T3A INDUSTRIAL

DOC # AP-05-1001 Issue # 10 Page 1 of 10

STANDARD OPERATING PROCEDURE

TITLE: CREATION OF STANDARD OPERATING PROCEDURES

ISSUE DATE: //. ASSIGNEE PREPARED BY REVIEWED BY APPROVED BY EFFECTIVE DATE: //. NAME WAEL MOHAMED ALI MOHAMMED ELASSADY MOHAMMED ELSAADY REVISION DATE: //. TITLE QA OFFICER QA OFFICER QA SECTION HEAD SIGN./DATE

HISTORY OF CHANGE

T3A INDUSTRIAL
DOC # AP-05-1001
ISSUE # From Issue# 001 to Issue# 002 From Issue# 002 to Issue# 003 From Issue# 003 to Issue# 004 From Issue# 004 to Issue# 005 ISSUE DATE 08/11/1999 31/5/2000 17/06/2002 01/05/2005 PAGE # 7 4 1-10 1 7 1 4 1 2 3 4 5 10 11

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SUMMARY OF CHANGE

1. Procedure: Insert the file name &path on each page 2. Add numbering for additional 2 types of documents 1. Change in the title & assignee persons 2. Change in procedures 1. Change the assignee persons 2. Change in item 4.8.3. 1. Change in responsibility 3.2. & 3.3. 2. Addition of other code 4.5.1. 1. Change the format of the issue #, date and whole Document. 2. Change the Assignee Persons 3. Addition of points 3.1.5, 3.2.4, 4.3.4., 4.3.5., 4.3.6., 4.5. And 4.15. 4. Change in Point 4.1.1.1., 4.4.2. , 4.14. and 4.6.1. 6. Change in the attachment 5.1. 7. Change in pages number. 1.Change of margins. 2. Change in attachment 5.1. 3. Addition of specification preparation procedures. 4. Addition of attachment 5.2.,5.3., 5.4. and 5.5. 1.Change in Procedure in item # 4.10., 4.11. and 4.20.1. 2.Change in Responsibility in Item # 3.4.

From Issue# 005 to Issue# 06

21/10/2005

From Issue# 06 to Issue# 07 From Issue# 07 to Issue# 08

21/01/2006

All

17/07/2006

2,5,10

HISTORY OF CHANGE
PA G E # All

ISSUE #

ISSUE DATE

SUMMARY OF CHANGE 1.Change in Assignee persons. 2.Change in SOP title. 3.Change in Objective, scope, responsibilities, procedures and attachments. 1. Change in item # 4.3.6. 2. Change in item # 4.3.24. 3. Removing format unique #. From all attachments.

From Issue# 08 to Issue# 09 From Issue# 09 to Issue# 10

17/01/2007

25/03/2007

All

_____________________________________________________________________________________________________ PREPARED BY: REVIEWED BY: ... APPROVED BY: ..

T3A INDUSTRIAL
DOC # AP-05-1001 1.OBJECTIVE:
1.1.This SOP describes the procedure for creation of standard operating procedures.

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2.SCOPE:
1.1.This SOP applicable for standard operating procedures in all departments in T3A Industrial.

3.RESPONSIBILITIY:
3.1.Originating department initiator: Collecting the data, making a draft, organizing all raw data available; preparation, circulation of draft; make the corrections if needed and delivering it to Quality Assurance Officer. 3.2.Department manager or designee: Reviewing the master SOP before delivering it to quality assurance department. 3.3.Quality assurance officer or designee: Receiving of the master SOPs, reviewing, delivering to QA manager for approval, distribution and archiving. 3.4. QA Manager or designee: Reviewing, approval and system compliance.

4.PROCEDURE:
4.1. 4.1.1. SOP Approval procedure: The SOP Initiator shall:

4.1.1.1. Acquire and collate raw data and instructions. 4.1.1.2. Formulate a draft copy of the SOP for reviewing. 4.1.1.3. Circulate the draft SOP to review & approval signatories for comments. 4.1.1.4. Retrieve the SOP from signatories and incorporate necessary corrections. 4.1.1.5. The signatures shall be in the original copy only by the blue ink pen. 4.1.1.6. Define the proposed departments that shall be having a copy of the SOP. 4.1.1.7. Initiating a creation list, distribution list, attaching it with the SOP and delivering it to quality assurance documentation officer. 4.1.2. 4.1.3. 4.1.4. Quality Assurance documentation officer shall Assure that the SOP has the required format, has a unique SOP number and current issue number. Quality assurance manager shall approve the master SOP, determine the issue date and review date for the SOP. Effective date shall be after approval, training and collection of the obsolete copies.
_____________________________________________________________________________________________________ PREPARED BY: REVIEWED BY: ... APPROVED BY: ..

T3A INDUSTRIAL
DOC # AP-05-1001
4.1.5. 4.2. 4.2.1. 4.2.2. 4.2.3. 4.3.

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Documentation officer shall distribute the SOP after approval of the proposed departments defined by initiator. SOP re-Issue procedure: Each DOC has an expiry date at this date the SOP is subject to change, the change control procedure shall be followed. A new issue number shall be given to the reissued SOP. In the history of change; in the column of "summary of change" type "periodic review- no changes in the SOP". SOP format requirements:

4.3.1.Page set-up shall be as follow: 4.3.1.1.Orientation: Portrait and/or Landscape 4.3.1.2.Alignment. 1.5 cm 2 cm 4.3.2.The SOP shall be specific, objective and clear, so as to achieve its purpose. 4.3.3.All SOPs shall be created using Microsoft word. 4.3.4.Spacing between each adjacent word shall be one movement 4.3.5.Language of all shall be English. Except work instructions shall be in local language. 4.3.6.The SOP shall include a SOP number consist of eight digits as follow: 12 - 34- 5678 Where, Digit 1: denotes the department issuing the SOP as follow: Quality Control Quality Assurance Production Regulatory Affairs Engineering Administration Materials management ISO Occupational health and safety Finance Q A P R E D M I S F

_____________________________________________________________________________________________________ PREPARED BY: REVIEWED BY: ... APPROVED BY: ..

