CONTROL DE PROCESOS

FARMACÉUTICOS
ENCARNA GARCÍA MONTOYA
FACULTAT DE FARMÀCIA i
CIÈNCIES DE L’ALIMENTACIÓ
Donat el caràcter i la finalitat exclusivament docent i eminentment
il·lustrativa de les explicacions a classe d'aquesta presentació, l’autor s’acull a
l’article 32 de la Llei de Propietat Intel·lectual vigent respecte de l'ús parcial
d'obres alienes com ara imatges, gràfics o altre material contingudes en les
diferents diapositives

TEMA AMB ACTIVITAT AVALUABLE

1
¿Qué es un proceso?

PROCESO:
secuencia de acciones u operaciones repetitivas, sistemáticas y relacionadas,
mediante las cuales transformamos un producto o bien, o generamos un
producto o servicio que agrega o tiene valor para un cliente.
 CONTROL DE PROCESOS
Consiste en medir resultados (pueden ser parámetros de
calidad, producción, máquina) y verificar con respecto a las
especificaciones, si está dentro o fuera del intervalo de
aceptación.

Según la situación, puede realizarse con todo el lote

(inspección 100%) o sólo sobre muestras tomadas
frecuentemente. Este segundo caso se denomina Control
Estadístico de Procesos.

Las medidas efectuadas se llevan a un gráfico que permite

visualizar el estado del proceso y tomar decisiones
Process data show
65 how the process
60 varies over time.
55
50
45
40
1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35 37 39 41
Un proceso está bajo control si …
1. … no hay resultados de las muestras fuera de
los límites de aceptación
2. … si la mayoría de los resultados de las
muestras están cerca del valor teórico o media
3. … aproximadamente los mismos puntos por
encima que por debajo de la media
4. … resultados distribuidos aleatoriamente
UCL = 0.32

R = 0.15

LCL = 0.00
En general, como monitorizamos la
calidad de nuestros productos…?

Observando la variación
de las medidas de
parámetros
importantes o críticos!
Control Estadístico de Procesos (SPC)

Cualquier resultado (output) tiene un valor objetivo a un

nivel aceptable de variación (con un límite de tolerancia
superior e inferior)
SPC usa muestras de las medidas de outputs para estimar la
media y su variación (desviación estandard)

Ejemplo
Queremos botellas de jarabe llenas con 120 ml ± 5 ml

Cuestión: Cómo demostramos que se han llenado bien y

todas cumplen estadísticamente con la especificación de
volumen?
Calculando media y su SD
Ejemplo:
para que sirve la media y la variación?
Número de trozos de pepperoni’s por pizza: 25, 25, 26, 25, 23, 24, 25, 27

Average: 25
Standard Deviation: 1,19

Número de trozos de pepperoni’s por pizza: 25, 22, 28, 30, 27, 20, 25, 23

Average: 25
Standard Deviation: 3,29

A qué proveedor de pizza comprarías

habitualmente si eres un estusiasta del pepperoni?
 PREMISAS DE ANÁLISIS EN EL CONTROL DE
PROCESOS
1. La calidad medida de un resultado de un proceso siempre
está sujeta a una cierta cantidad de variación o
variabilidad

* Sobre un sistema estable siempre se presenta variación por

causas aleatorias o comunes o naturales en cualquier método de
producción y es detectable en la realización de pruebas de calidad

* La variación dentro del sistema productivo es inevitable, por ello la

variación especial o asignable se debe detectar y eliminar (si
efecto es negativo..) o mantener o fijar al proceso (si su efecto
sobre la calidad es positivo).

Cuantificar la variación y los tipos es un punto de mejora

Common/
Natural Cause
Variation Special Cause
 Samples
To measure the process, we take samples and
analyze the sample statistics following these
steps
Each of these
represents one
(a) Samples of the sample of five boxes
product, say five of cereal
boxes of cereal taken
off the filling # #

machine line, vary Frequency # # #

from each other in # # # #
weight # # # # # # #

# # # # # # # # # #

Weight
 Samples
To measure the process, we take samples and
analyze the sample statistics following these
steps The solid line
represents the
distribution
Frequency
(b) After enough
samples are taken
from a stable
process, they form
a pattern called a
distribution
Weight
Frequency

