes should be identified and resolved
through the organizations change control or configuration management systems.
However, the procedure system should contain provisions to identify infrequently used
procedures and invoke special infrequent use review.

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Evidence that the Principle is fulfilled

To fulfill this principle, establish the criteria associated with verification and validation of
each type of procedure and establish a means for identifying the first-use or infrequent
use procedures.

Principle 10: Procedure authorization attests to procedure usability and

readiness to implement.
The approval process confirms completion of the procedure development phase and
establishes accountability and ownership for each procedure. To establish accountability
at the proper level, the procedure system should require an approval signature for each
procedure. The procedure is generally signed by the person at the lowest level with
authority to direct implementation of the procedure. This signature attests that the
procedure is technically correct, that workers can understand and use the procedure, that
appropriate verification and validation activities have been completed and that the new
procedure or a change to an existing procedure has been reviewed for impact on related
procedures. Authorization to use a given procedure must be based on a determination that
related work would not be adversely affected by implementing the new or revised
procedure. (Although the original procedure may be signed, copies issued may not show
the signature (as in many electronic systems). Where the signature is not evident, the
procedure system must have administrative controls to establish authentication for the
copies.
The approval process also should require the approval authority to determine an effective
date for implementing the procedure. The approval authority considers the technical and
management interfaces as well as the implementing requirements associated with the
procedure prior to establishing the effective date. These requirements include, but are not
limited to:

Available resources to implement the requirements of the procedure. Resources

include personnel, hardware and associated equipment.
Status of related procedures. Status includes other procedures under development or
revision that interrelate with the procedure to be approved.
Training needed for workers who will use the procedure. Depending on the
complexity of the work and experience and qualification of personnel, training may
range from reading the procedure, to reviewing it with supervisors, to formal training.

Evidence that the Principle is fulfilled

To fulfill this principle, establish an approval process that:

Identifies procedure approval criteria,

Includes an approval signature for each procedure,
Defines an approach for determination of the effective date for implementation of the
procedure,
Ensures effective and timely issuance of procedures.

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Principle 11: Change control is established for procedures.

A change control process ensures the continued integrity of a procedure. Revision and
periodic evaluation of procedures are necessary ongoing processes required to keep
procedures current with changes in mission, work, hazards, requirements, systems,
personnel or equipment; and to promote procedural adherence.
Revisions to procedures are typically driven by one or more of the following factors:

Change in the technical basis, requirements, facility configuration, standards, or

commitments or other bases;
Unusual operating conditions and configurations,
Evaluations, such as user feedback, periodic review, lessons learned, self-assessment,
and audits;
Changes in requirements, commitments, or expectations.

Focused review process

The procedure revision control process balances the need for thorough, disciplined
reviews of proposed revisions, with the flexibility to allow timely completion of a
revision in order to support the needs of the users. When revisions are made to a
procedure, a process should be in place to identify who reviews which type of changes,
based on the scope of material changes, the implications, and the affected organizations.
As with the initial review process, maintaining the integrity of the procedure system and
procedures is dependent on assigning the right resources at the right times.

Expedited revisions
In addition to supporting routine changes introduced as part of regular operations, the
revision process also includes an expedited process for reviewing and approving
procedure changes whose urgency demands immediate resolution. The ability to modify
procedures expediently is key to maintaining the highest standards for worker safety,
performance, and responsiveness to changing regulations or commitments.

Periodic review and cancellation

Revisions to procedures are made as necessary; however, the procedure process should
contain specific requirements to periodically assess the procedures. Such requirements
are established to ensure continued need for the procedure, technical correctness,
usability, and compliance with requirements. Organization policy may provide that low
risk procedures that are used frequently are "reviewed with use" and do not require
separate periodic review. This is only acceptable if the change control process strictly
controls the technical basis of the procedure. Procedures that are used infrequently may
require a full review prior to use depending on the hazards, complexity and uncertainty
associated with the work, irrespective of whether in the interim revisions have been
processed to specific sections of the procedure. While the organization may select a
variety of review and assessment strategies for various types of procedures, all authorized
procedures should have appropriate periodic review.

