DESIGN OF QUALITY MANAGEMENT SYSTEM

The FDA has identified in the QS regulation the essential elements that a quality system shall
embody for design, production and distribution, without prescribing specific ways to establish
these elements. These elements include:
personnel training and qualification
controlling the product design
controlling documentation
controlling purchasing
product identification and traceability at all stages of production
controlling and defining production and process
defining and controlling inspection, measuring and test equipment
validating processes
product acceptance
controlling nonconforming product
instituting corrective and preventive action when errors occur
labeling and packaging controls
handling, storage, distribution and installation
records
servicing
statistical techniques
All over seen by management and quality audits,
Because the QS regulation covers a broad spectrum of devices and production processes, it
allows some leeway in the details of quality system elements. It is left to manufacturers to
determine the necessity for, or extent of, some quality elements and to develop and implement
procedures tailored to their particular processes and devices. For example, if it is impossible to
mix up labels at a manufacturer because there is only one label to each product, then there is no
necessity for the manufacturer to comply with all of the GMP requirements under device
labeling.
QUALITY MANAGEMENT SYSTEM REQUIREMENTS:
Elements of a Quality Management Systems are,
1. Quality Policy
2. Quality Objectives
3. Quality Manual
4. Organizational structure and Responsibilities
5. Data Management
6. Processes - including purchasing
7. Resources - including natural resources and human capital
8. Product Quality leading to Customer satisfaction
9. Continuous Improvement including Corrective and preventive action
10. Maintenance
11. Sustainability - including efficient resource use and responsible environmental operations
12. Transparency and independence audit
13. Engineering Change Control
NEED FOR QUALITY MANAGEMENT SYSTEM:
A quality management system (QMS) is a collection of business processes focused on
achieving your quality policy and quality objectives i.e. what your customer wants and
needs. It is expressed as the organizational structure, policies, procedures, processes and
resources needed to implement quality management. Early systems emphasized predictable
outcomes of an industrial product production line, using simple statistics and random
sampling. By the 20th century, labor inputs were typically the most costly inputs in most
industrialized societies, so focus shifted to team cooperation and dynamics, especially the
early signaling of problems via a continuous improvement cycle. In the 21st century, QMS
has tended to converge with sustainability and transparency initiatives, as both investor and
customer satisfaction and perceived quality is increasingly tied to these factors. Of all QMS
regimes, the ISO 9000 family of standards is probably the most widely implemented
worldwide - the ISO 19011 audit regime applies to both, and deals with quality and
sustainability and their integration.
Other QMS, e.g. Natural Step, focus on sustainability issues and assume that other
quality problems will be reduced as result of the systematic thinking, transparency,
documentation and diagnostic discipline that sustainability focus implies. See sustainability
for more on this approach to quality management.

ISO 9001 AND QUALITY MANAGEMENT SYSTEM PROCESS
ISO 9000 is a series of standards, developed and published by the International
Organization for Standardization (ISO), that define, establish, and maintain a quality
assurance system for manufacturing and service industries. The standards are available
through national standards bodies. ISO 9000 deals with the fundamentals of quality
management systems, including the eight management principles upon which the family of
standards is based.ISO 9001 deals with the requirements that organizations wishing to meet
the standard must fulfill.
A QMS process is an element of an organizational QMS. The ISO9001:2000 standard
requires organizations seeking compliance or certification to define the processes which form
the QMS and the sequence and interaction of these processes. Butterworth-Heinemann and
other publishers have offered several books which provide step-by-step guides to whom
seeking the quality certifications of their products.
Examples of such processes include:
Order Processing
Production Planning
Measurement of product/ service/ process compliant with specified requirements
including statistical techniques such as Statistical Process Control and Measurement
Systems Analysis
Calibration
Internal Audit
Corrective Action
Preventive Action
Identification, labeling and control of non conforming product to preclude its
inadvertent use, delivery or processing.
Purchasing and related processes such as supplier selection and monitoring
ISO9001 requires that the performance of these processes be measured, analyzed and
continually improved, and the results of this form an input into the management review
process.
PRINCIPLE REQUIREMENTS
Although the management system standards developed at different times, they have matured
over the last 8 years and we can now see common features in the requirements even though they
are not structured identically as yet. The requirements in general address:
Policy: Defining, documenting, maintaining and communicating overall intentions relative to an
aspect of organizational performance. Eg., quality, environment, profit and safety.
Planning: Establishing objectives, measures and targets for fulfilling the policies, assessing risks
and developing plans and processes for achieving the objectives that take due account of these
risks.
Implementation: Resourcing, operating and controlling the processes as planned, including the
handing of conforming and nonconforming outputs.

