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Developing SOPs to Effectively Train Changeover Procedures
By Nancy Cobb

One of the most important topics to cover thoroughly during equipment training is proper changeover procedures. Although it is a well-known fact that poor changeover procedures are a major cause of equipment downtime, poor training in this area is one of the top complaints by end-users. Indeed, along with a comprehensive troubleshooting guide, the most requested job aid is a good changeover procedure.

With this in mind, we recently asked changover expert John Henry of Changeover.com to share his recommendations on how to develop an effective training tool to fill this need. His recommendation is a Standard Operating Procedure (SOP). Although an example of an SOP is included in the Certified Trainer Workbook (back of Section 4), a more in-depth look at changeover training procedures is warranted.

According to Henry, “a changeover is the total process of converting a machine from running one product to another.” It consists of the ”Three Ups”:

• CLEAN UP – removal of all components, materials and product from previous run

• SETUP – Replacement or adjustment of machine parts required to run the succeeding product.

• STARTUP – Fine tuning or adjustment after machine restart required to bring the machine to final operating conditions.

The SOP, which consists of detailed instruction on how to perform a task, should meet several criteria:

• It should be fully detailed and illustrated so that a person with minimal experience and training can perform it.

• It should be as long as necessary to fully describe all tasks and how they are to be performed.

• It should include additional information such as tools, materials, safety devices that are required. This allows preparation before the changeover.

• It should follow a standard format within a company (your end-user typically has a form they prefer, especially in the pharmaceutical industry).

Included in the links below is a template that Henry uses. The last component is a checklist, which, similar to our checklist, is a condensed version of the detailed steps.

The components on this template include: purpose, general information (scope, safety, responsibilities), materials, tools, definitions, procedures (in detail – similar to the job breakdown), documentation (other documentation that may need to be used with the SOP), attachments (machine drawings, layouts, settings), references and lthe checklist. Other necessary elements include the title of the changeover (what equipment it is for), who it was written and approved by, the approval/revision date and the SOP number.

Henry reinforces that “the key to successful changeovers is properly written SOPs/checklists. They should be used during training to ensure that proper settings are used and that all steps are carried out in the proper matter and sequence”. If you’d like additional information you can go to www.changeover.com to review some informational papers.

To download the template and sample, visit: http://www.pmmi.org/certified/secure/member.asp or If you’d like to attend the archived Webinar that presented by John Henry click here. Please contact Danny Martinez at danny@pmmi.org for entry password.