Policy vs Process vs SOP vs Work Instruction

Industry: Retail, Manufacturing, Service Industries

Keywords: Production, Quality, Process, Documentation

Level: Basic

LinkedIn: https://www.linkedin.com/in/mamdouh-subhy-105a4b96

There are many differences between a policy, process, procedure, SOP, or work instruction. When writing processes, policies, procedures, and work instructions, it is critical to understand the definitions and differences for clear communication and direction to your employees. Regulators and auditors hate to see policy mixed with the procedure in company procedures manuals and corporate training material, but they are unsure about how to separate them. Production follows several steps:

1. Goal: The first step is to know exactly what you wish to achieve. Knowing what you want may include your desired return on investment (ROI), maintaining your reputation and sticking to your ideas of business ethics. You wouldn’t just sign a contract on the basis of “We deliver, they pay.” Retaining clients should also be a part of your goal.

2. Policy: After that, you will want a policy (or, depending upon the extent of your operation, several different policies which never clash with each other). A policy will set boundaries and clarify your goal.

3. Process: After the last two preparatory elements, the broadest, most high-level overview shows how to achieve your goal without violating your own boundaries. Levels indicate chronology, not importance. The highest-level element is merely what comes first. Usually, it will contain the least details. The process is an overview of how the work is to be done. It is broken down into relevant subsections and described in detail when you create procedures.

4. Standard Operating Procedure: Even if your production has not reached the Lean stage, procedures should always be flawless. Procedures are the actual, hands-on work stage. Everything should be as perfectly planned as possible. The SOP, or standard operating procedure, focuses on getting one specific job done, flawlessly. “Standard” describes a “tool” that is expected to lead to Lean production. Every SOP should contain very specific information.

5. Work Instruction: Work instruction is the last “hands-on” stage of the production cycle which details every single step of how a certain job is done. It may get really detailed and complex if the job requires more. Regardless, the one thing that a work instruction will always have is absolute clarity, so that the worker who is doing the job is never in doubt about what is to be done or who to call if there is a doubt.

In this presentation, we will take a deeper dive into the difference between these important documents.

Dr. Mamdouh Mahmoud

Compliance Manager, Klybeck Life Science, Al Khobar, Saudi Arabia

Dr. Mahmoud is a Professional Summary Licensed Pharmacist with strong background in quality assurance and cGMP compliance with diverse experience in the pharmaceutical industry, manufacturing, packaging, validation in process control (IPC) and quality assurance documentation (sterile and non-sterile products). Certified Lean Six Sigma Black Belt by the Council for Six Sigma Certification (C.S.S.C). Certified as QP and QTM in alignment to PIC/S and SFDA guidelines. Work experience includes Compliance Manager at Klybeck Life Sciences SA from December 2022 till now.

• Quality Assurance Section Head (acting as QA manager) at Saudi Pharmaceutical Industry and Medical Appliance Co. (SPIMACO) from July 2022 till November 2022.
• Quality Assurance senior team leader (acting as QA inspection Supervisor) at Saudi Pharmaceutical Industry and Medical Appliance Co. (SPIMACO) from September 2019 till July 2022.
• Quality Assurance senior officer (acting supervisor) at Tabuk Pharmaceutical Manufacturing Company (TPMC) from May 2018 till August 2019.
• Quality Assurance officer at Tabuk Pharmaceutical Manufacturing Company (TPMC) from March 2013 till April 2018.
• Supervisor for central and eastern area at Oman Pharmaceutical Company (Zynova) January 2011 till February 2013.
• Medical representative at Oman Pharmaceutical Company (Zynova) December 2006 till December 2010.