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Quality Management System (QMS)

Quality

  • Quality impacts productivity, profitability, customer satisfaction, and public perception.

  • It also affects overall operating costs.

  • Focusing on quality strengthens all areas of a company.

  • "An ounce of prevention is worth a Pound of Cure" - Benjamin Franklin

  • Understanding the cost of quality and its potential impact are fundamental to quality management.

Quality Costs

Costs of Conformance (COC)

  • Associated with the design, implementation, and maintenance of the QMS.

  • Examples:

    • Writing SOPs

    • Process control

    • Calibration

    • Training

    • Maintaining equipment

    • Quality improvement

    • Audits

    • QC and CA

  • Prevention Costs

  • Appraisal Costs

Costs of Non-Conformance (CONC)

  • Money spent due to not conforming to quality requirements.

  • Examples:

    • Product recall

    • Scrap

    • Downgraded product

    • Rework

    • Customer complaints

    • Liability insurance

    • In-process Testing and Inspection

    • Inspecting goods received

  • Internal Failure Costs

  • External Failure Costs

Quality Cost Calculations - Formulas

  • CONCCONC → Cost of non−conformanceCost \space of \space non-conformance

  • COCCOC → Cost of conformanceCost \space of \space conformance

  • Constant=Constant = %CONC × COC

  • Total quality cost=CONC+COCTotal \space quality \space cost = CONC + COC

Quality Cost Calculations – Q1a

  • Each 1% of non-conforming goods costs €3200 per week.

  • At 6% non-conformance, the cost of conformance is €1800 per week.

  • Constant=Constant = %CONC × COC

  • Total quality cost=CONC+COCTotal \space quality \space cost = CONC + COC

  • Example Calculation Table:

    • 1% Non-Conformance: CONC = €3,200, COC = €10,800, Constant = €10,800, Total Cost = €14,000

    • 2% Non-Conformance: CONC = €6,400, COC = €5,400, Constant = €10,800, Total Cost = €11,800

    • 3% Non-Conformance: CONC = €9,600, COC = €3,600, Constant = €10,800, Total Cost = €13,200

    • 4% Non-Conformance: CONC = €12,800, COC = €2,700, Constant = €10,800, Total Cost = €15,500

    • 5% Non-Conformance: CONC = €16,000, COC = €2,160, Constant = €10,800, Total Cost = €18,160

    • 6% Non-Conformance: CONC = €19,200, COC = €1,800, Constant = €10,800, Total Cost = €21,000

    • 7% Non-Conformance: CONC = €22,400, COC = €1,543, Constant = €10,800, Total Cost = €23,943

Graph of Quality Costs

  • Draw a graph with % Non-conformance vs. CONC, COC, and Total Cost on the Y axis.

  • Determine the most economical % of non-conformance from the graph of total cost.

The Seven QC Tools

  1. Flowcharts

  2. Check sheets

  3. Histograms

  4. Cause-and-effect diagrams (Fishbone)

  5. Pareto diagrams (80:20 analysis)

  6. Scatter diagrams

  7. Control charts

Histograms

  • Graphical representation of the distribution of numerical data.

  • Displays large amounts of data that are difficult to interpret in tabular form.

  • Shows centering, variation, and shape (skew).

  • Provides useful information for predicting future performance.

  • Helps to answer the question “Is the process capable of meeting requirements?

  • Similar to a Bar Chart, but a histogram groups numbers into ranges.

  • Histograms visualize quantitative/numerical data, while bar charts display categorical variables.

  • In most instances, the numerical data in a histogram will be continuous (having infinite values).

Cause-and-Effect Diagrams

  • Show relationships between a problem and its possible causes.

  • Developed by Kaoru Ishikawa (1953).

  • Also known as Fishbone diagrams or Ishikawa diagrams.

  • Can be used to address defects.

  • Theory: none defect has a single cause.

  • A cause and effect diagram examines why something happened or might happen by organizing potential causes into smaller categories.

  • It can also be useful for showing relationships between contributing factors.

  • Process:

    1. Identify the effect (i.e., defect).

    2. Construct the framework of main causes.

    3. Start brainstorming.

  • Useful in quality circle settings or lab meetings.

