Introduction of Quality Management Systems course

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Introduction of Quality Management Systems course

© All Rights Reserved

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You are on page 1of 15

SUBJECTS

o Quality in design : description and role of quality in the design stage (for products and services) related to

customers

Practical tools:

- QFD Quality Function Deployment

- FMEACA Failure Mode Effect and Critical Analysis design new products and services taking care

of reliability

o Statistical Process Control: analysis of quality from the production point of view

Major practical tools:

- Control Charts

- Sampling plans

Review in statistic + How to combine probability together

o Performance Indicators

QUALITY

Definition of quality from the Standard ISO 9001 (standard of quality used for assessing and certifying companies and

organisations)

“Quality of a product or service refers to the degree to which the product or service is able to satisfy (stated or

implied) needs.”

Note that needs may be

o IMPLIED : not declared, expectations in the head of customers

In other words, Quality is the degree to which a product/service is conform to its requirements.

Every product posses a number of characteristics that are critical to quality (for the user/consumer):

→ quality characteristics.

e.g.

o duty of batteries

o thickness of the coat of paint

o amount of material in a tube of toothpaste.

Most organizations find it difficult (and expensive) to provide the customer with products that have quality

characteristics, which are always identical from unit to unit.

A quality (or technical) characteristic is a feature of a product that can be critical to quality

e.g.: For a pen: length, quantity of ink, geometrical form of the pen, etc.

It’s impossible to have identical products. differences can be imperceptibles but they exist and they cannot be

removed VARIABILITY

A major reason for this is VARIABILITY:

o if the variation is large, the customer may perceive the unit to be undesirable and unacceptable.

o beyond this, if the variation is large, these units cannot be interchangeable (e.g. problems in the assembly

process).

a large variation can compromised interchangeability (or make it expensive) and esthetical (e.g. lights)

o differences in materials;

o differences in the performance of the manufacturing equipment;

o differences in the way operators perform their tasks.

o Materials

o Machine: manufacturing equipment

o Men: Operators

o Methods

Example: the diameter (D) of a workpiece manufactured hole cannot be identical in all the products

SPECIFICATIONS

o a value of a measurement that corresponds to the desired value is called the NOMINAL (or target) VALUE;

specifications: a quality characteristic that a unit should have and represent a reference

o these values are usually bounded by a range of values that we believe will be sufficiently close to the target

so as to not impact the function or performance of the product if the quality characteristic is in that range.

Specifications are associated with a range (range around the nominal or target value in which the quality characteristic

should be included to be good or conforming to specifications). If technical characteristics are beyond the range, we

will have:

DEFECTIVES or SCRABS or NON CONFORMING (synonyms for units that do not satisfy specifications)

LSL (Lower Specification Limit): the smallest allowable value.

Specification ranges are not always symmetrical. It is also possible to have specifications for only one side (only LSL or

only USL). E.g. level of electricity in a circuit

Specifications can be settled externally by customer according to special requirements or by technicians or engineers.

Requirements should be respected.

Every process is affected by variability as a result of combination of the 3 Ms (or 4 Ms) but assuming that everything is

working correctly (no anomalies and absence of troubles and accidents).

The intrinsic variability of a process is called NATURAL VARIABILITY.

NATURAL VARIABILITY: process tendency towards producing (in normal conditions= absence of anomalies) products

with quality characteristics different from target values.

It depends on the specific products, it is not due to operators or machines or materials or methods.

e.g. length

→ it is an internal characteristic of the process

STATISTICAL PROCESS CONTROL methods (or disciplines) make it possible to control quality characteristics during

production (on-line= during the production), in order to maintain the process under-control (= governed only by

natural variability) and to detect and correct possible abnormalities.

In the presence of failure of accidents the natural variability may change (larger than the natural variability).

When one of the 3Ms factors predominates on the others, the variability can be more affected from the factor that

predominates.

How can we quantify the variability?

