design of quality management system.docx

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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 nonecessity 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 Policy2. Quality Objectives3. Quality Manual4. Organizational structure and Responsibilities5. Data Management6. Processes - including purchasing7. Resources - including natural resources and human capital8. Product Quality leading to Customer satisfaction9. Continuous Improvement including Corrective and preventive action10.Maintenance11.Sustainability - including efficient resource use and responsible environmental operations12.Transparency and independence audit13.Engineering Change Control

NEED FORQUALITY MANAGEMENT SYSTEM:


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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 implementedworldwide - 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 9000is 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

d d i b d ISO 9001 d l i h h i h i i i hi


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t d d i b d ISO 9001 d l ith th i t th t i ti i hi t t

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 thehanding of conforming and nonconforming outputs.

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

Review: Analysis and evaluation of the results of measurement, determination of performanceagainst objectives and determination of changes needed to policies, objectives, measures, targetsand 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). Hoylesuggests 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


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there is no conflict but ISO 9001 does not include requirements on results orientation and public


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Cause-and-effect diagram(also called Ishikawa or fishbone chart): Identifies manypossible causes for an effect or problem and sorts ideas into useful categories.

Check sheet:A structured, prepared form for collecting and analyzing data; a generictool 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 arelationship.

Stratification:A technique that separates data gathered from a variety of sources so thatpatterns 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 anelimination) 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 producethe 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


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3. Monitoring the ongoing production process, assisted by the use of control charts, todetect 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 stableprocess 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 ofvariation 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 analysisCause & effect diagrams

Pareto analysis


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Pareto analysis

Bar charts

Scatter diagrams

Matrix analysis

Histogram

DRIVEis an approach to problem solving and analysis that can be used as part of process

improvement.

Definethe scope of the problem the criteria by which success will be measured and agree the

deliverables and success factors

Reviewthe current situation, understand the background, identify and collect information,

including performance, identify problem areas, improvements and quick wins

Identifyimprovements or solutions to the problem, required changes to enable and

Sustain the improvements

Verifycheck that the improvements will bring about benefits that meet the defined

Success criteria prioritize and pilot the improvements

Executeplan 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 orIshikawa Diagram. It is also a useful technique for opening up

thinking in problem solving.


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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:

Itcan 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.


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p g g


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Control the future state process to ensure that any deviations from the target are correctedbefore 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 SixSigma"),features five phases:

Define design goals that are consistent with customer demands and the enterprisestrategy.

Measure and identify CTQs (characteristics that are Critical To Quality), productcapabilities, 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).


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