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Editorial: Quality Control, Quality Assurance and Quality Improvement-What is the Difference and Why Should You Care?
Editor's Note: This is the fourth in a series of brief quality-assurance notes and reminders. This is a guest editorial, and we appreciate the efforts of Joe Cabaleiro in putting it together for this newsletter. (Joe is a former Joint Commission on Accreditation of Healthcare Organizations surveyor and currently is a Pharmacy Compounding Accreditation Board surveyor.) A program of quality assurance is the responsibility of compounding pharmacists in all aspects of their practice.
The terms quality control, quality assurance, and quality improvement are often used interchangeably in compounding pharmacy circles. This causes some confusion among compounding pharmacists because, while these terms are related, they have different meanings. Understanding each term and incorporating them into your practice is vital if your compounding pharmacy's goal is to remain competitive in the current quality- and cost-conscious market.
To exemplify the different approaches taken by pharmacies on the topic of quality control, we briefly discuss in this newsletter three different pharmacies and their procedure for handling the topic of "undented capsules." All three pharmacies in these examples make the same capsules for a local hospital. The capsules contain an expensive ingredient, worth $0.50 per capsule.
Pharmacy A: The pharmacist at Pharmacy A sees dented capsules in pill vials every day. He explains to patients "The capsule machine dents them sometimes, can't help it-sorry." Clearly, Pharmacy A has no quality control, assurance, or improvement processes.
Pharmacy B: The pharmacist at Pharmacy B recognizes that if the capsules do not look good, patients will have reason to think they were made incorrectly. When he checks prescriptions, he painstakingly goes through every vial, removes and throws away every dented capsule, and replaces the dented capsules with good capsules. Pharmacy B has a quality-control program. The American Society for Quality (ASQ) defines Quality Control as "�the observation techniques and activities used to fulfill requirements for quality."
Pharmacy C: Pharmacy C also checks capsules before they are dispensed and dented capsules are removed and discarded. However, they have a training program for operating the capsule machine, and technicians are not allowed to produce capsules until they can make a sample batch with less than 5% dented capsules. As a result, their rate of dented capsules is less than half that of Pharmacy B. Pharmacy C has a quality-assurance program, defined by the ASQ as "�the planned and systematic activities implemented in a quality system so that quality requirements for a product or service are fulfilled." This pharmacy now decides that dented capsules are resulting in too much material and time waste. They decide to attempt to eliminate this problem. First, they measure the current percentage of dented capsules in a representative sample. Next, they make some improvements in the capsule filling process and in the setup of their machine, and they evaluate several brands of capsules to determine which work best with their equipment. Throughout this process, they continue to sample for dented capsules. They identity changes and these changes reduce the number of dented capsules to nearly zero. The technicians that make the capsules are taught to dispose of the now rare dented capsule. As a result of the stated changes, a pharmacist can be confident that a dented capsule will never wind up in a vial.
Pharmacy C has now implemented a system of quality improvement, defined by the ASQ as "�an ongoing effort to improve products, services or processes. These efforts can seek 'incremental' improvement over time or 'breakthrough' improvement all at once."
Why Should You Care?
Eventually, patient comments about the dented capsules from Pharmacy A cause the hospital to question the quality of all of their pharmacy procedures. As a result, the hospital starts telling patients to go to Pharmacy B or C.
Pharmacy B and C are equal in quality in regards to dented capsules, but at pharmacy B, if 1/10 capsules are dented, it represents a $5 extra cost in materials alone, not to mention the pharmacist time it takes to correct the problem.
Pharmacy C, because of its efforts to eliminate the problem, rather than correct defects, enjoys a profit and time advantage over Pharmacy B. In addition, pharmacists here seem just a little less rushed to customers because, as a result of their improvement activity, they shifted a quality control function to their technicians. Technicians at this pharmacy are more productive because defective capsules are so rare that quality control for dented capsules takes little time.
Joe Cabaleiro, RPh, BS Pharm
Triangle Compounding Pharmacy
Cary, North Carolina
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