Six Sigma 360

STANDARD OPERATING PROCEDURE

• A Standard Operating Procedure (SOP) is defined by ICH (International Conference on Harmonization) as “detailed, written instructions to achieve uniformity of the performance of a specific function”. An SOP describes a procedure and tells an operator how to perform it.

• Standard operating procedures (SOP) are essential to ensure the performance of a controlled process. If it is written to fulfil only that purpose efficiently and effectively, it becomes a rugged, flexible, and valuable quality assurance tool.

• The SOPs will provide seasoned human resource professionals a readily available resource as well as serve as an on-line mentoring guide for new employees. By having well-established procedures, an employee’s work consistency, quality and timeliness are improved.

Vision

• To create a user-friendly, real-time resource that highlights key procedures as a tool for HRSS professionals whereby central office and field staff understand more fully the operational impact of decisions.

• To produce a product that outlines HRSS procedures for functional tasks performed in the division and circle offices that are not otherwise outlined in existing HR policies. Relevant forms and processes (for example, online documentation and links) will be reviewed as a part of the SOP project as well. This will be accomplished in order to provide for:

  - Continuity and consistency of services,

  - Better communication internal and external to the division,

  - Enhanced orientation/mentoring reference, and

  - Improved customer service

Why

• To ensure consistent, repeatable processes;
• To facilitate training by giving trainees a point of reference;
• To facilitate cross-training of employees on tasks they don’t normally perform, such as when they need to substitute vacationing or sick co-workers.
• To reduce safety risks and other hazards by specifying how to avoid and prevent them;
• To have a basis for evaluation and improvement of processes;
• To comply with regulations and/or quality standards

Regulations

• Compliance with regulations and quality standards — is a key factor that drives an organization to establish and maintain SOPs.

• In ISO environments, the concept of quality is made tangible by the information and processes captured in SOPs, and proper implementation of those SOPs helps ensure quality.

• The presence and quality of these documents are essential when inspections take place, since the most frequent reported deficiencies during inspections are the lack of written SOPs and/or the failure to adhere to them

Benefits

• The development and use of SOPs minimizes variation and promotes quality through consistent implementation of a process or procedure within the organization
• SOPs can indicate compliance with organizational and can be used as a part of a personnel training program.
• It minimizes opportunities for miscommunication and can address safety concerns.
• The benefits of a valid SOP are reduced work effort, along with improved comparability, credibility, and legal defensibility.

Responsibilities and Instructions

• It is the responsibility of all Process Managers to ensure that no SOP’s or reference material is posted without compliance with this work instruction.
• The QA Team is responsible for maintaining the SOP database to control the number and revision of these documents.
• SOPs are summaries or highlights of work practices.
• If the subject matter involves any detail that could affect the quality of services delivered, it should  a SOP.
• If the subject matter involves any detail which would not affect the quality of services delivered, it should  be a Reference document.
• SOPs may exert from work instructions, procedures, drawings, product specifications, or process specifications.
• When revising or creating a new SOP, originators are required to work with the QA Team
• SOPs will be posted in work areas for quick access as needed.
• SOPs are stand-alone documents that do not require a reference to a higher level document unless one exists.

 Approval:

• SOP approval block must be signed off by all of the following: Process Manager, Process Head, and QA Team.

Posting

• After sign offs/approvals, SOPs will be posted as below:

•      In Hard Copy Library

•      In Soft Copy Library

Review

•    Operators and Supervisors are responsible for ensuring all SOP’s in their respective area are current.

•   The Department Supervisors are responsible for periodic review of SOP's with a minimum review every 2 months.

SOP Log

•      QA Team shall maintain a log or database of all SOPs and their current revision.

SOP Authenticity…mention

This is the property of Company. No part of this document may be reproduced or distributed in any form including electronic, mechanical, photocopying or otherwise without the explicit permission of Company

Document Control

•   If there is a change in Process, the version no. will change to the next no.(Ex: From Version 1.0 – after change  Version 2.0)

•   If there is a change in sub process, the version no. after decimal will change (Ex: From Version 1.0 – After change Version 1.1)

•   If there is a format change, will indicate a  “Revised” with on going version no.