Capabilities at Darcoid - Tools In Our QA Toolkit

Capabilities – Tools in our QA toolkit

Darcoid’s quality department has a bigger toolbox than most in our industry. These include: Non-contact metrology; FTIR verification; physical property checks; PPAP level 1-5; FAIR; Gauge R&R Studies; Regulatory compliance reporting and IMDS.

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We are able to offer a combination of the below based on the criticality of your application:

Contactless video measurement, automated

200x microscope metrology

Certificate, FTIR, and durometer hardness material verification

Lot, batch controls and traceability

Certification of compliance

PPAP Level 1-5 controls

First articles to AS9102

Gauge R&R studies

Custom go/no-go gauges

AQL sampling up to 100% vision inspection

Visual inspection performed to RMA, ISO3601-3 grade N/S/CS, AS871B

ASTM / SAE / ISO specifications

Regulatory requirements – REACH, ROHS, FDA compliance, USP class VI, NSF, AMS / MIL, UL

International Material Data System (IMDS)

PPAP

PPAP is a design & manufacturing inspection process used to verify a supplier's ability to reliably and repeatedly produce a part or set of parts for mass production.

PPAP validates a production process by inspecting parts after a completed production run. The PPAP report reviews 18 requirements such as design records, authorized engineering changes, engineering approval, dimensional results, control plan, and more.

Checklist

Purpose of PPAP Summary:

Validating supplier’s ability. Ability to meet customer and regulatory requirements.
Understanding customer requirements.
Establishing a reliable and repeatable process that won’t change without further customer approval.
Reducing cost and having faster time to market.
Maintaining expectations & compliance on both sides.

PPAP is typically required when:

A new part or product.
Product changes/corrections: design, materials, supply, and function.
Process changes/corrections: method, tools, location, and inspection criteria.
Inactive tooling for more than one year.

PPAP 5 Levels of Submission:

The PPAP report has 5 levels of submissions with Level 3 as the default level of PPAP submission approval.

Level 1: Part Submission Warrant (PSW) only submitted to the customer.
Level 2: PSW with product samples and limited supporting data.
Level 3: PSW with product samples and complete supporting data.
Level 4: PSW and other requirements as defined by the customer.
Level 5: PSW with product samples and complete supporting data available for review at the supplier’s manufacturing location.

PPAP 18 Elements

Design Records: A copy of the drawing or model provided by customer.
Engineering Change Documents: Detailed description of changes of parts from previous revisions called Engineering Change Notice.
Customer Engineering Approval: Customer approval of sample production parts.
Design Failure Mode and Effects Analysis (DFMEA): Prediction of a product's potential design failure.
Process Flow Diagrams: All steps in manufacturing process including components, measurement, and inspection.
Process Failure Mode and Effects Analysis (PFMEA): Prediction of a potential process failure that could occur during production.
Control Plan: Details the plan for how quality will be implemented to ensure a stable and reliable process.
Measurement System Analysis (MSA): Conformance to customer’s ISO or TS standard. Usually Gage R&R for critical impact characteristics to control repeatability and reproducibility and confirmation that gages are calibrated to measure these characteristics to control measurement bias.
Dimensional Results: A list of every dimension noted on the ballooned drawing or model with pass/fail assessment.
Material / Performance Test Results: Summary of every test performed on the part, usually in the form of DVP&R (Design Verification Plan and Report).
Initial Process Studies: Shows that critical processes are reliable. Includes SPC (statistical process control) charts.
Qualified Laboratory Documentation: All industry certifications for validation testing.
Appearance Approval Report (AAR): Customer approval on final product appearance including color, texture, fit, and more.
Sample Product: Sample from initial production run.
Master Sample: Sample part signed off by customer and supplier.
Checking Aids: Detailed list of all tools used to inspect and measure parts.
Records of Compliance with Customer-Specific Requirements: List of customer’s specific requirements for PPAP process.
Part Submission Warrant (PSW): Summary of entire PPAP submission.

AQL Sampling Rates

Darcoid’s part control plans incorporate Acceptance Quality Limit (AQL) sampling rates appropriate to the criticality of the seal for our customer’s end use.

Our baseline C=0 AQL sampling rate for visual inspection is 0.25 and this can be adjusted based on your application requirements to include 100% inspection for critical applications.

ISO, RMA

Our methodology for dimensional and workmanship quality inspection is aligned with requirements and best practices as defined by ISO 3601-1 and ISO 3601-3, the Rubber Manufacturers Association (RMA) handbook, and applicable aerospace AS871B \ standards.

The manufacture of elastomer products by compression, transfer, injection, calendaring or extrusion methods produces workmanship and surface defect classifications specific to elastomers. Defects include off register, flash, flow marks, voids and non-fills. Acceptability limits for each defect are classified and described, and our inspectors are trained to these standards.