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1

PCPC QUALITY METRICS

BENCHMARK SURVEY

YEAR FIVE

2

5th Year Quality Metric Survey

Business Success

Through

Continuous Quality Improvement

3

What is Benchmarking?

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4

Day Work Assignment!

Which (1 or 2) quality metric(s)

do you consider most

important to your business?

Is there another metric you

would like to see surveyed?

5

Part I: Company Information 1. What is the size of your company in gross

sales?

• < 1 million

• 1 to 10 million

• 10 to 100 million

• 100 million to 1 billion

• > 1 billion

2. Please identify whether your data are

based on Global or North American

markets.

6

Part I: Company Information (cont’d)

3. Which of the following descriptions best

fits your primary business? (new this year)

• Manufacturer of Finished Goods for

Retail/Online Distribution

• Contract Manufacturer

• Supplier of Raw Materials

• Supplier of Packaging Components

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Part II: Quality Metrics Data 4. What is your company’s total Quality

Assurance budget divided by company

gross sales?

5. What is your company’s annual parts per million

(ppm) non-conforming finished goods?

6. What is your company’s annual quality

complaints per million (cpm) units sold?

7. What is your company’s annual % 1st pass

batches?

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Part II: Quality Metrics Data (cont’d)

8. What is your company’s annual % 1st pass

finished goods?

9. What is your company’s annual % finished

goods microbiological reject rate?

10.What is your company’s annual ratio

(expressed as %) for QA and QC Full Time

Equivalent per total Manufacturing Full

Time Equivalent?

11.What is your company’s annual accuracy

level (right the first time) for batch

records? (new this year)

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Part III: Regulatory Data (new this year)

12.For personal care products, what is your

company’s annual Adverse Event (AE) rate

per million units sold?

13. For personal care products, what is your company’s

annual Serious Adverse Event (SAE) rate per million

units sold?

14. How many FDA inspections (domestic and

international) did you receive during this 12-month

reporting period?

15. How many 483 observations did you receive from

these inspections?

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10

= Top 20%

of reporting

companies

n = # reporting companies

M = company sales in millions

B = company sales in billions

Best In Class (BIC)

GRAPH NOTATIONS

Min = Minimum value

Max = Maximum value

Avg = Average value 2

0

1

2

0 - 5 5.1 - 10 10.1 - 15 15.1 - 20 >20%

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# 1 What is the size of your company based

on gross sales?

Part I: Company Information

12

2

9

21

24

0

5

10

15

20

25

<1 M 1 M - 10 M 10 M - 100 M 100 M - 1 B > 1 Billion

# C

om

pan

ies

Number of Companies by Annual Sales (2014)

n=56

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# 2 Please identify whether your data are based on

Global or North America markets

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2014 REGIONAL BREAKOUT

n = 56

17

Companies

39

Companies

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# 3 What is your company’s primary business-type?

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16

13

43

Business-Type (2014)

Supplier

Finished Goods

n = 56

17

13

43

4

13

9

30

0

5

10

15

20

25

30

35

40

45

50

Suppliers

# C

om

pan

ies

Finished Goods and Suppliers by Region (2014)

Total

North America

Global

Finished Goods

n = 56

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# 4 What is your company’s total Quality Assurance

budget divided by company gross sales?

Part II: Quality Metrics Data

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19

1.5

0.8 1.0 1.0 1.0

0.15 0.27 0.05 0.01 0.15

7.0

3.7

5.0

4.0

3.0

0.0

1.0

2.0

3.0

4.0

5.0

6.0

7.0

8.0

2010 2011 2012 2013 2014

Pe

rce

nt

Percent QA Budget / Gross $ Sales

Avg

Min

Max

34 Companies 11 Companies 38 Companies 19 Companies 28 Companies

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# 5 What is your company’s annual parts per million

(ppm) non-conforming finished goods?

21

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22

Lo

wer

is B

ett

er

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# 6 What is your company’s annual quality

complaints per million (cpm) units sold?

