QMS Operational Procedure QOP-82-04

FINAL ACCEPTANCE INSPECTION

Issued by: Quality Assurance Rev.: 01 Pg. 1 of 4

Written or Updated by:

Name Title Date Signature
Amnon Nachum QA Consultant 21-July-2013

Reviewed by:
Name Title Date Signature
Tovi Carmon COO 21-July-2013

Approved by:
Name Title Date Signature
Gaddi Menahem CEO 21-July-2013

Document Change History

Revision Responsible
Date Description of Change
Number Person
01 21-July-2013 Amnon Nachum First Issue

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 QMS Operational Procedure QOP-82-04
FINAL ACCEPTANCE INSPECTION
Issued by: Quality Assurance Rev.: 01 Pg. 2 of 4

I PURPOSE
The purpose of this procedure is to provide for a system and instructions, and to assign
responsibilities for performing the final acceptance inspection and release of the
finished product.

II APPLICATION
This procedure applies to all finished products.

III PROCEDURE

1 General
1.2 It is the policy of Orpheus Medical Ltd. to concentrate resources and attention on
defect prevention, rather than defect detection. The verification effort is therefore
focused on control of processes and in-process inspections. Normally, by the time
products are completed, all their components, parts and subassemblies have been
already verified through the program of receiving and in-process inspections. The
purpose of final inspection is to review records of all preceding inspections and tests,
and to complete the evidence of conformity by verifying those product characteristics
that have not been yet inspected (for example, functional testing, product labeling,
etc.).

2 Final inspection
2.1 All finished products are subjected to final acceptance inspection and formal release
before they are shipped to customers.
2.2 Quality Assurance is responsible for final inspections and for the release of product for
shipping or for transfer to the finished product stockroom. QC inspectors perform the
final inspection.
2.3 The final acceptance inspection is carried out in two stages. The first stage is to accept
the product and release it for packaging and labeling. The second stage is to inspect
the packaging and labeling and release the product for shipping (or finished product
stockroom).
2.4 The scope of the first stage of the final acceptance inspection includes:
Review of the work order to ascertain that all specified operations, processes, and
in-process inspections are signed off, and that all required traceability record and
process/inspection data are documented;
Review of other inspection reports, control charts, and production records
referenced in, or attached with the work order;

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 QMS Operational Procedure QOP-82-04
FINAL ACCEPTANCE INSPECTION
Issued by: Quality Assurance Rev.: 01 Pg. 3 of 4

Visual inspection of product to ascertain that all specified operations are completed
and to detect any visible quality problems;
Taking measurements and testing to complete the evidence of product conformity,
and recording the actual measurements and test results; and
Releasing product for packaging and labeling.
2.5 The scope of the second stage of the final acceptance inspection includes:
Inspecting product packaging and labeling, and
Releasing the product for shipping or for transfer to the finished product stockroom.
2.6 For complex products, and in particular when functional testing is involved, inspectors
are provided with checklists, inspection procedures, inspection report forms, and other
instructions as appropriate.
2.7 Products that pass all stage one reviews, inspections, and testing are labeled with an
ACCEPTED sticker or tag and the inspector signs off the work order in the block
where the stage one of final inspection is called out. Passed products are then moved
to the area where finished products are staged for packaging and labeling.
2.8 Products that pass the stage two packaging and labeling inspection are released in
accordance with Section 3 of this procedure.

3 Release of product
3.1 Only QC inspectors have the authority to release product.
3.2 Products are released immediately following the final packaging and labeling
inspection. Released products are labeled with a RELEASED sticker or tag and are
moved to the shipping area or to the finished product stockroom.
3.3 Product release is documented in the last block in the work order. The record includes
the date of the release and the name and signature of the QC inspector.
3.4 Only released products may be packaged in shipping cartons, and be dispatched or
stored in the finished product stockroom.

4 Nonconforming product
4.1 When a nonconforming product is identified or there are omissions or other problems
in the Device History Record (DHR), the QC inspector labels the product with a
REJECTED sticker or tag, prepares a nonconformity report, marks the nonconformity
report number on the sticker, and moves the product to a designated area. The
nonconformity report is further processed per Operational Procedure QOP-83-01,
Control of Nonconforming Product.

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 QMS Operational Procedure QOP-82-04
FINAL ACCEPTANCE INSPECTION
Issued by: Quality Assurance Rev.: 01 Pg. 4 of 4

5 Inspection record
5.1 To establish the final inspection record, inspectors document inspection results and
date and sign the work order in the block where the final inspection, stage one or two,
is called out. Any additional checklists or reports prepared during the inspection are
attached to the work order.

IV ASSOCIATED DOCUMENTS
Operational Procedure QOP-82-03, In-process Inspections
Operational Procedure QOP-83-01, Control of Nonconforming Product
V ASSOCIATED RECORDS
Final inspection and acceptance records: QC Inspector signoffs in production
work order (Form QF-75-01-1) in the last blocks where the final inspection is called
out. Where applicable, also checklists and reports prepared in the course of
conducting the final inspection (attached to the work order). Maintained in Device
History Record (DHR).

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