COST OF QUALITY Lower Control Limit (LCL) - bottom dashed line - goal: to uncover potential failures with the
- goal: to uncover potential failures with the design of the product that
COST OF GOOD QUALITY - cost of quality conformance, including any
associated costs with both appraisal and prevention
• Prevention Cost – designed to prevent poor quality in products
• Appraisal Cost – designed to measure, inspect, evaluate or audit
products to assure conformance
COST OF POOR QUALITY - total financial loss incurred by a company
due to providing poor-quality products or services to the customer
• Internal Failure Cost – to conform to a quality specification before
shipment to a customer
• External Failure Cost – to conform to a quality specification after
shipment to a customer
BENCHMARKING
- process of measuring performance of a company's products, services,
processes against those of another business considered to be the best
TYPES OF BENCHMARKING
1. STRATEGIC BENCHMARKING - process of deciding upon best practices
2. PERFORMANCE BENCHMARKING - determines how strong our
products and services are compared to our competition
3. PROCESS BENCHMARKING - examines the specific processes and
operations of high-performing companies within the industry
APPROACHES OF BENCHMARKING
1. INTERNAL BENCHMARKING - used to compare the work of separate
teams, units or divisions
2. COMPETITIVE BENCHMARKING - company compares itself with the
competitors inside its industry
3. EXTERNAL BENCHMARKING - looks both inside and outside industry
to find the best practices
4. FUNCTIONAL BENCHMARKING - easy to identify the best marketing,
finance, human resource or operations departments
5. GENERIC BENCHMARKING - focus on excellent work processes
rather than on the business practices of a particular organization
CONTROL CHART
- popular SPC tool - developed by Walter Shewhart
- graph used to study how a process changes over time
Control limits - voice of the process
- process event or measurement is likely to fall within that limit
- horizontal lines in a control chart that delineate the upper and lower
limits of the acceptable range of results for a process
Upper Control Limit (UCL) - top dashed line
Average of statistic being plotted - solid middle line
Specification limits - customer’s voice
- external tolerance values set by the user/customer and apply to
individual units.
2 TYPES OF PROCESS VARIATION
1. Common Cause Variation - intrinsic to process & always be present
- predictable and part of the normal stability of a process
2. Special Cause Variation - “assignable cause.
- stems from external sources and indicates that the process is out of
statistical control
- unpredictable and represent a point of instability in a process
DIFFERENT CONTROL CHARTS ACCORDING ON THE DATA TYPE
1. Variable (Continuous) Control Charts - Measure the output on
continuous scale - to measure quality characteristics of product.
⦁ X bar – R Charts (when data is readily available)
⦁ Run Charts (limited single-point data)
⦁ X – MR Charts (I – MR, individual moving range)
⦁ X bar – S Charts (when Sigma is readily available)
2. Attribute (Discrete) Control Charts - output is decision or counting
⦁ p Charts (for defectives – sample size varies)
⦁ np Charts (for defectives – sample size fixed)
⦁ c Charts (for defects – sample size fixed)
⦁ u Charts (for defects – sample size varies)
TYPES OF CONTROL CHART USED IN SPC
1. X-BAR CHART – “sample mean chart”, to monitor the average value
or mean of a process over time.
2. RANGE CHART – “R-chart”, to monitor the process variability or
dispersion over time
3. PROPORTION CHART – “P chart”, to monitor the proportion or
percentage of nonconforming items or events within a process.
4. COUNT CHART – “C chart”, to monitor the count or number of
occurrences of nonconforming items or events within a process.
FAILURE MODE EFFECT ANALYSIS
- proactive method of uncovering potential failures in business
processes in order to prevent them from happening/mitigate
TYPES OF FMEA
1. Design FMEA (DFMEA) - applicable to product design, particularly
during its early stage or end-stage.
could impact health & safety and the environment, among others
2. Process FMEA (PFMEA) - uncovering of risks within new or existing
processes. - done before a new process is implemented or conducted
before changes made to old processes take effect.
FMEA - Risk Priority Number (RPN)
SEVERITY x OCCURRENCE x DETECTION = RPN *Rating per criteria: 1-10
Severity – based on effect of failure mode
Occurrence – based on mechanism of failure
Detection – based on current process controls
HOUSE OF QUALITY
– product planning matrix that is built to show how customer
requirements relate directly to ways and methods
– use a design that resembles the outline of a house
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION (ISO)
- Promotes worldwide - Standards for the improvement of quality
- Productivity and operating efficiency
• ISO 9000:1987 - quality assurance in design, production, installation
servicing and development
• ISO 9001:1987 - production, installation, and servicing
• ISO 9003:1987 - final inspection and test covered only the final
inspection of finished product, with no concern
• ISO 9000:1994 - Quality assurance
• ISO 9001:2000 - Replaced all three former standards of 1994 issue,
ISO 9001, ISO 9002 and ISO 9003
• ISO 9000 Requirements - Approve documents before distribution
• ISO 9001:2008 - Re-narrates ISO 9001:2000
• 2012: ISO TC 176 - responsible for ISO 9001 development
• ISO 9000 - Provide framework for quality system development in all
types of industries
ISO 14000 - series of international, voluntary environmental
management standards, guides, and technical reports
- similar to ISO 9000 quality management in that both pertain to the
process of how a product is produced, rather than to the product itself
POKAYOKE
- developed by Shigeo Shingo in the 1960's.
- Japanese approach to "mistake proofing" in aspects of manufacturing
- lean tool that originated from the Toyota Production System
- purpose: to inhibit, correct or highlight an error as it occurs
Poka-Yoke = Error Proofing