In statistics, whenever you need to measure the dispersion or the variability, we use some indicators.

The most common indicators of dispersion is the STANDARD DEVIATION σ.

Other indicators are:

o RANGE : is the difference between the maximum and the minimum observation

o INTERQURTILE RANGE : difference between the third and the first range

o SIMPLE DEVIATION : difference between a value and another one

Using σ we can quantify the variability introducing a new parameter called the NATURAL TOLERANCE.

It is a range that is depicting the natural variability of the process. In other words it is a range in which quality

characteristics realisations of interest are likely to be included.

Natural tolerance (NT) range is a measure of the natural variability of the process.

The process variability is usually measured by the standard deviation (σ).

o Specification range (S) are determined “externally” (usually set by product designers).

A

B

We have 2 examples. In this case we compare the natural tolerance range and the specification range.

In the case A the NT range is larger than the specification range. The example B is the opposite case, in which the NT

range is more narrow than the Specification range.

The example B is the preferred situation because the variability is included within the specification. Apparently, we are

tented to say that all the production output characterised by this NT is inside the specifications range, that all the

product units satisfy specifications. So apparently in this situation there will be no defective elements (or scraps or non-

conforming elements) because the totality of the population is included in the specifications.

The situation A is much worse because the NT is external to the specification range.

For every product quality characteristic (e.g. geometrical dimensions) we define the specification limits (USL, LSL).

It is customary to define the upper and lower natural tolerance limits, say UNTL and LNTL, as 3σ above and below the

process mean.

The formula that link the NT and σ is

NT ≡ 6σ =

Why 6? In this case process is likely to be considered random, so it follow a random distribution. In statistics there are

many random distributions, the most popular is the normal distribution, characterised by the following curve, called

the Gaussian curve. However, there are several other random distributions (e.g. exponential distribution).

Assuming that the quality characteristic of interest is called x and follows approximately a normal distribution with

average µ and variance σ: 𝑥~ℕ(𝜇, 𝜎 2 )

If we define a range around the average value µ (remember that is a symmetrical distribution), the area subtended by

this curve corresponds to the probability of the realisation to be in a specific region.

Remember that the total area subtended by the Gaussian curve is 1 and the domain of the Normal distribution is

stated by the maximum and minimum values that x can assumed that is respectively +∞ and −∞.

This is due to the fact that – for a normal distribution – these limits include 99.73% of the process output.

PDF Probability Density Function of the normal distribution:

In order to identify a range with a very high probability of including realisation of quality characteristic of interest.

Very high does not means 100%, still that can be realisations plotting beyond the Lower Natural Tolerance Limit or

can be above the Upper Natural Tolerance Limit.

Therefore, the previous example B is only apparently without any defects. The complementary probability is 1 −

0.9973 … ≅ 0.27 = 𝛼 (negligible but not zero)

It is the probability that even though the process is governed by natural variability the probability that the value of

the quality characteristic is external with expect to the entire range is very small but larger than zero.

We cannot use the same for other distribution.

For other distributions (for example the exponential), the 6σ interval does not necessarily include 99.73% of the

process output (population).

1

𝜇=𝜎= 𝑖𝑛𝑑𝑖𝑟𝑒𝑐𝑡 𝑝𝑟𝑜𝑝𝑜𝑟𝑡𝑖𝑜𝑛𝑖𝑡𝑦

𝜆

Remember that the distribution is not defined for negative value

𝜇+3𝜎

∫ 𝒻(𝑥)𝑑𝑥

𝜇−3𝜎

assuming µ=σ

4𝜎 4𝜎

4𝜎

∫ 𝒻(𝑥)𝑑𝑥 = ∫ 𝜆𝑒 −𝜆𝑥 = [−𝑒 −𝜆𝑥 ]0

0 0

1

𝑝𝑜𝑖𝑐ℎè 𝜆 =

𝜎

1 4𝜎

− 𝑥

= [−𝑒 𝜎 ] = −𝑒 −4 + 𝑒 0 = 1 − 𝑒 −4 ≅ 0.98

0

Note that 0.98 differs from 0.9973… obtained using Normal distribution.

