Monday, 19 August 2013

SOP Standard Operating Procedure



SOP Standard Operating Procedure. In this challenging face of regulatory environment, some of the leading Pharmaceutical companies have found ways to improve quality and costs significantly. In order to drive this kind of beneficial change, first of all the companies must create a culture where all quality objectives are transparent and well understood, and also undoubtedly these goals can be achieved by following certain sets of procedures called as “Standard Operating Procedures” (SOP).  

SOP Standard Operating Procedure?

SOP Standard Operating Procedure  is a set of written instructions that document a routine or repetitive activity which is followed by employees in any organization. We know that the development and use of SOPs are an integral part of a successful quality system which provides us an information to perform a job properly and consistently in order to achieve pre-determined specification and quality end result. 

SOP Need

  1. SOPs detail the regularly recurring work processes that are to be conducted or followed within an organization. They document the way of activities are to be performed to facilitate consistent conformance to technical and quality system requirements and to support data quality. 
  2. They may describe for example fundamental or programmatic or technical actions such as analytical processes, processes for maintaining as well as calibrating and using equipment. 
  3. Sops are specific to the organization or facility whose activities are described and assist that organization to maintain their quality control and quality assurance processes and ensure compliance with Governmental regulations.
  4. SOP must contain step by step instructions that employ must refer in daily work to complete various tasks more reliably and consistently. 
  5. SOP’s makes clear about followings things; 
  • What is the objective of SOP (Purpose) 
  • What are the applicability and use of SOP (Scope) 
  • Who will be performing tasks (Responsibility) 
  • Who will ensure implementation of procedure (Accountability) 
  • How tasks will be performed (Procedure)

SOP Standard Operating Procedure Benefits

  1. To provide people with all the safety as well as health and environmental and operational information necessary to perform a job properly. 
  2. To ensure that production operations are performed consistently to maintain quality control of processes and products. 
  3. Processes continue uninterrupted and are completed on a prescribed schedule. 
  4. To assure no failures will occur in manufacturing and other processes that would harm anyone in the surrounding community.
  5. Approved procedures are followed in compliance with company and Government regulations. 
  6. To serve as a training document for teaching users about the process for which the SOP was written. 
  7. To serve as a checklist for co-workers who observe job performance to reinforce proper performance. 
  8. To serve as a checklist for auditors. 
  9. To serve as an historical record of the how or why and when of steps in an existing process so there is a factual basis for revising those steps when a process or equipment are changed.
  10. To serve as an explanation of steps in a process so they can be reviewed in accident investigations. 
  11. It helps to prevent the introduction of errors, variations and misunderstanding. 
  12. It improve the planning's and organization. 

SOP Standard Operating Procedure How to Write?

  1. SOPs shall be written in a proper and concise, it must be step by step and easy to read and follow format. 
  2. The information presented should be unambiguous and should not be complicated and the active voice and present verb tense should be used. 
  3. SOP shall be simple and short. 
  4. Information should be conveyed clearly and explicitly to remove any doubt as to what is required. 
  5. Flow chart shall also be used to illustrate and explain in brief about the process.

Sop Preparation

The organization should have a procedure in place for determining what procedures or processes need to be  well documented and all those SOPs should then be written by any individuals which are knowledgeable with the activity and the organization's internal structure . Now these individuals are essentially subject-matter experts who actually perform the work or use the process. Again most important part is, A team approach can be followed for better results. 

It is necessary that SOPs should be written by only an individual who routinely performs the tasks  or someone who is directly responsible for the performance of the task. 

Ideally, SOP’s should be written by teams that include some or all of the following people:-

  • One who will perform the job 
  • One who will perform maintenance on equipment involved in an SOP 
  • An Engineers or others who design equipment and processes 
  • One who is Technical initiator 
  • Again one Safety personnel 
  • An Environmental personnel 
  • An Equipment manufacturers 

Team which are writing accomplish several goals besides just producing an SOP:

1. It  also ensures that comprehensive knowledge acquired from different perspectives is applied to the SOP. 

2. It creates "buy-in," which increases the likelihood that the SOPs will be implemented under the guidance of the initiator. 

3. It trains trainers the people who write the SOP. Now Having participated in in-depth decision making about the SOP here initiator know it intimately and are more likely to be effective trainers (coaches). 

4. It involves people from diverse parts of the operations as a whole which helps to ensure that when new and modified processes are implemented then after someone goes back and updates the SOP. 

5. It encourages employees to follow the SOP and listen to the coaches because the employees know that the initiator invested time and effort on behalf of the employees. 

Writing in teams do not have to sit together to write. But They can also write or edit parts of an SOP independently and then one person can combine all the individual contributions.Now after combined, it circulate the draft SOP for review among the initiator before editing a final draft for review by supervisors and subsequent supervised testing by employees.Then Ideally a writing team should meet at least once in the beginning of a project to establish writing objectives as well as  targets and responsibilities, and also then can work semi-independently with one person serving as coordinator. Now Most important is,  SOPs should be reviewed by several people qualified to evaluate the SOP in terms of its completeness and clarity of subject matter. 

Following are the  ideas to keep in mind while writing Standard Operating Procedures (SOP)

1. How much someone knows about an entire process or job affects the way he or she does the job.  And Incorporate safety and  health and environment into the traditional how to operate or to dosteps. Now this  teaches the person comprehensively so that he or she has a complete picture of the responsibilities for doing a job well. This knowledge base simplifies follow-up training. 

2. Write an SOP to be as long as necessary for a specific job. And All jobs differ in the number of steps required to complete properly. And Short changing someone by providing short and incomplete SOP sets up failure. and write an SOP to satisfy the definition of SOP- not a standard company format that no one has thought about in years. 

3. People tend to ignore long SOPs because they cannot remember more than 7 to 13 steps. If your SOP goes beyond 9 to 10 steps, consider these solutions: 

o Break the long SOP into several logical sub-job SOPs, 
o Write an accompanying shortened SOP that lists only the steps but not detailed explanations of those steps
o Make the long-form SOP a training document or manual to supplement the shorter sub-job SOPs mentioned earlier. 

4. Prepare the longer comprehensive training SOP first to get a picture of what training is needed. And then decide how to break it into shorter sub-job SOPs. Now writing sub-job SOPs first, and then trying to put them together,and  may leave out linkage steps that make sub-jobs interdependent. 

5. Write SOPs for people who perform under different interpersonal circumstances. 
  •  Write some SOPs for people who work alone. 
  •  Write some SOPs for two or more people who work together as a team. 
  •  Write some SOPs for people who will supervise other people doing a job. 
  •  Write some SOPs for the people who not familiar with rules generally understood by your employees.  

6. Consider the work culture within which people will work. Now If you write for people in a culture in which shortcuts are accepted as practice, explain the reasons behind certain steps so that SOP users will understand the importance of following all the steps in the proper order. 

7. Consider the age, education and  knowledge as well as skill or an  experience and training-and work culture of the individuals who will be performing the SOP steps. 

8. Keep in mind that many people do not read all the steps before starting on step one. And many people read one step, perform it and read the next step and perform it  and so on. and  try to get around this habit,  and forecast future effects and steps at certain points in the SOP to tell reader things they should know in advance and such as upcoming steps that require caution and precision or timing and assistance and personal protective equipment. 

9. Once you have completed writing an SOP will  have several workers test it and give you the feedback. Now If you did not consult safety and health and environmental experts prior to writing the SOP-have them observe the SOP being tested so they can add comments. 

10. Review the effectiveness of SOPs after a few weeks and make necessary changes if in-the-field practice suggests that descriptions should be improved. 

11. Review SOPs when processes and equipment are changed.