Measurement Monitoring, measuring and auditing processes, the fulfillment of objectives and
policies and satisfaction of stakeholders.

Review: Analysis and evaluation of the results of measurement, determination of performance
against objectives and determination of changes needed to policies, objectives, measures, targets
and processes for the continuing suitability, adequacy and effectiveness of the system.
How do these requirements relate to other models?
All the principles of the quality management system standards can be related to the principles
and concepts within the European excellence model (see Excellence models and awards). Hoyle
suggests in Quality Management Essentials that depending on the meaning of the words used
there is no conflict but ISO 9001 does not include requirements on results orientation and public
responsibility.
How should these standards be used?
An organization has many stakeholders (see Stakeholders) and delivers outputs than are in the
main intended to satisfy these stakeholders. The management system standards serve the
achievement, control, assurance and improvement of stakeholder requirements and their
applicability to the various stakeholders is shown in the table below:


There are three ways of using these standards.
As a source of information on best practice that can be consulted to identify opportunities for
improvement in business performance
As a set of requirements that are implemented by the organization
As criteria for assessing the capability of a management system or any of its component parts.
IMPLEMENTING ISO OFTEN GIVES THE FOLLOWING ADVANTAGES:
1. Creates a more efficient, effective operation
2. Increases customer satisfaction and retention
3. Reduces audits
4. Enhances marketing
5. Improves employee motivation, awareness, and morale
6. Promotes international trade
7. Increases profit
8. Reduces waste and increases productivity
BASIC QUALITY ENGINEERING TOOLS
The Old Seven OR The First Seven OR The Basic Seven
Start your quality journey by mastering these tools,
Cause-and-effect diagram (also called Ishikawa or fishbone chart): Identifies many
possible causes for an effect or problem and sorts ideas into useful categories.
Check sheet: A structured, prepared form for collecting and analyzing data; a generic
tool that can be adapted for a wide variety of purposes.
Control charts: Graphs used to study how a process changes over time.
Histogram: The most commonly used graph for showing frequency distributions, or how
often each different value in a set of data occurs.
Pareto chart: Shows on a bar graph which factors are more significant.
Scatter diagram: Graphs pairs of numerical data, one variable on each axis, to look for a
relationship.
Stratification: A technique that separates data gathered from a variety of sources so that
patterns can be seen (some lists replace stratification with flowchart or run chart).
STATISTICAL PROCESS CONTROL
Statistical process control (SPC) is a method of quality control which uses statistical
methods. SPC is applied in order to monitor and control a process. Monitoring and
controlling the process ensures that it operates at its full potential. At its full potential, the
process can make as much conforming product as possible with a minimum (if not an
elimination) of waste (rework or Scrap). SPC can be applied to any process where the
"conforming product" (product meeting specifications) output can be measured. Key tools
used in SPC include control charts; a focus on continuous improvement; and the design of
experiments. An example of a process where SPC is applied in manufacturing lines,
OBJECTIVE ANALYSIS OF VARIATION
SPC must be practiced in 2 phases: The first phase is the initial establishment of the
process, and the second phase is the regular production use of the process. In the second phase,
we need to decide the period to be examined, depending upon the change in 4-M conditions
(Man, Machine, Material, Method) and wear rate of parts used in the manufacturing process
(machine parts, Jigs and fixture and tooling standard).
EMPHASIS ON EARLY DETECTION
An advantage of SPC over other methods of quality control, such as "inspection", is that
it emphasizes early detection and prevention of problems, rather than the correction of problems
after they have occurred.
INCREASING RATE OF PRODUCTION
In addition to reducing waste, SPC can lead to a reduction in the time required to produce
the product. SPC makes it less likely the finished product will need to be reworked. SPC may
also identify bottlenecks, waiting times, and other sources of delays within the process.
LIMITATIONS
SPC is applied to reduce or eliminate process waste. This, in turn, eliminates the need for
the process step of post-manufacture inspection. The success of SPC relies not only on the skill
with which it is applied, but also on how suitable or amenable the process is to SPC. In some
cases, it may be difficult to judge when the application of SPC is appropriate.
APPLICATION OF SPC
The application of SPC involves three main phases of activity:
1. Understanding the process and the specification limits.
2. Eliminating assignable (special) sources of variation, so that the process is stable.
3. Monitoring the ongoing production process, assisted by the use of control charts, to
detect significant changes of mean or variation.
CONTROL CHARTS
The most common method of statistical process control is to take samples at regular
intervals and to plot the sample mean on a control chart.


