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Quality Systems Manual and Organizational Structure, ISPEAK May 2003
QUALITY SYSTEMS MANUAL AND ORGANIZATIONAL STRUCTURE By Ralph W. Donnelly and Andrew DiFelice
PURPOSE AND INTRODUCTION
Quality Systems have been used since the since Dr.Demming in the 1940s and then enhanced by Dr.Juran in mid 1950s.They may have been called by different names, but the intent was the same. That is to raise the level of quality management to the total organization. It was developed as a tool to enhance production. This concept has laid dormant in the pharmaceutical and medical products industries until the early 1990s when the medical device industry started to have regulatory inspections that although not referring to Quality Systems were finding operations that lacked a Quality Systems approach to production. Many in the industry have found that this approach can improve product quality as well as improve the production process and increase profitability. As the automobile industry has learned, quality is built in. The US automobile industry has been transformed since the 1980s with our 10-year cars to the quality of cars that we have today. They have been improved in driving, comfort, efficiency, and reliability. An additional example is a medical products manufacturing facility that had some significant regulatory problems. These problems were significant and led to production being curtailed by the FDA. Through quality circles and a significant shutdown, the company re-evaluated its production layout, methods, training, and personnel approach. The results were a 30%increase in production with less manufacturing personnel. During the early 1990s, the concept of Quality Systems was brought to the FDA’s regulated device industry. Recently, the drug industry found that the FDA was encouraging the concept of Quality Systems. This manifested via the FDA requests and their modus operandi to explore a company’s systems through its Quality Systems Manual or Quality Systems organization. The purpose of this article is to propose a structure and organizational template to enable an organization to implement a successful Quality Systems Manual for the management of their cGMPs governed disciplines. It is also recommended that this approach be extended to other areas of the manufacturing and support structure to achieve both product quality improvements and improved profitability The FDA has indicated that the purpose of the Quality Systems Manual is to define the Quality Systems integral in a company’s GMP compliant manufacturing, laboratory, and controlling operations. The Manual applies to all operations that fall under the jurisdiction of title 21 of the Code of Federal Regulations (CFR), parts 210 and 211.Compliance with these Policies, Guidelines, and Procedures is mandatory for all company employees. The Manual will be a living, maintained, and robust document that will ensure that the compliance driven values of an organization are sustained for the life of the company. The Quality Systems Manual will represent the organization’s systematic approach to GMP control of the site. The Manual and subsequent documents also should provide obvious connectivity to each other and connectivity to the governing CFR section. There should be a stratified chain of connectivity showing the CFR as the governing legal driver, and the Quality Systems and subordinate subsystems and documents: CFR>Quality System>Quality Subsystem>Work Instructions>Training.
The company’s stratified system is set up as follows: Quality System Level: establishes the Quality System, the GMP compliance-driven values, policies, and the mandatory critical elements to be contained in the subsystems and procedures. Subsystem Level: guides the subsystems that are affected by the policies in each Quality System. Work Instruction and Procedure Level: detailed work instructions to carry out GMP compliant practices in each subsystem. The manual is a “roadmap”to demonstrate the connectivity of the interrelated Quality Systems.
QUALITY SYSTEM LEVEL
Initially, the list of Quality Systems can be based on the functions that respond to the rules of 21 CFR parts 210 and 211.These functions contain, at a minimum:
Each of these functions serves as the foundation for the Quality Systems Manual. From these, the multitude of subsystems can be fitted into each parent Quality System. At this level, the company’s values and operational policies are manifested. In military terms, the “Rules of Engagement” are documented at this level. Each subsystem must comply with the policies and values established at this level. A picture is worth a thousand words, or in this instance, an example.
SECTION ONE Table A lists the Quality Systems incorporated into the Manufacturing, Laboratory, and Control Operations at “X” Company.
Table A. Quality Systems List.
SUBSYSTEM LEVEL This tiered, pyramidal approach by its very nature forces a subsystem to be an integral part of the whole. This structure also allows for a very easy and logical Quality System/Subsystem/Procedure numbering system that will aid in efficient navigation through the organization. The subsystems, as stated earlier, are subordinate to the Quality System that it supports. The subsystems delineate the next level of specificity in the organization
Table B. Individual Quality Systems.
Once again, a picture is worth a thousand words, or in this instance, an example. The Manual and connectivity between the Quality System and a Subsystem is shown in Table B.
SECTION TWO It should be clear at this point how the system is structured. It is simply an iterative process changing only the subsystem name and details.
Work Instruction and Procedure Level This is the level that engages the physical world. This is the level at which the actual operating procedures are documented and implemented by the employees. Each Subsystem should employ a governing Standard Operating Procedure (SOP), but the number of subsequent SOPs needed to drive the subsystem is totally dependent on the operational needs. Some organizations may need more than one thousand SOPs to drive their operation.
Table C. List of Work Instructions and SOP’s.
Let’s view an example of this levels manifestation -Table C .Once again; it should be clear at this point how the subsystem is structured. It is simply an iterative process changing only the procedure names and details.
UTILITY OF THIS PROPOSAL
FDA, Client, and Internal Auditing Amenability Through direct and indirect means, the authors have been exposed to the Agency’s desire to review a company’s GMP prowess via their Quality Systems Manual or structure. The simple stratified approach that is offered in this article will be of great utility for an organization’s interaction with the government. It is both elementary and comprehensive. Like the US Constitution, much can be said in a short, but powerful document. For similar reasons as stated above, the company’s internal auditing function can use this same “roadmap” to carry out its reconnoitering tasks to ensure interdepartmental GMP compliance. An additional utility within the auditing venue is the CFR references. This definitive referencing will allow an auditor to sort the systems by their respective CFR sections This capability will support an efficient means of directly assessing the company’s CFR obligations.
Organizational Structure In our world of science and GMPs, the fact that pharmaceutical companies still exist to make profits can be forgotten when one is dealing with the slings and arrows of outrageous fortune that the GMP environment can wield. If the company chooses, the structure of the Quality Systems Manual can even be extended to include all operating departments. The system easily extrapolates to include each department. The numbering systems can be extended to the non-GMP areas and can aid in a comprehensive accounting process. Areas like the GMP-governed disciplines can be culled out, and exact costs of these “over- head” or “life support” departments can be precisely calculated and reported.
CONCLUSION As complicated as our industry is, we can still interject utilitarian simplicity with the application of the ideas in this article. An organization’s Quality Systems Manual is a definitive roadmap showing the interconnectivity of all GMP-ruled areas and the comprehensive list of the procedures that drive the organizations operation. Quality can be built into the process. This process provides an effective tool to improve profitability and improved product quality. Figure 1 is an example of the Quality System Manual and the connectivity of the Manual with its subordinate parts and CFR drivers.
References 1.Berry,Thomas H.,“Managing the Total Quality Transformation.” 2.Mizuno,Shigeru,“Company-Wide Total Quality Control.”
About the Authors Andrew DiFelice, Associate Director of Pharmaceutical Services for R. Donnelly andAssociates, DiFelice can be reached by phone at 602/818-8091, by email at andy_difelice@rda-group.net, or by mail at R Donnelly andAssociates, 93 Cinnamon Tree Court, St. Charles, MO 63304 Ralph W. Donnelly, President of R. Donnelly andAssociates Inc., Donnelly can be reached by phone at 636/922-4785 or by e-mail at ralph_donnelly@rda-group.net. or by mail at R Donnelly and Associates, 93 Cinnamon Tree Court, St. Charles, MO 63304
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