February 20, 2015

Developing Effective Standard Operating Procedures

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Effective standard operating procedures are essential to organizing and managing companies big and small no matter what industry they serve.

They ensure that all personnel are conducting procedures in a standardized manner and as such, it's important to understand how to create a set of operating procedures that make genuine improvements to the way you do business.

Responsibilities of Pharmaceutical Executives

As part of updating and revising standard operating procedures, pharmaceutical executives should determine who in management should be responsible for revising them.

They should communicate with the other members of these departments to determine what these roles look like and the expectations that come with them. In addition, they must also understand the appropriate steps involved so that they can delegate these responsibilities accordingly.

3 Steps to Developing Standard Operating Procedures

There are three main steps involved in developing standard operating procedures:

  1. Conduct a needs assessment
  2. Develop standard operating procedures
  3. Implement the standard operating procedures
 
 

1. Conduct a Needs Assessment

The first steps in developing effective standard operating procedures is to conduct a needs assessment. As part of the process, the personnel developing the standard operating procedures should determine what standard operating procedures will actually make a difference to the way they work.

They should consider federal and state regulations, industry and practice standards, and the operating environment.

Personnel should consider the operating environment and the factors that affect it. The steps in the development of needs assessment include:

  1. Developing support of the organization
  2. Developing a plan of action
  3. Reviewing current standard operating procedures
  4. Gathering information on internal factors that affect standard operating procedures
  5. Considering external factors that affect standard operating procedures
  6. Developing a list of required standard operating procedures on the basis of the needs identified
  7. Analyzing existing standard operating procedures
  8. Creating a formal needs assessment document

After reviewing both internal and external factors, consider the needs that arise from the review. Develop a list of required standard operating procedures based on these needs. In addition, they should also look at the current standard of practice to use as a reference point. Make sure the changes you're making are improving upon what you had before.

Next, compare the existing standard operating procedures with the items on the list. This analysis will enable them to determine if there are any gaps you need to go back and cover.
Lastly, write up a formal needs assessment document. In this document, the findings should be summarized and recommendations should be provided in full detail. Include an explanation of the priorities and a rationale for changing the standard operating procedures.

2. Develop Standard Operating Procedures

The next step is to develop the improved standard operating procedures. Pharmaceutical executives should follow these steps when putting it together:

1. Build a development team

2. Provide support to the organization

3. Establish the procedures for the team

4. Gather information and provide alternatives

5. Analyze and select the alternatives

6. Write the standard operating procedures

7. Review and test the standard operating procedures, and

8. Approve the standard operating procedures

Next, managers should gather information and discuss options. Members of the team should review the needs assessment document to identify what standard operating procedures are missing and where the deficiencies are.

Then they should identify the options and select the most appropriate one. When selecting the most appropriate option, executives should consider whether the option is feasible; to what extent of can be implemented; and whether it would withstand the scrutiny of the public, the Food and Drug Administration, and other entities.

Once the appropriate options have been determined, the appropriate personnel should write up the standard operating procedures. In general, standard operating procedures should include broad-based guidelines.

They should also be clear, concise, and written in nontechnical terms. Although they should be unambiguous, they should also allow for flexibility.

Conduct a peer review once the standard operating procedure is drafted. Those working in departments affected by the standard operating procedure and other relevant personnel should review the documents and provide feedback.

Then the feedback should be analyzed and changes should be made accordingly. During this stage, managers should carefully weigh the advantages and disadvantages of making last-minute changes. Team members should also be ready to explain the rationale for the change.

The standard operating procedure should be approved after all feedback has been considered.

Topics: Process