Central tendency Variation Shape

Weight Weight Weight

 Samples
To measure the process, we take samples and
analyze the sample statistics following these
steps
(d) If only natural
causes of variation
are present, the Frequency
output of a process Prediction
forms a
distribution that is
stable over time
and is predictable Weight
 Samples
To measure the process, we take samples and
analyze the sample statistics following these
steps
?
?? ??
(e) If assignable / ?
? ?
?
special causes are ?
?
? ?
?
??
?? ?
present, the Frequency
process output is Prediction
not stable over
time and is not
predicable
Weight
Figure S6.1
 Control Charts
Constructed from historical data, the
purpose of control charts is to help
distinguish between natural variations and
variations due to assignable causes
 Process Control
(a) In statistical
control and capable of
producing within
Frequency control limits

Lower control limit Upper control limit

(b) In statistical control
but not capable of
producing within
control limits

(c) Out of control

Size
(weight, length, speed, etc.) Figure S6.2
 Central Limit Theorem
Regardless of the distribution of the population,
the distribution of sample means drawn from the
population will tend to follow a normal curve

1. The mean of the sampling

distribution (x) will be the same as x=
the population mean 
2. The standard deviation of the
sampling distribution (x) will equal 
the population standard deviation x =
() divided by the square root of the n
sample size, n
 Population and Sampling
Distributions
Three population
distributions Distribution of
sample means
Mean of sample means = x
Beta
Standard
deviation of 
the sample = x =
Normal n
means

Uniform

| | | | | | |

-3 x -2 x -1 x x +1 x +2 x +3 x

95.45% fall within ± 2 x
99.73% of all x
fall within ± 3 x
These interval are the variation natural of the process due to the natural causes of variation
 The Normal
Distribution
 = Standard deviation

A recordar:
Un proceso “normal”
estadísticamente Mean
está produciendo -3 -2 -1 +1 +2 +3
el 99,74% de los 68.26%
productos 95.44%
Entre x ± 3σ 99.74%
18
 Assignable
Control Charts causes
likely

UCL

Nominal

LCL

1 2 3
Samples 19
 Control Charts for Variables
 For variables that have
continuous dimensions
 Weight, speed, length,
strength, etc.
 x-charts are to control
the central tendency of the process
 R-charts are to control the dispersion of the
process
 These two charts must be used together
 Control Charts for Variables
• Mean chart (X Chart)
–Measures central tendency of a
sample
• Range chart (R-Chart)
–Measures amount of dispersion
in a sample

• Each chart measures the process

differently. Both the process average
and process variability must be in
https://support.minitab.com/es -mx/minitab/18/help-and-how-to/quality-and-process-
control for the process to be in improvement/control-charts/how-to/variables-charts-for-subgroups/xbar-r-
chart/interpret-the-results/key-results/
control.

21
 Setting Chart Limits
For x-Charts when we know 
Upper control limit (UCL) = x + zx

Lower control limit (LCL) = x - zx

where x = mean of the sample means or a target value
set for the process
z = number of normal standard deviations
x = standard deviation of the sample means*
= / n
 = population standard deviation
n = sample size
*O se calcula con calculadora
 Setting Control Limits
Hour 1 Hour Mean Hour Mean
Sample Weight of 1 16.1 7 16.2
Number Oat Flakes 2 16.1 8 16.4
1 17 3 16.2 9 16.3
2 13 4 16.3 10 13.3
3 16 5 16.0 11 13.1
4 18 6 16.4 12 18.6
n=9 5 17
6 16 IF x = 15,91 ozs AND x = 1,38
7 15 For 99.73% control limits, z = 3
8 17 UCLx = x + zx = 15,91 + 3(1,38) = 20,05 ozs
9 16
Mean 16.1 LCLx = x - zx = 15,91 - 3(1,38) = 11,77 ozs
 Setting Control Limits
Control Chart
for sample of 9 Variation due
Out of to assignable
boxes control causes

20,05 = UCL

Variation due to
16 = Mean natural causes

11,77 = LCL

Variation due
to assignable
| | | | | | | | | | | | causes
1 2 3 4 5 6 7 8 9 10 11 12 Out of
control
Sample number
 Setting Chart Limits
For x-Charts when we don’t know 

