Documented Processes

Once the design is developed, the part is disclosed to the SQS. This kicks off a process lasting 2 to 3 years to assure that the redesigned parts are available to the assembly line and that they meet quality standards. The SQS, the engineer, and the supplier form a product team that works toward this goal. The documented processes described in the next section cover the scope of their activity. 

DaimlerChrysler requires that its suppliers be certified to the automobile industry s quality standard, called QS-9000. That standard defines the internal quality processes that suppliers must use. An independent registrar must certify compliance with these processes. They cover continuous improvement, defect prevention, and reduction in variation. QS-9000 provides a foundation of basic requirements for any supplier wanting to serve any of the major automobile companies. 

DaimlerChrysler supplements these requirements with its own procedure for new-product introduction. DaimlerChrysler characterizes its quality efforts two ways — advance and current. DaimlerChrysler refers to efforts to anticipate problems as Advance Quality Planning (or AQP). As the name implies, the hope is to head off problems before they happen. Current quality efforts focus mostly on problems in assembly plants. They also address continuous improvement after a component is in production. Suppliers are continuously graded on their performance, and low performers are subject to corrective action, even if the parts they provide are carryover parts that have no design changes. 

The AQP process begins with a risk assessment. This is a triage event sorting new or modified components into low-, medium-, or high-risk categories. The type of risk determines how advance quality assurance will be handled 

Chrysler supplements these requirements with its own procedure for new product introduction. Chrysler characterizes its quality efforts in two ways advance and current. Chrysler refers to efforts to anticipate problems 

Current quality efforts focus mostly on problems in assembly plants. They also address continuous improvement after a component is in production. Suppliers are continuously graded on their performance, and low performers are subject to corrective action, even if the parts they provide are carryover parts that have no design changes. 

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Does the facility conduct documented process hazard analyses on new processes ... 

This information must be organized and coordinated to satisfy a company s process and facilities documentation process and regulatory requirements. 

The standard requires a documented process for determining customer satisfaction, including the frequency of determination and how objectivity and validity are assured. 

Develop Certification Strategy 1- Document Process Parameters (Control, Capability) Confirm Measurement System 1- Classify Process Parameters... 

System description is tlie compilation of tlie process/plant information needed for tlie risk analysis. For e. ample, site locations, environs, weatlier data, process flow diagrams (PFDs), piping an instnmientation diagrams (P IDs), layout drawings, operating and maintenance procedures, technology documentation, process chemistry, and tliermophysical property data may be required. 

Palladium-catalyzed aminations of aryl halides is now a well-documented process [86-88], Heo et al. showed that amino-substituted 2-pyridones 54 and 55 can be prepared in a two-step procedure via a microwave-assisted Buchwald-Hartwig amination reaction of 5- or 6-bromo-2-benzyloxypyri-dines 50 and 51 followed by a hydrogenolysis of the benzyl ether 52 and 53, as outlined in Fig. 9 [89]. The actual microwave-assisted Buchwald-Hartwig coupling was not performed directly at the 2-pyridone scaffold, but instead at the intermediate pyridine. Initially, the reaction was performed at 150 °C for 10 min with Pd2(dba)3 as the palladium source, which provided both the desired amino-pyridines (65% yield) as well as the debrominated pyridine. After improving the conditions, the best temperature and time to use proved... 

Preconfigured LIMS— This LIMS does not require extensive customer programming. To meet specific needs of end users, the vendors provide a comprehensive suite of configuration tools. These tools allow end users to add new screens, menus, functions, and reports in a rapid and intuitive manner. The tools also allow the LIMS to be more easily integrated with other business applications such as document processing, spreadsheets, and manufacturing systems. 

Audit A systematic, independent and documented process for obtaining evidence and evaluating it objectively to determine the extent to which set procedures or requirements have been fulfilled. 

Collect Chemical Reactivity Data Process Knowledge and Documentation Process Safety Information Identification of Major Hazards... 

Document Chemical Reactivity Risks and Management Decisions Process Knowledge and Documentation Process Risk Management Process Safety Information Process Hazard Analysis Operating Procedures Operational Control... 

In the 13 case studies documented processes and experiences of attempts to substitute hazardous substances in the 1980s and 1990s were examined. The aim of the choice of cases was to cover a wide spectrum of substitution conditions consumer-close and consumer-remote products, product auxiliary materials and process auxiliary materials, SMEs and large-scale industiy, environment, consumer and occupational health and safety subjects, technical and organisational iimova-tions. 

Systematic, independent, documented process for obtaining records, statements of fact or other relevant information and assessing them objectively to determine the extent to which specified requirements (need or expectation that is stated) are fulfilled [ISO 17000]... 

Each in vitro assay is fully validated using several criteria. The validation step for each assay and each experiment follows a specific, well-detailed and documented process. Strict quality standard guidelines ensure the construction of a high quality database of reliable and reproducible data. 

Several vendors have experience in the operation of ex situ thermal desorption systems and have documented processing costs per ton of soil or waste material treated. The overall range varies from approximately 100 to 400 (1993 dollars) per ton of material treated. Costs are also highly variable due to the following factors ... 

Figures 3 and 4 illustrate how a biennial document review process and document processing cycle time metrics faltered in their early stages due to lack of process ownership, definition, and management review. This situation presented a compliance risk to the organization and resulted in poor business efficiencies. Improve-...

Documented process structure provides rapid employee assimilations when transferring employees between sites. New employees, replacing existing process owners, are enabled to rapidly execute process responsibilities due to the abbreviated learning curve when processes have been well defined and documented. Systems designed as described here provide meaningful and comparable metrics for leadership to evaluate progress, compliance, and performance. 

Intramolecular hydrogen abstraction of this type is a well-documented process (the Norrish type-2 process) in the photochemistry... 

Sound development package in place Ranging studies completed and documented Facility qualification completed and documented Equipment qualification completed and accepted Appropriate analytical methodology implemented and validated Personnel training completed and documented Process trials and demonstrations executed and documented Change control in place and effective... 

NOTE In Subsection 4.2 is a blank Reaction Sheet, suggested for use to document process chemistry. 

Formalized and documented processes shall be established and used for every site and technology that ... 

Although transesterification and transamidation reactions of simple carbonyl ligands are usually associated with the involvement of a co-ordinated nucleophile, there are some well-documented processes which unambiguously involve attack by an external nucleophile upon a co-ordinated electrophile. Dithiocarbamate complexes contain a chelated. S, 5"-bonded dithioamide ligand and undergo facile transamination reactions upon treatment of the copper complexes with amines (Fig. 3-22). 

The International Standards Organization (ISO) definition of audit is Systematic, independent, and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which agreed criteria are fulfilled. The bottom-line goal of the software developer audit process is to allow you to assess the developer s quality assurance (QA) system. 

It is easy to simply state that a well-executed PDLC will reduce or possibly eliminate future OOS results, since in actuality is process almost always occurs over the course of years and involves tens if not hundreds of technical personnel. Maintaining control over such a long and complex path may seem a daunting task, but if each phase is carefully planned, managed, and controlled through a premeditated and well-documented process ... 

Metallation of amine derivatives adjacent to nitrogen and further electrophilic substitution is a well-documented process to elaborate amines, provided that the starting amines are activated.124... 

The author would like to thank Martin Simonetti, Andrew Jones, Linda Blackwood, Ken Olsen and Anthony Chen for their expert assistance and advice. Special thanks to the Genentech Document Processing staff for the preparation of this manuscript. 

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