  • Enables a team to focus on the content of a problem, not on the history of the problem or differing personal interests of team members.

  • Creates a snapshot of collective knowledge and consensus of a team; builds support for solutions.

  • Focuses the team on causes, not symptoms.

Pareto Principle

  • 80:20 analysis: Pareto principle

  • 19th century Pareto noticed that 20% of the people in the Italian economy owned about 80% of the wealth.

  • Afterwards noted that the 80:20 rule applied in many areas.

  • Juran used the term “vital few, trivial many”. He noted that 20% of the quality problems caused 80% of the dollar loss.

  • Even if it’s not an equal 80:20 split, the idea that a few factors drive a large proportion of outcomes supports the principle of factor sparsity.

Scatter Diagrams

  • Analyze data to confirm a hypothesis that two variables are related (or not).

  • Provides both a visual and statistical means to test the strength of a relationship.

  • Provides a good follow-up to cause and effect diagrams.

Regression Line Slope

  • A positive correlation indicates that as the value of the independent variable increases, the mean of the dependent variable also tends to increase (directly correlated).

  • A negative correlation indicates that as the independent variable increases, the dependent variable tends to decrease (indirectly correlated).

  • Positive correlation: height and weight—taller people tend to be heavier, and vice versa.

  • Negative correlation: A student who has many absences has a decrease in grades. The more one works, the less free time one has.

Benchmarking

  • A benchmark is a reference point against which a company compares itself.

  • It highlights what is possible, an understanding of how it can be achieved and a goal to aim for and exceed.

  • Assists a Lean Six Sigma team in setting the targets and finding new ways to achieve them.

  • Benchmarking is used to determine if there is a gap in performance that can be closed by improving performance.

  • Benchmarking should include direct and secondary competitors, and aspirational brands.

  • The objective of benchmarking is to understand and evaluate the current position of an organization in relation to best practice and to identify areas and means of a performance improvement.

  • Over time, best practices emerge based on the experience of what actions led to successful outcomes.

  • Innovation programs aligning with industry standards may be more likely to build a positive reputation in the ecosystem, provide ongoing value to parent corporations and avoid shut down.

Why is Benchmarking needed?

  1. Performance Improvement

  2. Meeting Quality Standards

  3. Meeting Customer Expectations

  4. Facilitating Innovation

Benchmarking cycle

  • Complete the Audit & re-benchmark

  • Start the project

  • Analyze current plans & performance

  • Establish benchmarking data and analyze differences

  • Get the improvements in practice

  • Identify best practices & most useful improvements

  • Assess improvements

  • Start

Types of benchmarking

  • Internal Benchmarking: Benchmark of other departments, products, or processes in the same organization. Limited by the organization culture, norms, and history. E.g., Consumable cost of one department in the company compared to other departments.

  • Competitive Benchmarking: Benchmark best industry practices outside of the organization, but within the same industry type. Limited depending on the type of the industry. E.g., Comparing the performance or quality of similar products or services offered by different organizations (cost of the product…)

  • Functional Benchmarking: Benchmark of similar functions outside of organization’s industry. Provides large opportunities to achieve high level of performance. E.g., a hospital looking to improve patient care might benchmark its processes against a top-performing airline known for its excellent customer service.

  • Generic Benchmarking: Benchmark with cooperation between various functions or organizations. This gives innovative solutions and best results. E.g., Camera functions in mobile phones.

  • Best-in-Class Benchmarking: Similar to competitive benchmarking, but it goes beyond direct competitors. In this approach, an organization looks outside its industry to compare its performance against top performers in entirely different sectors. E.g., a retail chain seeking to improve its supply chain efficiency might benchmark its logistics operations against a leading e-commerce company. By studying the e-commerce giant’s advanced supply chain management techniques, the retail chain can identify novel ways to enhance its own operations

  • Process benchmarking: Demonstrates how top performing companies accomplish the specific process in question. Collected via research, survey, interviews, and site visits. Supports decision making by executives

  • Performance benchmarking: Performance benchmarking involves evaluating an organization’s performance over time by comparing current data with historical data. This approach enables organizations to track their progress, identify trends, and set realistic improvement targets. Identify Performance gaps to find opportunities for improvement

  • Strategic benchmarking: Identify winning strategies that have enabled high performing companies to be successful. Examines how companies complete. Ideal for corporations with long-term perspectives.

