Improve Product Performance Through Annual Review Barbara Copeland Amway Corporation
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Improve Product Performance Through
Annual Review
Barbara CopelandAmway Corporation
Learning ObjectivesBe able to:• Perform an Annual Product Review• Modify it for any industry• Determine areas for improvement• Use to measure progress
Understanding Current Status• Global impact of the drug industry• Rising costs• Health and safety of consumers• Protect investments • Maximize profits
FDA Regulatory EnvironmentFDA 21 CFR 211.180(e) states that:
“Written records required by this part shall be maintained so that data therein can be used for evaluating, at least annually, the quality standards of each drug product to determine the need for changes …”
FDA Regulatory Environment
Let’s see that again….
FDA Regulatory Environment
“Written records required by this part shall be maintained so that data therein can be used for evaluating, at least annually, the quality standards of each drug product to determine the need for changes …”
FDA Regulatory Environment
“Written records required by this part shall be maintained so that data therein can be used for evaluating, at least annually, the quality standards of each drug product to determine the need for changes …”
FDA Regulatory Environment
“Written records required by this part shall be maintained so that data therein can be used for evaluating, at least annually, the quality standards of each drug product to determine the need for changes …”
FDA Regulatory Environment
“Written records required by this part shall be maintained so that data therein can be used for evaluating, at least annually, the quality standards of each drug product to determine the need for changes …”
Annual Drug Product Review
• Understand current status• Identify areas for improvement• Don’t just check the box!
Annual Drug Product ReviewOverview:• Production statistics• Data analysis and compliance• Non-conformance history• Rework history• Complaint analysis• Change Control
Scope of the Review• Single product or product family• Size• Type of container• Manufacturing site
Production Statistics• Number of lots produced• Number of lots rejected• Number of non-conformances• Number of recalls
Data Analysis• Finished product• Raw Materials• Components• Process data
Data Analysis• Lab analysis
–Chemical–Physical–Microbiological
• In-process testing–Weights–Torques–Anything that is measured
Time Series Plot
Process Capability
0.540.520.500.480.46
LSL USLLSL 0.45Target *USL 0.55Sample Mean 0.499701Sample N 134StDev (Within) 0.00599904StDev (O v erall) 0.00812869
Process DataC p 2.78C PL 2.76C PU 2.79C pk 2.76
Pp 2.05PPL 2.04PPU 2.06Ppk 2.04C pm *
O v erall C apability
Potential (Within) C apability
% < LSL 0.00% > USL 0.00% Total 0.00
O bserv ed Performance% < LSL 0.00% > USL 0.00% Total 0.00
Exp. Within Performance% < LSL 0.00% > USL 0.00% Total 0.00
Exp. O v erall Performance
Process Capability of Active Ingredient
Time Series Plot
Histogram
4.44.34.24.14.03.9
18
16
14
12
10
8
6
4
2
0
pH
Freq
uen
cy
USLLSLHistogram of pH
Raw Material Analysis
37332925211713951
100.0
99.5
99.0
98.5
Observation
Indi
vidu
al V
alu
e
LSL
USLAssay of Raw Material
In-process Analysis• Weights• Torques• Pressures• Temperatures• Anything that is measured
Non-conformance History• Out-of-specification incidences• Repeated incidences• Root Cause Analysis
History of Actions Taken• Corrective Actions• Preventive Actions• Responsibility and Timing• Follow up• Effectiveness checks• Tracking
Rework – The Hidden Factory• Review rework history• Trends• Repeated issues• Root cause detemined• The Hidden Factory!
Stability Data
Complaint Analysis• Number by type of complaint• Pareto chart to determine trends
YTD 132 69 22 17 10Percent 52.8 27.6 8.8 6.8 4.0Cum % 52.8 80.4 89.2 96.0 100.0
C1 OtherColorAdverse EventCodingSeal
250
200
150
100
50
0
100
80
60
40
20
0
YTD
Per
cen
t
Pareto Chart of Complaints
Change Control• Review the change control history• Number processed• Types of changes• Proactive or reactive?
Non-drug products• Determine critical metrics• Examples:
–Reliability data–Line Fall-out–Mean time to failure–Mean time to repair
Problem Solving• “Minor” issue repeats • Review reveals frequency• Related customer complaints
= Escalated priority!
Problem Solving• Lotion with lumps • Emulsion formation problem• Mix history RPM • Raw material viscosity history • Root cause = Combination
Draw Conclusions• The state of the product• The state of the process• The need for change• Where to focus resources!
Next Year…• Compare to the previous review• Has improvement been made?• Take it all to the next level!
Learning ObjectivesBe able to:• Perform an Annual Product Review• Modify it for any industry• Determine areas for improvement• Use to measure progress
QUESTIONS?
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