Operating procedures, documentation

In the author s experience, systematic failures receive too little attention from functional safety practitioners. Systematic failures are not random. They do not occur at a random time, and do not result from one or more of the possible degradation mechanisms in the hardware. Instead they are related in a deterministic way to a certain cause, which can only be eliminated by a modification of the design or the manufacturing process, operational procedures, documentation or other relevant factors. 

Standard operating procedures Documentation Verification Testing... 

Fluid flows, temperatures, and pressures must be kept witiiin the limits of the operating procedures. Document any variances, intentional or accidental, for investigation. The documentation should describe ... 

What records Written process safety information (chemical hazards, process technology, process equipment) Written process hazard analysis Written operating procedures Document employee training... 

Quality control encompasses all activities used to bring a system into statistical control. The most important facet of quality control is written documentation, including statements of good laboratory practices, good measurement practices, standard operating procedures, and protocols for a specific purpose. 

The second aspect of quahty documentation is to detail how the work processes referred to in the manual are performed. The QA unit is often the organization responsible for issuing a set of procedures designed to assure conformance to the appropriate standards or to company poHcy. The procedures, often called standard operation procedures (SOP) or quahty operating procedures (QOP), should include such topics as customer complaints, audit protocols, stabihty testing, preparation of COAs, test method vahdation, etc. 

Are appropriate directions for reacting to out-of-specification situations documented m standard operating procedures ... 

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. 

The confusion matrix (NSAC-60) is a method that identifies potential operator errors lemming from incorrect diagnosis of an event. It can be used to identify the potential for an operator to conclude that a small LOCA has occurred, when it is actually a steam line break. This provides a method for identifying a wrong operator response to an off-normal plant condition. It is particularly useful in Step 5 of the. SHARP procedures, Documentation requirements are presented in Table 4.5-2. 

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. 

Some organizations divide their quality system documentation into three levels a quality manual, a set of operating procedures, and the support documentation. 

Operating procedures prescribe how specific tasks are to be performed. Subcategories of these procedures may include test procedures, inspection procedures, installation procedures, etc. These should reference the standards and guides (see below) which are needed to carry out the task, document the results, and contain the forms to be used on which to record information. 

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). 

The documents that define the calibration process themselves are derived documents and therefore will be governed by your control procedure. They do not need to be listed along with all your other control and operating procedures in the index of quality system documents. A separate index of calibration methods should be maintained. Calibration methods are like test and inspection procedures, they are product specific. 

Documenting the Process. The net effect of these steps is a process description, defined in terms of customers and suppliers and their interaction. Next, the team can summarize that description in the form of a process flowchart, to illustrate the roles and responsibilities of each process stakeholder (see Figure 6-8). This chart provides the basis for developing standard operating procedures, or other process documentation, that the company can incorporate into existing practices. 

What Is the Expected Output or Work Product. The specific form of the finished product will vaiy according to your company s practices and needs. However, it s reasonable to expect that the team s efforts will ultimately produce a set of documented Standard Operating Procedures (SOPs) for the management system, or their equivalent within your organization (see Section 6.3). Interim work products may include progress reports (see Chapter 8), documentation of discussions and analyses, flowcharts, or other materials. 

This technique sets out to collect data about near-incidents or critical events that have been experienced by the operating team but that are unlikely to be documented. The basic premise of the technique is that events that could have led to serious consequences would tend to be remembered by the workers. Through individual or group interviews, significant events are recalled which are then analyzed in order to generate useful information about the difficulties involved in the performance of a task, the adequacy of the operating procedures, any problems with the equipment or control panel design and so on. The technique can be used in three areas ... 

To gather information about the factors which contributed to the above incident, interviews were held with the workers and their management. Relevant documentation such as standard operating procedures and documentation relating to the incident was also collected. A task analysis (see Case Study 3) of the job of the top floor person was carried out in order to examine the operations involved and the factors which could affect job performance. Two techniques were used for the analysis of this incident, namely variation tree analysis and root cause analysis. 

Table 2 The steps of recognizing a problem, proposing a solution, checking it for robust operation, and documenting the procedure and results under GMP are nested operations...

Standard operating procedures (SOPs)— The SOPs are controlled in a way similar to that of specification documents and analytical methods. It must be ensured that the correct versions of the SOPs are accessed and used by the scientists. After use, the hard copies should be destroyed and disposed of properly. An added requirement is that the SOPs should be accessible during working hours without interruption. Hard copies should be available at a manageable location so that the SOPs are available when the electronic system is down. 

Yet under the original requirements of 21 CFR Part 11 both companies would have had to conduct extensive test on the software to write and implement eight to ten standard operating procedures to document the requirements, development, and change history of the code and to record and archive all records. In this case, as in so many, such an investment in time and dollars would have been justihed for the pacemakers but wasted in the case of the tongue depressors. 

In the author s experience, field residue trials can be conducted in Latin America under complete compliance with all ERA guidelines and recommendations. More time does need to be spent in planning and preparation to ensure that the personnel involved in the testing have been trained in GLP and that this training, as well as the compliance of equipment, storage and archival sites, standard operating procedures (SOPs), and quality assurance (QA) audits, are properly documented. 

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