Document Control Requirements

1\. 10 CFR 830.120, 121, 122 / DOE O 414.1C:

# 

# Criterion 4 - Documents & Records

Documents shall be prepared, reviewed, approved, issued, used, and
revised to prescribe processes, specify requirements, or establish
design. Records shall be specified, prepared, reviewed, approved, and
maintained.

2\. ISO 14001:2004 Standard:

**Control of Documents**

Documents required by the environmental management system and by this
international standard shall be controlled. Records are a special type
of document and shall be controlled in accordance with the requirements
given in 4.5.4 (Control of Records).

The organization shall establish, implement, and maintain a procedure(s)
to

a\) approve documents for adequacy prior to issue;

b\) review and update as necessary and re-approve documents;

c\) ensure that changes and the current revision status of documents are
identified;

d\) ensure that relevant versions of applicable documents are available
at points of use;

e\) ensure that documents remain legible and readily identifiable;

f\) ensure that documents of external origin determined by the
organization to be necessary for the planning and operation of the
environmental management system are identified and their distribution
controlled; and

g\) prevent the unintended use of obsolete documents and apply suitable
identification to them if they are retained for any purpose. \[ISO
14001, 4.4.5\]

3\. OHSAS 18001:1999 Specification:

**Document and Data Control**

The organization shall establish and maintain procedures for controlling
all documents and data required by this OSHAS specification to ensure
that:

a\) they can be located;

b\) they are periodically reviewed, revised as necessary, and approved
for adequacy by authorized personnel;

c\) current versions of relevant documents and data are available at all
locations where operations essential to the effective functioning of the
OH&S system are performed;

d\) obsolete documents and data are promptly removed from all points of
issue and points of use, or otherwise assured against unintended use;

e\) archival documents and data retained for legal or knowledge
preservation purposes, are suitably identified. \[OSHAS 18001, 4.4.5\]

**Accidents, incidents, non-conformances and corrective and preventive
action**

The organization shall implement and record any changes in the
documented procedures resulting from corrective and preventive action.
\[OHSAS 18001, 4.5.2\]

4\. OHSAS 18001:2007 Standard:

Documents required by the OH&S management system and by this OHSAS
Standard shall be controlled. Records are a special type of document and
shall be controlled in accordance with the requirements given in 4.5.4.

The organization shall establish, implement and maintain procedure\[s\]
to:

a\) approve documents for adequacy prior to use;

b\) review and update as necessary and re-approve documents;

c\) ensure that changes and the current revisions status of documents
are identified;

d.) ensure that relevant versions of applicable documents are available
at points of use;

e.) ensure that documents remain legible and readily identifiable;

f.) ensure that documents of external origin determined by the
organization to be necessary for the planning and operation of the OH&S
management system are identified and their distribution controlled, and

g.) prevent the unintended use of obsolete documents and apply suitable
identification to them if they are retained for any purpose.

5\. DOE 5480

CONDUCT OF OPERATIONS REQUIREMENTS FOR DOE FACILITIES

Change 2: 10-23-01

CHAPTER XVI

OPERATIONS PROCEDURES

A. INTRODUCTION

Operations procedures are written to provide specific direction for
operating systems and equipment during normal and postulated abnormal
and emergency conditions.

Operations procedures should provide appropriate direction to ensure
that the facility is operated within its design bases and should be
effectively used to support safe operation of the facility. Other
methods of disseminating operational information are addressed in
Chapter XI, Operator Orders, and Chapter XVII, Operator Aid Postings.
This chapter describes the important aspects of operations procedure
development and use.

B. DISCUSSION

Procedures are a key factor affecting operator performance. Appropriate
attention should be given to writing, reviewing, and monitoring
perations procedures to ensure the content is technically correct and
the wording and format are clear and concise in accordance with
NUREG‑0899. Although a complete description of a system or process is
not needed, operations procedures should be sufficiently detailed to
perform the required functions without direct supervision. Consistency
in procedure format, content, and wording is essential to achieve a
uniformly high standard of operator performance. Operators should not be
expected to compensate for shortcomings in such procedures as poor
format or confusing, inaccurate, or incomplete information. Instead,
procedures should be written in such a way that they can be easily used
without making mistakes.

