1.0 Purpose : To provide instructions for handling of recalled products.
2.0 Objective : To provide a documented procedure of handling of recalled products.
3.0 Scope : This procedure is applicable for handling of recalled products.
4.0 Responsibility :
· Primary: Chemist–QA
· Secondary: Officer-QA
5.0 Procedure:
· Possible Recall points.
Ø From within the company
Ø From some point within the distribution chain
Ø From customer or user
Ø From the regulatory authorities of national / international.
· Procedure
Ø QA will take the Overall responsibility for co-ordination of Recall or Hold/ Freeze. In the absence of QA, Plant Manager will assume the responsibility.
Ø Take the decision of Recall/Freeze in co-ordination with Corporate QA using the Distribution records.
Ø Once decided to recall the non-conforming product, distribution record shall be Checked and following information, to be sent to Export department for recall of product.
o Product(s) Name
o Batch Number
o Nature of defect
o Date of Manufacturing
o Date of Expiry
o Exported to
o Point of recall
o Total Quantity to be recall
o Shipper Carton No. Drum no. or container no.
Ø The QA shall ensure that all those, within the company, concerned with the storage, packing and destruction of products and materials are aware of the problem and action to be taken.
Ø The QA shall convey following information to concern department
o Name of product(s)
o Batch Number(s)
o Nature of defect
o Action to be taken
Ø All affected, or potentially affected, kits and any other stocks or materials shall be securely segregated, and effectively quarantined so as to be sure they cannot be dispatched.
Ø The QA shall arrange for prompt preparation of a list of the recipients of the defective goods, down to the level at which recall or freeze is to take place. QA shall ensure that all the listed recipients are informed of:
o Name of product(s)
o Batch Number(s)
o Nature of defect
o Action to be taken
Ø According to the urgency/extent of potential hazard, direct mailing shall convey this information, telephone call confirmed by mail, or fax.
Ø If the defect is considered to be too serious to permit any delay, steps should be taken to inform all potential or possible recipients without necessarily waiting for the collection of full distribution data.
Ø If defect is considered to represent a serious and immediate hazard to user or consumers, then consideration should be given in consultation with marketing department to the use of the media to provide wider awareness of the problem.
Ø When recall has been initiated, arrangements must be made by QA to receive the returned goods, and to ensure that they are securely segregated from other stock, and stored in specified area.
Ø The progress of the recall shall be recorded and monitored by QA, so that the quantity of goods returned can be reconciled against the amount produced, distributed, and still held in stock.
Ø When it is considered that the recall/freeze has been affected as completely as possible, a full report shall be prepared by the QA.
Ø The detailed report shall contain
o Reason for recall/freeze
o Results of full investigation into cause(s) of the defective product
o Action taken to recall etc.
o Numerical details of the reconciliation exercise
o Action taken to prevent re-occurrence.
o Copy of this report shall be forwarded to Managing Director.
6.0 Reference Document :
v Product complaint logbook
Log book for complaint log book.
Complaint no. | Date of received | Product Name | Batch No. | Mfg. Date | Exp. Date | Received From | Nature of rejection | Action taken | Remarks |
7.0 Abbreviations :
· QA = Quality Assurance department
· SOP = Standard Operating Procedure
· QC = Quality Control
8.0 Copies to Distribution Sites. :
· QA
9.0 Review History :
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