PRINCIPLES OF MISTAKE PROOFING
• ELIMINATION – seeks to eliminate possibility of error by redesigning
the product or process.
• REPLACEMENT – substitutes more reliable process to improve consistency
• PREVENTION – engineers the products or process so that it is
impossible to make mistake at all.
• FACILITATION – employs techniques and combining steps to make
work easier to perform.
• DETECTION – identifying error before further processing occurs
• MITIGATION – seeks to minimize the effects of errors
2 STATUSES OF POKA YOKE 3 FUNCTIONS OF POKA YOKE
1. The fault will happen 1. Stop 2. Check 3. Alarm
2. The fault has happened
POKA-YOKE APPROACH
1. Control Approach - senses problem & stops line/process so that
corrective action can take place immediately, avoiding serial defect gen
2. Warning Approach - signals occurrence of deviation/trend of
deviations thru escalating series of buzzers, or other warning devices
3 types for detecting & preventing errors in mass production system:
1. Contact method: identifies product defects by testing the product's
shape, size, color, and other physical attributes.
2. Fixed-value method: alerts operator if certain number of
movements are not made
3. Motion-step method: determines whether the prescribed steps of
the process have been followed.
PROCESS CAPABILITY
- ability of process to meet customer specifications w/o addtl. effort
- measures goodness of process by comparing VOP and VOC
Voice of the Process - communicates its performance capability to
meet the expectations, wants, and needs of the customer
Voice of the Customer - gathering vital information regarding what
customers think and feel about their experiences with a business
PROCESS CAPABILITY INDEX
Cp Index - measure of potential of process as it
represents what process might be able to
achieve if process was centered
PROCESS CAPABLITY ANALYSIS - statistical technique used to assess
ability of process to consistently meet specifications
CAPABILITY INDEX – (Cp, Cpk, Pp, or Ppk), used to evaluate the
capability of a process to meet specifications
CAPABILITY RATIO – “Cpm”, used to assess the capability of a process
to meet specifications
QUALITY CIRCLE
• Total – whole made up of • Circle – grp of ppl w/ shared
• Quality – zero defects profession, interests
- Ishikawa introduced the QC - essential part of TQM
- 6-8 members - semi-permanent - from single functional dept
- “quality control circle”; group of workers who do same/similar work,
who meet regularly to identify, analyze & solve work-related problems.
STRUCTURE OF QUALITY CIRCLE
Top Management – Steering Committee – Co-Ordinator – Facilitator –
Leader – Members – Non-QC Members
QUALITY CIRCLE PROCESS
- refers to phases followed by employees working in same dept. to
help come up with problem-solving solutions
QUALITY POLICY
- brief statement that aligns with an organization's purpose, mission,
and strategic direction
QUALITY PLANNING
- systematic process that translates quality policy into measurable
objectives and requirements, and lays down a sequence of steps for
realizing them within a specified timeframe
QUALITY INFORMATION FEEDBACK
- allows team members to stay on track, as they can assess their perf
QUALITY AUDIT
- systematic & independent examination to determine whether quality
activities and related results comply with planned arrangements
QUALITY FUNCTION DEPLOYMENT
• Quality – meeting customer requirements
• Function – what must be done, focusing the attention
• Deployment – who will do it, when
Hin Shitsu - feature attribute quality
Ki No - function mechanization
Ten Kai - diffusion deployment evolution
QFD – method of transferring customer needs and requirements into
technical specifications for new product and service development
– developed by Yoji Akao
QUALITY MANAGEMENT SYSTEM
Quality System - set of policies, processes, procedures, and work
instructions that are designed to ensure that an organization's
products or services consistently meet or exceed customer
expectations.
QMS - formalized system that documents processes, procedures, and
responsibilities for achieving quality policies and objectives.
STATISTICAL PROCESS CONTROL (SPC)
- industry-standard methodology for measuring and controlling quality
during the manufacturing process.
SPC - Activities that monitor a process in real-time to prevent defects
while a lot is being manufactured
- process inputs (independent variables)
SQC - activities that occur after manufacture to keep defects from
reaching a patient by additional inspection
- process outputs (dependent variables) - acceptance sampling
7 QC Tools:
• Statistical Process Control - industry-standard methodology
• Cause-and-Effect Diagram - identifies many possible causes for an effect
• Check Sheet - collecting and analyzing data
• Control Chart - how a process changes over time
• Histogram - showing frequency distributions
• Pareto Chart - arranges items
• Scatter Diagram - pairs of numerical data
TOTAL QUALITY MANAGEMENT (TQM)
- comprehensive management approach that aims to improve the
quality and efficiency of products, services, and processes within an
organization.
BUSINESS PROCESS REENGINERING
- Promoted by Hammer and James Champy published book
Reengineering the corporation
- mid-1990s, BPR became popular as justification for downsizing
Business - series of actions taken in order to achieve particular end
Process - branch of science and technology concerned with the design,
building, and use of engines, machines, and structures
Reengineering - fundamental rethinking and radical redesign of
business process to achieve dramatic improvements

