Chapter 3, Subject 4
QMP Reference Standard and Compliance Guidelines
Section 7

7. Record Keeping

Reference Standard Requirements:

7.1 Records must be kept for the QMP Plan as follows:

7.1.1 For all Prerequisite and RAP Plans, record keeping may be "by exception".

7.1.2 For the HACCP Plan, record keeping is mandatory for all testing, measurements, and monitoring at CCPs and for corrective actions when the critical limits are exceeded.

7.1.3 For all verification activities and results, record keeping is mandatory.

7.1.4 For amendments or changes to the QMP Plan, a record must be maintained.

Intent:

Two types of records are components of the QMP Plan, the record of the development and the components of the quality management program, referred to as "documents" or "documentation" and those records taken as a result of the implementation of the quality management program, simply termed "records".

It is important to balance the volume of record keeping with the true needs of the organisation and the resources available to deliver the system. The development, usage and maintenance of documentation and records should be sufficient to provide evidence that the system was developed properly, is being implemented as written, and can demonstrate trends to identify a problem.

Compliance Guidelines:

1. Copies of all of the records (e.g., blank examples) described in the QMP Plan, including monitoring, verification, corrective action and personnel training records, are part of the QMP Plan documentation.
2. When records by exception are permitted, records are only required when a deficiency is identified during the monitoring procedures. In these cases the processor is required to record the deficiency and document it using a Corrective Action Record.
3. When a QMP Plan or any part of its documentation is amended, the date and the changes and the date they are made must be recorded. An accepted practice is to include an amendment log in the QMP Plan. This will ensure that the written QMP Plan continues to reflect the controls that are being applied in the processing operation.
4. The effectiveness of record keeping is improved by ensuring that personnel understand why they are taking records, when, and how to complete the record accurately. The processor should review records periodically to ensure they are current and relevant. Records may contain information outside of the scope of the QMP Plan and processors may combine records to reduce paper load.
5. Records remain current, legible, readily identifiable and retrievable. The location of all files and records in respect of the QMP Plan must be identified. The retention time for records is a very important issue. Records must be retained for at least 36 months and should be retained for a period of time which is relevant to the product shelf life. Records should be stored in a manner which is secure, easily accessible, and which protects the integrity of the record.
6. Consideration can also be given to technology to allow for continuous monitoring or automatic capture of data through computers or remote sensors. When microprocessor technology is used, specific controls must be developed to control the creation and maintenance of electronic records and electronic signatures. Further guidance on this subject is provided in the Appendices of this document.

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