Documentation instructions

Any treatment, such as fumigation, used to reduce fungal or microbiological contamination or other infestation, together with methods of determining the extent of such contamination and potential residues, should be documented. Instructions on the conduct of such procedures should be available and should include details of the process, tests and allowable limits for residues together with specifications for apparatus used. 

The earliest indication of qinghao as an antimalarial medication stems from a famous healer and alchemist, Ge Hong (284-346), during the Jin Dynasty (265-420 AD), who documented instructions to prepare extracts in his medical text Emergency Prescriptions Kept up one s Sleeve (Zhou hou beiji fang) (Fig. 5.189). [455]... 

In order to guarantee the correct tests intercomparison, the test procedure was done according to the norm UNE 66543 [2] where documentation, instructions and statistic planning are stated. So that the measurements will be always made in the same way, the measuring method should be standardized by means of a written procedure which will describe how to carry out the measurements. 

To elicit similarly structured replies from all the vendors, either a section can be inserted in the tender document instructing the vendor how to respond or a checklist containing all the relevant questions that should be answered can be enclosed. It is important to know whether a function is available as standard in the package, needs to be configured within the standard package, customized, or is not available in the current released version of the system. 

Most people have little or no practice in just looking at what happens, and it may therefore be useful to make a deliberate effort, at least initially. Work descriptions often start from ideas about how an activity ought to be carried out - for instance, as they can be found in design documents, instructions, procedures, training materials, etc. Looking at what happens is, however, about Work-As-Done rather than about Work-As-Imagined and must therefore refer to work as it is usually is done in an everyday setting. 

Approved techniques for manual and mechanical sampling are often documented for various commodities handled in commerce by industiy groups. Examples are the International Standards Organization (ISO), British Standards Association (BSA), Japan Institute of Standards (JIS), American Society for Testing Materi s (ASTM), and the Fertihzer Institute. Sampling standards developed for use in specified industry applications frequently include instructions for labora-toiy work in sample preparation and analysis—steps (2) and (3) above. 

Are specific packagmg/repackagmg instructions (for example, specific container type, pounds) documented ... 

Has each task that has been identified as critical in the area of quality and/or safety been documented with full operating instructions and are these instructions reviewed regularly ... 

For any chemical whose identity is claimed as a trade secret, you must submit to EPA two versions of the substantiation form as prescribed in 40 CFR Part 350, published July 29, 1988 In the Federal Register (53 FR 28772). Use the order form In this document to obtain a copy of the rule and substantiation form. One version identifies the chemical the second version does not Identify the chemical specifically, but provides instead a generic identity. Only this latter version will be available to the public. For further explanation of the trade-secret provisions, see the instructions below... 

The submissions of section 313 reports in magnetic media and computer-generated facsimile formats has been approved by EPA. Magnetic media submissions to EPA must follow basic specifications set forth by EPA in the document. Magnetic Media Submissions Instructions fEPA 560/4-90-008) which is also included in EPA s Toxic Chemical Release Inventory Reporting Package for 1989 (EPA 560/4-90-001). To order these documents, see the document request form in Appendix I. 

You should be careful not to omit any steps. Care should be taken not to make the job hazards too detailed. Too much detail will make a JHA ineffective. Make sure that only safety steps are recorded. One of the common mistakes is to mix work elements with job hazards. A JHA is not intended to document work process instructions, although some people believe that they should be included. 

I am particularly indebted to Dr. Howard Lambert of Lawrence Livermore Laboratory and FfA Associates for providing the PC computer codes FTAP (fault ti ee code), POSTER (post processor), IMPORT (importance calculation), MONTE (Monte Carlo error determinadoni, and supporting documentation and instructions. 

It is always inadvisable to activate in a stream of hot or cold air (hair drier), because laboratory air is then blown over the layer. Such details also belong in the documentation of working instructions. 

You need an improvement system that causes improvement opportunities to be identified. Relying on chance encounters will not create the conditions needed for continuous improvement. The data that needs to be analyzed will be generated by a particular process and this process governed by particular documented procedures. By having already placed instructions in these procedures for certain data to be transmitted to your data analysts, you can cause opportunities to be identified. Other opportunities that are less dependent on product or process data may arise from the audit process and particular projects such as benchmarking, customer and supplier surveys. 

Instructions concerning safety and environmental issues should be integrated into the control and operating procedures such that the instructions are given at the stage in the process when they apply. In this way staff do not have to consult several documents and the chance of error is reduced. 

For a quality manual to be a manual it should contain the procedures and instructions, as does a computer manual or a car maintenance manual, so whether one volume of the manual contains or refers to other documents does not prevent the collection of documents being referred to as the quality manual. Manuals tend to include operating instructions, hence the word manual. The quality manual should therefore contain all the policies and practices but not necessarily in one volume. 

The problem with this approach is that the term supporting documentation fails to convey what might be included. In many cases the supporting documentation has been limited to the work instructions but in reality there are many different types of documents that are needed to produce quality products (see Part 2 Chapter 5). 

The 1987 version of ISO 9001 required the quality policy and the quality system procedures and instructions to be documented, clearly identifying three levels of documents in practice, organizations produced an intermediate level between the quality policy statement and the procedures which addressed the requirements of the standard and cross-referenced the associated procedures. This intermediate level together with the quality policy statement was often referred to as the quality manual. However, some manuals merely paraphrased the requirements of the standard, some described the quality system, and others confined the manual to the organization s operational policies. The guidance given in clause 5.3.1 of ISO 9004-1 suggests that the quality system documentation consists of policies and procedures. Clearly these policies are of a somewhat lower level than the corporate quality policy addressed in Part 2 Chapter 1. 

Work instructions define the work required in terms of who is to perform it, when it is to commence and to be completed, what standard it has to meet, and any other instructions which constrain the quality, quantity, delivery, and cost of the work required. Work instructions are the product of implementing a control procedure, an operating procedure or a document standard (see further explanation below). 

Not all instructions need to be documented - it depends upon the nature of the message being conveyed. Many types of forms have been conceived to convey instructions. Purchase Orders, Change Requests, Amendment Instructions, Engineering Orders, and Print Requisitions are all instructions that cause people to do work and hence are work instructions rather than procedures. 

It follows therefore that the idea of calling documents procedures when they only apply to interdepartmental activities and calling documents work instructions when they apply to departmental activities is ill-conceived. Both types of documents are in fact procedures. In both cases work instructions may be needed to initiate work and procedures may be needed to define the sequence in which the work is to be executed, where the instructions alone are insufficient. 

The standard requires the results of process studies to be documented with specifications for means of production, measurement and test, and maintenance instructions. 

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. 

The documentation for design changes should comprise the change proposal, the results of the evaluation, the instructions for change and traceability in the changed documents to the source and nature of the change. You will therefore need ... 

A Change Notice, which provides instructions defining what has to be changed. This is issued following approval of the change as instructions to the owners of the various documents that are affected by the change. 

Prior to commencement of production, design changes do not require any modification documentation, the design changes being incorporated in prototypes by rework or rebuild. However, when product is in production, instructions will need to be provided so that the modification can be embodied in the product. These modification instructions should detail ... 

Produce procedures that govern the generation, proving, and publication of product/ service support documents, such as handbooks, operating instructions, etc. 

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