Therefore, the conventional way 𝑁𝑇 ≡ 6𝜎 is valid until the distribution is normal.

Homework:

Calculate the natural tolerance range for exponential distribution to get the probability 99.73%.

(for sure the number will be longer than 4σ).

Returning to the concept of NATURAL VARIABILITY, natural means that the process is not affected by accidents or

anomalies so it reflects the natural behaviour and potential of the process. When a process is governed by its NT

only, it is likely to follow a generic RANDOM distribution. When a process is RANDOM, typical pattern is the so

called WHITE NOISE (used to heart control) used to indicate the natural alternation of a quality characteristic

around certain value, generally the AVERAGE value. In the example, we are chronologically plotting the evolution

of a process measuring the quality characteristic of some elements, for example we have a collection of pens

produced and we periodically measure the length (characteristic of interest x). If the process is governed by NT, we

have a natural alternation around the average value. This is the typical pattern for Random distribution, not only

Normal distribution.

A process operating with only chance causes of variation (not other assignable causes) generally shows a random

pattern (also defined as white noise).

typically it follows a NORMAL DISTRIBUTION

Example: non random pattern (RUN), due to the presence of assignable causes (e.g. thermal expansion, tool wear…)

Apparently, there is a natural random alternation. However, you can see in the background an increasing trend. It is

typical in start-up. This is not a random pattern because the alternation is around an increasing or decreasing value.

The name of this pattern is SHIFT or DRIFT or RUN because the tendency is gradually shifting.

Example: non random pattern, due to the presence of two points related to assignable causes (e.g. failures in the

process)

Apparently, we have a natural alternation around this abnormal point that is much higher. This point in statistic is

called OUTLIER that can be due to anomalies in the sources of variability e.g. failure in the machining equipment that

produces 2 pieces to make a geometrical form instead of the normal.

Another NON random pattern can be the PERIODICAL behaviour like a sinusoid behaviour. e.g. the production is

affected by the temperature conditions of the external environment. For example assuming that the isolation of the

plant is not perfect, the warming conditions are affected by the external temperature that is smaller in the morning, it

tends to rise during the day and then it goes down in the evening.

In a NON RANDOM pattern the value of one point is not affected by the value of the previous or the next one, so they

are independent from each other.

The specifications on an electronic component in a target-acquisition-system are that its life must be between 5000

and 10000 h. The life is normally distributed with mean 7500 h. The manufacturer realizes a price of $10 per unit

produced; however, defective units must be replaced at a cost of $5 to the manufacturer. Two different manufacturing

processes can be used, both of which have the same mean life. However, the standard deviation of life for process 1 is

1000 h , whereas for process 2 it is only 500 h. Production costs for process 2 are twice those for process 1. What value

of production costs will determine the selection between processes 1 and 2?

To calculate the natural tolerance NT ≡ 6σ, we should know the standard deviation (σ) of the population.

µ and σ are unknown parameters that should be estimated.

σ can be estimated by using the sample standard deviations (s) or the sample ranges (R), related to several samples

extracted from the population.

Example: m samples are extracted from the population; each sample is made of n observations

In the following we will see how.

What is the NT of a product made up of different parts, each of those having its own NT?

Example: I = A + B + C

(dimensional quality characteristics of 3 components assembled together)

A way to estimate I is empirical (take measure of I components)-> based on observation (direct way). However, it

requires labour-> time consuming and expensive.

The same information can be reached in another way.

Assuming that we already determined A, B, and C (independent variables->they are independent from each other)

I=A+B+C ADDITIVE METHOD

The variability of the 3 parts is different. Fluctuations in one part does not affects the others.

