Records management, Good

ISPE/PDA (2002), Good Electronic Record Management, Good Practice and Compliance for Electronic Records and Signatures (www.ispe.org). 

A common concern expressed by managers is that PSM and ESH are costs to their operations that adds little or nothing to customer satisfaction. The use of quality management approaches should ensure that the new systems will be more efficient and so costs will actually fall. It may also be possible to demonstrate that facilities with excellent PSM and ESH records have good performance in other areas. You should look for such examples within your own organization. 

The fnndamental challenge to confignration management record keeping is whether it can make a Ml system rebnild possible by relying solely on these records. A good test is to assess the measure of confidence the responsible person has that the system conld be successfnlly restored on a first attempt. At a practical level, this capability is the fonndation of disaster recovery, directed at the effective snpport of bnsiness continnity plans. 

In the longer term, pharmacentical firms mnst work with the regnlatory bodies and PLC control system and eqnipment snppliers in order to achieve a consistent indnstry-wide approach to defining good practice on this important issne. This process has already started with the issue of the Good Electronic Records Management gnideline. ... 

Question 6 relates to the construction methods, the experience of the contractor and the available personnel for site work. Under 6(c) the relevant considerations are the safety record of the contractor, whether there is a record of good labour relations, good management procedures and no evidence of slack site control. Is the contractor likely to adhere to the declared erection scheme so that the structure is built as-designed ... 

One study analyzed the safety records of crews working under particular supervisors. The study found that those supervisors whose crews had a better safety record managed differently from those with poor records. The supervisors with good safety records also had high productivity. The successful supervisors controlled anger, kept stress from their crews, and maintained close contact with their workers. They also integrated safety into production tasks rather than simply admonishing workers to be safe. 

It is good practice to reviewa project on completion and record the reasons for departure between planned and actual performance. Where lessons can be learned, or opportunities exploited, they should be incorporated into project management guidelines. Some companies hold post project sessions with their contractors to explore better ways of handling particular issues, especially when there is an expectation of additional shared activities. 

There would be little point in conducting a pilot without being able to measure the improvement achieved. The team should try to find a department where there are good records of PSM and ESH performance, and ideally records that enable the efficiency of the existing management systems to be measured. 

Formal inspection programs present a good opportunity for the water treatment service company representative to undertake an informal internal inspection to observe the various boiler surfaces first hand, perhaps undertake some limited nondestructive testing (NDT) work, and record the results of the previous 12 months water treatment management program. 

By reviewing the main record book (referred to in one laboratory as the Good Book ) at least once a day, a laboratory manager can keep track of how work progresses. 

The requirements for regulatory approval and intellectual property management, and in particular the ability to file USPTO patent submissions, do place constraints on what systems can be applied for record keeping, but the good news is that there are no insurmountable barriers to these records being captured and managed electronically. 

Today, much more than just data are produced electronically. Many documents needed for studies that fall under the Good Laboratory Practice (GLP) standards regulations are being managed electronically. These records include not only data, such as chromatographic data from automated electronic capture systems and raw data collected in electronic field notebooks, but also other documents, such as methods, protocols, reports and standard operating procedures (SOPs). Frequently, these records are generated, distributed, reviewed, and archived electronically. 

Use a good document management system and stress to the team that almost any document generated may become part of the public record. 

If management decides to reject, modify, or delay implementation of a recommendation, it is a good practice to document the reasons for not accepting or implementing the recommendation as submitted by the investigation team. A common and avoidable mistake is to provide inadequate documentation for this decision. An example of inadequate documentation would be a brief entry in the record to the effect that this recommendation is not considered justifiable, with no further explanation. Examples of more adequate reasons for not accepting a recommendation may be the recommendation did not specifically address a root cause, or the recommendation is not technically feasible. In either case, an alternate recommendation should be presented. 

Because closure is a new and unprecedented activity at JACADS and unexpected problems may arise during field activities, it may not be possible to identify all sources of risk during the planning phase. However, good project planning, risk assessment, and experienced proactive management can reduce the uncertainty. If new sources become evident as work progresses, they must be carefully addressed and the experience recorded to assist in closures of other disposal facilities. 

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