SCRIBD

SOP for Product Recall

Judul terkait
3
dari 5 Q
Q
Q Cari dokumen
Ук як
4.7.
4.6.3. The recalled finished product as well as any portion if inventory lying in
the finished product store or in transit of the same session are identified and
recalled. These sessions are kept separately, rejected after thorough investigation
by Quality Head/Designee. All such actions shall be authorized by Quality
Head/Designee and recorded in product recall record.
4.6.4. Wherever applicable depending on the seriousness of the Product safety
issue, the statutory authorities and customers shall be informed by the top
management through appropriate channels.
4.6.5. All stocks of recalled products are either destroyed or reprocessed based on
the investigation by quality department and nature of the problem. The identity of
entire reprocessed product is being maintained for traceability purpose. Production
Head/Designee along with Quality Head/Designee is authorized to destroy or
reprocess the product.
4.6.6. The effectiveness of product recall is periodically tested for its
effectiveness by mock drills and all actions are recorded.
Organization of Product Recall:
4.7.1. Once a decision is made, the responsible persons appointed are to initiate
and undertake the product recall as well as to follow-up on any matters arising
from such
a recall. The primary distribution records should be maintained and made readily
available to the persons responsible for recalls. They should also contain
sufficient information of distributors.
4.7.2. Product Recall Team Members:
<