Upper control limit (UCL) = x + A 2 R

Lower control limit (LCL) = x - A2 R

where R = average range of the samples

A2 = control chart factor found in Table S6.1
x = mean of the sample means
Control Chart Factors for Mean
Sample Size Mean Factor
n A2
2 1.880
3 1.023
4 .729
5 .577
6 .483
7 .419
8 .373
9 .337
10 .308
12 .266

Table S6.1
Setting Control Limits

Process average x = 12 ounces

Average range R = .25
Sample size n = 5
 Setting Control Limits
Process average x = 12 ounces
Average range R = .25
Sample size n = 5

UCLx = x + A2R
= 12 + (.577)(.25)
= 12 + .144
= 12.144 ounces
From Table
S6.1
 Setting Control Limits
Process average x = 12 ounces
Average range R = .25
Sample size n = 5

UCLx = x + A2R UCL = 12.144

= 12 + (.577)(.25)
= 12 + .144 Mean = 12
= 12.144 ounces

LCLx = x - A2R LCL = 11.857

= 12 - .144
= 11.857 ounces
 R – Chart

 Type of variables control chart

 Shows sample ranges over time
 Difference between smallest and
largest values in sample
 Monitors process variability
 Independent from process mean
 Setting Chart Limits
For R-Charts

Upper control limit (UCLR) = D4R

Lower control limit (LCLR) = D3R

where
R = average range of the samples
D3 and D4 = control chart factors from Table S6.1
Control Chart Factors for Range
Sample Size Upper Range Lower Range
n D4 D3
2 3.268 0
3 2.574 0
4 2.282 0
5 2.115 0
6 2.004 0
7 1.924 0.076
8 1.864 0.136
9 1.816 0.184
10 1.777 0.223
12 1.716 0.284

Table S6.1
 Setting Control Limits
Average range R = 5.3 pounds
Sample size n = 5
From Table S6.1 D4 = 2.115, D3 = 0

UCLR = D4R UCL = 11.2

= (2.115)(5.3)
= 11.2 pounds Mean = 5.3

LCLR = D3R LCL = 0

= (0)(5.3)
= 0 pounds
 Mean and Range Charts
(a)
These (Sampling mean is
sampling shifting upward but
distributions range is consistent)
result in the
charts below

UCL
(x-chart detects
x-chart shift in central
tendency)
LCL
UCL
(R-chart does not
R-chart detect change in
mean)
LCL
Figure S6.5
 Mean and Range Charts
(b)
These
(Sampling mean is
sampling
constant but
distributions
result in the dispersion is
charts below increasing)

UCL
(x-chart does not
x-chart detect the increase in
dispersion)
LCL
UCL
(R-chart detects
R-chart increase in
dispersion)
LCL
Figure S6.5
Steps In Creating Control Charts
1. Take samples from the population and
compute the appropriate sample statistic
2. Use the sample statistic to calculate control
limits and draw the control chart
3. Plot sample results on the control chart and
determine the state of the process (in or out of
control)
4. Investigate possible assignable causes and
take any indicated actions
5. Continue sampling from the process and reset
the control limits when necessary
 Zones for Pattern Tests
UCL =
3 sigma = x + A2R
Zone A
= 2
2 sigma = x + 3 (A2R)

Zone B
= 1
1 sigma = x + 3 (A2R)
Zone C
Process =
x
average
Zone C
=
1 sigma = x - 1 (A2R)
3
Zone B
=
2 sigma = x - 2 (A2R)
3
Zone A
=
LCL 3 sigma = x - A2R
| | | | | | | | | | | | |
1 2 3 4 5 6 7 8 9 10 11 12 13
Sample number
Copyright 2006 John Wiley
4-39
& Sons, Inc.
 Automated Inspection

 Modern
technologies
allow virtually
100% inspection
at minimal costs
 Not suitable for
all situations
Manual and Automated
Control Charts
¿Qué proceso es mejor?
 Este es nuestro control de proceso
del peso de comprimidos..

Time 1

Time 2

Time 3

Time 4

El proceso está bajo control?

Hay pocas unidades fuera de
especificaciones?
Se puede mejorar?