During the course of operations, technical and operational requirements
change and better ways of doing things develop. To ensure that
procedures in use provide the best possible instructions for the
activity involved, periodic review and feedback of information are
essential.

The facility policy on use of procedures should be clearly understood by
all operators. Properly controlled and readily available procedures
promote use and ensure that operational activities will be conducted in
the manner intended.

C. GUIDELINES

1\. Procedure Development

To ensure consistency among operations procedures, the methods for
developing new procedures, including procedure formats, should be
clearly defined. Administrative procedures and/or writers\' guides
should direct the development and review process for procedures.

Procedures should be developed for all anticipated operations,
evolutions, tests, and abnormal or emergency situations.
Annunciator/alarm response procedures that guide the operator in
verifying abnormal conditions or changes in plant status and provide the
appropriate corrective action should be developed for all alarm panels.
All procedures should provide administrative and technical direction to
conduct the intent of the procedure effectively. The extent of detail in
a procedure should depend on the complexity of the task, the experience
and training of the user(s), the frequency of performance, and the
significance of the consequences of error.

Procedure preparation, verification, and validation should receive
high‑level attention. Qualifications for procedure writers should be
considered, including operating organization and experience. Review,
verification, and validation should be formalized for written and
software procedures.

2\. Procedure Content

To provide uniformity in operations procedures, the content of
procedures should conform to prescribed guidelines. The procedure
aspects described below should be followed when developing operations
procedures:

a\. The scope and applicability of individual procedures should be
readily apparent. Procedures with single‑unit applicability should be
distinctively identified to avoid confusion with sister‑unit procedures.
In addition, to enhance rapid retrieval, emergency procedures should be
distinguishable from other procedures. Color coding could be used for
these purposes.

b\. Procedures should incorporate appropriate information from
applicable source documents, such as the facility design documents,
safety analysis documents, and vendor technical manuals.

c\. Prerequisites and initial conditions should be detailed. Careful
consideration should be given to the location of this information within
the procedure in order to help ensure that the intent of the procedure
is understood. In addition, any hoses, tools, or other temporary testing
equipment should be verified operable, calibrated, or inspected and in
good condition where possible, before implementing any test procedure,
to ensure that they function as expected during the test. These
verifications should be identified in the prerequisite section, with
completion sign‑offs required. \"Hold\" points (requiring independent
verification and/or approval) should be clearly delineated.

d\. Definitions used in the procedure should be explained.

e\. Procedures should be easily understood, and actions should be
clearly stated.

f\. Procedures should contain only one action per step.

g\. Procedures should contain sufficient but not excessive detail. The
skill level, experience, and training of the users should be considered.

h\. Warnings, notes, and cautions should be easily identifiable and
should not contain action statements. The probability of missing an
action step increases when it is included in a warning, note, or
caution.

i\. Warnings and cautions should precede the step to which they apply.
Warnings, notes, and cautions should appear on the same page as the step
to which they apply. This ensures that operators are alerted to
necessary information before performing a procedural step.

j\. Procedures should be technically and administratively accurate
(i.e., the instructions and information should be correct; referenced
documents should be correctly identified; and necessary instructions
should be present to guide the user when transferring between
procedures).

k\. Individual sign‑offs should be provided for selected critical steps.
One sign‑off should not be applied to more than one action.

l\. Limits and/or tolerances for operating parameters should be
specified and should be consistent with the readable accuracy of
instrumentation. Operators should not be required to perform mental
arithmetic to determine if a specified parameter is acceptable.

m\. Acceptance criteria for surveillance or test procedures should be
easily discerned, including tolerances and units. If calculations are
needed to compare data to acceptance criteria, the calculations should
be clearly explained. n. Sequence of procedural steps should conform to
the normal or expected operational sequence. Training on this sequence,
reinforced with procedures that show the same sequence, will serve to
improve operator performance by development of patterns of action that
are more easily remembered.

o\. Procedures should be developed with consideration for the
human‑factor aspects of their intended use. For example, references to
components should exactly match drawing and label‑plate identifiers,
units should be the same as those marked on applicable instrumentation,
and charts and graphs should be easily read and interpreted. Important
factors (such as operating limits, warnings, cautions, etc.) should be
highlighted.

p\. Emergency operating procedures should provide guidance in responding
to single and multiple casualties.

q\. Portions or steps of other procedures that are used or referred to
when performing a procedure should be specifically identified within the
procedure so that operators will not be confused when transferring
between procedures.

r\. Component or system shutdown and restoration requirements following
shutdown or a surveillance or test activity should be specific and
controlled by the procedure.

