Records of Procedures

Procedures used in a laboratory must be recorded for easy reference, down to the smallest detail. An analytical laboratory will often use standard procedures from official publications, but to these must be added references to specific types of equipment used. As a result, a laboratory needs its own procedure manual to use in day-to-day work. Every operation should be described in detail, with references made to official methods where applicable. It takes thought and skill to write such a manual in a manner that will make is useful to all workers. Safety measures, where needed, must be included. Simple operations, such as the preparation of reagent solutions, should be specified. 

Many laboratories use a numbering system for their procedures for easy reference. Procedures should always be dated, since they will some day be superseded by new versions. At that time, the outdated ones should be carefully filed. There may be cases where reference will have to be made to them in the future. One person should be in chai ge of the methods books and make sure it is kept up to date. 

A suitably sized ring binder with a sturdy cover is recommended, preferably covered with plastic. This procedure manual must be kept where aU who use it will have easy access to it. More than one copy may be needed in a large laboratory. Just in case an accident should take place, an extra copy must be kept in a safe spot. For durability and protection from spills each page can be inserted in a vinyl sheet protector. No pages must ever be borrowed from the book even on a temporary basis. 

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Auditability for safety considerations and to allow automatic recording of procedures, synthesis history and results. 

Figure 3.3. Formalized recording of procedures at value examination of prognostic reliability of the kinetic model for a multistep reaction.

Chemical methods involve removing a portion of the reacting system, quenching of the reaction, inhibition of the reaction that occurs within the sample, and direct determination of concentration using standard analytical techniques—a spectroscopic metliod. These methods provide absolute values of the concentration of the various species that are present in the reaction mixture. However, it is difficult to automate chemical mediods, as the sampling procedure does not provide a continuous record of tlie reaction progress. They are also not applicable to very fast reaction techniques. 

The audit team, through its systematic analysis, should document areas that require corrective action as well as where the process safety management system is effective. This provides a record of the audit procedures and findings and serves as a baseline of operation data for future audits. It will assist in determining changes or trends in future audits. 

All processes and equipment should be proven capable of performing the task for which they were designed and so should either be subject to qualification tests or process capability tests. There may be documentation available from the supplier of the equipment which adequately demonstrates its capability, otherwise you may need to carry out qualification and capability tests to your own satisfaction. In the process industries the plant is specially designed and so needs to be commissioned and qualified by the user. Your procedures need to provide for such activities and for records of the tests to be maintained. 

The second part of the requirement deals with inspection and test records, which are also covered in clause 4.10.5. The difference between these requirements is that clause 4.10.1 requires you to document the records to be established (in other words define ) in the quality plan or procedures and clause 4.10.5 requires you to produce the records defined in the quality plan or procedures. Your inspection and test procedures therefore need to specify or contain the forms on which you intend to record the results of the inspections and tests performed. The details are covered later in this chapter, but there are two types of record to be considered the record that shows which inspections and tests have been performed and the record that shows the results of these inspections and tests. One may be a route card, shop traveler, or document which acts as both a plan of what to do and a record of the progress made and the other may be a table of results with specified parameters and accept/reject criteria. 

Your inspection and test records or verification records should be of two forms one which indicates what inspections and tests have been carried out and the other which indicates the results of such inspections and test. They may be merged into one record but when parameters need to be recorded it is often cleaner to separate the progress record from the technical record. Your procedures, quality plan, or product specifications should also indicate what measurements have to be recorded. 

There are two categories of equipment which determine the selection of equipment general-purpose and special-to-type equipment. It should not be necessary to specify all the general-purpose equipment needed to perform basic measurements, which would be expected to be known by appropriately trained personnel. You should not need to tell an inspector or tester which micrometer, vernier caliper, voltmeter, or oscilloscope to use. These are the tools of the trade and they should select the tool which is capable of measuring the particular parameters with the accuracy and precision required. However, you will need to tell them which device to use if the measurement requires unusual equipment or the environmental conditions prevailing require that only equipment be selected that will operate in such an environment. In such cases the particular devices to be used should be specified in the test or inspection procedures. In order to demonstrate that you selected the appropriate device at some later date, you should consider recording the actual device used in the record of results. With mechanical devices this is not normally necessary because wear should be detected well in advance of there being a problem by periodic calibration. 

There is only a requirement for a record of changes in procedures and not changes in plans, specifications, and drawings, which are clearly not procedures, but whether it be procedures, work instructions, or other types of instructions, you will need to be able to demonstrate that you have a system for preventing the recurrence of nonconformities. 

In addition to issuing the procedures you will need to reference them in the appropriate work instructions in order that they are implemented when necessary. In some cases it may be more appropriate to include these provisions as an integral part of other procedures rather than have separate procedures. Whatever the method, you will need traceability from the identification of need to implementation of the provisions and from there to the records of achievement. 

Audits of practice against procedure or policy should be recorded as they are observed and you can either do this in note form to be written up later or directly onto observation forms especially designed for the purpose. Some auditors prefer to fill in the forms after the audit and others during the audit. The weakness with the former approach is that there may be some dispute as to the facts if presented some time later. It is therefore safer to get the auditee s endorsement to the facts at the time they are observed. In other types of audits there may not be an auditee present. Audits of procedure against policy can be carried out at a desk. You can check whether the documents of the quality system satisfy all the clauses of the standard at a desk without walking around the site, but you can t check whether the system is documented unless you examine the operations in practice. There may be many activities which make the system work that are not documented. 

Define operating procedures covering the receipt and recording of calls or letters, their acknowledgement, and who to route them to for action. 

All critical errors and recovery points for task steps are recorded in accordance with the conventions of the PHEA and provide a valuable input to the specification of warnings and cautions for the design of procedures. In addition, various performance-influencing factors which contribute to the occurrence of critical errors can be identified which can provide input to the development of other error reduction measures such as training, and control panel design. 

It should be borne in mind that although it is possible to generalise on sampling procedures, all industries have their own established methods for obtaining a record of the quantity and/or quality of their products. The sampling procedures for tobacco leaves will obviously differ from those used for bales of cotton or for coal. But although the types of samples differ considerably the actual analytical methods used later are of general application. 

Data collected on the day-to-day operation of a facility are a more immediate source of information. This requires the recording of all non-conformances, procedure... 

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