If the sample mean lies within the warning limits (as point (1)) the process is assumed to
be on target. If it lies outside the action Limits (as point (2) the process is off target and the
machine must be reset or other action taken. If the mean is between the warning and action limits
(as point (3)) this is a signal that the process may be off target. In this case another sample is
taken immediately. If the mean is still outside the warning limits action is taken. If however the
second sample mean is within the warning limits production is assumed to be on target.

STABLE PROCESS
When the process does not trigger any of the control chart "detection rules" for the
control chart, it is said to be "stable". A process capability analysis may be performed on a stable
process to predict the ability of the process to produce "conforming product" in the future.
EXCESSIVE VARIATION
When the process triggers any of the control chart "detection rules", (or alternatively, the
process capability is low), other activities may be performed to identify the source of the
excessive variation. The tools used in these extra activities include: Ishikawa diagrams, designed
experiments, and Pareto charts. Designed experiments are a means of objectively quantifying the
relative importance (strength) of sources of variation. Once the sources of variation have been
quantified, actions may be taken to reduce or eliminate them. Methods of eliminating a source of
variation might include: development of standards; staff training; error-proofing and changes to
the process itself or its inputs.
TECHNIQUES FOR PROCESS DESIGN AND IMPROVEMENT:
The tools and techniques most commonly used in process improvement are:

Problem solving methodology, such as DRIVE
Process mapping
Process flowcharting
Force field analysis
Cause & effect diagrams
Pareto analysis
Statistical process control (SPC)
Control charts
Check sheets
Bar charts
Scatter diagrams
Matrix analysis
Histogram

DRIVE is an approach to problem solving and analysis that can be used as part of process
improvement.

Define the scope of the problem the criteria by which success will be measured and agree the
deliverables and success factors

Review the current situation, understand the background, identify and collect information,
including performance, identify problem areas, improvements and quick wins

Identify improvements or solutions to the problem, required changes to enable and
Sustain the improvements

Verify check that the improvements will bring about benefits that meet the defined
Success criteria prioritize and pilot the improvements

Execute plan the implementation of the solutions and improvements, agree and implement
them, plan a review, gather feedback and review

FORCE FIELD ANALYSIS:
It is a technique for identifying forces which may help or hinder achieving a change or
improvement. By assessing the forces that prevent making the change, plans can be developed to
overcome them. It is also important to identify those forces that will help with the change. Once
these forces have been identified and analyzed, it is possible to determine if a proposed change is
viable.
Driving force Restrainig force













CAUSE & EFFECT DIAGRAM

A useful way of mapping the inputs that effect quality is the Cause & Effect Diagram, also
know as the Fishbone or Ishikawa Diagram. It is also a useful technique for opening up
thinking in problem solving.













PROBLEM

OR

EFFECTS




FACTORS OR CONCERNS

The effect or problem being investigated is shown at the end of a horizontal arrow; potential
causes are then shown as labeled arrows entering the main cause arrow. Each arrow may have
other arrows entering it as the principal causes or factors are reduced to their sub-causes;
brainstorming can be effectively used to generate the causes and sub-causes.

PARETO ANALYSIS:
It can be used to analyze the ideas from a brainstorming session. It is used to identify the
vital few problems or causes of problems that have the greatest impact. A Pareto diagram or
chart pictorially represents data in the form of a ranked bar chart that shows the frequency of
occurrence of items in descending order. Usually, Pareto diagrams reveal that 80% of the effect
is attributed to 20% of the causes; hence, it is some-times known as the 80/20 rule.





CONTROL CHART:
One of the key tools of SPC is a Control Chart. It is used to monitor processes that are in
control, using means and ranges. It represents data, Eg, sales, volume, customer complaints, in
chronological order, showing how the values change with time. In a control chart each point is
given individual significance and is joined to its neighbors. Above and below the mean, Upper
and Lower Warning and Action lines (UWL, LWL, UAL, LAL) are drawn. These act as signals
or decision rules, and give operators information about the process and its state of control. The
charts are useful as a historical record of the process as it happens, and as an aid to detecting and
predicting change.