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A process for canceling existing procedures is also established to provide a method for
ensuring that procedures that are no longer necessary or no longer used are effectively
removed from the system.

Evidence that the Principle is fulfilled

To fulfill this principle, develop change control provisions that:

Include adequate restrictions to ensure the revision process contributes to maintaining

procedure integrity,
Ensure timely completion of revisions,
Ensure all affected organizations review the proposed revisions,
Provide a mechanism for periodic review and cancellation of procedures.

Procedure System Support Principles

A procedure process does not end once a procedure is signed off as approved. Support
processes and resources are needed that:

Make sure procedures are provided in a timely and disciplined manner to the users,
Maintain and ensure retrievability of records of the procedures development and use,
Match production resources to the numbers and complexity of procedures generated
and to the distribution needs,
Maintain an effective link between the procedure system and the training program.

Principle 12: A document control and delivery system ensures that the correct
and current versions of procedures are available for use.
An important part of the overall procedure system is controlled delivery to ensure that the
correct and current version of a procedure is available where and when needed. Control
of procedures should be an integral part of an organization's document control system.
Several elements are needed to properly control procedure distribution: a procedure
index, standardized distribution lists, a method for providing receipted control, and a
delivery system commensurate with the volume and types of procedures.

Procedure index
A procedure index lists all approved procedures, listing at a minimum the procedure
name, number, and revision. This list is maintained to ensure that the most current
version of the procedure is used to perform the task. Because selecting an outdated or
superseded procedure is a frequent cause of procedure-related human performance error,
the index is not only a basic administrative control but also allows procedure users to
locate the correct, current, and approved procedure.

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Delivery control system

The delivery control system provides a means to ensure procedures are in place, are made
available to procedure users, and the procedure users know where to find them. All
procedure presentation types, hard copy, electronic and user aids must be controlled in
accordance with procedure system requirements. As appropriate, the delivery system is
able to accommodate:

Procedures to be issued on a routine basis,

Procedures that require expedited processing,
Procedures that may require special controls due to inclusion of sensitive,
proprietary, or classified information.

Each of these attributes carries specific requirements for reproduction activities, access
control, and delivery administration. Therefore, several factors - not only the number of
procedures or the number of procedure users - demonstrate why document control is
recognized as integral to the overall procedures system.
Delivery lists identify the location where controlled procedures are available. These lists
may be structured on a procedure-by-procedure basis or may be grouped in support of the
work (for example, by institution, facility or activity). These lists are maintained to
ensure that those who use the procedure receive the appropriate procedure and
subsequent revisions.
The receipt system - which is often accomplished by written receipts or computer records
from electronic distribution - records which version of the procedure has been issued,
identifies each controlled copy of a procedure, provides notifications and updates when
procedure changes are released, and logs the procedures back -if a mandatory return
program is used.

Evidence that the Principle is fulfilled

To fulfill this principle, design and implement a document control program capable of
handling the types, number, and volume of procedures. This document control program
includes:

An index of procedures,
Controlled delivery lists for hard copy or electronic distribution,
Mechanisms for documenting and monitoring custodial assignments,
Production and distribution capabilities.

Principle 13: Procedure records are accessible and retrievable

A records program provides the historical counterpart to the document control program.
Ready access to the history of proceduralized operations is needed for development of
new procedures, revision of existing procedures, procedure reviews and audits. The
records program includes access to and retrievability of procedure records, including:

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procedure history files that document the bases and decisions made in the
development of the initial procedure and its revisions,
superseded versions of procedures,
feedback records generated following use of the procedures,
periodic reviews.

The procedure system must ensure:

that procedure files and procedure-generated records such as checklists, forms, and logs,
are retained and made part of institution records program.
that results of periodic procedure reviews and audits are maintained to document that
procedures were reviewed for technical accuracy and usability on a regularly scheduled
basis.
that the records program affords a timely and effective means to retrieve superseded
procedure revisions and interrelated supporting materials (e.g. bases information). The
latter is important because reviews may require support materials, not just the superseded
procedure.

