Document 5LpOVgg7e15EXpaNyz10mNOzN
Section Number: issue Number Original Date: Revision Date: Titl :
Ref rences:
Ethanolamines/Glycol Ethers
Tier 3 Operating/Quality Procedure
1506
2.1
10- 24-92
11- 11-96
Author Mike Viator
Procedures - ISO Format, Issue Determination, Revision And Approval Method
For All Procedures.
ISO 9002-1994
QSP03 Document Control
1501 Assignment Of Section Numbers
1-809 Management of Change
1515 Document Manager System Operation
1506 Procedures - ISO Format, Issue Determination, Revision And Approval Method For All Procedures:
1.0 Objective: 1.1 To ensure consistency in procedure development, approval, and revision/issue determination.
2.0 Responsibility: 2.1 The responsibility for document control, approval and issue rests with the plant Superintendent and production supervisor.
2.2 It is the responsibility of individual plant employees, developing new or modifying existing procedures, to follow this procedure for formatting, approval and issue.
2.3 It is the responsibility of the Operations personnel to insure that the approval process is completed prior to procedure use for new or modified procedures.
2.4 It is the responsibility of the Document Manager, Office Professional, and Production Supervisor (those persons having security access to the Document Manager System) to insure that procedures input into the Document Manager System follow the requirements of this procedure.
3.0 Proc dure: 3.1 Format:
3.2 All procedures are to be written in the ISO format. ISO format primarily pertains to systematic numbering of procedure steps and inclusion of an objective and responsibility statements. This document is an example/ guide of formatting. Procedures developed for specific or unique jobs are defined as "Special procedures" in QSP03 and do not have to follow ISO formatting requirements at the time the job is done, but must have the appropriate approval signatures. These procedures should be formatted and input into the Document Manager System at the earliest convenient time.
3.3 Trouble shooting guides do not have to specifically follow the ISO format, but need to have the ISO headers and revision dates and notes.
3.4 All procedures input into the Document Manager System will address the following subjects. (Special procedures need to have these area addressed as appropriate to insure safe/quality-secure operation.)
Date Printed: April 18,1998 Paper Copies Of This Document Are Uncontrolled & Not Subject To Update.
The Controlled Document Resides In File: T:\ORIGINAL\QUAUTY\lsOFOR.DOC
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3.4.1 Objectiv : Needs to clearly define the purpose and/or intent of the procedure - Why the procedure is being written, what will you know when you finish reading the procedure, etc.
3.4.2
Responsibility: The responsibility area should address who will be responsible for the various aspects of the procedure. If multiple jobs are defined in the procedure, then responsibility needs to be defined for each job to insure proper completion.
3.4.3
Safety Notations: Any pertinent Personal Protective Equipment key to safe job completion (above and beyond standard PPE) needs to be listed in this category. If there are special handling, reactive chemical, or critical operating issues, then these would be listed in the safety notations area. This section may not be applicable to many procedures and can be left out if special safety notes are not needed.
3.4.4
Special Notations: This section should be used where appropriate to identify critical issues that need to be brought to the reader's attention other than safety issues. Examples may be critical environmental notes, critical operating issues that may affect quality, or notes referencing other documents critical to the proper completion of this procedure.
3.4.5 Procedure: Includes the detailed steps for proper completion of the task/s or process being described.
3.4.6
References: The reference listing in the header of the document needs to identify documents or other procedures that may provide clearer insight to the reader on various details associated with the current procedure or documents that are tied directly to the procedure such as checksheets. Examples: QSP03 is listed as a reference for this procedure because of the internal reference defining "special procedures". Management of Change is listed as a reference because it provides more detailed steps for getting approval for new or modified procedures. On a procedure requiring the use of a flex hose, the procedure "Use of Flexible Hoses" should be referenced because it provides background information to the reader on how to check flex hoses prior to use. The reference section allows a short cut means of referencing other procedures to prevent having to rewrite that information in every procedure. The intent is to list key procedures/documents critical to the safe or proper completion of the task, not every procedure that has some token bearing. The reference section also provides an easy method of insuring that all related documents get revised as needed changes are made.
