Operations and Logistics Management of Pfizer Company

 

The Pharmaceutical Company: Pfizer Company

 

Pfizer Inc. is dedicated to better health and greater access to healthcare for people and their valued animals. The purpose is helping people live longer, healthier, happier lives through discovering and developing breakthrough medicines; providing information on prevention, wellness and treatment; consistent high-quality manufacturing of medicines, consumer products and global leadership in corporate responsibility. Pfizer is a research based global pharmaceutical company that discovers, develops, manufacturers and markets leading prescription medicines for humans and animals and consumer healthcare products. Thus, managing quality is so integrated into an organization’s culture and work that it becomes inseparable from any other aspect of management. Therefore, without abandoning the aim of integrating quality into everyday clinical activities and emphasize medical staff credentialing, patient satisfaction surveys and structured quality review and describe models of quality management committees and departments that would fit into the hospitals. (2006) Aside, it is necessary to respect the environmental aspects, for in the developed world it is the accepted philosophy that quality products can be only those which are produced in an environment friendly way, which in their use do not cause harmful effects on the environment as the good practices are international instructions, which in the developed world are incorporated into state legislation on the production of drugs.

 

Then, Pfizer treat good practice as an obligation for operations, then the other quality systems signify an extension of overall quality also to those areas which are not directly linked to pharmaceutical production. In the world, the most widespread standards are those from the ISO family to the constant concern for the environment for introducing the ISO9000 standard. (1993) The quality management system, which enables to implement total quality management from all aspects, is incorporated into the new quality regulations, which contain the requirements of pharmaceutical practices, as well as the ISO 9000 and ISO 14001 standards. ( 2006) The building up of the existing quality system to the level of business excellence will take place gradually, in conformity with the business policy of the entire company. This is realized by promoting personal and professional development, further training and concern for safe and sound working conditions. The system of environmental management is based on the recognized environmental considerations in quality manual and represent part of the company’s policy on quality, developing and managing the technology as prescribing the manner of collecting and removing forms of waste products and checking emissions into the environment and their conformity with the legislation such as endeavor of industry to achieve and demonstrate progress in the fields of health security, safety and environmental protection as the system of environmental management which actually comprises a wider area than is covered by the ISO9000 as it includes not only the environment but also safety at work and health security. ( 2006)

 

 

Part A

 

One of the most important areas of Pfizer Global Manufacturing is where scientists take drug lots and test them for conformity to specifications. The Quality Operations team makes sure that all the processes used to make the drugs follow regulatory rules and Pfizer policies. Quality is responsible for testing the processes used in manufacturing for effectiveness and efficiency. Pfizer Global Manufacturing’s number one core value is quality, a necessity in the manufacturing of Pfizer’s drugs and products. (2006) Quality management plays a key role in the pharmaceutical industry in order to ensure that products are safe and effective, manufacturing processes are subject to strict legal conditions. National and international authorities constantly monitor the manufacturers’ adherence to regulations. The directives and procedural instructions for validation require companies in the industry to document the entire logistics chain in full – from goods inwards to delivery and from the development of new preparations to the maintenance of mixers and packaging lines. (2006) 

 

There creates the basis for thorough and unambiguous documentation and that each pharmaceutical product runs through various stages of the quality control process during production – from the laboratory analysis of the base materials and tests during each individual production stage right through to the final checks. (1993) These tests and checks, for example, verify that the active agent content and its release correspond precisely with the manufacturing specifications. When numbering individual production batches and managing test and release information, provides the manufacturer with assistance. (2002) More extensive analysis options are also available, enabling product quality to be tracked through analyses of the number and type of fault reports per batch. This industry solution is also augmented by options for total quality control in the production of medications and sample data for various administration forms For example, pharmaceutical companies need to accurately weigh out all the substances and materials according to the formulas prescribed by the authorities before production actually begins. ( 2002) The security of documents in the pharmaceutical industry has become a critical issue since the advent of electronic data transfer. The regulations also require that secure, computer-generated, time-stamped audit trails are used to record the date and time of operator entries and actions that create, modify or delete electronic records.  

 

The theory is much easier to accept than the practice. Before the task of maintaining document security becomes overwhelming and will save time and later frustration to look at the number and nature of records involved. (1993) For the pharmaceutical industry as embarking on ISO9000:2000 quality system development – documents included the process of contract management, statutes, regulation, jurisdiction, purchasing, receiving and shipping, design and development, production and administration are considered “quality records” and “critical.” (2002) The control and security of documents is more manageable if distribution is limited to those who “need to know.” ( 2002) This means setting out the criteria for distribution at a very early stage in design and production development. Hard copy and electronic documents must be available for use where and when they are most needed. Every aspect of development and production, and the people involved in the process, must be considered carefully to ensure that everyone has the information they need when they need it. The main thing is to start the document control process in small, manageable pieces, there can create categories for the master document list from components of standards such as ISO9000:2000, which cover every aspect of a quality system as this will ensure that you have included all possible document sources. There is assigning of relevant authorities and responsibilities to assess and categorize documents for ISO9000:2000. ( 2002)