3\. Procedure Changes and Revisions

Procedure changes and revisions are necessary to ensure that procedures
reflect current operating practices and requirements. The review and
approval process for each procedure change or revision should be
documented. For the purpose of these guidelines, a \"procedure change\"
refers to an on‑the‑spot change (whether for permanent or for
one‑time‑only use). Procedure changes do not involve retyping or
reissuing a procedure. \"Procedure revisions\" constitute a new, retyped
edition of the procedure. Procedure changes and revisions should conform
to the following practices:

a\. Procedure changes intended for use more than one time should be
documented in a location readily available for operator reference. To
avoid the possibility of error, these changes should also be referenced
in procedure copies used by operators.

b\. Appropriate procedure changes and revisions should be initiated when
procedure inadequacies or errors are noted.

c\. Procedure revisions should be initiated when a change has been
outstanding for an extended period (e.g., greater than 6 months) or when
a procedure has been affected by several changes (e.g., more than five).
All currently effective procedure changes should normally be
incorporated when the procedure is revised.

d\. Procedure revisions should be implemented concurrently with
modifications. Procedure updates required by temporary modifications
should be handled as procedure \"change\" and implemented concurrently
with the temporary modification installation.

e\. Important information regarding changed or revised procedures should
be communicated to appropriate operations personnel via the required
reading system (Chapter XIV), a pre‑shift briefing, or a similar method.

f\. Documentation of the reason for key procedure steps should be
maintained and reviewed when implementing changes or revisions that
alter these steps. This practice is important to ensure that the reason
for any step is not overlooked.

g\. The review process should involve verification and validation of the
procedure using walkthroughs or similar methods.

4\. Procedure Approval

Operating procedures should be approved by the operations supervisor. In
addition, procedures that affect safety‑related equipment and emergency
procedures should be reviewed by the facility safety review committee or
by another appropriate review mechanism. Procedure revisions should
receive the same depth of review and level of approval as the initial
versions. New and revised procedures should be approved prior to use.

Changes in Operations procedure that do not affect the intent of
operations procedure should be approved by two individuals; one should
be a qualified operator, and the other should be a member of facility
management. For this purpose, management could be interpreted to mean
the operations supervisor or a more senior individual within the
operating organization. Within 2 weeks, these procedure changes should
be concurred with by the individuals who would normally approve a
revision or the Initial version of the procedure. Changes that alter the
intent of a procedure should receive the same approval as a new or
revised procedure.

5\. Procedure Review

New and revised operations procedures should be reviewed prior to
issuance and at periodic intervals to ensure that the information and
instructions are technically accurate and that appropriate human‑factor
considerations have been included. The frequency of subsequent reviews
should be specified; it may vary with the type and complexity of the
activity involved and with time as a given plant reaches operational
maturity. Applicable procedures should be reviewed after an unusual
incident (such as an accident, an unexpected transient, significant
operator error, or equipment malfunction). During reviews, procedures
should be compared to source documents to verify their accuracy. In
addition, new procedures should be validated by walk‑throughs in the
facility or by operation on a facility‑specific simulator to ensure
workability.

6\. Procedure Availability

A controlled copy of all operations procedures should be maintained in
the control area for operator reference, and selected controlled
procedures should be maintained at other appropriate locations. For
example, controlled procedures for facility shutdown from outside the
control area should be maintained at the remote shutdown location(s). It
may be desirable to have procedures for routine evolutions available at
local work stations.

Working copies of controlled procedures should be available for use
during evolutions. However, since these documents have only a limited
lifespan, working copies should be controlled and a system should be in
place to ensure that outdated procedures are not used by mistake and
that working copies are replaced according to approved procedures. For
example, uncontrolled working copies could be verified by comparison to
a controlled copy prior to use.

