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Principle #4 - Proving That Systems Do What They Are Designed To Do By Validating Work
The most important component in the production of quality food, drugs, cosmetics, and medical devices is people. Everyone plays an important part in determining the quality of your products. Because of this joint quality effort, your customers continue to show their trust in you by purchasing your products. You earn the trust and confidence of the customer and of your company by consistently performing your jobs to the best of your ability. In a way you are like an actor. The audience counts on the actor to make the character come to life. Your customers count on you for quality. Your responsibility is to manufacture a safe and effective product. Let's take a closer look at this responsibility and how documentation and validation help you ensure the quality of your products.
Consistency is the Key
Just as actors must perform their roles with the same consistent quality night after night, your consistent performance ensures the safety and effectiveness of every product you produce, and is the key to your company's reputation for high quality.
Also, like the actors in a play you must know the specific requirements of your jobs and work with others to get that job done properly. To perform your roles consistently you, like actors, must rely on:
| Actors | Us |
| Scripts | Written procedures |
| Costumes | The special clothes we wear |
| Props | Equipment and materials |
| Scenery | Buildings and facilities |
| Direction | Supervisors and Good Manufacturing Practice Regulation |
Documentation & Validation
The actors' proof of a job well done is the applause they receive from the audience. You rely on a different kind of proof of your success. Your personal proof is found in the documented records you keep. The proof of your quality products comes from the validation of each of your manufacturing processes - in other words proving that these processes do what they say they do.
Through your performance and your proof you earn the right to take pride in the reputation of your company, after all you are building that reputation. Documentation and validation are important tools in achieving high quality standards. Let's take a closer look at them:
Documentation
 | Documentation requires that you record, sign, and date every step of the operations you perform. |
| Documentation should always be done promptly, accurately, legibly and in accord with your written procedures. |
| Documenting this way serves as a testimony to the quality of your products. |
| Just as a pilot uses a checklist as a record to avoid mistakes and ensure safety, your documentation serves as a check and double check against costly mixups and errors. |
| Documentation is your proof that your products are produced in compliance with the GMP regulation and your company's operating procedures and standards. |
Validation
| Validation is your proof of the safety and effectiveness of your products. |
| Validation proves that your systems, facilities, and processes do what you say they do. |
| Validation assures that your production processes consistently meet the specifications your company has established. |
| In a court of law having a witness swear under oath and be cross-examined is the court's way of validating his testimony. Your tests for validity work in the same way. Once validity is established you can be confident you are producing quality products time after time. To maintain this validity you must carefully follow your written procedures. |
| Validation gives meaning to the documented records you keep. |
Summary
The factors we have just discussed all affect the consistent quality of our products. We can summarize these factors as the 3 P's of GMP . They are:
Performance
Above all else it is your job performance which affects the quality of your products, and that performance is your responsibility. These are a few guidelines to successful job performance:
| You must understand the specific requirements of your job. |
| You must work together to produce quality products. |
| You must make proper use of written procedures, special clothes, buildings, equipment, tools, materials, supervisors and the GMP regulation to help you perform well. |
Pride
| Pride in being associated with a company that has a reputation for quality. |
| Pride in the key role you play in building that reputation for your company. |
| Pride in the confidence your customers show by purchasing our products. |
Proof
| Proof established through validation that our systems, facilities and processes work as you say they do. |
| Proof through documentation that you have carefully and exactly followed your written procedures in doing your jobs. |
| Through all of these factors we produce quality products and remember . . . your customers count on you for quality. |