 

As certain advances in technology and globalization have changed organizations, work processes and records and have concomitantly altered the role of records managers. These challenges, however, also bring new possibilities. For example, international standards such as the ISO 9000 suite of quality standards highlight the essential role that records play in the operation of a quality company, in particular by providing essential evidence of the operation of quality systems. (2002) These standards provide the first concrete evidence that conventional records management is necessary and is an integral part of business operations, the new records management standard is intended to play a special role in relation to ISO 9000 by providing a benchmark for the management of quality records. Meeting the ISO 9000 requirements is promoting the role of records managers while simultaneously testing traditional record’s methods and techniques. Information technology exacerbates problems of preserving records, but it also facilitates the development of techniques and tools and consequently new responsibilities for records managers. For example, to ensure systems capture adequate metadata linked with records, records managers will have to identify, prior to records creation, the specific types of metadata that reliable and authentic records require.

 

 

The preservation of reliable records depends in part upon the maintenance of essential metadata as it is a vital tool in helping an organization fulfill the recordkeeping specifications required by external bodies, including compliance with ISO 9000 requirements. ISO 9000 is an international standard for organizing and documenting processes and procedures used to establish a quality system. ( 2006) The purpose of the guidelines is to improve the quality of products and services while increasing productivity and reducing costs. They provide a mechanism and structure for building and maintaining a system of excellence that internal staff and external clients and users can depend upon and trust. (2006) Moreover, ISO 9000 serve as an effective blueprint for management since they specify the types of procedures and documentation that a company must develop, the records or evidence it must create, as well as the training and measurement that it must conduct on an ongoing basis. This standard has increased the importance and profile of many records management programs. Organizations have always kept records, but prior to ISO 9000 such managers considered them to be a necessary evil instead of an essential component of a quality system. (2002)

 

 

A quality system requires three different types of documentation: records of business processes; documentation of the business rules that control the business processes and systems documentation. Records emanate from business processes; they therefore serve as objective evidence of the activities and transactions that support the creation of products or the provision of services. ISO 9000 guidelines provide specifications that relate to the creation and maintenance of quality records. (1996) ISO 9000 dictates that records must be legible. Legibility means that records are capable of being read as the legibility of the record relies upon information about hardware, software or operating systems dependencies. Furthermore, the system needs to know about any encoding such as ASCII or UNICODE, any methods of encryption or compression if applicable and any standards that the record complies with. (2002) Thus, the system requires both the record and metadata about its hardware and software environment to meet the ISO 9000 requirement of legibility. Thus, quality records provide many advantages for organizations and can help companies meet the ISO 9000 certification. However, systems must be designed to create the appropriate metadata to ensure they comply with recordkeeping requirements, particularly those identified by records management standards and the proposed international standard as it provide benchmarks for recordkeeping best practice. (1996)

 

 

 

Part B

ISO 9000 is a set of quality standards that assists an organization to identify, correct and prevent errors, and to promote continual improvement. Pfizer is implementing ISO 9000 as they face increasing external pressure to maintain accountability for services and product control. Although ISO has been successful in manufacturing and service industries, the application to Pfizer is relatively new and not without its problems like for instance, time-consuming implementation process during the implementation of ISO 9000. (Wilson, 1996) Pfizer company can gain ISO 9000 certification by establishing an effective quality system designed to overcome obstacles commonly faced by independent firms in their bid for the coveted award. The achievement of this quality system is divided into three phases that begin with an understanding of the company’s present situation in relation to the requirements of the standard. This is followed by documenting and implementing production process control and finally, implementing all the elements of the quality system. In today’s global market, customers require their expectations and needs to be continually met. Quality of products, services and processes therefore has become a crucial factor in the performance of an organization. (2002)

 

 

 

Aside, to assure the customer that the products will meet specified needs, ISO 9000 quality standards were developed, mainly by professionals from large companies. The standards were quickly adopted by large companies worldwide, then proliferated to be used by their smaller partners. However, in applying the ISO standards, Pfizer may face some issues including: (2006)

 

Ø  Owners/managers do not understand the standards

Ø  Funding for establishing the quality system is inadequate

Ø  Human resources within a firm are unfamiliar with the standards

Ø  Excessive paperwork is required by the standards

Ø  The cost may never be justified

Moreover, the standards present three models: ISO 9001, 9002 and 9003 – which stipulate a number of requirements on which an organization’s quality system can be assessed by an external party according to the ISO 10011 quality system audits standard. A quality system involves organizational structure, processes, and documented procedures constituted towards achieving quality objectives. A quality system documentation is structured in the form of a pyramid, with the quality manual at the top, followed by procedures, work instructions and records at various levels. (1989)

 