Steps in Benchmarking

  1. Define your objectives: Why are you benchmarking, what specific goals do you want to achieve? Define you stands for key performance indicator (KPIs). E.g., vendor lead time, late deliveries, instances of material rejection, number of suppliers per buyer, time to place order…

  2. Identify competition: Perform extensive market research to identify your direct and indirect competitors – framework for your analysis

  3. Measure your KPIs: Gather and organize data systematically (sorting and organizing)

  4. Analyze the Information: Most critical step – make sense of your data, identify the areas for improvement

  5. Apply Benchmark Results: Develop practical and FEASIBLE action plan based on your findings

  6. Evaluate the impact of the implemented changes: Remeasure your KPIs to see if your achieving the desired results

What can be benchmarked?

  1. Customer satisfaction:

    • Product conformance to requirements

    • Reliability

    • On-time deliveries

    • Lead times

  2. Financial Performance:

    • Sales per employee

    • Age of debts

    • Investment in R & D

  3. Distribution:

    • Cost of distribution activities

    • Time in distribution cycle

    • Number of levels of distribution

  4. Purchasing: • Number of suppliers • Late deliveries • Rejection rate

  5. Materials management:

    • Warehousing space

    • Inventory

    • Cycle times

  6. Design:

    • Time to introduce new products

    • Number of engineering changes

    • Customer satisfaction

  7. Performance

    • Process capabilities

Benchmarking tools

  • Determining the key activities is essential because this drives the benchmarking program.

  • The team may identify the key activities using information from a variety of sources:

    1. Customer surveys: to determine the performance and the requirements of its customers

    2. Functional analysis: identifies the purpose of the business in terms of satisfying internal customers. Process efficiency. Performance.

    3. Financial analysis: indicates the activities which account for a large proportion of costs and where significant non-conformance costs occur.

Lean manufacturing

  • Lean manufacturing is a systematic method for waste minimization within a manufacturing system without sacrificing productivity

  • Lean manufacturing attempts to make obvious what adds value, through reducing everything else (because it is not adding value)

  • Henry Ford the founder of Ford believed in the concept of lean manufacturing…

The eight wastes of lean

  • DEFECTS: Waste from a product or service failure to meet customer expectations

  • OVERPRODUCTION: Waste from making more product than customers demand

  • WAITING: Waste from time spent waiting for the next process step to occur

  • UNUSED TALENT: Wastes due to underutilization of people's talents, skills, and knowledge

  • TRANSPORTATION: Wasted time, resources, and costs when unnecessarily moving products and materials

  • INVENTORY: Wastes resulting from excess products and materials that aren't processed

  • MOTION: Wasted time and effort related to unnecessary movements by people

  • EXTRA-PROCESSING: Wastes related to more work or higher quality than is required

Lean tools: Just-in-time (JIT) systems

  • The JIT inventory system is a management strategy that aligns raw-material orders from suppliers directly with production schedules

  • Companies use this inventory strategy to increase efficiency and decrease waste by receiving goods only as they need them for the production process, which reduces inventory costs

  • This method requires producers to forecast demand accurately

Lean tools: 5S

  • 5S is a system of arranging data or items into a more organized manner which makes them easier to interpret

  • 5S stands for the 5 steps starting with the letter “S” of this methodology:

    1. Sort

    2. Set in order

    3. Shine

    4. Standardize

    5. Sustain

  • These steps involve going through everything in a space, deciding what's necessary and what isn't, putting things in order, cleaning, and setting up procedures for performing these tasks on a regular basis.

The five principles of lean

  1. Define value: Specify value from the standpoint of the end customer by product family what aspects are they willingly pay for? The customer defines the value of a product or service. Hence, the first step is to identify customers. Classify the process activities into a) non-value added, b) b) value-added and c) c) enabling value added.

