Thursday, September 25, 2008

Maintaining Documents and Records

Every key step or change in the project or quality control change needs to be documented so that the reason for any changes can be traced at a future date. The documentation serves as authorization for action and evidence that the change did occur.

Project or process documentation begins with the original concept plan. It then evolves into activity-based documentation in which there are a variety of possible documentation types.
  • Checklists - can be developed to ensure that documentation flows properly and that certain documents are retained for archival purposes. There should be a checklist for every major activity that needs to be completed before another can begin.
  • Control sheets - record the flow of key documentation and changes. Data on decisions, changes, and who made them, are recorded.
  • Sign-off sheets - are documents which verify that a particular stage to a project has been completed to the quality goals. Sign-off sheets record specific information about which activity has met the standard and when.
  • Approval forms - verify that permission was given to advance to the next stage in a tightly controlled project. They are somewhat similar to sign-off sheets.
  • Reviews - examine a process or stage of a project to ensure it has met the particular goals set out in the original plan or to other quality standards. Most reviews recommend changes of some sort.
  • Testing reports - are carried out by specialists such as laboratory technicians, programmers, and quality testers. Their language is quite technical, however the use of non-statistical and statistical techniques can aid understanding. Test reports can express if a change, or no change, is required.
  • Logbooks - record the movement of documentation and when certain activities occur. This ensures an orderly flow and if a problem arises, it can be examined to see when and even what was responsible. Logbooks in manufacturing often contain the data required for analysis.
  • Acceptance reports - indicate whether a project or product was done satisfactorily. If not acceptable, suggestions can be offered. It is similar to a sign off sheet, but with more detail.
In addition to these activity-based documents, various standards organizations may require you to maintain records verifying conformance to industry standards. These records may be in the form of:
  • inspection reports
  • test data
  • qualification reports
  • validation reports
  • survey and audit reports
  • material review reports
  • calibration data
  • quality-related cost reports.
Depending on the project, you may also need to save instructive documents such as:
  • drawings
  • specifications
  • inspection procedures
  • test routines
  • work instructions
  • control sheets
  • the quality manual
  • operational procedures/checklists
  • quality system procedures.
All records and documentation need to be clear, legible, dated (including revisions), identified, accessible, and stored to prevent deterioration or loss. These can be in the form of images, hard copy, CD-ROM, and electronic files. The quality management plan for the project or company should specify how long documents need to be kept and how they should be disposed of once out-dated.

The control of documentation depends on the process or project undertaken. Long duration projects may require documents and records to be archived at set intervals. Short duration projects may allow subordinates to retain documents until the end of the project and then they are stored. For most projects there should be some sort of post project review. The idea is that the record keeping can provide specific information to see if the various procedures work well. This is a function of quality assurance.

Documentation is often relegated to minor status in a project. Many people think once the key work is done, that there will be time later to catch up on the paperwork. However, in a proper project, documentation is designed into the process to ensure an orderly flow, without unnecessary paperwork. The preservation of data, decisions made, and the general plan and outline of the project are key to ensuring quality.

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