Evidence that the Principle is fulfilled

To fulfill this principle, establish a records program that:

Identifies and collects designated procedure materials as part of the ongoing records
program.
Allows for retention and retrieval of interrelated procedure materials (superseded
revisions, development materials) as part of an overall effort to document the
historical integrity of operations.
Ensures personnel are knowledgeable of records requirements and deliver materials
to the records program in an appropriate and timely fashion.

Principle 14: Information management resources support the procedure

system.
A comprehensive procedure system requires significant information management
support. This support includes production capabilities for procedures, integration
programs to track commitments and interrelationships among procedures, document
control systems, records management for retrieval of support documentation, and
distribution capabilities. Therefore, the development and design of the procedures
system requires up front acknowledgement, design, and allocation of information
management resources.
Among the information management resources needed to support the processing and
production of the procedures are:

Production capabilities to support effective use of development and design principles,

Production capabilities consistent with the anticipated volumes and to support
effective use of development and design principles,

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Information management resources that support tracking of commitments and

requirements to ensure agreed to obligations are traceable and visible within the
procedure system,
Identification and tracking of procedure bases documentation to ensure development
logic is retrievable as needed,
Integration of procedures to afford coordinated processing of all procedures affected
when a revision or new procedure is introduced,
Technology assessment and upgrades for other production activities such as printing,
distribution, and control of procedures. This support may include distributed
processing of a document, multiple distribution centers, on-demand printing, and
electronic procedure programs.

During all phases of the document life cycle, it is important that information is available
on the status of a document (whether in development, review, revision, etc.), the current
version of the document, the availability of the document (for example, where it can be
accessed), and who has ownership and custodial responsibility for the document. For
these reasons, allocation of appropriate information management support services is a
significant contributor to establishing and maintaining an effective procedures program.

Evidence that the Principle is fulfilled

To fulfill this principle, assess the kinds and amount of information management
resources needed to operate the procedures system. These resources include support for:

Procedure production,
Tracking of commitments, requirements, and procedure bases documentation,
Document control and records activities,
Procedure duplication and distribution,
Continued technology reassessment and upgrades to the procedure management
program.

Principle 15: An effective training and qualification program supports the

procedure system.
Procedure systems are supported by training and qualification designed to ensure
personnel understand the procedure system requirements, and that they are capable of
developing, using, and revising procedures.

Managers training
Managers responsible for the work are trained on:

the logic of procedure system management requirements,

when procedures are needed,

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how procedures support ISM and safe and efficient operation,

how procedures interconnect with other procedures and support management control
systems,
how procedures support management expectations and commitments.

Most importantly, the training emphasizes that procedures, as with systems, equipment
and tools, should be owned by managers and workers who are accountable for their
proper production and use.

Procedure users training

The procedure training program shows employees how and when to use procedures and
the procedure system including:

operation by procedure,
how the procedure process works,
the employees obligation in ensuring the integrity of the procedure system.

Training on specific procedures is also provided and training logic and resources (for
example, simulators) made available, consistent with objectives of the procedure system.

Procedure developers training

Procedure developers are trained in performing work and human performance task
analyses, developing and documenting the procedure bases, and in the use of writers
guides. Reviewers and validators are trained to understand the procedure system and its
relationship to ISM, and to perform appropriate technical and interdisciplinary reviews.
Validators are trained to understand the methods of validation and the requirements for
validation.

Qualification
In addition to training, the organization should establish provisions to determine that
managers, procedure developers, procedure reviewers and procedure users are qualified
to perform their responsibilities. Qualification factors include knowledge and experience,
the level of supervision involved in assigned tasks and whether assigned tasks will be
performed individually or by a team.

Evidence that the Principle is fulfilled

To fulfill this principle, ensure the availability of procedures system training and
qualification for:

Management,
Procedure users,
Procedure developers,
Procedure Reviewers.

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