24

0

100

200

300

400

500

600

700

800

900

1000

1100

1200

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35

Co

mp

lain

ts

pe

r M

illio

n

# Companies

Complaints Per Million Units Sold

Lower

is better

Industry Avg. 166

Best in Class .05-50

n=35

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25

0 4 0.2 0 0.05

156 140

264

165 166

996

1096

819 819

1086

0

200

400

600

800

1000

1200

Complaints per Million Units Sold Five Year Trend - Min, Avg, Max%

Lower Is

Better

2010

2011

2012

2013

2014

cpm

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# 7 What is your company’s annual %

1st pass batches?

27

90

92

94

96

98

100

1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35

2014 % First Pass Batch Approval

Industry

Avg 98.5%

Best In Class

99.5 - 99.8%

Higher

is

Better

# Companies

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28

97.5 98.4

96.0

98.4 98.5

91.0 92.0

79.5

93.0

95.7

99.8 100.0 99.9 100.0 99.8

75.0

80.0

85.0

90.0

95.0

100.0

2010 2011 2012 2013 2014

% F

irs

t B

atc

h A

pp

rov

al

% First Batch Approval Five Year Trend - Min, Avg, Max %

Avg% Min% Max%

Higher

is

Better

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# 8 What is your company’s annual %

1st pass finished goods?

30 # Companies

90

91

92

93

94

95

96

97

98

99

100

1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35

%1s

t P

ass

FG

2014 % 1st Pass Finished Goods

Industry Avg

98.3%

Best In Class

99.7 100%

Higher

is

Better

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31

98.4 99.0 98.8

98.0 98.3

95.0

96.7

94.8

90.0

91.7

99.9 99.9 99.8 100.0 100.0

90

91

92

93

94

95

96

97

98

99

100

2010 2011 2012 2013 2014

% 1

st

Pa

ss

FG

Ap

pro

va

l

% First Pass Finished Goods Five Year Trend - Min, Avg, Max %

Avg% Min% Max%

Higher

is

Better

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# 9 What is your company’s annual % finished goods

microbiological reject rate?

33

n = 36

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34

Lower

is

Better

35

# 10 What is your company’s annual ratio (expressed

as %) for QA and QC Full Time Equivalent per total

Manufacturing Full Time Equivalent?

36

n = 39

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37

38

# 11 What is your company’s annual accuracy level

(right the first time) for batch records?

39

0 1

5

9

8

9

0

1

2

3

4

5

6

7

8

9

10

0 - 49% 50-59% 60-69% 70-79% 80-89% 90-100%

Annual % Batch Record Accuracy

Annual % Batch Record Accuracy n=32

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40

0

10

20

30

40

50

60

70

80

90

100

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32

Annual % Batch Record Accuracy

Annual % Batch Record Accuracy

Average = 79%

BIC = 90%

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# 12 For personal care products, what is your

company’s annual Adverse Event (AE) rate per

million units sold?

Part III: Regulatory Information

42

4

1 1

0 0 0

1

0

1

2

3

4

5

1-5 6-10 11-20 21-30 31-40 41-50 51-60

2014 Adverse Events per Million Sold

Annual Adverse Events per Million Sold

n=7

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43

0.02 2.11 2.55

4.19 6.1

16

52.7

0

10

20

30

40

50

60

1 2 3 4 5 6 7

2014 Adverse Events per Million Units Sold

Annual Adverse Events per Million Units Sold

Average = 18 ppm

BIC = 0.02 ppm

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# 13 For personal care products, what is your

company’s annual Serious Adverse Event (SAE) rate

per million units sold?