  2. Value stream mapping: Identify all the steps in the value stream for each process, eliminating whenever possible those steps that do not create value. The value stream mapping process shows the workflow process steps for a product or service. The value stream mapping helps to identify & eliminate NVA activities.Maps the current flow of specimens/information/products through operations. Identifies performance and process opportunities for improvement. Begins with customer and works backwards

  3. Create flow: Make the value-creating steps occur in tight sequence so the result will flow smoothly toward the customer. Create flow to the customer by ensuring continuous flow system in producing product or service. Flow will optimize the process to maximize process efficiency.

  4. Establish pull: As flow is introduced, let customers pull value from the next upstream activity. Establish pull approach by meeting or exceeding system beat time (the beat time is the rate at which a product must be ready to meet the customer demand). JIT is a tool promoting pull system. This ensures smooth workflow of the process without any disruptions. It also helps to diminish inventory level.

  5. Seek continuous improvement: Continuous improvement until a state of perfection is reached in which value is created with no waste. Finally, you must put consistent efforts to improve the existing business processes to cater ever-changing customer needs. This ensures elimination of waste and defects free products and quality service to customers.

Six Sigma

  • Developed in the early 1980s by Motorola Corporation to improve product reliability

  • Defined sequence of steps with specific target values

  • The Six Sigma strategy measures the amount by which any process deviates from its goal (variation)

  • The “Six” in Six Sigma refers to the ideal goal of all processes that six standard deviations fit within the defined tolerance limits

  • The Sigma value indicates how often errors are likely to occur; the higher the Sigma value, the less likely that errors will occur

  • A Six Sigma process is one in which 99.99966% of all opportunities to produce some feature of a part are statistically expected to be free of defects

  • The results? A radical elimination of business and process costs resulting in massive increases in profitability.

  • This methodology represents an evolution in quality management that is being widely implemented in business, manufacturing and lately, pathology laboratories, for example

Six Sigma: DMAIC

  • The Six Sigma DMAIC approach is typically used to improve an existing process.

    • Define the problem and desired outcome

    • Measure the ability of the process

    • Analyze the data and identify the root cause of variations (defects)

    • Improve or modify the process so that fewer variations (defects) are produced

    • Control the process - prevent and correct variations before they result in defects

Six Sigma: DMADV

  • When designing a new process, the Six Sigma DMADV is used. It is also known as DFSS (design for Six Sigma).

  • The DMADV acronym stands for:

    • Define design standards that align with the product or process goals

    • Measure and identify characteristics of the product or process that are critical to quality

    • Analyze the data, and identify possible sources of defects

    • Design to eliminate the source of defects or errors

    • Verify that the design will meet the requirements

LEAN vs SIX SIGMA

LEAN

  • Waste Removal

    • Increased Speed

    • Removal of non-value-added process steps

    • Fixed connections between process steps

    • Customer Focused

SIX SIGMA

  • Improved Quality

    • Variation Reduction

    • Improved Quality

    • Reduction of variation at each remaining step

    • Optimized remaining process steps

    • Customer Focused

Together
SPEED and ACCURACY
Improved Delivery
Satisfied Customer
Statified Employee

THE LEAN SIX SIGMA BELT SYSTEM:

  • WHITE: Understands the structure and goals of Lean Six Sigma, Uses basic Lean Six Sigma vocabulary terms, Reports process issues to green and black belts

  • YELLOW: Understands basic Lean Six Sigma concepts, Reports process issues to Green Belts and Black Belts, Participates on project teams and receives just-in-time training

  • GREEN: Starts and manages Lean Six Sigma projects, Has Lean Six Sigma expertise but in less detail than Black Belts, Provides just-in-time training to others, Can report to a Master Black Belt

  • BLACK: Has advanced Lean Six Sigma expertise, Functions as a coach, mentor, teacher, and project leader for project teams, Works with leaders to identify gaps and select projects

  • MASTER BLACK: Coaches, mentors, teaches, monitors, and leads projects, Responsible for Lean Six Sigma implementation and culture change

  • CHAMPION: Executive leader who drives the initiative, Helps select projects and remove barriers for project teams, Supports change and develops a Lean Six Sigma culture

Lean Six Sigma

What Is Lean Six Sigma?

