Principle #2 - Carefully Following Written Procedures To Prevent Contaminations, Mixups, and Errors

How would you answer this question - "What is the best way to ensure compliance with the Good Manufacturing Practice Regulation?" Hopefully, your answer would be, "By carefully following each step of your company's written procedures."

Why? Because the heart of GMP is the establishment of well written procedures for each step of our manufacturing and quality operations. These written procedures provide the controls necessary to minimize the chance of mixups and errors in the manufacture of products. When you carefully follow written procedures, you not only ensure compliance with the GMP regulation, but, more importantly, you ensure the consistent quality of your company's products.

Shortcuts or Deviations

Sometimes it seems that the steps described by the written procedures are not the most efficient way to do the job. If you are an experienced employee, you may see shortcuts that appear to save the company time and money or may make your job easier.

Even so, never deviate from your written procedure without the approval of your supervisor. First, many apparent shortcuts have pitfalls that can be costly in the long run. Second, each step in a well written procedure has a purpose. This may not effect you directly but may be there as a check or balance to another phase of the operation. Only those designated persons with a view of the total process can approve shortcuts or deviations in following written procedures.

If you do have an idea for improving an operation, talk to your supervisor. If your ideas is a good one, it should become part of the written procedure so that everyone can benefit.

Summary

The written procedure is the most valuable tool that you have at your disposal to ensure product quality.

A written procedure is a well thought out plan to help you attain the consistent quality in your work in which you can take pride.

Written procedures are as important to the experienced veteran as they are to the newly hired employee.

The written procedure is your key to ensure compliance with the Good Manufacturing Practice Regulations.

Remember, the next time somebody asks you "what's the best way to insure compliance with the GMP regulations, you can answer "by carefully following each step of our company's written procedures." Written procedures are your roadmap to quality. Don't take a shortcut!