45

3

2 2

0

0.5

1

1.5

2

2.5

3

3.5

0-0.0009 0.001-0.009 0.01-0.09

2014 Serious Adverse Events per Million Units Sold

Serious Adverse Events per Million Units Soldn=7

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46

0.00000 0.00000 0.00000 0.00010

0.00860

0.01000

0.01600

0.00000

0.00200

0.00400

0.00600

0.00800

0.01000

0.01200

0.01400

0.01600

0.01800

1 2 3 4 5 6 7

2014 Serious Adverse Events per Million Units Sold

Serious Adverse Events per Million Units Sold

Average = 0.005 ppm

BIC = 0 ppm

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# 14 How many FDA inspections (domestic and

international) did you receive during this 12-month

reporting period?

48

20

9

2 1 1

0 1

0

5

10

15

20

25

0 1 2 3 4 5 6

# Annual FDA Inspections (2014)

# Annual FDA Inspections n=34

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49

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

1 1 1 1 1 1 1 1 1

2 2

3

4

6

0

1

2

3

4

5

6

7

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34

# Annual FDA Inspections (2014)

# Annual FDA Inspections

Average = 0.76

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# 15 How many 483 observations did you receive

from these inspections?

51

22

3

1 0

1 1 0

2

0 0 0 1

0

5

10

15

20

25

0 1 2 3 4 5 6 7 8 9 10 11

# 483's Issued (2014)

# 483's Issued n= 31

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52

11

7 7

5

4

2

1 1 1

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

2

4

6

8

10

12

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

# 483's Issued (2014)

# 483's Issued

Average = 1.25

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483’s per Inspection

Ratio # 483’s/# Inspections

Minimum 0

Maximum 7

Average 1.6

13 respondents reporting inspections

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Company Identification

S

U

M

M

A

R

Y

2010 2011 2012 2013 2014

Responses

North

American 10 9 12 14 17

Global 11 8 16 27 39

Total 21 17 28 41 56

Company Size

>$1B 10 10 12 18 24

$100M -

$1B 6 3 6 16 21

$10M -

$100M 4 3 8 5 9

$1M -

$10M 1 0 2 1 2

<$1M 0 1 0 1 0

Business Type

Finished

Goods 43

Supplier 13

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Quality Metrics

S

U

M

M

A

R

Y

2010 2011 2012 2013 2014

% QA Budget /

Revenue Average 1.5% 0.8% 1.0% 1.0% 1.0%

PPM Finished Goods

Defects Average

3,759 ppm 2,563 ppm 13,358 ppm 24,581 ppm 23,843 ppm

BIC 20 – 50 BIC 0 - 1 BIC 10 - 1,214 BIC 0 – 1,057 BIC 217 - 3,200

Complaints per Million

Units Sold Average

156 cpm 140 cpm 264 cpm 165 cpm 166 cpm

BIC .3 – 12 BIC 4 - 20 BIC 0.2 - 95 BIC 0 - 51 BIC .05 - 50

% 1st Pass Batch

Approval Average

96.80% 98.40% 96.00% 98.40% 98.50%

BIC 99.2 – 99.8 BIC 99.9 - 100 BIC 99.4 - 99.9 BIC 99.5 - 100 BIC 99.5 - 99.8

% 1st Pass Finished

Goods Average

98.4% 99.0% 98.8% 98.0% 98.3%

BIC 99.4 – 99.9 BIC 99.7 - 99.9 BIC 99.5 - 99.8 BIC 99.6 - 100 BIC 99.7 - 100

% Finished Goods

Micro Rejects Average

0.06% 0.18% 0.17% 0.06% 0.04%

BIC 0 BIC 0 BIC 0 BIC 0 BIC 0

% QA FTE / Mfg. FTE Average 9.50% 8.60% 8.50% 12.10% 12.30%

% Batch Record Accuracy Average 79%

BIC >90%

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Regulatory Data

S

U

M

M

A

R

Y

2010 2011 2012 2013 2014

Annual Adverse Events (ppm)

Average

11.95 ppm

Serious Adverse Events (ppm)

Average

0.005 ppm

# FDA Inspections Average

0.76

# 483's/inspection

Average

1.6

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QUESTIONS?

Thank You!!

Reminder --

Complete 2014 annual metrics report will be available on the

PCPC website: http://www.personalcarecouncil.org/