Controlled annunciator response procedure information should be easily
accessible to the operators responsible for responding to alarms. Some
facilities can provide annunciator response procedures at local control
panels. If this is not done, annunciator response procedures should be
provided at an alternate location convenient to the equipment operator.

7\. Procedure Use

Facility operation should be conducted in accordance with applicable
procedures that reflect the facility design basis. The requirements for
use of procedures should be clearly defined and understood by all
operators. If procedures are deficient, a procedure change should be
initiated. In exception to this policy, operators may take whatever
action is necessary during emergency conditions to place the facility in
a safe condition, and to protect equipment, personnel, and public safety
without first initiating a procedure change.

Operators should have procedures with them and follow them in a
step‑by‑step manner when the procedures contain sign‑offs for the
various activities. In addition, procedures should be referenced during
infrequent or unusual evolutions when the operator is not intimately
familiar with the procedure requirements or when errors could cause
significant adverse impact to the facility. Operators need not reference
emergency procedures during the performance of immediate actions since
these actions, are committed to memory; however, the emergency procedure
immediate action instructions should be reviewed after the actions are
performed, thus, verifying, that all required actions have been taken.

CHAPTER XVII

OPERATOR AID POSTINGS

A. INTRODUCTION

Facility operator aids (information posted for personnel use) should
provide information useful to operators in performing their duties. An
operator aid program should be established to ensure that operator aids
that are posted are current, correct, and useful. This chapter describes
the important aspects of an operator aid program.

B. DISCUSSION

Operator aids provide an important function in the safe operation of the
facility. Operator aids may come in many forms: copies of procedures
(portion or pages thereof), system drawings, handwritten notes,
information tags, curves, and graphs. It is important to make sure that
these types of postings reflect the most current information available
and that they do not supersede or conflict with any other controlled
procedure or information.

C. GUIDELINES

1\. Operator Aid Development

Any facility employee could develop an operator aid; however, it should
be approved prior to posting. Operator aids (system drawings,
maintenance procedures, etc.) may often be posted by individuals other
than operations personnel; therefore, all facility personnel should be
informed of the importance of controlling posted information and the
procedure to be followed when posting information.

2\. Approval

The operations supervisor, or a higher authority, should approve all
operator aids. The person approving an operator aid should ensure that
the aid is necessary and correct. Operator aids that alter procedures
should not be approved. Instead, appropriate procedures should be
changed to incorporate the necessary information.

3\. Posting

Operator aids should not be posted in such a way as to obscure
instruments or controls. The aids should be located in close proximity
to the area of their expected use. The operator aids should, when
possible, be protected (laminated) and should be securely fastened to
the equipment to which they refer.

4\. Use of Operator Aids

Operator aids should be viewed as a convenience to the individual using
them, not a requirement. In most cases, operator aids remind users of
information that might otherwise be overlooked and provide guidance that
is not procedural in nature. Operator aids may supplement approved
procedures, but they should not be used in lieu of approved procedures.

5\. Documentation

A listing of all approved operator aids should be maintained along with
a copy of each aid posted in the facility. This list should be used
during periodic reviews of operator aids in order to help ensure that
the posted aids remain current, and to provide a reference copy should
an operator aid be missing during the review. The list should be kept in
the control area, the operations supervisor\'s office, or other
appropriate location. References from which operator aids were derived,
control numbers (including revision), and dates of approval should be
provided.

6\. Review

The posted operator aids should be reviewed periodically to ensure they
are still correct and necessary. In addition, an operator should audit
the control area listing to ensure that only currently posted aids are
recorded on the listing. Operator aids no longer posted should be
removed from the listing, and missing aids should be replaced.

Some operator aids are graphs, curves, or other portions of approved
procedures. To help ensure that these types of operator aids are the
most current versions, they should be updated when the \"parent\"
procedure is revised. One way to accomplish this is to notify
appropriate document control personnel of those operator aids that are
derived from procedures. When a revision is made to one of these
procedures, document control would notify the control room to check the
affected operator aid and see if changes are necessary.

During routine facility inspections, operations personnel should review
operator aids to ensure that they are approved. Unapproved postings
should be submitted for approval or removed. It is important for all
personnel to understand that the use of an out‑of‑date operator aid
could be just as detrimental as the use of an out‑of‑date procedure.