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QMS Operational Procedure	QOP-82-04
Section 8.2	Section Revision: B	Revision Date:5/9/2017
In-Process Inspections
Approved By: Todd Gifford		Date: 7/12/2010

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 products throughout the order fulfillment cycle.  This procedure concerns Picking and Quality Assurance.

III PROCEDURE

1. Scope and responsibilities

In-process inspections include operator self-inspections throughout the production process. Also, additional in process verifications are performed as required by the Work Instructions.

2. First-Time-Buy Part and Production Assembly inspection

1st Article Procedure Flow Chart

In an effort to reduce risk for the client, Dee Electronics will perform a 1^st article inspection on all new parts when the part is assessed as a high risk part, regardless if the client requires one or not. “Part” is identified as any new finished good added to the Dee system and includes component off the shelf parts, custom parts, and Dee assembled / manufactured parts. The following ways are used to flag a part as high risk; therefore, requiring 1^st article inspection:

1. Each part is scored upon entry into the Dee system based upon cost, product category, and customization.
2. When Dee mgmt. deems the part warrants a 1^st Article Inspection
3. When the client requires a 1^st Article Inspection
4. All Dee assemblies require 1^st Article Inspection

The elements of each 1^st Article Inspection will vary from part to part, but each and every 1^st Article will have the following steps performed:

1. Sales and Quality will work together to identify the quantity of the first purchase / build
2. Verify measured elements of part from the print (if a print is supplied)
3. Identify CTQ elements of said part. Below are a few ways to identify CTQ elements:

1. Sales will identify if the client has any CTQ elements
2. If assembly, Production and Quality will perform a PFMEA Risk Analysis of the build
3. Quality will study the print to identify any CTQ elements
4. Quality will physically assess the part in house to identify any CTQ elements
5. Quality will use historical corrective actions for similar parts for CTQ elements

When a new part is identified as not high risk; therefore, not requiring 1^st Article Inspection, the following steps are still performed by the warehouse during the first incoming inspection:

1. Ensure the part received matches the part number on the packing slip and PO.
2. Inspect for visual damage on the outer box, and inside the box
3. Attempt to verify the part is the correct part by reading Dee’s internal description of the part.
4. If there is a print or picture, then the print / picture is verified against the part received.

When the 1^st Article Inspection is completed, the results will be filed and uploaded to the Inventory Card. The elements identified to pose risk will then be translated into Incoming Inspection by one of two means:

1. When a CTQ element is identified, Dee will ask the mfg to supply a C of A for the specific element of the CTQ. Incoming Inspection will require the C of A to be shipped with the product, and a warehouse personnel will find the C of A and confirm it was sent. If no C of A was sent, then the Warehouse will follow Dee’s Control of Non-Conforming Product (QOP-83-01). The C of A could ask for any of the following as examples (or anything else, below are just a few examples):

1. Verify measurements
2. Verify for damage
3. Verify unit powers

1. If the C of A will not be provided by the Mfg, then Dee will attempt to perform risk reduction methods of said CTQ element in house during Incoming Inspection. Incoming Inspection will identify who, and what, will be performed before the part can be received into Dee’s system. If the part does not pass inspection, then Dee’s Control of Non-Conforming Product (QOP-83-01) will be followed.

3. Picking Process

1. • Personnel picking parts verify each item associated to the work instructions is correct as picked.
   • Personnel also visually inspect parts as they are picked as appropriate and feasible.

4. All in-process inspections required during the assembly process are noted in the assembly work instructions.  Appropriate records of assembly in-process inspections are kept.

5. Quality Check Process

 

As product is moved throughout the production process any in-process quality inspection is verified as required by the work instructions. Any required in-process check is then documented / recorded and stored per production order.

Quality Audit is a Final Inspection process that is performed based upon the documented requirements in the Work Instructions.

6. Release of product

Completed product is routed to the Quality Assurance queuing area where the Quality Assurance inspector verifies the product is conforming to the work instructions and requirements.  If conforming, the product is released to ship and documented electronically.

7. Nonconforming product

If a product is found to be non-conforming, Quality Assurance is notified and moves the product to a HOLD area.

8. Design, Material, Plant, or Process changes

DEE works to proactively identify historical and future Plant / Part / Material / Process / Design changes.

Each month an automated email is sent to Suppliers asking for any historical or future Plant Changes or Part Design Changes.  Whenever the supplier answers Yes to any of the questions, then the Sr. VP of Sales and VP of Quality are notified of the entry via automated email.  Immediately following the receipt of information, the following action items occur:

1. The system will automatically tag the part as High Alert which stops any further quoting, order entry, and picking of the part without approval from upper mgmt.
2. DEE, upon learning of a potential or historical change, will immediately and formally notify our client.

At this time, Sales and Quality will work together to identify the following:

1. If the change already occurred, then the following will happen:

1. Quality will analyze historical corrective actions for trending data.
2. Sales will analyze the information and identify if the client needs to be notified

1. If the change has not occurred yet, then the following will happen:

1. Quality will assess risk of the part.  If part is identified as a high risk part, then the part will be tagged requiring 1^st Article Inspection, and the procedure for 1^st Article Inspection, QOP-71-02, will be performed.
2. Sales will analyze the information and identify if the client needs to be notified.

1. Quality will update the card with appropriate notes from the review.
2. A change of plant, material, design, or process will trigger a revalidation or a new 1^st Article approval process, verified with the client

 

ASSOCIATED DOCUMENTS

QF-82-04-01 Quality Form (DBA Form # WO-D): Picking Form

QF-82-04-03 Quality Form: Instruction/Inspection Log Form

QF-82-05-02 Quality Form:  Quality Assurance Audit Form

QOP-82-05 Operational Procedure: Final Inspection

QOP-74-03 Operational Procedure: Verification of Purchased product

QOP-83-01 Operational Procedure: Control of Nonconforming Product