LEAN:
Reduce waste by streamlining the process.
Uses the PDCA method and tools like 8 Wastes and 5S to achieve continuous improvement
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SIX SIGMA:
Reduce defects by effectively solving problems
Uses the DMAIC method and tools like Control Charts and FMEA to achieve continuous improvement
==(equals)
Lean Six Sigma:
Leverages the best problem-solving methods to help organizations achieve their missions and satisfy customers
LEAN accelerates SIX SIGMA: Solving problems and improving processes is faster and more efficient.

Lean Six Sigma is a systematic approach used to improve performance by removing waste and reducing variation across all aspects of an organization.

Training

  • Knowledge: the theoretical or practical understanding of a subject; awareness or familiarity gained by experience of a fact or situation

  • Skill: developed aptitude or ability in a particular intellectual or physical field; application of knowledge

  • Attitude: an internal state which effects your choice of action towards some objects, persons or events

Training Vs. Education

  • Training differs from education in that it seeks to impart a set of established facts and skills and to obtain a uniform predictable behavior from the trainees.

  • Education on the other hand, seeks to have the student learn skills and to understand why actions are taken or not

Types of training

  • Induction training: aimed at new recruits and covers general aspects of the company e.g. history, objectives, more specific aspects of the job

  • Retraining programm covers some topics from induction, ensures the standards set are maintained

  • Upgrading/upskilling programs developing technology, change in markets/organization direction, optimization of new equipment

  • Development programs aimed at staff to be promoted to new grades/responsibilities

Training methods

  1. Self instruction: audiovisual aids, training films, programmed instructions.

  2. Classroom training or online training (E-learning)

  3. In-house training e.g. Quality manuals, fire evacuation plan, waste management

  4. Company (external) visits e.g. To suppliers or sister companies

  5. Professional organizations, courses, seminars etc.

  6. Publications, books, journals, internet.

  7. Day-to-day experiential learning: normal work situation, objectives understood, explanation and demonstration.

  8. Reflection: reflective practices: integrated into continuous professional development (CPD)

  9. Mentor approach

Training documentation

  1. Training Program – compiled and approved by relevant function head

  2. Training schedule: for each department lists

    • operators/ personnel trained for a particular job

    • Date of completion of training

    • Supervisor/ instructor involved

  3. Training records:

    • prior training

    • qualifications of personnel

    • stages in program completed

Training in Quality

  1. Upper management: broad coverage of all quality activities in company e.g.:

    • Quality policy

    • Statistical methods

    • QC / QA implementation

  2. Middle management: some of upper management training, also elements of:

    • Planning

    • Supervision

    • Cost control

    • Quality problem-solving tools

  3. Quality Management:

    • Training in business orientation

    • QA

  4. Supervisors:

    • Procedures

    • Planning systems

    • Sampling concepts

    • Statistical methods

    • Quality Control charts

    • Problem solving techniques

    • Quality improvement methods e.g. Quality circles

    • Problem-solving techniques

  5. Operators:

    • Quality standards and specifications

    • Standard operating procedures

    • Testing and inspection methods

    • Control charts

    • Operator control

    • Sampling methods

    • Quality circles and quality improvement techniques

    • Teamwork

Motivation

  • Motivation is the driving force that prompts an individual to take action toward a desired goal or outcome.

  • It is an internal state that energizes and directs behavior toward a particular objective or purpose .

  • It can be influenced by various factors, such as personal interests, needs, values, and goals.

Motivational techniques – employee motivation

  • Indifference theory: Proposes that people are not interested in their work & that the most effective way to increase output is by other incentive schemes.

  • Craftsmanship theory: Proposes that all people have an inherent desire to take pride in their work. With encouragement, they will work well and make suggestions for improving quality

  • All Quality Systems reject the indifference theory and base the methods of achieving quality on the craftsmanship theory

Quality Circles

  • A Quality Circle is a group of employees doing similar work under one supervisor who meet voluntarily each week to discuss quality problems, recommend solutions and (with management approval) implement them.

