Can time be met?

General CTQ and

Functional

Specifications Determined for Process

Determine severity of failure if CTQ is not

obtained in manufacturing

Revision to

process needed?

ATL APQP/ NPD Work Structure -

R&D Device Master -

FMEA and/ or Test Run Form

Generate

Test Run (or production run) In

ATL Schedule

ATL ADVANCED PRODUCT QUALITY (APQP) PLANNING

Begin APQP/ NPD Test Run (or

production run)

Additional

resource

available?

Revision To

Process

Needed?

Review/ Rank Potential Process

Failures

Determine FMEA RPN's.

Rank RPN's (Pareto)

construct Control Plan(s).....

Tolerances,

Measurement-

Sample Size -

Inspection Frequency

Control Method -

Access Stability, short term Cpk, and X Bar and R chart OR Median Chart for shop floor continuing

process control

ATL APQP - Review Of Customer Requirements

(Quotation Reviews)

Yes

No Yes

Yes

No

No No

Yes

End of Test/ Production Run. Cpk's Determined for all CTQ's. All

control charts reviewed as applicable.

Revision

needed?

No -Yes

Ship To Customer

Review and Correct

AD TAPE & LABEL CO., W140 N9504 FOUNTAIN BLVD, MENOMONEE FALLS, WI, 53051 PHONE 1-800-444-5144 www.atlco.com

CTQ = Customer Items

Critical To Quality

FMEA =

Failure Modes

& Effects

Analysis

Note: RPN's = Risk Priority Numbers for

potential failures in the NPD process. All

potential process failures are ranked by

severity, likelihood of occurrence, & the

ability to detect and prevent the failure.

FMEA allows ATL to identify potential

failures before they happen in production.

ATL APQP FLOW CHART, CUD/ DJD, REVISION 05-20-2015

Note: Control Plans list the CTQ

characteristics, the specification tolerance, measurement technique, sample size, sample frequency, and

data recording method. Ppk/ Cpk and defects per million are calculated for

variables measurement CTQ's.

Note: DOE = Design of

Experiments. This technique

allows us to optimize a process

by examining process factors

at multiple levels. The critical

"F" and "P" values are calculated

for statistical significance.

Note: Gauge repeatability and

reproducibility test(s) are performed

on critical gauges to assure that

measurement error (within operator

variation and between operator

variation) does not cause a loss

of accuracy and precision in ATL's

capability studies for the product.

Note: ATL is ISO-13485

Registered and FDA

cGMP compliant

Note: An Analysis of

Variance (ANOVA) allows

us to compare multiple test

or production runs to deter-

mine if the populations of

production (values) are the

same, or statistically

significantly different. This

is called hypothesis testing.

CONTROL PLAN ISSUED

Note: For cGMP compliance, IQ

(Installation Qualifications), OQ

(Operational Qualifications), and PQ

(Performance Qualifications) are

completed for machines, methods,

materials, software, and personnel. This is

part of our "Systems Validation Protocol".

Inference

error

determined

at a 95%

confidence

interval