Example with 2 variables:

𝑍 =𝑎∙𝑋+𝑏∙𝑌

Model that allows to find NT

Example: I = A + B + C

(dimensional quality characteristics of 3 components assembled together)

Probabilistic method:

If the different quality characteristics (A, B, C) are statistically independent (the occurrence of one event occurs does

not affect the outcome of the occurrence of the other event) and normally distributed, then we can use the following

formula:

The average value of product I is given by the sum of A, B and C average values → I = 1.000+0.500+2.000 = 3.500 cm

But how to calculate the NT of product I? A possible way is to use an Additive method:

EXAMPLE

Assuming that a chain is made of 100 chainrings, the chain average length is given by:

Additive method: If we calculate σchain adding up the single st. deviations, we obtain:

Probabilistic method: σchain can be correctly calculated by applying the following formula (probabilistic method)

The lengths of the parts can be assumed independent. When the process is operating in regular conditions, the length

of one part is not influenced by the length of the previous

…Let notice that – in this case – the global variability (σchain) is much lower than in the previous one. This is due to

a sort of compensation among the variations in the parts assembled together.

If X and Y are not statistically independent, all the previous equations are not valid. Additional terms should be

introduced (COVARIANCES).

EXAMPLE

A shaft is to be assembled into a bearing. The internal diameter of the bearing is a normal random variable – say

x1 – with mean μ1=1.500 inches and standard deviation σ1=0.002 inches. The external diameter of the shaft – say

x2 – is normally distributed with mean μ2=1.480 inches and standard deviation σ2=0.004 inches. When the two

parts are assembled, interference will occur if the shaft diameter is larger than the bearing diameter – that is, if:

Often, the overall NT of a component is assigned and it is necessary to define the NT of the single parts, in order

to satisfy it.

o Example: I = A + B + C

(dimensional quality characteristics of 3 parts assembled together)

A) 1.000 ± ??? cm

B) 0.500 ± ??? cm

C) 2.000 ± ??? cm

Assuming NTI = 0.0035 cm, how to split it among NTA, NTB, NTC?

1) Depending on the production constraints: for some processes it is more difficult (or expensive) to achieve

narrow tolerances than for others.

2) In the absence of particular reasons, NTI can be uniformly split up among NTA, NTB, NTC.

If we calculate the NT of the parts, by considering the sum of their values (additive method):

However, calculating the NT of the parts using the first (probabilistic) method, entails the risk of producing (a

small portion of) assembled components out of natural tolerance limits.

… Probabilistic method is based on an implicit hypothesis of compensation

Example: if for every part we consider its lower limit value:

… in this case the assembled component length would be BELOW its LNTL.

… let remember that if the distributions of independent variables (A, B and C) are normal, also the dependent

variable (I) is normal. In this case we implicitly assumed A, B and C to be normal.

o In other terms, since NTI = ±3·σI, the probability of assembling components outside the natural tolerance

limits is almost 0.3%.

we have σI = 0.00116 cm

Hypothesis: considering the distribution of I as normal, the probability of assembling components out of NT limits,

below the LNTLI, is given by:

The same goes for the probability of assembling components above the UNTLI.

To simplify, we assume:

Consequently:

Anyway, let notice that the probabilistic method - even under conditions of normal variability - entails a 0.3% risk of

producing assembled components out of NT limits.

assumptions:

o statistical independence of the quality characteristics (we intuitively mean that knowing something about the

value of one of them does not yield any information about the value of the other)

So far, we have been considering linear functions only (among the assembled component and the parts).

In some problems, the dimension of interest may be a nonlinear function of the part dimensions (x1, x2, … , xn)

For non linear functions, what is the relationship among variances?

Considering a first order Taylor series (truncated) development of the previous function, in the neighbourhood of the

mean values of the parts:

In order to develop the function, we implicitly assumed that:

o it should be derivable

o it should be continuos in the neighborhood of the point

o statistical independence of the quality characteristics (we intuitively mean that knowing something about the

value of one of them does not yield any information about the value of the others)

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