If the minimum requirements are met, a registrar accredited by a national accreditation institution issues a certificate of compliance and the organization’s quality system becomes ISO 9001, 9002, or 9003 registered. Guidance for the standards selection and use are presented in ISO 9000. The concept of a quality loop presents the chain of activities – from marketing through design, production and sales – that have an impact on quality. ISO 9000 standards require that those activities are documented, and the documents are implemented. (1996) These procedures will be developed in subsequent steps of the documentation/implementation process as the process of documenting a quality system is easier if the documents follow such appropriate format. It is often stated that pharmaceutical firms should establish their ISO 9000 quality system according to their needs. However, they often do not have the expertise, money, or resources to facilitate the process as they operate with minimum documentation and have to start the ISO 9000 process from scratch. Nevertheless, capitalizing on their strengths and with the boost from the ISO 9000 representative, Pfizer can acquire the experience and expertise in a short time, and proudly accomplish the task the best way they know how: by themselves. (1989)

 

Aside, ISO 9000 certification does not guarantee that a company has a quality product but only ensures that there is a quality control system in use. Advocates for ISO 9000 said that there should be more emphasis on product quality as the use of ISO 9000 standard may the one of best ways to create a field of suppliers that all adhere to an international standard. In his book, he also discusses the many challenges posed by ISO 9000 – the users of the standard are increasingly saying no. The rapidly emerging view is that implementing ISO 9000 also means implementing base line business management principles. (1996) In ISO 9000, quality management is defined as the processes an organization puts in place to ensure that its products or services satisfy the customer’s quality requirements and comply with any regulations applicable to those products or services. The company being certified is responsible for setting its own objectives to measure the success of its quality management system. To become ISO 9001:2000 certified, an organization must receive written certification by an independent, external body that has audited the organization’s management system and verified that it conforms to the requirements specified in the standard. (1990, 1986)

 

However, total quality management strategy called for establishing a formalized, ongoing quality assurance program that would improve the company’s efficiency and enhance service to customers, which would help the company to grow and become more profitable. (1990, 1986) ISO certification requires that the company develop a quality-management system to ensure that products and services conform to customer requirements. The system must be subject to continual performance improvement. There is perhaps no better way to demonstrate return in a service industry than through measurable quality of service and ISO certification to be a powerful tool in measuring and maintaining customer satisfaction. (1993) The Pfizer management must embrace the process and take personal charge of quality such as: (1993)

Ø  Top-down cascade of training from the chief executive through the organization

Ø  Effective gathering of statistical data, its correct interpretation and utilization

Ø  Clear quality goals must be written into business plans

 

 

TQM led to measurable bottom-line benefits and many other organizations was quick to follow down the TQM route to quality. (1990,  1986) Henceforth, the TQM adoption strategies suggested that many had simply attempted processes that could be described as overlay and resulted in low levels of ownership and poor integration far from being of advantage to quality management, it became counter-productive with staff losing motivation and are able to demonstrate quality improvements with concomitant improvements in production and decrease in costs. (1996) ISO9000 is an international quality management system adopted in various countries: recognition has been achieved by many organizations. It aims to provide quality assurance and consistency in products and services. Its popularity is due to the independent inspection and accreditation system and to the re-interpreting of the standard so that it can be applied within a service sector. (1996) A successful implementation of TQM can lead to improvements in the quality of products and services, reductions in the waste of resources, and overall increases in efficiency and productivity. Such improvements contribute to good customer relations, growth in market share and sustained competitive advantage. (1990, 1986, 1988)

 

 

 

The use of a quality strategy is a major strategic change which requires considerable research and planning and it is important to combine the hard edge of quality with the soft side of cultural change. (1990, 1986, 1988) TQM is a style of managing which gives everyone in the organization responsibility for delivering quality to the final customer, quality being described as ‘fitness for purpose’. ( 1996) TQM views each task in the organization as fundamentally a process which is in a customer/supplier relationship with the next process. ( 1989)

 

Quality Strategy

The traditional quality model stipulates an economically optimized level of quality. This model proposes that the total cost of production increases as prevention and appraisal costs to reduce defects rise. Conversely, as inspection and appraisal costs drop the number of defects increases causing quality to decrease ( 1989). The TQM model stipulates that high quality, in fact ever increasing levels of quality, can be obtained while reducing inspection and appraisal costs ( 1990, 1986).

 

The TQM model proposes that high quality products and services lead to increased profitability, market share, employee and customer satisfaction and competitiveness (1990,  1986,  1988). High quality has been linked with survival of corporations faced with strong global competitors (1986, 1988, 1991) The TQM model is a systematic approach to improving quality based on: team-based work groups, personal responsibility for group success, control of the work process owned by the individual, quality desired over quantity, motivation, and facilitated communication between groups and functional areas. (1991) The model is egalitarian in nature with suggestions for improvement sought from every level of the organization and motivation supplied through recognition/award programs and profit sharing, perhaps the key facet of the TQM is training employees in a scientific approach to fact-based problem solving using specific tools like: statistical process control charts, cause and effect analysis diagrams, process flow charts, team-building and group dynamics skills (1986, 1988, 1991).

 

 

 

 

 

 

Credit:ivythesis.typepad.com

http://researcharticlebase.blogspot.com/2011/09/operations-and-logistics-management-of.html