This SOP establishes procedures for documenting unexpected occurrences and unplanned deviations from the instructions provided in the Master Manufacturing Record, standard operating procedures, or other specification documents. (If the deviation is intentional, i.e. approved in advance by quality assurance (QA) and other management, see SOP template QA-9040. If a calibration failure occurs, see QA-9020.)

21 CFR 111 does not require companies to implement an SOP for “unplanned events” but rather instructs firms to document “corrective action plans” (21 CFR 111.75(h)(2)(i) and 21 CFR 111.210(h)(5)),“treatments, in process adjustments, reprocessing” (e.g. 21 CFR 111.77(a)), and “deviations or unanticipated occurrences” (e.g. 21 CFR 111.75(b)(2), 21 CFR 111.90), and for the quality department to conduct appropriate material reviews and decide the disposition of any questionable materials (e.g. 21 CFR 111.113). In order to implement these regulatory requirements, companies may use a combination of strategies; see the preface to SOP template QA-9040 for more information.

Examples of issues which might be documented using this SOP include:

• Equipment malfunction during processing of a batch.
• Operator errors during processing of a batch, e.g. the operator deviating from the allowed equipment settings or instructions specified in the MMR.
• Use of the incorrect ingredients, components, or labels to process a batch.
• Excessive spillage or loss during processing of a batch, or yield outside the allowed range established in the manufacturing record.

A unplanned deviations report and report log are also provided.