QMS Operational Procedure QOP-82-03

IN-PROCESS INSPECTIONS
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-82-03
IN-PROCESS INSPECTIONS
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 and recording in-process inspections.

II APPLICATION
This procedure applies to materials, components and subassemblies during
manufacture and assembly.

III PROCEDURE

1 Scope and responsibilities

1.1 Depending on the product and process involved, the program of in-process product
verification may include checking of job set-ups (first article inspections), operator
and QC inspections of process output and automated inspections. The program is
defined and documented in the production work order.
1.2 Irrespective of whether in-process inspections are conducted by QC inspectors or
production personnel, all inspection activities are defined, managed and supervised by
Quality Assurance. Automated inspection machines are usually set up and validated by
outside contractors, under supervision of Quality Assurance.

2 First article inspection

2.1 When starting new production and whenever processing equipment or machines are
reset for any reason (for example, maintenance, repair, tool change, product change,
etc.), the set-up may need to be verified by conducting the first article inspection.
Quality Assurance is responsible for determining whether first article inspection will
be required for a given product and/or process.
2.2 When specified, first article inspections are called out in the production work order.
2.3 QC inspectors conduct the first article inspection. When the inspection is satisfactory,
the inspector signs off the work order in the block where the inspection is called out.
Inspection data may also be recorded, where appropriate. The sign-off constitutes the
record of the inspection, identifies the inspector, identifies the inspection status of the
product, and authorizes continuing production. Products that fail the inspection are
identified, segregated and processed in accordance with Operational Procedure QOP-
83-01, Control of Nonconforming Product.

3 Process output inspections

3.1 The purpose of process output inspection is to verify the result of a particular process.
The inspections are performed immediately following the process, and in accordance
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IN-PROCESS INSPECTIONS
Issued by: Quality Assurance Rev.: 01 Pg. 3 of 4

with a specified sampling plan.

3.2 Whenever practicable, process operators and other production personnel visually
inspect their work. Personnel are instructed what to look for and how to identify
nonconforming product. When a formal visual inspection is specified in the quality
plan, it is called out in the production work order and its results are recorded.
3.3 When specified in the quality plan, QC inspectors or process operators perform more
technical inspections that may involve using gauges, templates or other measuring
equipment. Personnel performing these inspections are either provided with written
instructions and acceptance criteria, or are trained in performing the inspections.
Inspections in this category are called out and recorded in the production work order.
3.4 When the result of the inspection is satisfactory, the operator/inspector signs off the
work order in the block where the inspection is called out. Inspection data may also be
recorded, where appropriate. The sign-off constitutes the record of the inspection,
identifies the inspector, identifies the inspection status of the product, and authorizes
continuing production. Products that fail the inspection are identified, segregated and
processed in accordance with Operational procedure QOP-83-01, Control of
Nonconforming Product.

4. Automated inspection equipment

4.1 Various inspection equipment and machines are included in the automated production
lines. The automated inspection equipment is usually installed, set up, and validated
by outside consultants and contractors. These suppliers are selected and monitored in
accordance with Operational Procedure QOP-74-01, Supplier Evaluation and
Monitoring.
4.2 Automated inspection equipment is tested and validated before it is used in
production. Testing and validation protocols are usually prepared jointly by the
contractor installing the equipment and Quality Assurance. In any event, Quality
Assurance is responsible for reviewing and approving any validation protocol.
Validation records are established and maintained (refer to Operational Procedure
QOP-75-03, Validation of Processes and Software).
4.3 Where custom computer software controls the automated inspection equipment, the
software is validated, and it is identified and controlled with regard to the product (part
or drawing number) to which it applies, and the software revision level.

5 Release of product
5.1 Products are prevented from passing on to the next processing stage before all
specified in-process verification activities are completed with satisfactory results.
Products that are released for further processing or use are identified with a positive

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IN-PROCESS INSPECTIONS
Issued by: Quality Assurance Rev.: 01 Pg. 4 of 4

inspection status. The identification may be in the form of a sticker, tag, mark, color of
container, or signed-off paperwork (work order) accompanying the product (refer to
Operational Procedures QOP-75-05, Product Identification and Traceability).

6 Nonconforming product
6.1 If a nonconforming product is identified, the operator/inspector labels the product with
a REJECTED sticker or tag and prepares a product nonconformity report. Operators
are prohibited from proceeding to repair nonconforming product without first
reporting to Quality Assurance.

IV ASSOCIATED DOCUMENTS
Operational Procedure QOP-74-01, Supplier Evaluation and Monitoring
Operational Procedure QOP-75-03, Validation of Processes and Software
Operational Procedure QOP-75-05, Product Identification and Traceability
Operational Procedure QOP-83-01, Control of Nonconforming Product
V ASSOCIATED RECORDS
In process inspection records: Inspector/operator signoffs in production work
order (Form QF-75-01-1) in blocks where in-process inspections are called out.
Established by QC inspectors or process operators. Maintained in Device History
Record (DHR).
Process monitoring records: Process parameters recorded in production work
order (Form QF-75-01-1) in the blocks where the monitored process is called out.
Established by process operators. Maintained in Device History Record (DHR).

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