  • Otherwise known as a quality improvement team

  • Focus:

    • Cost reduction

    • Waste reduction

    • Energy saving

    • Safety

    • Equipment

    • Procedures / work methods

  • Components:

    • Steering committee

    • Facilitator

    • Leader

    • Members

    • Specialists

Components of a quality circle

  1. Steering committee
    *May or not be present when quality circles happen at a local or more informal level. If present, usually headed by a senior executive (or top management, human resources)Establish policy, plans and direct the quality circle

  2. Facilitator
    *Key person who represents management’s commitment to the process. The role of the facilitator is to: Promote the quality circle, Liaise between quality circles, Liaise with management, Organize training programs, Keep records

  3. The circle leader
    *Quality circles operate within the same structures as already exist in the organization. The circle leader is usually a team leader/line manager. Part of the role of the leader should be to foster team thinking. And to facilitate time off during work schedules for meetings

  4. The circle members
    *Membership must be voluntary. Need not be permanent. Circles generally work best if the members are from the same work area. Numbers should be few enough to make an effective team but numerous enough to allow a flow of creativity without being handicapped by absentees

  5. Specialists
    *Not all problems can be solved by the team itself. Sometimes it is necessary to invite a specialist to impart technical, mathematical or engineering information to help to solve a problem. E.g. healthcare professional: doctor (?cons), nurse; statistician; quality manager; computer programmer; financial advice; HR, etc

Elements of a successful quality circle

  • Management attitude – need sufficient support and lack of interference. Quality circles can be seen as a threat.

  • Voluntary participation – all members should be volunteers. In a successful quality circle, the turnover rate is between 10 and 20% per year

  • Training – should involve a focus first on problem-solving techniques. Disciplined approach, skilled communication, perhaps training in inter-personal relations. Need for teamwork.

  • Solving problems – Quality circles are a formal way to provide solutions to production, testing, logistical and quality problems

Customer requirements

  • Hard customer requirements: Must be met by delivered product/service Size, weight, color, taste Functions, reliability Packaging, labeling, delivery times Cost and payment arrangements, Customer support required

  • Soft customer requirements: relate to perception given to customer Telephone answering, Security and parking, Maintenance of premises etc, Hospitality, Personality

  • The quality of output of a product depends on the quality of internal processes.

  • A Process is any activity which takes an input and transforms it into an output

  • A Supplier is anyone who supplies the input

  • A Customer is anyone who receives the output from a process

  • All activities within an organization are made up of a series of complex Supplier/Customer Chains. For Right First-Time customer requirements for each process within the chain must be met.

Introduction Product Liability:

  • can be defined as liability for damages in a case when due to a defect in the product, a life, body or property is injured.

  • The person who manufactured, processed, imported or put its name etc. on the product is liable for damages of the injured person.

  • Product liability is the area of law that governs the liability of the entities that are responsible for placing products into the stream of commerce i.e., the manufacturer, distributor, wholesaler and retailer, who are liable for injuries caused by defective products.

  • Product Liability Law is mainly derived from a TORT law Torts – acts or omissions that give rise to injury or harm to another and amount to civil wrongs for which courts can impose liability
    lawsuit
    All members of the distribution chain are liable

Product Liability Law:

  • The characteristics of good product liability law are: The law should ensure that those who manufacture and supply goods should bare the risk of losses caused by what the goods do. The law should take full account of other causes of those losses

  • The law should provide the cheapest and most efficient means of determining compensation claims
    Product liability requires… That the plaintiff needs to prove all of the following: They were injured or suffered losses. They were using the product as it was intended The defect caused the injury The primary product defect types considered [in pharmaceutical industry] are:

