Submitting Corrective Actions
Corrective actions must be provided for those clients attempting to gain certification under BRC Food, BRC Storage & Distribution, or SQF schemes. Corrective actions provide must consistent of three basic components to demonstrate that the source of the issue has been addressed. These components must consist of a root cause analysis, corrective action, and objective evidence.
Root Cause Analysis
The purpose of the root cause analysis is to identify the source of the deviation not necessarily the immediate cause. Root cause should determine the source of the deviation and led to corrective actions that will prevent recurrence.
Common mistakes when identifying a root cause :
- Re-stating the non-conformity – The root cause should not match the non-conformity. The root cause must answer why the non-conformity occurred which procedure was not implemented that resulted in the non-conformity.
- “Overlooked by management” – Why was the item over looked? Are management review procedures appropriate?
- “Wear and tear of the facility” – It is reasonable to expect facility issues to arise over time – roofs sometimes leak and floor get pitted and cracked. What internal procedures were not followed, facility / GMP audit, that would identify this type of issue.
- “Unaware of the standard requirement” – It is the responsibility of the facility to know and understand the standard.
- “Employee not following procedure” – Why were they not following the procedure? Improperly trained? Not provided the correct tools for the task?
The FSNS C&A does not require a corrective action and preventative measure because the expectation is that correcting the root cause of the deviation prevents the deviation from re-occurring. Please keep in mind that the corrective action must address the root cause.
Once the root cause of the deviation has been identified, measures must be taken to correct the source of the deviation. A concise corrective action which details the measures taken to address the root cause of the non-conformity must be provided. Corrective actions must be implemented and evidence of implementation provided prior to the corrective action plan being approved by FSNS C&A.
In order to demonstrate that corrective actions have been fully implemented, objective evidence must be provided to demonstrate that the plant is in compliance with the standard. Objective evidence may include a revised program, training material, work orders, pictures, completed forms to demonstrate implementation, etc. and must demonstrate that the root cause of the deviation has been addressed. Evidence provided by our customers is kept confidential and only used for the purpose of assessing compliance with the corrective action requirements.
Items identified as part of the corrective action must be accompanied by objective evidence. If three elements were identified as part of the corrective evidence then each of these elements must be part of the evidence provided. For example: Corrective action was to update an outdated program, change monitoring form, and train personnel. Evidence provided must include the updated program, a completed monitoring form to demonstrate implementation, and copy of the training log.