The purpose of this procedure is to define the method
for Document Control which includes the following:
·
Document
development
·
Document
review
·
Document
approval
·
Document
issuance
·
Changes
to Documents
·
Identification
and removal of obsolete documents
·
Document
Storage
2.0
Scope
This procedure is applicable to all QMS documentation
(as identified in the Master List of Documents – except Records) and all
personnel whose activities affect drinking-water quality.
Document Categories subject to the scope of this
System Level Document:
·
Operational
Plan
·
System
Level Documents
·
Templates
·
Process
Maps
·
Standard
Operating Procedures
·
Work
Instructions
·
Blank
Forms
·
Documents
of external origin (as specified in the Master List of Documents)
3.0
Definitions
·
·
DCR: Document
Change Request
·
Operational
Top Management: Waterworks General Manager, Manager of IMS, Manager of
Infrastructure, Manager of System Engineering, Manager of Operations &
Maintenance, Training Coordinator, QMS Controller
4.0
Procedure
Document Development
4.1
Any
employee of the Markham Waterworks may request that a document be created and
included under the control of this procedure.
4.1.1
Employees
shall obtain a DRF from the QMS Representative or from the on-line repository
of QMS Forms.
4.1.2
The
employee shall complete the form and submit a hard-copy to the QMS
Representative.
4.2
The
QMS Representative shall review the DRF.
The purpose of the review is to ensure that the newly requested
document:
·
Does
not already exist in the system, in whole or in part
·
Adds
value to the QMS.
If the requested document does not exist, go to: 4.3.
4.2.1
If
the document already exists then the QMS Representative shall advise the
employee of the title and location of the document.
4.2.2
If
the document exists only in part, then the QMS representative shall determine
if modifications to the existing document would add value to the QMS.
4.3
The
QMS Representative shall determine if the requested documentation adds value to
the QMS. In making this determination,
the QMS Representative may at his/her discretion, seek input from other
sources.
4.3.1
If it
is determined that the requested document does not add value to the QMS then
the QMS Representative shall document the rationale for rejecting the request
per the DRF and return a copy of the DRF to the originator.
4.3.2
If
the requested document is to be developed and added to the QMS, then the QMS
Representative shall approve the DRF and forward a copy to the originator.
4.3.3
The
completed (original) DRF shall be filed in the Document Control Master File
retained by the QMS Representative.
4.3.3.1 The Master List of Documents shall be
updated identifying the new document by name, it’s alpha-numeric control
designation and it’s status (Draft).
4.4
The
document originator shall select the appropriate document template and then,
using that template, produce a draft document as per the requirements
identified in the DRF.
Document Review, Approval
and Issuance
4.5
A
copy of the draft document shall be placed in the “Pending Approval Folder” by
the document originator.
4.6
The
originator shall advise the QMS Representative that a draft copy of the new
document has been placed in the “Pending Approval Folder”.
4.7
The
QMS Representative shall conduct an initial review to confirm all spelling,
grammar and format, as well as to ensure that all required portions of the
document template have been completed by the originator. If the document is
acceptable as submitted, then go to 4.7.3.
4.7.1
Any
errors or omissions shall result in a notification being sent to the originator
requesting the necessary changes.
Changes may also be suggested using a hard or soft copy of the original
document.
4.7.1.1 All comments and required changes shall be
annotated using the “Track Changes” function in the Word Processor, or in hard
copy.
4.7.1.2
The
QMS representative shall delete the copy of any draft returned to the
originator from the “Pending Approval” folder.
4.7.2
The
Draft Document shall be amended by the originator and returned to the “Pending
Approval Folder”. The originator shall
advise the QMS Representative that the document has once again been placed into
the folder.
4.7.3
Draft
documents that meet the requirements of the initial review shall be submitted
by the QMS Representative to the Section Manager for review. A copy of the
draft shall remain in the “Pending Approval Folder”.
4.8
The
Section Manager shall review the submitted draft procedure and make one of the
following recommendations:
·
Accept
as is, or
·
Return
it to the QMS Representative to address identified concerns.
4.8.1
If
the document is “Accepted as is”, the Section Manager shall inform the QMS
Representative indicating it has been accepted, then go to 4.9.
4.8.2
Concerns
shall be annotated using the “Track Changes” function in the Word Processor, or
in hard copy.
4.8.3
The
annotated document shall be forwarded to the QMS Representative.
4.8.3.1
The
QMS Representative shall replace the existing document in the “Pending Approval
Folder” with the annotated Document received from the Section Manager.
4.8.3.2
The
QMS Representative shall advise the originator, by email, that the document has
not been accepted by the Section Manager and will require changes/updating.
4.8.3.3
The
document originator shall make the required changes. Go to 4.6.
4.9
The
QMS Representative shall approve the new document and update the status of the
Master List of Documents to “Released”.
4.10
The
QMS Representative shall move the new document from the “Pending Approval
Folder” to the “Controlled Document Folder”. All Section
4.11
For
Operational Plan and System Level Documents, endorsement from the Owner will be
required after any major revision. For any lower level documents, approvals can
be obtained by Operational Top Management.
4.12
The
first issue of each controlled document is revision 1.0, and will be added by
1.0 after each revision.
