Department | Quality Management | Document no | QMS-145 | ||
Title: Classification of Defects in Manufacturing Operations | |||||
Prepared by: | Date: | Supersedes: | |||
Checked by: | Date: | Date Issued: | |||
Approved by: | Date: | Review Date: | |||
1.0 DOCUMENT OWNER
Technical/Quality Manager
2.0 PURPOSE
To provide a guide for the actions required to investigate and document the occurrence of an event or an observation suggesting the existence of a potential quality related problem.
3.0 SCOPE
This SOP applies to all semi-finished goods, manufactured finished goods and fully imported products within disposition management.
This procedure defines the requirements for the following:
– Identification of defects and their respective AQLs (Acceptable Quality Limits)
– Actions that must be taken when critical, major or minor defects are encountered during the Production/ Packaging Process.
Note: SOP QMS-150 covers the Classification of Defects for Incoming Packaging Components.
4.0 RESPONSIBILITY
4.1 Responsibility of Production and Packaging Operators / Managers
4.1.1 It is the responsibility of the Production/ Packaging Operators and Manager to ensure this SOP is adhered to.
4.1.2 It is the responsibility of the Production/ Packaging Operators to immediately inform Production/ Packaging Manager and Quality Assurance if a deviation from control methods specified in Production/ Packaging documents or from standard operating procedures is detected.
4.1.3 It is the responsibility of the Production/ Packaging Manager to train Production/ Packaging Operators.
4.1.4 It is the responsibility of the Production/ Packaging Manager to ensure that the product that has been involved in an unusual event is segregated from the rest of the lot or batch.
4.2 Responsibility of Quality Assurance Manager / Manager or Delegate
4.2.1 It is the responsibility of the Quality Assurance Manager or Delegate to ensure this SOP is adhered to.
4.2.2 Quality Assurance Manager is responsible for deciding on the disposition of the batch after the inspection. If the batch exceeds the acceptance criteria it is the responsibility of the Quality Assurance Manager or delegate to notify the Production Manager to establish the corrective action to be carried out.
4.2.3 It is the responsibility of the Quality Assurance Delegate to ensure that all batches under investigation are to remain in Quarantine Hold status until the inspection is complete and all relevant data / signatories from Quality Assurance and Production/ Packaging have given approval of the deviation report or rework procedure.
4.2.4 It is the responsibility of the Quality Assurance and Compliance Manager or Delegate to determine the need for a Cross Functional Investigation (CFI).
5.0 PROCEDURE – DEFECT DECISION TREE
Figure: Defect Decision Tree
5.1 Determine the Type of Defect Found
5.1.1 If the defect is found to be a bulk defect, Operators need to determine the Defect classification and its AQL as per instruction in Section 5.2.
5.1.2 If the defect found corresponds to a Packaging Defect, Operators should notify the Packaging specialist who will determine the origin of the defect.
5.1.3 In case the packaging defect is defined not to be a supplier issue, Operators need to determine the defect classification and its AQL as per instruction in Section 5.2.
5.1.4 However, if the Packaging defect is defined to be a supplier issue, Operators should follow the below instructions to return the defective component to the warehouse in order to send it back to the supplier:
5.1.4.1 The component should be isolated and returned to the warehouse using a Packaging Reconciliation Form (Form 865). In this case:
5.1.4.2 The Packaging Specialist notifies the Quality Assurance Manager or Delegate and the Quality Audit / Supplier Qualification Officer. The Operator enter the details to Packaging Reconciliation Form (Form 865) and return the component from the packaging floor.
5.1.4.3 The Quality Assurance delegate applies Q-Hold labels. Quality Assurance Manager will assess and determine if a Deviation is necessary.
5.1.4.4 The Warehouse team returns the inventory to ERP system.
5.1.4.5 Quality Assurance delegate confirms when the inventory has been returned to ERP system by viewing the “special notes for production orders”. To do this:
5.1.4.6 If applicable Quality Assurance delegate will sublot the defective components in the ERP system. The sub-lot components can then be dispositioned as per QMS-090 Evaluation of Batch Documentation and Release for Sale.
5.2 Determine the Defect Classification and AQL
The Acceptance Quality Levels (AQLs) are levels at which an inspection is classified as Acceptable or Unacceptable for a particular lot size. The AQLs have been set out as follows for the various defect categories:
Figure: Defect categories
5.2.1 Refer to the correspondent Appendix to determine the classification of the defect found according to its defect category. Inform the Production/ Packaging Manager.
5.3 Defect Classification: Minor
If the defect is found randomly during the process, Operators is requested to perform an IPC test (In Process Control) to define the occurrence of this defect.
5.3.1 If the defect is found to be minor within the specification (= 4%), Operators rectify the problem if applicable and continue the Production/ packaging operation. Operators write a comment to state the time and a description of the problem in the Batch Record.
