NPIC In-Line Process Inspection and Control Procedure

Document Code: QAD-IIC-01.02

Original Issue Date: 03-23-2009
Revision Date: 07-12-2009
Prepared by: Tina Gan

1. Purpose
This procedure describes the quality control and inspections of all the in-line
processes to ensure the safety and quality of products.

2. Scope
The procedures defined in this document are applicable to the control of all the
process involved in product manufacturing, from supplier approval, material
receiving to distribution of finished products.

3. Responsibility
3.1 QC Department is responsible for setting the control points, QC inspection spec,
inspection time points, inspection frequency, sampling plan, inspection items,
test standard and method.
3.2 QC Department is in charge of performing the inspection of raw materials, WIP,
semi-finished and finished products.
3.3 QC department is accountable for implementing the food safety programs and
verifying the effectiveness of the programs.
3.4 Warehouse and Production departments take the responsibility of executing the
procedures and adhere to all the food safety programs.

4. Classification of defectiveness
4.1 Minor Defectiveness
“Minor defectiveness” denotes raw materials or products with flawed quality
within normal specification/parameter deviation, or a small quantity of defective
products that is statistically insignificant.
4.2 Major Defectiveness

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 “Major Defectiveness” refers quality defects that do not conform to product
characteristics, functionality, or a large quantity of defective products that is
statistically significant.

4.3 Critical Defectiveness

“Critical Defectiveness” denotes raw materials or products that create hazard
risks or health threats to consumers.

5. Procedures
5.1 Incoming raw material inspection (refer to “Raw Material Receiving
Procedure”)
5.1.1 QC inspector checks the pallet condition and package condition of the
material, no damage or infestation sign should be visible.
5.1.2 QC inspector compares the material spec and COA. COA should conform
to the spec.
5.1.3 QC inspector collects a sample of the incoming raw material.
5.1.4 Inspect the color, appearance and odor. Fill out the “Incoming Raw
Material Inspection Report”.
If inspection is not passed, label the material “Reject”, follow the “Out of
5.1.5
Spec Product Control Procedure” and notify Purchasing for replacement
or return of material.
5.2 Inspection of the mixing step (Refer to “Raw Material Mixing Procedure”)
5.2.1 Raw material shall be dispatched according to the “Raw Material
Handling and Dispatch Procedure”.
5.2.2 QC inspector checks official formula with material mixing record (Pick
List) for the formula number (verify with Mass Production Formula
Number Log), ingredients name, weight and lot number.
5.2.3 QC signature will be released if the mixing data is correct.
5.2.4 If pick list record doesn’t match formula, follow the “Out of Spec Product
Control Procedure”.
5.2.5 If formula is not loaded correctly, QC should hold the process and notify
Production Supervisor followed by the “Corrective or Preventive Action
Control Procedure”.

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 5.2.6On line QC randomly checks the pre-mixed material number and the work
order number on the Traveler.
5.3 Inspection for Work-In-Process
5.3.1 First piece inspection
For production of each shift or switching formula, after injector/extruder
stabilizes and starts to produce products that meet Product Specs, operator
notifies on line QC inspector for the “First Piece” inspection. “First Piece
Inspection Record” will be recorded on the “Mass Production Processing
Data Record” and signed by QC before mass production.
5.3.2 In line QC inspection on product quality
QC inspects product quality and processing condition periodically during
injection or extrusion processing. “Mass Production Processing Data
Record” will be filled out hourly by operator and engineer. QC verifies the
accuracy and integrity of the record.
5.3.3 QC inspection on process and employee practices
On line QC inspects all the processes for compliance to our Process Specs
and Ingredients Traceability Program. Follow “Corrective or Preventive
Action Control Procedure” if violation is identified.
5.4 Semi finished and finished product inspection by statistical acceptance sampling
test. Product/QC Spec for each product is the inspection standard.
5.4.1 Define the sample batch (normally, “lot” will be used as the unit) and
attributes. Look up the sampling plan in the “Military Standard 105E” and
determine the sample size base on the following criteria:
i. Inspection Level – Normal level II
ii Acceptable Quality Level (AQL) – 2.5%
5.4.2 Randomly pick product samples according to the pre-determined sample
size
5.4.3 Perform single inspection on the collected product samples based on the
criteria set in the Product Specifications at three different control points:
i. Semi-finished goods after drying
ii. Bag inspection after packaging
iii. Outer box inspection
5.4.4 Test moisture content (MC%) and water activity (Aw) (1 sample per work

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 order).
5.4.5 If the inspection result failed to pass the criteria set for the sampling plan
in 3.2, the whole lot of the products will be rejected, and the products will
be handled according to the “Out of Spec Product Control Procedures”.
5.4.6 Document and record the results along with the data analysis.
5.4.7 Only products that have been inspected and passed are allowed to be
moved to the next process.
5.4.8Finished goods need to have a “QC Pass” stamp on the “To-and-From
Warehouse Form” before they are transferred to Warehouse.
5.5 Incoming finished goods from OEM
5.4.1 Inspect each pallet’s condition for any infestation sign or damage.
5.4.2 According to the lot quantity on Packing List, look up the sampling plan in
the “Military Standard 105E” and determine the sample size base on the
following criteria:
i. Inspection Level – choose the appropriate level as needed
ii Acceptable Quality Level (AQL) – 2.5 %
5.4.3 Randomly pick product samples according to the pre-determined sample
size
5.4.4 Perform single inspection on the collected product samples based on the
criteria set in the Product/QC Specifications.
5.4.5 Test moisture content (MC%) and water activity (Aw) (1 sample per lot).
5.4.6 If the inspection result failed to pass the criteria set for the sampling plan
in 5.4.2, the whole lot of the products will be rejected, and the products
will be handled according to the “Out of Spec Product Control
Procedures”.
5.4.7 Document and record the results along with the data analysis.

6. Revision History

Revision Date Description of Change Requested By

00 03-23-2009 Initial release Tina Gan

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 01 06-26-2009 Revised basic content, added Tina Gan
inspection of OEM products
02 07-12-2009 Changed the title and revised Tina Gan
the scope and responsibilities

7. Reference Documents
7.1 NPIC Mass Production Raw Material Specifications
7.2 Certificate of Analysis for each raw material purchased for mass production
7.3 Raw Material Receiving Procedure
7.4 Incoming Raw Material Inspection Report
7.5 Raw Material Handling and Dispatch Procedure
7.6 Mass Production Formula Number Log
7.7 Raw Material Mixing Procedure
7.8 Ingredients Traceability Program
7.9 Mass Production Processing Data Record
7.10 Re work Handling Procedure
7.11 Out of Spec Product Control Procedure
7.12 Product/QC Specification for each product
7.13 Process Spec for each product
7.14 To-and –From Warehouse Form
7.15 Extrusion Product QC Inspection Record Form
7.16 Injection Product QC Inspection Record Form
7.17 Incoming OEM Product QC Inspection Record Form

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