Changes to Documents
4.13
All
changes to documents shall be made through the use of the Document Change
Request (DCR).
4.14
Any
employee may request a change to an existing document by completing a DCR.
4.14.1 The DCR shall be submitted to the QMS
Representative to determine if the change requested is necessary.
4.14.2 The QMS Representative shall review the
validity of the change requested and make the determination if the change is
required.
4.14.2.1
If
the change is required, go to 4.14.3
4.14.2.2
If
the change is deemed to be unnecessary, the originator shall be advised, by
email, that no change to the subject document shall be at this time.
4.14.2.3
The
QMS Representative shall destroy the DCR.
4.14.3
The
QMS Representative shall change the document, following steps 4.5 through 4.9
inclusively.
4.14.4
The
changed document shall be placed in the QMS Master Document Folder.
4.14.4.1
The
obsolete copy shall be removed from both locations and destroyed.
4.14.4.2
The
Master Document List shall be updated showing the new revision level of the
changed document.
4.15
The
QMS Representative shall advise Operational Top Management, that a document
change has been made. The completed DCR shall be filed in the Document Control
Master File.
4.16
Any
minor change that does not affect the content of the controlled document (i.e.
format, reference, etc.) will be completed by the QMS Representative, and new
revision will not be issued until a major change is required, but the changes
will be recorded.
Documents Control
4.17
Master
copies of all controlled documents are maintained electronically by the QMS
Representative. These documents are available online for view only access. Any
changes to any controlled document must be requested via the Changes to
Documents process (4.12 to 4.15).
4.18
The
electronic master copies are controlled by the QMS Representative to ensure the
documents are up-to-date and at the latest revisions. Any printed copy of any
controlled document will become uncontrolled and is not controlled under this
process.
4.19
Staff
shall always refer to the online copy as the current revision of each
controlled document. Any printed copy shall be verified with the online copy
prior to be in use, in order to ensure the printed copy still valid.
4.20
QMS
Representative can issue controlled hard copy of any controlled document when
deemed necessary. Such hard copy will be identified as Controlled Document, and
will be controlled as such. Any hard copy controlled document will be listed on
the Master List of Controlled Document.
Annual Documents Review
4.21
To
ensure all controlled documents are up-to-date, each document will undergo an
annual review.
4.22
The
QMS Representative will keep track of the issue date of each controlled
document. Upon the anniversary of each controlled document, the QMS
Representative will coordinate the review of such controlled document with the
original author, or the Section Manager of the belonging controlled document.
4.23
If
the controlled document is required to be updated to reflect the current
practice, proper Document Change to procedure must be followed (4.12 to 4.15).
4.24
If no
change is required, the reviewer will advise the QMS Representative and the
review date will be recorded on the Master List of Controlled Document to
indicate such controlled document has been reviewed.
Obsolete Documents
4.25
The
QMS Representative shall ensure that all obsolete documents shall be removed
from all point of issue not later than 4 weeks after the issuance of an updated
version, or, after having been identified during the course of an internal or
external audit.
4.26
Minimum
retention requirements for obsolete documents are shown in the table below, not
including records. Retention of
documents beyond the requirements listed in the table is at the discretion of
the QMS Representative.
|
Document |
Minimum Retention |
|
Operational Plan |
At least the previous revision level,
retained indefinitely |
|
System-Level Document |
At least the previous revision level,
retained indefinitely |
|
Template |
No retention of obsolete template
required |
|
Process Map |
At least the previous revision level,
retained indefinitely |
|
Standard Operating Procedure |
At least the previous revision level,
retained indefinitely |
|
Work Instruction |
At least the previous revision level,
retained indefinitely |
|
Blank Form |
No retention of obsolete template
required |
|
Document of External Origin |
At least the previous revision level,
retained indefinitely |
|
Other |
At the discretion of the QMS
Representative |
4.26.1 Obsolete documents shall be clearly marked
as being “Obsolete”.
4.26.2 All obsolete documents shall be retained
in the “Obsolete Documents Folder” that is maintained by the QMS
Representative. Access to this folder
shall be restricted to the QMS Representative and/or his/her designate, as
appropriate.
4.26.3 Obsolete documents not being retained
shall be destroyed by the QMS Representative or designate.
Network Back-Up of QMS Folder
4.27
The
ITS Manager shall ensure the network QMS folder is backed-up.
4.27.1 Tape backups of all servers shall be
performed every weekday evening.
4.27.2 Backup software shall be utilized when
applicable.
4.27.3 Tapes shall be rotated bi-weekly, with an
appropriate number of tapes allocated for backups.
4.27.4 Tapes shall be stored in the ITS fireproof
safe.
4.27.5 Data restores from tape shall be tested
quarterly by ITS personnel.
5.0
Associated
SOPs
·
Not
applicable
6.0
References
·
DWQMS
Element 5 Document and Records Control
·
Legislative
references as outlined in Section 5.0
7.0
Records
·
Completed
Document Request Forms
·
Completed
Document Change Request Forms
8.0
History
of Changes
|
Revision |
Date |
Description |
By |
|
2.0 |
|
Additions
4.11, 4.12, 4.16, 4.17 to 4.24; Realign referencing paragraph numbers;
Sections 4.7.1.1 & 4.8.2. |
E. Wu |
|
|
|
|
|