PowerPoint Presentation

Let’s take once scenario to explain application of the key QMS processes.

​. Documentation and records used in manufacturing and supporting processes should meet a certain standard to ensure product quality and safety. Handwritten records should be: Attributable: It must be clear who recorded the data. Legible: All entries must be legible, including corrections. Contemporaneous: Data must be recorded as soon as practicable. Original: Data should be recorded directly onto the original form. Accurate: The recorded data must be a true reflection of the actual reading or observation..

Correcting Errors in documents. Understandably, errors will be made when recording data. ​ When this happens, correct the error by: Making a single line through the error – the underlying incorrect data must remain legible if possible. Initialling and dating the correction for traceability..

Blank fields in documents. Where there is no data to be entered into a single field on a form, write 'N/A' When the data does not fill all the available lines or spaces in a field, rule out the ‘extra’ spaces with a single diagonal line to prevent the addition of data at another time. Label the line “N/A” and initial and date. Do not use ditto marks ("). Always fill data in completely..

Do not;. A red circle with a black background Description automatically generated.

​. Document Archive process. Document archiving involves the long-term storage of inactive documents. You should archive documents that you need to retain for legal, regulatory, or auditing purposes. Physical documents use in BRA placed for more than 2 (two) years old that are no longer refer could move into an Archive Box. SOP-0029 documents the archiving process at BRA including details of retention period requirements.