GOOTEN

Quality Control

Product Qualification 

1.1  PPAP

The PPAP is identification of requirements and specifications for the products and any required packaging included in the Request for Quote, or RFQ.  It is the expectation that our production line and equipments meets all identified requirements and specifications with no exception.  Our production team will be

required to submit samples according to sample order requirements identified in the RFQ.  Samples order must be production and equipment intent unless otherwise specified.  GOOTEN will also determine other documentation that is required to be submitted with samples, including but not limited to Process Flow, DFMEA, PFMEA, and Control Plans.  The expectations for these documents can be

found in the sections listed in our factory’s production Manual in ENGLISH.

1.1.1  Process Flow

The process flow for product specifics will have clear start and end criteria.  If the process flow has a decision diamond, the outputs of the decision will also be clear and concise.  Outsourced processes are also shown on the process flow. 

1.1.2  DFMEA (if ODM) 

If the product is ODM project basis, a Design Failure Mode and Effect Analysis, or DFMEA will be submitted for the client to reviewing the DFMEA to ensure all failure modes have been considered, the severity ranking, occurrence ranking, and detection rankings are sufficient, and high RPN items have a clear action plan assigned. 

1.1.3  PFMEA 

The purpose of the Process Failure Modes and Effect Analysis, or PFMEA, is to identify risks associated with the production of the product. 

The client will review the PFMEA to ensure all process steps are included, all failure modes have been considered, the severity ranking, occurrence ranking, and detection rankings are sufficient, and high RPN items have a clear action plan assigned. 

1.1.4  Control Plan 

GOOTEN will submit a Control Plan for the item before production.  The control plan documents the elements of quality control that are required to ensure a product meets quality standards.  The outputs of the DFMEA and PFMEA should help provide input to the control plan.

GOOTEN will be reviewing the control plan to ensure all process steps are included, all parameters to be measured are indicated, the quantity and frequency of sampling are adequate, and there are clear reaction plans in place in case of defective claims for corrective actions.

2.2  ISIR Process 

Once the samples and documentation are submitted by GOOTEN to the client based on order, we will also open an Initial Sample Inspection Report, or ISIR.  The ISIR is the internal approval process used to validate the samples and documentation.  The ISIR process includes product review, packaging review,

document review, and compliance review.  If the samples do not pass any of these reviews, the ISIR will be rejected and our production team will be required to resubmit samples.  ISIR approval is required to move into the Feasibility Review.

2.3  Feasibility Review

The Feasibility Review will be required to begin mass production.  The purpose of the Feasibility Review is to ensure the production team can consistently provide quality product as well as the capability to support client’s business needs.

GOOTEN reserves the right to determine if the Feasibility Review will be a Supplier Self-Review, On-Site Review, or a combination of these two reviews.  

If the production team’s Self-Review is required, all sections must be completed truthfully and accurately and report to the client within 7 days.  

If an On-Site Review is required, GOOTEN’s sales team will communicate with the client to determine a date to perform the review.  Once the date is finalized, GOOTEN reserves the right to change the date if required.  

The production team will sign off on the Feasibility Review in order to begin mass

production.

Completion of the Feasibility Review may also be required as a result of a product change, process change, packaging change, location change, or sub-supplier change

Change Management.

2.4  Manufacturing Validation 

Manufacturing Validation ensures GOOTEN production team can maintain quality product in a mass production run. Client can request samples from the GOOTEN at this stage of mass production.  Samples must come directly from the production line and in final packaging.  These samples will be sent to the client, and

validation testing will be performed on these samples.  If any issues arise during validation testing, the production team must respond as per the timelines set forth in the section Root Cause Analysis and Timing.  Product must pass Manufacturing Validation prior to shipping. 

2.5  Safe Launch 

It is the Supplier’s responsibility to ensure the product meets client’s expectations prior to leaving the facility.  The Safe Launch process is intended to be a short-term process meant to validate controls in the manufacturing process are robust and repeatable.  Safe Launch is required for:

•  New product

•  Change in design, process, product, location, or material

A Safe Launch plan will be submitted by the production team to be confirmed by the client or the 3rd party Quality Representative if needed, and this Safe Launch plan will detail the inspections that must be completed and documented per shipment.  Once inspections are completed by GOOTEN, the production team will submit an Inspection Report to the client and 3rd party Quality Representative.

GOOTEN will not be able to ship product until it is approved to do so by the client.

If the shipment is rejected, rework is required by the Supplier.  The Supplier is then

required to re-submit an Inspection Report to the client or Quality Representative. 

In the case where an inspection must be validated and a client representative cannot make an on-site visit, a third party inspection may be required at the client’s cost.

Safe Launch will occur until the 3rd party Quality Rep. determines the manufacturing process will continuously produce to the quality standard expectations.  At this time, the production team will be notified that Safe Launch has closed on the products by the client representative or 3rd party Quality Representative.  After closure by the client, the Supplier may choose to continue Safe Launch

activities on their own. 

Once Safe Launch is closed, the Supplier will no longer need to follow the Safe Launch plan or send Inspection Reports to the client per shipment.  The Supplier will still be expected to maintain internal quality records, and the client/consignee can request a copy of these records at any time.