Creation of SOP - 10

7/30/2019 Creation of SOP - 10

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T3A INDUSTRIAL

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

STANDARD OPERATING PROCEDURE

TITLE: CREATION OF STANDARD OPERATING

PROCEDURES

ASSIGNEE NAME TITLE SIGN./DATE

PREPARED BY WAEL MOHAMED ALI QA OFFICER

REVIEWED BY MOHAMMED ELASSADY QA OFFICER

APPROVED BY MOHAMMED ELSAADY QA SECTION HEAD

HISTORY OF CHANGE

ISSUE DATE: //. EFFECTIVE DATE: //. REVISION DATE: //.


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HISTORY OF CHANGE

_____________________________________________________________________________________________________

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

ISSUE # ISSUE DATE PAGE # SUMMARY OF CHANGE

From Issue# 001

to Issue# 002 08/11/1999

7

4

1. Procedure: Insert the file name &path on each page

2. Add numbering for additional 2 types of documents

From Issue# 002

to Issue# 00331/5/2000 1-10

1. Change in the title & assignee persons

2. Change in procedures

From Issue# 003

to Issue# 00417/06/2002

1

7

1. Change the assignee persons

2. Change in item 4.8.3.

From Issue# 004to Issue# 005

01/05/200514

1. Change in responsibility 3.2. & 3.3.2. Addition of other code 4.5.1.

From Issue# 005

to Issue# 0621/10/2005

1

2

3

45

1011

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.

From Issue# 06

to Issue# 0721/01/2006 All

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.

From Issue# 07to Issue# 08

17/07/2006 2,5,10 1.Change in Procedure in item # 4.10., 4.11. and 4.20.1.2.Change in Responsibility in Item # 3.4.

ISSUE # ISSUE DATE

PA

G

E

#

SUMMARY OF CHANGE

From Issue# 08

to Issue# 09 17/01/2007 All

1.Change in Assignee persons.2.Change in SOP title.

3.Change in Objective, scope, responsibilities, proceduresand attachments.

From Issue# 09

to Issue# 1025/03/2007 All

1. Change in item # 4.3.6.

2. Change in item # 4.3.24.3. Removing format unique #. From all attachments.


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1.OBJECTIVE:

1.1.This SOP describes the procedure for creation of standard operating procedures.

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. SOP Approval procedure:

4.1.1. 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. Quality Assurance documentation officer shall Assure that the SOP has the required format, has

a unique SOP number and current issue number.

4.1.3. Quality assurance manager shall approve the master SOP, determine the issue date and review

date for the SOP.

4.1.4. Effective date shall be after approval, training and collection of the obsolete copies.

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4.1.5. Documentation officer shall distribute the SOP after approval of the proposed departments

defined by initiator.

4.2. SOP re-Issue procedure:4.2.1. Each DOC has an expiry date at this date the SOP is subject to change, the change control

procedure shall be followed.

4.2.2. A new issue number shall be given to the reissued SOP.

4.2.3. In the history of change; in the column of "summary of change" type "periodic review- no

changes in the SOP".

4.3. 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 Q

Quality Assurance A

Production P

Regulatory Affairs R

Engineering E

Administration D

Materials management M

ISO I

Occupational health and safety S

Finance F

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Research and Development N

Information technology T

Human Resource HSales & Marketing K

Logistics & Services L

Other (not included as above) O

Digit 2 denotes the type of document as follow:

Procedure P

Digits 3" & "4 reflect the No. of the subject of the SOP as follow:

Management responsibility. 01

Quality system. 02

Contract review. 03

Design control 04

Document and data control. 05

Purchasing. 06

Control of customer supplied product. 07

Product identification and traceability. 08

Process control. 09

Inspection and testing. 10

Control of inspection, measuring and test equipment. 11

Inspection and test status. 12

Control of non-conforming product. 13

Corrective and preventive action. 14

Handling, storage, packaging, preservation and delivery. 15

Control of Quality records. 16

Internal Quality Audits. 17

Training. 18

Servicing. 19

Statistical techniques. 20

_____________________________________________________________________________________________________



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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. 1 of 3, 2 of 3 and 3 of 3.

4.3.9. 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.

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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

_____________________________________________________________________________________________________



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5. ATTACHMENT:

5.1. SOP cover template.

5.2. Factory Formats list.

_____________________________________________________________________________________________________



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5.1. Template for SOP cover

T3A INDUSTRIAL

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

STANDARD OPERATING PROCEDURE

TITLE:

ISSUE DATE: //. EFFECTIVE DATE: //. REVISION DATE: //.

ASSIGNEE NAME TITLE SIGN./DATE

PREPARED BY

REVIEWED BY

APPROVED BY

HISTORY OF CHANGE

ISSUE # ISSUE DATE PAGE # SUMMARY OF CHANGE

..

..

...

_____________________________________________________________________________________________________



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5.2. Factory Formats list:

_____________________________________________________________________________________________________


UniqueUnique

NumberNumber Form TitleForm Title Attached in Doc. TitleAttached in Doc. Title Doc #Doc #

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Creation of SOP - 10