UAL

UWL

MEAN

LWL

LAL

TAGUCHI METHODS FOR PROCESS IMPROVEMENT:
Japanese: are statistical methods developed by Genichi Taguchi to improve the quality of
manufactured goods, and more recently also applied to engineering,

biotechnology, marketing
and advertising. Professional statisticians have welcomed the goals and improvements brought
about by Taguchi methods, particularly by Taguchi's development of designs for studying
variation, but have criticized the inefficiency of some of Taguchi's proposals.
Taguchi's work includes three principal contributions to statistics:
A specific loss function
The philosophy of off-line quality control; and
Innovations in the design of experiments.
Among the above three methods, the second and third will be much better for manufacturing
purposes.
OFF-LINE QUALITY CONTROL:
Taguchi's rule for manufacturing
Taguchi realized that the best opportunity to eliminate variation is during the design of a product
and its manufacturing process. Consequently, he developed a strategy for quality engineering
that can be used in both contexts. The process has three stages:
System design
Parameter (measure) design
Tolerance design
System design: This is design at the conceptual level, involving creativity and innovation.
Parameter design: Once the concept is established, the nominal values of the various
dimensions and design parameters need to be set, the detail design phase of conventional
engineering. Taguchi's radical insight was that the exact choice of values required is under-
specified by the performance requirements of the system. In many circumstances, this allows the
parameters to be chosen so as to minimize the effects on performance arising from variation in
manufacture, environment and cumulative damage. This is sometimes called
robustification.Robust parameter designs consider controllable and uncontrollable noise
variables; they seek to exploit relationships and optimize settings that minimize the effects of the
noise variables.
Tolerance design:With a successfully completed parameter design, and an understanding of the
effect that the various parameters have on performance, resources can be focused on reducing
and controlling variation in the critical few dimensions.

DESIGN OF EXPERIMENTS:
Taguchi developed his experimental theories independently. Taguchi read works following R. A.
Fisher only in 1954. Taguchi's framework for design of experiments is idiosyncratic and often
flawed, but contains much that is of enormous value. He made a number of innovations.
Outer arrays: Taguchi's designs aimed to allow greater understanding of variation than did
many of the traditional designs from the analysis of variance (following Fisher). Taguchi
contended that conventional sampling is inadequate here as there is no way of obtaining a
random sample of future conditions.

In Fisher's design of experiments and analysis of variance,
experiments aim to reduce the influence of nuisance factors to allow comparisons of the mean
treatment-effects. Variation becomes even more central in Taguchi's thinking.
Taguchi proposed extending each experiment with an "outer array" (possibly an
orthogonal array); the "outer array" should simulate the random environment in which the
product would function. This is an example of judgmental sampling. Many quality specialists
have been using "outer arrays".
Later innovations in outer arrays resulted in "compounded noise." This involves
combining a few noise factors to create two levels in the outer array: First, noise factors that
drive output lower, and second, noise factors that drive output higher. "Compounded noise"
simulates the extremes of noise variation but uses fewer experimental runs than would previous
Taguchi designs.
SIX SIGMA:

The term Six Sigma originated from terminology associated with manufacturing, specifically
terms associated with statistical modeling of manufacturing processes. The maturity of a
manufacturing process can be described by a sigma rating indicating its yield or the percentage
of defect-free products it creates. A six sigma process is one in which 99.99966% of the products
manufactured are statistically expected to be free of defects (3.4 defective parts/million),
although, as discussed below, this defect level corresponds to only a 4.5 sigma level. Motorola
set a goal of "six sigma" for all of its manufacturing operations, and this goal became a by-word
for the management and engineering practices used to achieve it.

METHODOLOGIES:
Six Sigma projects follow two project methodologies inspired by Deming's Plan-Do-Check-Act
Cycle. These methodologies, composed of five phases each, bear the acronyms DMAIC and
DMADV.
DMAIC is used for projects aimed at improving an existing business process.
DMADV is used for projects aimed at creating new product or process designs.
DMAIC
The DMAIC project methodology has five phases:
Define the system, the voice of the customer and their requirements, and the project
goals, specifically.
Measure key aspects of the current process and collect relevant data.
Analyze the data to investigate and verify cause-and-effect relationships. Determine what
the relationships are, and attempt to ensure that all factors have been considered. Seek
out root cause of the defect under investigation.
Improve or optimize the current process based upon data analysis using techniques such
as design of experiments, poka yoke or mistake proofing, and standard work to create a
new, future state process. Set up pilot runs to establish process capability.
Control the future state process to ensure that any deviations from the target are corrected
before they result in defects. Implement control systems such as statistical process
control, production boards, visual workplaces, and continuously monitor the process.
Some organizations add a Recognize step at the beginning, which is to recognize the right
problem to work on, thus yielding an RDMAIC methodology.
DMADV or DFSS: The DMADV project methodology, known as DFSS ("Design For Six
Sigma"),

features five phases:
Define design goals that are consistent with customer demands and the enterprise
strategy.
Measure and identify CTQs (characteristics that are Critical To Quality), product
capabilities, production process capability, and risks.
Analyze to develop and design alternatives
Design an improved alternative, best suited per analysis in the previous step
Verify the design, set up pilot runs, implement the production process and hand it over to
the process owner(s).