What is quality?

Definition
A degree of excellence (Oxford) Fitness for purpose (Defoe & Juran, 2010) The totality of features & characteristics that bear on the ability of a product/ services to satisfy a given need (BS 4787) Conformance to requirement (Croby 1979) Degree to which a set of inherent characteristics fulfils requirements (ISO 9001: 2007) Quality poor, good, excellent Inherent >< assigned (permanent ><given characteristics) Requirement: Need or expectation that is stated, generally implied or obligatory
Generally implied: custom/common practice of org, customer, interested parties Obligation: explicitly stated in document

Characteristics: inherent or assigned A characteristic: qualitative / quantitative Various classes:

Physical: mechanical, electrical, chemical ... Sensory: smell, touch, taste, hearing Behavioral: honesty, courtesy Temporal: availability, punctuality, reliability Functional: speed of aircraft

Degree grade Category or rank of given to different quality requirement for product, process, system having the same functional use
Ex: Air ticket Hotel

Note: when establishing a quality requirement, the grade is generally specified

Other definition
Product: result of a process Process: set of interrelated or interacting activities which transform inputs to outputs

QUALITY: customer + technical perspective Customer:

Economic Artistic Personality Comfortable

Technical
Functionality Durability Reliability

Definition
Defined by customers Associated with creating value for customers Changed over time Meets or exceed customer expectation, some are unspoken A complex concept => all work together

History & background

Mid 18th century 1920s: Inspection 1920s 1950s: Quality control 1950s 1970s: Quality assurance 1970s present: Quality management

Principles: customer focus

Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations. Who are our customers? Organization or person that receives a product Internal customer External customer ...Depend on customers Buy your products Generate revenue Along with you, generate products Indirectly change your business activities Decide orgs success Customer is the only boss who has the right to dismiss employees and managers, even liquidate the company by spending money in other places

Customer satisfaction: Customer's perception of the degree to which the customer's requirements have been fulfilled Customer complaints are a common indicator of low customer satisfaction Does their absence necessarily imply high customer satisfaction? If customer requirements have

Been fulfilled, does this necessarily ensure high customer satisfaction?

15-40% satisfied customers still move to buy products from your competitors The cost to attract a new customers is 5-7 times to the cost to retain an existing one 98% unsatisfied customers dont complaint but move to by products from your competitors

Importance of Voice of Customers VOC Collective insight into customer needs, wants, perceptions, and preferences gained through direct and indirect questioning. These discoveries are translated into meaningful objectives that help in closing the gap between customer expectations and the firm's offerings.

CTC: Critical To Customer

Measurable standards of performance for a product that are essential in order to meet the requirements of the customer. Critical to customer elements are targeted for process improvement initiatives in order to identify ways to improve business or manufacturing processes.

2. Leadership
Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization's objectives To show strong commitment to quality
Communicating the importance of meeting customer needs & regulation Establishing quality policy Ensuring quality objectives established Conducting management review Ensuring the availability of resources

LEADER: 1. Do a job 2. supervise a group of people 3. Manage a group of people 4. Ensure all employees are satisfied 5. Involve people to meet org. objectives

3. Involvement of people
People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization's benefit

4. Process approach
A desired result is achieved more efficiently when activities and related resources are managed as a process.

Inputs -> Process-> Outputs

5. System approach
Identifying, understanding and managing interrelated processes as a system contributes to the organization's effectiveness and efficiency in achieving its objectives

6. Continual improvement
Continual improvement of the organisations overall performance should be a permanent objective

Things need to improve continuously:

P: Production capacity Q: Quality C: Cost D: Delivery timing S: Safety M: Morale
PQCDSM of TODAY is better than YESTERDAY, TOMORROW is better than TODAY

7. Factual approach
Effective decision makings are based on the analysis of data and information

8. Mutual benefit with suppliers

An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value

Understanding QM
1. Customer focus 2. Leadership focus 3. People focus 4. Process focus 5. System focus 6. Continuous improvement focus 7. factual focus 8. Relationship focus 9. Strategic focus

What is wrong with traditional approach? 1. Lack of leadership 2. Short-term focus 3. Lack of customer focus 4. Cost/quality trade off 5. Lack of system thinking 6. Human resource mentality

Chapter 2: Models in Quality Management

Cost of quality
Cost of quality = cost of control (cost of conformance) + cost of failure of control (cost of non-conformance) Cost of control: Preventing cost: arise from efforts to keep defects from occurring at all Ex: Quality planning/Statistical process control/Quality training and workforce development/product design verification/market research Appraisal cost: arise from detecting defects via test audits inspection Ex:Tests and inspection of purchase materials/Inspection/Testing/Quality audit

Cost of failure of control: Internal failure cost: arise from defects caught internally and dealt with by discarding or repairing the affect items Ex: Scrap/Rework costs/Management of the rework systems/Rejection paperwork External failure costs:arise from defect that actually reach final customer Ex: Warranty cost/Out of warranty complain/Products recall/Products liability claim/loss of customers goodwill.