BPR - analysis & redesign of workflows within and between enterprises

in order to optimize end- to-end processes

EXPERIMENTAL DESIGN
- systematic and strategic process of planning, organizing, and
conducting scientific experiments to investigate the relationship
between variables and establish cause-and-effect relationships.

QUALITY EDUCATION
- collection of techniques aimed at aligning every aspect of a business
with the specific quality needs and expectations of its clients or
customers is employed to optimize quality and minimize inefficiencies.

HIERARCHY OF QUALITY
- provides a roadmap for organizations to progressively improve their
quality management practices
1. INSPECTION - most basic level of quality management, where
products or processes are inspected to identify defects or deviations
2. QUALITY CONTROL - implementation of systematic processes to
monitor and control product or process characteristics
3. DETECTION - identifying and addressing defects or deviations from
established standards.
4. QUALITY ASSURANCE - focusing on preventing defects rather
than simply detecting and correcting them
5. PREVENTION - focuses on addressing the root causes of problems
and eliminating their occurrence.

ISO 9000:2000 REVISIONS HAD FIVE GOALS

1. Meet stakeholders needs
2. Be usable by all sizes of organizations
3. Be usable by all sectors
4. Be simple and clearly understood
5. Connect quality management system to business processes

STEPS IN BUILDING HOQ

1. Captures customer requirements and weight them
– What do customers want? (VOC)
2. Competitive analysis from customer’s perspective
3. Define product attributes
4. Determine relationships
5. Analyze interrelationships
6. Determine importance
7. Define target values and competitive analysis