5.3.2 If the defect is found to be minor outside the specification (> 4%), the
Production/ Packaging Manager or Manager will determine if the quantity of products since the last IPC within specification is to be reworked (based on the occurrence of the defect since the last IPC within specification) or needs more investigation.
5.3.3 If the Production/ Packaging Manager determines that the quantity of finished products since the last IPC within specification is to be reworked, the Quality Assurance delegate is informed to put this quantity on Quarantine Hold, as per SOP-180 Quarantine Hold Procedure for a sample of Q-Hold Label).
5.3.4 Operators rectify the problem (if applicable) and continue the Production/ packaging operation and the quantity of products on Q-Hold will have to be 100% inspected and reworked at the end of the batch.
5.4 Defect Classification: Critical, Major
5.4.1 If the defect has been classified as Critical or Major, Operators must stop the machine or line.
5.4.2 Ensure that the quantity of products since the last IPC within specification is segregated. For this, inform the Quality Assurance delegate to put the quantity in Q-Hold and then perform an inspection following the steps below:
5.5 Determine the Sampling Requirements
5.5.1 Select the inspection plan as illustrated in Appendix 6.
5.5.2 Using the Defective Product Inspection Form (Form 870), Operators and/or
Production / Packaging Manager record a brief description of when and where the deviation was found and whether it is Critical, Major A, Major or Minor out of specification.
5.5.3 Determine the “batch size” by establishing the number of units produced since the last IPC within Specification.
5.5.4 Once the number of units has been established, use the Single Sampling Plan in Appendix 6 to determine the number of samples required as well as the Acceptance number (Ac) and the Rejection number (Re).
5.5.5 Determine an equal number of units from each bucket / shipper to be inspected by dividing the total sample size by the number of buckets / shippers affected in order to obtain representative samples.
5.6 Perform Inspection
5.6.1 Operators and Production/ Packaging Manager shall perform the inspection.
5.6.2 Inspect each sample for the defect and record the results on the Defective Product Inspection Form (Form 870). Retain all defective samples for further investigation.
5.6.3 Inform the Quality Assurance Delegate.
5.7 Review Results of the Inspection
5.7.1 If the number of nonconforming items is equal to or less than the Acceptance number (Ac), the lot is being considered ACCEPTABLE and therefore passes the inspection. In this case, no deviation will be raised.
5.7.2 If the number of nonconforming items is greater than the Acceptance number (Ac) the lot is being considered UNACCEPTABLE therefore fails the inspection. In this case, the Production/ Packaging Manager will raise a deviation.
5.7.3 Sign and date the Form 870 and ensure it is attached to the Batch Record.
5.8 Make Adjustment
5.8.1 If the inspection passes, the defect has been identified and the problem can be adjusted, then:
Resume the packaging / Production operation.
Write a comment to state the time and a description of the problem in the Batch Record.
Perform 4 x ½ hour checks. If those checks successfully pass, Operators can perform the IPC normally as requested by the Packaging Shop Order.
5.8.2 If the inspection passes but the problem can’t be adjusted, then:
Resume the packaging / Production operation.
Write a comment to state the time and a description of the problem in the Batch Record.
Increase the checks to every ½ hour until the end of the batch.
5.9 Assess the Batch Disposition
If the inspection fails, the Quality Assurance Manager and Packaging / Production Manager must be notified in order to investigate and decide on the disposition of the lot in question.
5.10 Rework the Batch
If the decision is made to rework the batch in question, then:
5.10.1 Production will raise a Rework Protocol.
5.10.2 The Rework Protocol must be authorized by either the Packaging / Production Manager and must be approved by Quality Assurance Manager or delegate prior to the Rework operation to begin as per QMS-200-Repackaging Procedure.
5.11 Reject the Batch as per SOP QMS-190-Reject Procedure
If the decision is made to reject the batch in question, then:
5.11.1 The Quality Assurance delegate must document the Reject status on the relevant Batch Record.
5.11.2 The Quality Assurance Delegate applies a Red Rejected label to each drum / container of material or at least 2 sides of unitized pallet (if labelling each drum / container is not practical).
(Follow the procedure QMS-190-Reject Procedure for a sample of Reject label to be used.)
5.11.3 The material status must be immediately updated to “R” in ERP system as per QMS-090 Evaluation of Batch Documentation and Release for Sale.
5.11.4 The Quality Assurance delegate arranges for material to be rejected as per QMS-190-Reject Procedure.
APPENDIX 1: Defect Classification Criteria and Acceptance Quality Limits (AQLs)
APPENDIX 2: Classification of Defects – Manufacturing
APPENDIX 3: Classification of Defects – Blister Packaging
APPENDIX 4: Classification of Defects – Packaging of Tubes / Syringes / Suppositories
APPENDIX 5: Classification of Defects – Packaging of Bottles
APPENDIX 6: Single Sampling Plan for Normal Inspection of Manufacturing and Packaging Materials