Quality management testing programs

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. 

Product verification requires inspection and testing programs to confirm that product meets the quality requirements. In PSM and ESH terms, the product is the management of environmental, health and safety issues and may be difficult to separate from measurement (Chapter 7) and Audit. 

An active program of surveillance of the quality of the immunostains produced must be defined. The primary elements of such a quality assurance (QA) program include procedures and policies for patient test management, quality control, proficiency testing, comparison of test results, relationship of clinical information to patient test results, personnel assessment, communications, complaint investigations, QA review with staff, and QA records. The documentation and review by the laboratory director of all QA procedures is imperative and cannot be overstressed. A brief explanation of each of the QA elements is as follows ... 

Test facility management Test site management Sponsor Study director Principal investigator Quality assurance program Standard operating procedures Master schedule... 

One of the most significant features of software is branching — its ability to execute alternative series of instructions based on different logic states and/or inputs. This feature contributes heavily to another characteristic of software its complexity. Even short programs can be very complex. Comprehensive testing is seldom practical, and latent defects may remain hidden within unexercised and untested software pathways. Quality management practices are therefore essential to ensure with sufficient confidence that software is fit for purpose. 

Jack Hubball is a lead criminalist with the Connecticut State Police Forensic Laboratory. The Chemistry Section of the laboratory provides analyses for organic compounds from a variety of samples submitted from crime scenes. However, the majority of samples are from suspect-arson fire scenes. Many of these samples contain pyrolysis products and/or polymer additives. During his tenure at the Forensic Laboratory, Dr. Hubball has analyzed more than 10,000 items. In addition to his duties as an analyst, he is the quality manager for the Forensic Laboratory and is responsible for most aspects of the lab QA/QC program. He is the laboratory representative to the Connecticut State Police K-9 Unit and provides final testing and third party certification for the accelerant, drug and explosives detection teams. 

The products identified may be technical ones, such as software components and their supporting documentation, management products, such as plans and reports of various types, or items that are the by-products of processes to ensure software quality, such as testing scripts. The products may be ones that will be delivered to the customer (deliverables) or intermediate products created at various stages of the project for internal purposes, for example, to clarify and communicate design decisions between members of the development team. The concept of a product is a broad one, so that a person could be a product (e.g., a trained user ) or the product could be a revised version of a previously existing product (e.g., a tested program ). 

Quality audit program. (Under this program, the Quality Manager or Supervisor periodically makes unannounced checks on inspected units, accuracy of gauges and test equipment, etc., to verify the accuracy as well as adequacy of quality assurance systems)... 

The focus of the validation program is usually the quality attributes of the system implementation, change control, and the verification and testing of modifications made to the baseline system. The configuration management of the system, including its documentation, is a key area of concern. Specifically, documentation management is extremely critical for the information contained in both the master production records, and in the application. 

---