PDCA cycle
Plan Do Establish objectives and how they will be achieve Put the plan into effect

Check Action

Verify that the process achieved the desired results /Analyse any differences and their causes Take action to improve things

(It is an iterative process so repeat to continue achieving improvement)

Q-Base system
For SME with lack of resources to implement fully ISO 9001, Telarc Q-Base provides an excellent alternative. Q-Base Code is based upon the ISO 9001. It enables you to implement basic management disciplines to assure quality of products and services.
Requirement

< 10 employees Rarely employ staff who are quality management professionals. Are managed by the owner who has a strong hands-on role and spends afterhours on paperwork. Work on low profit margins Rarely have a documented system and procedures manual.

Q-Base system: clauses

Management of the quality system Control of documents and records Customers' needs Purchasing Training and work instructions Inspecting and control of substandard work Continual Improvements Association, Industry or other criteria

GMP:Good Manufacturing Practice

GMP ensures that quality is built into the organization & processes involved in manufacture GMP covers all aspects of manufacture including collection, transportation, processing, storage, QC & delivery of the finished product

Part of QA(quality assurance) which ensures that products are consistently produced & controlled to the quality standards appropriate to their use. GMP is an integral part of QA.
GMP in solid dosage forms GMP in semisolid dosage forms GMP in Liquid orals GMP in Parenterals Production GMP in Ayurvedic medicines GMP in Biotechnological products GMP in Nutraceuticals & cosmeceuticals GMP in Homeopathic medicines

Good Manufacturing Practice Good Management Practice Get More Profit Give more Production GMP Training with out tears

Ten Principles of GMP

1.Design & construct the facilities & equipments properly 2.Follow written procedures & Instructions 3.Document work 4.Validate work 5.Monitor facilities & equipment 6.Write step by step operating procedures & work on

instructions
7.Design, develop & demonstrate job competence 8.Protect against contamination 9.Control components & product related processes 10. Conduct planned & periodic audits

Beyond GMP
Reduce pollution - Zero discharge Adaptation of environment friendly methods Consideration for better & healthier life tomorrow Consideration of ethics in life One should begin with end in mind otherwise it will be the beginning of the end

PERSONNEL
Adequate staff with relevant knowledge, experience and capabilities in assigned task a. Production and QC are headed by different persons, neither of whom shall be responsible to the other b. Responsibilities and authority of key personnel are clearly defined c. Training on the understanding of procedures, work instruction, GMP principles, etc.

3 Key Personnel
The head of production The head of QC The head of QM (QA)

The head of production

Should be a qualified pharmacist, adequately trained, possess good practical experience in pharmaceutical manufacture & managerial skill. Should have full authority & responsibility to manage production of pharmaceutical products.

The head of QC

The head of QC should be a qualified pharmacist, have adequate training & practical experiences which enable him/her to perform him/her function personally. The head of QC should given full authority & responsibility in all QC duties.

The head of QM (QA)

The head of QM (QA) should be a qualified pharmacist, have adequate training & practical experiences which enable him/her to perform him/her function personally. The head of QM (QA) should given full authority & responsibility in all quality system/assurance duties.

PREMISES
Specify the requirements of location, design , constructions and maintenance of manufacturing premises with respect to the following: a. prevention of contamination from surrounding environment and pests b. prevention of mix up of materials and products c. facilities such as toilet, changing rooms, sampling areas and QC lab d. defined areas for certain activities e. wall, ceiling, drains , air intake and exhaust, lighting and ventilation, pipe work and light fitting f. storage areas

Suitable location, design , constructions and maintenance for manufacturing premises : defined areas for certain activities (e.g material sampling & dispensing) wall, ceiling,
drains , air intake and exhaust, lighting and ventilation, pipe work and light fitting storage areas of adequate space. Physical separation of toilets and QC lab from production

Building & facilities

Design and construction features. Lighting. Ventilation, air filtration, air heating and cooling. Plumbing. Sewage and refuse. Washing and toilet facilities. Sanitation. Maintenance.

Design and Construction Features

Any building or buildings used in the manufacture, processing, packing, or holding of a drug product shall be of suitable size, construction, and location to facilitate cleaning, maintenance, and proper operation.

Product Areas
Premises should preferably be laid out in such a way as:
To allow the production to take place in areas connected in a logical order corresponding to the sequence of the operations, the requisite cleanliness levels, To avoid crowding and disorder, To allow effective communication and supervision.

Weighing Area
The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use. Such areas may be part of either storage or production areas.

Storage Areas
Specify the requirements concerning storage of materials/ products with respect to the following
Space, design, security and cleanliness Storage of quarantine stocks Storage of hazardous substances Conditions of storage area (e.g. temperature & relative humidity) Receiving of incoming materials Stock control (e.g. FIFO principle, properlabeling on the container)

Ventilation, Air Filtration, Air Heating and Cooling

Equipment for adequate control over air pressure, micro-organisms, dust, humidity, and temperature shall be provided when appropriate for the manufacture, processing, packing, or holding of a drug product. Air-handling systems for ... penicillin shall be completely separate from those for other drug products for human use.

