Requirements document

Does all rework of off-spec materials require documented Quality Assurance authorization ... 

Kanholm, Jack. ISO 14001 Requirements 61 Requirements Checklists and Compliance Guide. Pasadena, Calif. AQA Press, 1998. - Interprets and explains the ISO 14001 standard as 61 distinct requirements and discusses, with respect to each of these requirements, how to implement, required documentation, and what auditors will look for as evidence of compliance. 

Employees stated that they had received confined space training and were prepared to perform confined space rescue, but they had not rehearsed rescue procedures. In addition, the confined space entry permit form for both contractors did not ask for all required information. For example, the form did not require documentation of the duration for the permit, the intended communications procedures for entry operations, or documentation of hot work performed during confined space entry operations. Completed permits did not contain documentation of hot work performed during confined space entry operations, even though hot work had been performed during such operations at least twice during the project. 

Hazardous Waste Compliance GENERAL REQUIREMENTS Documentation... 

From this table one can see that all the additional requirements in ISO/TS 16949 were sourced from one or more of the four national quality system requirement documents. The location and wording of the requirements changed on incorporation into ISO/TS 16949. Many requirements from QS-9000 have been incorporated verbatim, whereas extracts from VDA, AVSQ, and EAQF were reworded so as to phrase the statements as requirements. 

In order to identify the differences in detail one would have to compare each of the four existing automotive quality system requirement documents with ISO/TS 16949. This is an exercise that forms part of the lATF Auditor Qualification Course and is not duplicated here. However, a summary of the 26 requirements that are additional to those in QS-9000 Third Edition are listed below ... 

Are the means used to ensure that product conforms to specified requirements documented in the form of a quality manual and quality system procedures ... 

The standard requires documented procedures to be prepared consistent with the requirements of this international standard, but what does this mean Preparing procedures consistent with the requirements of the standard means preparing those procedures where the standard requires them. Outside ISO 9001, ISO/TS 16949 does not use the same wording to require procedures. In some clauses it requires a process and in others it requires methods or a methodology or a system. Although systems are not procedures, procedures are not processes and methods are not necessarily procedures, systems, or processes. Some methods, however, will inevitable need one or more procedures. By including systems, methods, and processes, the standard now requires 43 documented procedures directly. 

The standard also requires documents such as FMEA, control plans, etc. to be marked with the customer s specific symbols to indicate those process steps that affect special characteristics. As the characteristics in question will be specified within documents, the required symbols should be applied where the characteristic is mentioned rather than on the face of the document. For drawings, the symbol should be applied close to the appropriate dimension or item. Alternatively, where a document specifies processes that affect a special characteristic, the appropriate symbol should be denoted against the particular stage in the process that affects that characteristic. The symbols therefore need to be applied during document preparation and not to copies of the document. The instructions to apply these symbols should be included within the procedures that govern the preparation of the documents concerned. 

Do maintain the design requirement document even after you have produced the product specification. 

Before any assessment can be performed, die team must be supplied with required documentation and process details. As widi other hazard identificadon steps, die following materials are usually needed ... 

The revamp objectives, constraints, and requirements must be clearly stated in a statement of requirement document transmitted to the engineering contractor. The document should be sufficiently detailed and require minimum interpretation so as to avoid oversights and unnecessary site visits. 

Protocols should require documentation of actual application practices and times. Samples of applied pesticides should be collected to document application rates to study sites. The test substance must be applied with typical equipment used for the crop, and the application must be made in accordance with the labeled use. Another variable that impacts such studies is the fact that most landowners have their own application equipment, which increases the variance in actual application rates among fields and may cause differential intra-field heterogeneity in application rates. 

The programming staff or IT department personnel should develop a software/computer system design description based upon the requirements document. This description should outline the specifics required in the system, including security... 

The basic requirements for the CBMS II are to reliably detect and identify with sufficient sensitivity and selectivity both CWA and BWA in point detection and reconnaissance missions, in order to be deployable in wheeled reconnaissance vehicles and be operable by nontechnical personnel wearing, at the extreme, MOPP IV protective gear. Contrary to the usual practice for a military detector system, the CBMS II does not have its own requirements document. Instead, the requirements and specifications for the CBMS II are based on the detector requirements of the host platforms in which it will be deployed. These requirements are described in terms of performance, as opposed to the usual practice of being enumerated in volumes of detailed specifications. As is usual for a complex multiyear program, the requirements changed over the course of the CBMS II program as the requirements for the host platforms evolved. 

Management can use a variety of criteria to select and prioritize corrective actions and safety improvements. They include costs, other competing priorities, implementation schedules, the effectiveness of risk reduction, and technical feasibility. These criteria, as well as management decisions about corrective actions, must be documented. If after evaluating an action item, management chooses to take no further action, that decision must also be documented. In addition to requiring documentation of management decisions, the PSM Rule requires a system to track implementation of corrective actions to be made. 

Experience with formal notations shows that the precision of the notation tends to flush out these issues at the appropriate stage. Anyone who has spent a day or two in a specification workshop, creating a model for a business or a new system, is aware of how quickly important questions are raised. Many of these issues would never have been thought of had the requirements document been in plain natural language (English or your local favorite). 

The people who will use your product need to see the requirements, although not the design. How this works depends on what sort of clients they are. If they are another design team using your software component, you can expect them to understand the documents directly. Still, it is essential that you clearly separate the external view from the internal workings. The requirements documents form part of the client s contract with you. 

The contract between you and the client can take the form of a requirements document of the traditional kind written in natural language. But having been through the process of formalization, both sides can be confident that it is achievable and consistent and masks no big unknowns. 

You write business models and requirements documents by talking with people who know the business and will use the product that you are designing. They may be end users, or... 

As with business models, the main message is to keep the users well involved. The worst method is to take an informal requirements document, go off into a back room for three years, and then proudly present users with something that isn t what they wanted in the first place and is inappropriate now. You need to make it clear to users that their ideas are invited, take steps to stimulate ideas, and keep them in touch with the process. 

Requirements A requirements document is a document written in terms that can be discussed with users. 

IRBs must require documentation of informed consent in all studies except those specified in the regulations in which documentation may be waived. Clinical drug... 

The outcome of planning should include the generation of a method definition requirement document (MDRD) in which all stake holders agree, prior to method development, on the critical attributes of the method. Considerations such as what impurities/degradation products should be monitored, requisite reporting thresholds, the need for an MS-compatible method, if identical methods for DP and DS are required, etc., should be clearly decided and agreed upon by all stakeholders. 

Design qualification (DQ) is the process used to determine a system that will function within the intended purpose. It can be compared to a user s requirements document for a piece of software. For example, if a CE is being purchased to run DNA sequencing samples, then the system purchased will need to include a fluorescence detector. The main vendors for CEs have similar options for their CE instruments reducing the utility of DQ protocols. Their main utility is to define the specific equipment needed for the purchase order. This only needs to be performed before the system is purchased initially. If desired, this can also be done when additional features need to be purchased (i.e., new detectors, etc.). 

Complete required documentation of event Incident Commander... 

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