Quality management documentation

Introduction to the supplier s QMS and qualification strategy Detailed analysis of the quality management documents and the qualification strategy (qualification of the QMS in the sense of certification)... 

The supplier must not only be able to show that there is a QMS but also that it is actively used. SAP manages quality management documents and quality item lists electronically and thus ensures that employees have constant access to the most up-to-date information. Because it is managed electronically, it is possible to construct automatic workflows to ensure that the process steps prescribed are followed. It is important to note that suppliers do not have to conform with U.S. 21 CFR 11 governing the use of electronic records and signatures. Customers should nevertheless expect suppliers to ensure that electronic records are secure and that their integrity cannot be compromised by data corruption or unauthorized manipulation. 

TQM involves all the organizations, all the functions, the external suppliers, the external customers and involves the quality policy. Similarly, TQM cannot be achieved without good Quality Management Systems (QMS) which bring together all functions relevant to the product, providing policies, procedures and documentation. The elements of a quality organization consist of these three mutually dependent items (Field and Swift, 1996) ... 

Quality management is both a technical subject and a behavioral subject. It is not a bureaucratic administrative technique. The rise in popularity of ISQ 9000 has created some unhelpful messages such as the document what you do strategy. There has also been a perception in the service industries that ISQ 9000 quality systems only deal with the procedural aspects of a service and not the professional aspects. For instance in a medical practice, the ISQ 9000 quality system is often used only for processing patients... 

A signed statement by management without its approval to the quality system documented policies and procedures will indicate that it is not committed to honoring the policies and procedures. Managers need to approve the documents within the quality system that prescribe activities for which they themselves are responsible. This serves to demonstrate that they agree with the manner in which the policy has been interpreted and are prepared to provide the resources needed to implement the documented practices. 

The standard doesn t require a procedure for Management Review and while it does require procedures for Design Control it does not specify that a Design Review Procedure is required. The phrases consistent with and in accordance with have the same meaning as both imply compatibility and agreement. If you restrict yourself to a literal interpretation of the standard, you need produce no more than 43 documented procedures - possibly less if some aspects do not apply to your business. You can combine several procedures in one document, the size of which depends on the complexity of your business. The more complex the business the greater the number of quality system documents. The more variations in the ways that work is executed, the larger the quality system will need to be. If you have a small business and only one way of carry-... 

Quality Management system priorities to consider are management responsibility, quality system principles, auditing, contract review, design control, corrective action, document control, quality records, training, product safety and liability, and statistical techniques, because these are critical aspects of the Quality Management system where Xmple Inc. already has some systems in place. 

You will need to undertake a series of interviews to understand existing PSM and ESH programs. You may also need to conduct some interviews to confirm aspects of your quality management system. However, if the Quality Management system is not well documented this may indicate a weakness, and you should reconsider the wisdom of moving forward with the proposed integration. It is essential to test how the processes are actually functioning, as this frequently differs from any description, formal or informal. 

A quality system comprises the organizational structure, responsibilities, procedures, processes, and resources used to implement quality management, or ESH/PSM management in this case. This part of the standard includes a somewhat detailed discussion of each of the parts of the quality system as well as its documentation. 

Quality Management Personnel Premises and Equipment Documentation Production Quality Control Contract Manufacture and Analysis Complaints and Product Recall Self Inspection... 

We have described the CQP concept from a techno-managerial perspective which means that we explicitly pay attention to the roles of both the food and human systems that constitute a food quality management system. The principle beyond the CQP concept is that one need only to control those steps in the process that are critical toward decay of the quality attributes. CQPs must be monitored, documented, and validated in such a way that the system is able to assure a certain quality level. 

There is an abundance of references defining and describing the role played by QA, Quality Control (QC) and Total Quality Management (TQM) in a modem commercial analytical laboratory. The role played by reference materials (RMs) and certified reference materials (CRMs) in the pursuit of analytical measurement accuracy is also well documented. 

In the previous chapters of this book, we have looked at many aspects of quality in laboratories. Some of the relevant Standards have been mentioned and their similarities and differences outlined. This chapter aims to give more detail on the components of the Standards and show how a quality management system can be achieved in the laboratory. The documentation required and the processes necessary to demonstrate that the management system operates to the requirements of International Standards will be explained. It is important to be clear that the overall management system of a laboratory or organization will cover all of their operations this includes quality, administration and technical systems. 

In terms of documentation, the requirements of ISO/IEC 17025, ISO 9001 and ISO 15189 are very similar and so will be dealt with together. For a quality management system to be effective, all of the components (policies, systems, programmes, procedures, instructions, etc.) must be clearly documented so that everyone in the organization knows what is expected of them. Figure 9.1 shows... 

All members of staff of a laboratory are responsible for ensuring that they are familiar with the quality management system, as set out in the Quality Manual and any supporting documentation. They are expected to follow the... 

The guidelines also stress that the perfunctory execution of any quality system will not guarantee the production of data of adequate quality. The correct procedures for feedback, remedial action and staff motivation must also be documented and acted upon. In other words, there must be a genuine commitment to quality within a laboratory for an internal quality control programme to succeed, i.e. the IQC must be part of a complete quality management system. 

Chapter 4.2 demands that the laboratory must have a quality management system appropriate to the scope of its activities. This must be documented in a quality manual which is written in an imderstandable form and available to all persoimel (see chapter 7 in this book). 

The first requirements are concerned with the quality management system (QMS) and the documentation that is necessary for the effective operation of the system, which is quite substantial. The numbering of the paragraphs is the same as in the standard to make it easier to look up further details. 

The laboratoiy quality manual is a document addressing the quality management system requirements and shall... 

---