QC Areas
QC laboratories should be designed to suit the operations to be carried out in them. QC laboratories should be separated from production areas. Areas where biological or radioisotope test methods are employed should be separated from each other

Ancillary Areas
Rest and refreshment rooms should be separated from production & QC laboratory areas. Facilities for changing clothes and for washing and toilet purposes should be easily accessible & appropriate for the number of users.

HACCP
In the early 1960s, food scientists at Pillsbury, in collaboration with NASA scientists realized that traditional food safety methods testing and analysis - would be inadequate to guarantee food quality in space. Taking strategy from munitions makers, they were asked to identify certain critical failure areas and eliminate them from the system.

What is HACCP?
NASA had already mandated the use of Critical Control Points in their engineering management, so Pillsbury adopted it for food. In 1971 and 1972 there were numerous incidents of botulism poisoning from commercially canned foods in the US.
The US Government asked Pillsbury to train its inspectors and help with a new food safety program based on Pillsburys NASA experience, which eventually became HACCP.

Hazard Analysis and Critical Control Points. This program is often cited as a very successful collaboration between industry and government. The initial HACCP system was based on three principles:
1. Conduct a hazard analysis. 2. Determine critical control points. 3. Establish monitoring procedures.

Based on its experience, Pillsbury quickly adopted two additional principles:

Establish corrective actions to take when deviations occur at a CCP. Establish critical limits to be enforced at CCPs.

HACCP Today
1.Conduct a hazard analysis. 2.Determine the CCPs. 3. Establish critical limit(s). 4.Establish a system to monitor control of the CCPs. 5. Establish the corrective action to be taken when monitoring indicates that a particular CCP is not under control. 6. Establish procedures for verification to confirm that the HACCP system is working effectively. 7. Establish documentation concerning all procedures and records appropriate to these principles and their application. Used in all types of manufacturing, not simply food or beverages. Adopted by brewers in the early 1990s.

Other models
6 sigma JIT Just in Time Benchmarking SA 8000 TQM

The quality mantra Quality can not be tested into products; it has to be built in by design

Chapter 3: 7 tools in Quality Management

7 basic tools

What are 7 basic Tools? A basic technique that is used in solving problems concerning quality, costs and production problems that arise in the workplace.
1. Cause and effect diagram 2. Check sheet 3. Pareto Diagrams 4.Flow charts and Graphs 5. Histograms 6.Control Charts 7.Scatter Diagrams

Cause & effect diagram

A graphic tool that helps identify, sort, and display possible causes of a problem or quality characteristic. 1. Select the most appropriate cause & effect format. 2. Generate the cause needed to build a cause and effect diagram. 3. Construct the cause & effect diagram. 4. Make sure every one agrees on the problem statement. 5. Include as much information as possible. 6. Interpret or test for Root cause.

Check sheet
It is used to systematically record and compile data from historical sources, or observations as they happen, so that patterns and trends can be clearly detected and shown. Tabular format: To count how often something happens Location format: To show the exact physical location of a defect or characteristic Graphic format: Data can be recorded and displayed at the same time

Check sheet: how to do?

1. Agree on definition of the events or conditions being observed. 2. Decide who will collect data, over what period, and from what sources. 3. Design a Check Sheet form that is clear, complete and easy to use. 4. Collect the data consistently and accurately

Check sheet: example

You are QC at a furniture firm. Here is the record: Mon: painting 3, scratch 3 Tue: painting 2, smooth 4, scratch 1 Wes: painting 5, smooth 2, length: 3 Thus: painting: 3, scratch 2, length: 1,smooth 2, height: 1 Fri: painting 4, scratch: 3, smooth: 3,length: 2, height: 1

Pareto diagram
A series of bars whose heights reflect the frequency or impact of problems. The bars are arranged in descending order of height from left to right. This means the categories represented by the tall bars on the left are relatively more significant than those on the right
1. Collect the data 2. Order the data 3. Calculate the accumulated percentage 4. Label the vertical axis 5. Label the horizontal axis 6. Plot the bars 7. Add up the count 8. Add up the cumulative line 9. Add title, legend, date 10. Analyze the diagram

Flow chart
A diagram that uses graphic symbols to depict the nature and flow of the steps in a process

Flow chart: benefit

Promote process understanding Tool for training Identify problem areas & improvement opportunities Depict customer-supplier relationship

Histogram
A vertical bar chart that depicts the distribution of a set of data

Histogram: when?
Summarize large data sets graphically Compare measurement to specification Communicate information to teams Assist in decision making

Histogram: how?
Count the number of data point Summarize on a tally sheet Compute the range Determine number of intervals Compute interval width Determine interval starting points Count number of points in each interval Plot the data Add title and legend

Control chart
A statistical tool used to distinguish between process variation resulting from common causes and variation resulting from special causes