A Procedure for Procedures

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Title: Developing New Procedures

Ref: XXXX/YY

1. Purpose

The purpose is to guide the development of new procedures and ensure new procedures are consistent and complete.

2. Scope

This procedure covers all formal procedures at MASA. Procedures or standards will not be valid unless they are developed and approved according to this procedure.

The activities in this procedure starts after a need for a new procedure has been identified and a person or group has been made responsible for developing a new procedure. Once the new procedure has been approved, the communication and implementation of the procedure must happen according to the responsibilities listed in the procedure.

3. Flow

 +----------+    +-----------+    +-----------+    +-----------+    +-----------+
 | Identify | -> |  Develop  | -> |  Verify   | -> |  Verify   | -> |  Verify   |
 |   Need   |    | Procedure |    | Procedure |	   | Procedure |    | Procedure |
 +----------+    +-----------+    +-----------+	   +-----------+    +-----------+

4. Activities

#	Activity	Tasks
1	Identity Need (Responsible Manager)	The Responsible Manager must appoint an Author to draft the new procedure The Responsible Manager must ensure the Author understands the purpose and scope of the procedure
2	Develop Procedure (Author)	The Author must use the ISO Procedure Template (the template) The Author must complete the purpose and scope section in the template and verify this with the Responsible Manager before completing the rest of the sections The Author must obtain information from stakeholders and other information sources to complete all the sections in the template The Author must individually review the procedure using the ISO Procedure Review Checklist
3	Verify Procedure (Author)	The Author must verify the completed procedure with stakeholders that provided information to the procedure
4	Review Procedure (Author)	The Author must review the procedure using the ISO Procedure Review Checklist with the Responsible Manager, the Quality Manager, and Stakeholders as determined by the Responsible Manager
5	Approve (Responsible Manager)	The reviewed procedure is signed and dated The approved procedure is controlled as described in section 7. Control of Records

5. Responsibilities

Role	Responsibilities
Responsible Manager	The Responsible Manager will be the person with authority over the activities and tasks that are covered by the procedure. The responsible manager must ensure that the purpose and scope is accurate, clear, and complete; and also that there is no overlap or conflict with existing procedures. The Responsible Manager is overall responsible for the development of the procedure, and the communication and implementation of the procedure.
Author	The Author is responsible for developing the new procedure and ensuring that it fulfills the purpose and covers the scope as defined by the Responsible Manager. The author must engage with relevant stakeholders and consult other sources of information to describe the activities and tasks required for the new procedure.
Quality Manager	The Quality Manager must ensure that the new procedure conforms to this procedure (Regulatory Procedure: Developing New Procedures) and that the approved procedure is maintained as part of the ISO Quality System.
Stake Holders	The Responsible Manager and the Author must determine the stakeholders that should be included in developing and reviewing the new procedure. The stakeholders are responsible for providing information about activities and tasks required for the new procedure and reviewing the completed procedure.

6. Forms

Form Title	Location
Procedure Template	Available in the document repository
Procedure Review Checklist	Available in the document repository

7. Control of Records

New procedures becomes permanent records in the Quality Management System and will be stored in document repository.

8. Revision History

Rev	Description of Change	Author	Effective Date
1	Initial version	Mikkel Christiansen	2018-09-19

9. Approvals

Name	Title	Signature	Date
Alice	General Manager		2018-09-24
Bob	Quality Manager		2018-09-24

11. References

Title	Document No. or Location
Humphrey, Watts S (2005) PSP	Page 292 (Process Definition)

12. Terms and Definitions

Term	Definition
Section	A section of the procedure with a heading such as ‘Purpose’, ‘Scope’, etc.
Completed Procedure	A procedure where all the sections have been completed and the author has reviewed it, but the procedure has not been through a formal review or approved
Reviewed Procedure	A completed procedure that has been through a formal review by the Responsible Manager and other stakeholders
Approved Procedure	A reviewed procedure that has been approved by the Responsible Manager, the Quality Manager, and relevant stakeholders