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Standard Operating Procedures 


PART II. 

 

Team Meeting #2

Prior to the meeting time, have the room set up in a 'U' or circle shape. Facilitator should ask each sub group to tell of their experience and pass out a copy of their typed SOPs that are ready to be reviewed. Go around the room and read aloud the SOPs step by step. Stop when there is a disagreement and discuss the topic until everyone can agree and move on.

It is very important that representatives from Quality Assurance, Engineering, Maintenance, etc., are present and agree with the procedure that is being approved.

Review previous assignments, let the sub team meet to determine their future action plans to complete assignments, and then as a team schedule the next meeting date, time, etc.

Team Meeting #3, #4, #5,......

Continue the reading, discussing, and approving process. Do a hands-on demonstration if necessary to approve the process by having the entire team meet at a particular work center and walk through the process. Make sure the actual and written procedures are the same.

Formatting SOPs

Create a standard format that meets the needs of tracking and documenting the SOP. Items'such as numbering, dating, names, department, approval sign-off, originator, etc., need to be determined. (See example #1) Choose one department that will be responsible to format the SOPs. This could be engineering, Research & Development, Qual­ity Assurance, Training, Human Resource, etc.

Celebrate

Call the team together and celebrate!! Have subteams present their completed (formatted) SOP to the team. If its not too lengthy, take the time to go around the room one more time and read aloud the SOP This might seem ho-hum at first, but dang, what a great feeling at the end. Break out the fixins for banana splits and celebrate!!

SOP Uses

Now that you have this live document, what are you going to do with it? Put it in a file cabinet and lock it up so it won't get dirty, or better yet, put it in the com pany vault so no one will steal it. WRONG—USE IT! Make copies of it. Train new employees with it. Re-train current employees with it. Make an SOP book for each work center and keep all current SOPs in it. Build OSHA, FDA, safety, and GMP compliances into SOPs. Then stand back and watch what happens. Wow—like magic, employee morale will soar. Tasks are going to be completed correctly the first time, every time, with quality and efficiency.

Documentation Process

Create a tracking form (see example #2) that designates SOP activity (i.e., are they in the creation process, are they active at the work center, do they need reviewing, etc.). Update this form monthly.

When employees are trained on a specific SOP, document the activity by completing a Course Attendance Roll (see example #3). Pill in the SOP, SOP number, instructor (a supervisor, lead worker, etc.) and any other explanation. When the training is complete, have the employee(s) who is being trained complete their portion of the form with proper name, signature, etc. Turn in all completed Course Attendance Rolls to the Training administrator where the employees' Individual Course Record (see example #4) will be updated and the roll filled for future documentation proof.

SOP Control

As mentioned before, choose one department to control SOPs. This task would include 1) all formatting (see example #5), 2) original hard copy file of SOPs, 3) keep updated SOPs at designated work center in their book, 4) update all SOP changes when necessary, 5) be responsible to have approval sign-off completed, and 6) keep record of every SOP update from start to current.

SOP Update—Performance Measurement

There are various times and reasons why or when an SOP should be updated. Employees who use the SOPs should notify supervisors when they can see a variance between how the SOP is written and how they actually complete the process. If there is an equipment change, then obviously there will be an SOP change. Sometimes if products change then the procedure will change. The best guarantee is to keep the SOPs a living document, and make changes when necessary. Review all SOPs on an annual basis if there has not been a change or an update during the past year just to make sure something has not been overlooked.

Summary

Determine why it is important for your company to have employee-owned SOPs. Organize your team, have re­quired meetings, and get your teams walking, talking, and writing. Meet again, review progress, and continue until final approval is given by the team. Format the SOPs and celebrate! Like magic—your company will have correct, updated, usable, Standard Operating Procedures, and happy employees that feel their worth!!


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