3.5 Other issues to address in a procedure may be definitions, method, inventory requirements , check sheets, description, etc. Other subjects will depend on the procedure itself, (where appropriate operating limits and consequences of deviation will be included in the body of the procedure.)
4.0 Issu D termination: 4.1 All original procedures will start out as issue one with no revisions. (1.0)
4.2 This will be documented in the header of the procedure.
4.3 As procedures are revised, each revision will be given the next number in a revision series. A revision series is defined as six total versions of the documents (the original and 5 additional revisions). An example of a revision series is documents 1.0 (original), 1.1,1.2,1.3,1.4, and 1.5.
4.4 Five revisions (six versions including the original version of the series) will be allowed for each number before the next revision series begins. This means that issue numbers 1.0 to 1.5 may occur. The sixth revision will mandate another revision series starting. The issue number following 1.5 will be 2.0, not 1.6.
4.5 An exception to the revision series numbering will occur when a Tier 1,2 or 3 procedure has been drastically changed making the recording of all the changes in the revision notes impractical. When these type changes occur, the issue number will go to the original status in the next revision series with no
Date Printed: April 18,1998 Paper Copies Of This Document Are Uncontrolled & Not Subject To Update. The Controlled Document Resides In File: T-.'0RIGlNAL\QUAUTY\lS0F0R.D0C
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revisions recorded. (Example: 1.3 is virtually rewritten. The new issue number would be 2.0 instead of 1.4) Changes can be seen by checking the management of change filed by the document control manager.
4.6 As a revision is made, a revision note will be recorded on the bottom of that document indicating the revision number, the date the revision was made and a description of the revision itself. Revision notes should be listed on all issues except the original issue in a revision series of documents (i.e., 1.0, 2.0, 3.0, etc. will have no revision notes.)
4.7 An example of a revision note is as follows:
4.7.1 Revision #1
Date Of Revision
Identification
5.0 Approval/Procedure:
5.1 Tier 3 procedure (a new procedure) will be reviewed by knowledgeable persons and approved by the
production supervisor or plant superintendent. The procedure must be signed and dated prior to use
and/or entry into the Document Manager System.
5.2 Tier 3 procedure (a change required in an existing procedure) will be reviewed and checked by a knowledgeable person and approved by the production supervisor or plant superintendent after a management of change form has been initiated.
5.3 Tier 2 procedure (a new or revised quality system procedure) will be approved by the production supervisor or plant superintendent.
5.4 Tier 1 procedure (a new or revised quality manual procedure) will be approved by the plant superintendent.
6.0 Section Numbers: 6.1 The document control manager or Office Professional will assign section numbers.
7.0 Issue/Revision Status: 7.1 The Document Manager System will be used to identify invalid and/or obsolete procedures. Only procedures in the Document Manager system or special procedures that are approved and dated will be considered valid procedures. Changes can not be made to the document manager system without a minimum of intermediate approval from the production supervisor.
8.0 Yearly Procedure Review: 8.1 All procedures are involved in this review. This includes Tiers 1,2 and 3 procedures and checksheets.
8.2 All procedures with current year origination or revision dates are considered reviewed. In addition, procedure review may be documented via the procedure tracker system. Review will not mandate a issue change and revision date change unless other changes are needed for the document.
8.3 All procedures to be deleted will be deleted without an MOC form. Hardcopy versions of these documents will be approved for deletion (signature and date) by the production supervisor and filed by the Document Manager with the MOC documents.
9.0 Revisions:
Revision 1
11-11-96
Added 3.3 and renumbered. Revised 3.4.6, 4.7.1,5.1,5.3, 8.1 and 8.2. Deleted 8.3 and 8.4
Date Printed: April 18, 1998 Paper Copies Of This Document Are Uncontrolled & Not Subject To Update. The Controlled Document Resides In File: T.\OfilGINAL\QUAUTY\lsOFOR.DOC
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