To lay down the procedure for preparation of formats and numbering system for formats.
1.0 PURPOSE
To lay down the procedure for preparation of formats and numbering system for formats.
2.0 SCOPE
2.1 This procedure is applicable for preparation and numbering the formats used in all departments.
3.0 RESPONSIBILITY
3.1 Head of User department
3.1.1 Identify the type of format which needs to be prepared i.e whether data is captured at the given moment or data is continuously updated.
3.1.2 Develop the format as per the sequence of activities and get the draft reviewed by QA for compliance to this procedure.
3.1.3 Identify personnel for maintain index of formats and assign number when the requirement arises.
3.1.4 Provide for necessary resources like stationery, printing, etc.
3.2 Head of QA department
3.2.1 Review the formats proposed along with the procedure.
3.2.2 Identify personnel to create a system for issue of formats.
4.0 ACCOUNTABILITY
4.1 Manager – QA & RA
5.0 PROCEDURE
5.1 Format Preparation
5.1.1 The person, who writes the SOP, shall prepare the recording format along with the SOP. He shall assign the number to the format as per the procedure laid down in this SOP.
5.1.2 The characters of format shall be taken in “Times New Roman” with font size of “12” either in portrait or in landscape as appropriate in the format xxxxx
5.1.3 The format consists of the following Information in the respective cells of the specimen format xxxxx
Cell Number Information Font
01 To write the company name along with location Bold & Upper case
02 To write the name of the originating department Title case
03 To write the title of the format Bold & Upper case
04 Page X of Y [X is the page number and Y is the total number of page] Sentence case
5.1.4 The contents (text matter) of the format shall be made as applicable to the SOP.
5.1.5 Define if the format is used for discrete data or updated data.
5.1.6 For discrete data, give the sequence of activities and data limits (e.g. acceptance criteria for calibration format) etc.,
5.1.7 For updating data, create a template for recording the data as and when required. (Ex. SOP index, Authorized signatory etc.,)
5.1.8 Head of the department shall review the format for its contents, adequacy of the layout, etc. and forward to QA along with the respective SOP.
5.1.9 QA personnel shall review the format for compliance to this SOP and addressing all the data collection activities as per the SOP.
5.1.10 For discrete data collection, the forms are issued through QA system for regular use either by photocopying or printing.
5.1.11 Concerned department has to maintain the list of formats as per the format xxxxx
5.2 Format Numbering
5.2.4 All formats shall have a unique number consisting of 19 characters of alphanumeric system as described below.
Example: The first format originated from SOP Format Preparation And Numbering System
END OF DOCUMENT
Numbering system, format preparation, quality assurance, continuously updated
