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Corrective Action Procedure Reviewed
Corrective Action Procedure Reviewed
:
FOOD & OCCUPATIONAL SAFETY, HEALTH, ENVIRONMENT AND
Issue No: 1
QUALITY MANAGEMENT SYSTEM
Date
TITLE: CORRECTIVE ACTION PROCEDURE July 2017
Effective:
Prepared by:
Quality Systems Approved By: Quality Assurance Manager Page no.: 1 of 3
Manager
1.0 OBJECTIVE
The purpose of this procedure is to establish the process for identifying, documenting and analysing non-conformities and
mitigating their impacts by implementing appropriate corrective actions to bring the system/process back under control.
1.1 Scope
The scope of this procedure is applicable to all customer orders, suppliers and our company production
processes.
3.0 RESPONSIBILITY
3.1 Quality Assurance Manager - Reviewing and approving overdue CAR/SCAR dates extension. Passing
resolution on overdue CAR/SCARs.
3.2 Quality Systems Manager- Reviewing and approving overdue CAR/SCAR dates extension. Passing
resolution on overdue CAR/SCARs.
3.3 Quality Assurance Officer - Has the responsibility for the implementation and maintenance of this procedure
and tracking of the Internal Corrective Action process as described in this procedure. QAO shall review the
corrective action request and approve its requirement / adequacy before assigning / reassigning to the
responsible process owners. QAO shall make the necessary consultations and ensure definition of the
problem / finding reported shall be genuine and worth to proceed with Corrective Action process.
3.4 Quality Control Manager - Implementation and maintenance of this procedure.
3.5 Microbiologist - logging in SCARs in DMS or raising remedial action for suppliers.
3.6 Purchasing Manager – Accepting / Rejecting SCARs logged in DMS.
3.7 Departmental heads - communicate identified problems / findings / non-conformities with the QAO for review
of adequacy before logging in / accepting / rejecting them in DMS. HODs shall coordinate investigation of
CARs assigned to them. Whoever originates a request shall ensure appropriate immediate corrections are
taken if the observations cause a direct impact on the process or customer satisfaction. No Corrective action
request shall be processed unless appropriate corrections are ensured. If no Corrective Action required, the
same shall be recorded in the system.
3.8 Sales / Marketing – Sales / Marketing shall be responsible for receiving and logging in customer complaints in
DMS as well as coordinating and preparing a response to all Customer (external) concerns or corrective
actions.
3.9 Purchasing (Buyer)- shall be responsible for sending and receiving SCAR / remedial action forms to and from
local suppliers in a timely manner.
3.10Purchasing (Procurement Administrator)- shall be responsible for sending and receiving SCAR / remedial
action forms to and from non-local suppliers in a timely manner.
3.11 All *** employees- It is the responsibility of all **** Foods employees to identify and report problems/findings
and bring them to the attention of their HODs.
5.0 PROCEDURE
5.1 The Corrective Action System shall be initiated / triggered when : -
o There are employee reports of problems with procedures, processes, forms, work instructions, guidelines;
o Resolving trends associated with product nonconformities; Individual product issues (incorrect or nonconforming
parts, etc.) should be first written up per the procedure Control of Nonconforming Product. When trends are
noticed within nonconforming products, (3 remedial reports for the same non conformity) then a Corrective Action
Request may be issued to investigate the cause of the trend.
o Audit findings (internal or external) showing non-fulfilment of requirements.
o Critical limits are exceeded
o Customer complaints are raised
5.2 It is the responsibility of all *** Foods employees to identify and report problems/findings and bring them to the
attention of their HODs.
5.3 The department head shall alert the QAO of the identified problem / nonconformity for review and approval of the
request’s requirement / adequacy during which the QAO will assign the CAR to one or more **** Foods staff
members who are best able to research and resolve the issue. After approval, the department head can log in
the CAR in DMS and send an email alert and phone call to the assignee and other relevant parties.
5.4 Microbiologist raises SCARs. When a Supplier Corrective Action Request is issued for a Supplier / Vendor
deficiency, the request will describe the specific details of the deficiency(s) per requirement. Quality Assurance
personnel issuing SCARs to a Supplier shall forward the completed SCAR form to the responsible Purchasing
personnel for distribution to the Supplier. Purchasing personnel responsible for the distribution of the Supplier
SCAR forms to Suppliers shall ensure the distribution occurs as soon as possible. When there is a reason for not
distributing the SCAR form on time, Quality Assurance and QAO shall be informed in writing stating the reason.
5.5 CAR/SCARs should be accepted in DMS within three days of receiving email notification.
5.6 QAO will assign a response date for the CAR; this can be whatever time the QAO deems suitable for the issue
being investigated. This time frame will take into consideration the level of effort expected, costs, risks, etc.; for
example, some actions may take months to correct and resolve, while others may take days or less. If necessary,
the QAO will determine this time frame with the help of the assignee.
5.7 The DMS log will highlight when CARs are overdue, based on the assigned date. In the event of an overdue
CAR, the QAO will either negotiate a revised date with the assignee, or escalate the CAR to the assignee’s
manager for attention.
5.8 The assignee shall conduct a root cause analysis to determine the cause(s) of the problem. This exercise should
be thoughtful and detailed, so as to ensure the actual root causes are identified.
NB: Failure to properly conduct root cause analysis may result in the wrong cause being acted upon, and thus
the problem not being permanently resolved.
5.9 The assignee will then develop an action plan to address the root cause and eliminate it. The assignee will
implement the plan, updating the text of the CAR as the plan progresses. During this time the plan may change,
or expand, etc., so the text must be updated to reflect the actions assigned and taken.
NB: By eliminating the root cause, the problem should never occur or recur.
5.10Once the action is complete, and the assignee feels the issue is resolved, he / she will submit the CAR in DMS
and indicate a completion date and send an email alert to the QAO and all other relevant parties.
5.11 The QAO will update the log entry for the CAR in DMS, indicating the action complete date. The QAO will
perform independent verification of the actions taken to ensure the actions are effective in resolving the root
cause(s). This verification should examine evidence and take into consideration the following:
5.13 If the QAO determines the issue is not properly addressed, the Corrective Action Request may be re-assigned
for further action (when implemented actions fail to address the identified problem) or a new CAR filed (if
investigations done indicate existence of a different problem than the one initially defined). The Corrective Action
Request system generates trend reports for both corrective and preventive actions over time; these are reported
during weekly Food Safety meetings and monthly management review.
8.0 RECORDS