T3A INDUSTRIAL
DOC # AP-05-1001
Research and Development Information technology Human Resource Sales & Marketing Logistics & Services Other (not included as above) Digit 2 denotes the type of document as follow: Procedure Management responsibility. Quality system. Contract review. Design control Document and data control. Purchasing. Control of customer supplied product. Product identification and traceability. Process control. Inspection and testing. Control of inspection, measuring and test equipment. Inspection and test status. Control of non-conforming product. Corrective and preventive action. Handling, storage, packaging, preservation and delivery. Control of Quality records. Internal Quality Audits. Training. Servicing. Statistical techniques. P 01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18 19 20 Digits 3" & "4 reflect the No. of the subject of the SOP as follow:

Issue # 10
N T H K L O

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T3A INDUSTRIAL
DOC # AP-05-1001 Issue # 10 Page 6 of 10

Digit 5 denotes the issuing section or certain function in the department, it shall be expressed as a number unique to each section or function within the department (Each department shall have a key for this type of section or function numbering). Digits (6), (7), (8) indicate the SOP serial number. 4.3.7.Each SOP shall include an issue number which consist of 2 digits. 4.3.8. The SOP shall be consecutively numbered; each page has a number indicating the sequence of that page [Including the cover page and attachments] in the total number of pages of the SOP. e.g. 4.3.9. 1 of 3, 2 of 3 and 3 of 3. The font of the text shall be Times New Roman

4.3.10. The font size of document type shall be 14 Bold [All caps]. 4.3.11. The title of the SOP shall be unique, brief, descriptive title that relates to the process and/or the action accomplished. 4.3.12. The font size of title shall be 16 Bold [All caps]. 4.3.13. Font size of the issuing, revision and effective date shall be 12 Bold [All caps]. 4.3.14. Date style shall be as follow: 2 digits [for day], 2 digits [for month] and 2 digits [for year] 4.3.15. The name of preparer, reviewer and approver shall be 12 Bold [All caps]. 4.3.16. The history of change shall be added at the first page in the SOP (may extended to the next pages). 4.3.17. The title of history of change shall 14 Bold [All caps]. 4.3.18. The table which describe the changes shall include the issue#, issue date, page# and summary of change the table header shall be 12 Bold [All caps] 4.3.19. The font size of subtitles (e.g. objective, Scope,etc) shall be 14 Bold [All caps]. 4.3.20. The font size of any other texts shall be 12. 4.3.21. The paragraph numbering shall be the same concepts as follow: 1. 1.1. 2. 2.1. 2.1.1.
_____________________________________________________________________________________________________ PREPARED BY: REVIEWED BY: ... APPROVED BY: ..

T3A INDUSTRIAL
DOC # AP-05-1001 Issue # 10 Page 7 of 10

4.3.22. Each paragraph to be followed by a full stop. 4.3.23. Margins shall be same and regular in all SOPs with left side alignment. 4.3.24. The attachments which included in the SOP shall have a unique number consist of the Doc # / attachment # as follow: 00-00-0000 / 00, a list for this unique number shall be only with QA documentation officer. 4.3.25. Each paper in the SOP shall be signed by the preparer, reviewer and approver. 4.3.26. The signatures of the preparer, reviewer and approver shall be in the footer from page 2. 4.4. Subtitles that are common as follow: 1. OBJECTIVE: Describes the task that this procedure covers and what is accomplished or produced when the procedures is successfully completed 2. SCOPE: Describes the sites, areas, plants, and/or departments that this procedure applies to. 3. RESPONSIBILITY: Describes the responsible persons for execution this procedures. 4. PROCEDURE: Describes the steps of procedures and the person(s) involve in carrying them out 5. ATTACHMENT: List all of items that are attached

_____________________________________________________________________________________________________ PREPARED BY: REVIEWED BY: ... APPROVED BY: ..

T3A INDUSTRIAL
DOC # AP-05-1001 5.
5.1. 5.2.

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ATTACHMENT:
SOP cover template. Factory Formats list.

_____________________________________________________________________________________________________ PREPARED BY: REVIEWED BY: ... APPROVED BY: ..

T3A INDUSTRIAL
DOC # AP-05-1001
5.1. Template for SOP cover

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T3A INDUSTRIAL
DOC # 00-00-0000 Issue # 00 Page 0 of 0

STANDARD OPERATING PROCEDURE

TITLE:

ISSUE DATE: //.

EFFECTIVE DATE: //.

REVISION DATE: //.

ASSIGNEE PREPARED BY REVIEWED BY APPROVED BY

NAME

TITLE

SIGN./DATE

HISTORY OF CHANGE
ISSUE # ISSUE DATE PAGE # SUMMARY OF CHANGE .. .. ...

_____________________________________________________________________________________________________ PREPARED BY: REVIEWED BY: ... APPROVED BY: ..

T3A INDUSTRIAL
DOC # AP-05-1001
5.2. Factory Formats list: Unique Number

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Page 10 of 10

Form Title

Attached in Doc. Title

Doc #

_____________________________________________________________________________________________________ PREPARED BY: REVIEWED BY: ... APPROVED BY: ..