Implications for Industry

  • The law of strict liability imposes a burden on the producers of all movable products in respect of: The product itself · Labels · Packaging and containers · Installation and use instructions· Warranty documents · Sales brochures, catalogs, advertising materials The best approach to deal with product liability risk is to have an effective Quality System to prevent injury or damage and thus avoiding claims
    Insurance Areas of the Quality System which insurance companies focus on are Research and design procedures Ongoing test and inspection routines Product labelling and ‘safe use’ instructions Export compliance with regulations Legal responsibilities
    Insurance Areas of the Quality System which insurance companies focus on are Research and design procedures Ongoing test and inspection routines Product labelling and ‘safe use’ instructions Export compliance with regulations Legal responsibilities
    Product Liability Prevention Companies must install a Product Liability Prevention Program that includes: Corporate Safety Policy: A public statement of the company’s general commitment to reliable and safe products Design and Product Development: · New focus on design function: Products designed to entail their use or possible misuse Products: Designed and tested with best equipment Comply with national mandatory standards Application of techniques for examining potential hazards of each component e.g. Failure Mode and Effect Analysis (FMEA)
    Product Liability Prevention Manufacturing and Inspection: Involves provable inspection and control of raw materials and the production process are important in the product liability limitation policy e.g. Control checks, calibrations etc Packaging, Labels and Instructions: All designed with a view to customer safety. e.g. Shelf storage, warnings etc. Advertising materials: Technical and utilization prospects must be accurate.
    Product Liability Prevention Field Monitoring: A system designed to indicate properties of the product which the customer find unsatisfactory, so re-design is possible before damage occurs. What is an example of such in pharmaceutical industry? This system works via: Customer complaints · Sales-people Field Service operatives
    Product Liability Prevention Product Recall Procedures: This involves putting the whole distribution program into reverse Advertising has to announce product not to be used or sold Sales personnel must remove product from outlets Accounts department must send out credit notes to customers Company must trace and reclaim all items in the marketplace
    Product Liability Prevention
    Documentation: Records should be maintained:
    Results of all inspections, tests, calibrations, training, QC, audits, CAPAs,Customer complaints formal system.Design documentationBatch/ process records

Customer Complaints System

  • Provides a formal method for complaints to the company → complaints are important to company: → non-complainer → no further custom

  • Benefits to an organization:

    • Improved company image → customer satisfaction after the complaint New product ideas → product development team

    • Product performance information → e.g. Usage instructions correct → use/misuse of product by customer
      4.4

Elements of Complaints System

  • Generate complaints: when, where to complain Input System: e.g. Phone, fax, email, logging system, classification system product liability a priority

  • Input system, Response System: Acknowledgement of receipt of complaint, a course of action, a line of contact for further information → customer satisfaction e.g. Restoration of service/product, refund, good will restored

  • Complaint corrective action: In-depth evaluation of cause (problem solving analysis) Corrective action implemented, important for first time complaints
    System Management: Audit, analysis of complaint by product (e.g. Type, area) raw material supplies speed of response to complaint cost (warranty, handling costs) of product from the marketplace → batch/lot records, documentation system, traceability

Recalls

  • A complaint or reported product defect may lead to the need for a product to be withdrawn from the market.

  • For an effective recall, any action taken to recall a product should be prompt and in accordance with a predetermined plan.

  • The procedure to be followed should be specified in writing and made known to all who may be concerned to facilitate smooth and fast implementation of the recall. See https://www.ccpc.ie/consumers/product-safety/product-recalls/ - recalls on Irish market

  • Pharma Cases ofRecalls

Pharma recall classes

  • Class I Recalls: Result from quality defects of medicinal products which are potentially life-threatening or could cause serious risk to health.

  • Class II Recalls: Recalls due to quality defects which could cause illness or mistreatment but are not Class I.

  • Class III Recalls: Recalls due to quality defects which are not likely to pose a significant hazard to health but where a recall has been initiated for other reasons.

Distribution Records

  • Complete distribution records are key to effective recalls.

  • Distribution records must include:

    • date, name and pharmaceutical form of the medicinal product

    • quantity supplied

    • name and address of the supplier and of the consignee

    • batch number for all wholesale-to-wholesale transactions

    • batch number at least for products bearing the safety feature applicable transport and storage requirements

  • note: this detail may be supplied separate to delivery docket or invoice

  • HPRA Guide to Good Distribution Practice of Medicinal Products for Human Use
    24/7
    Characteristics of a recall procedure Availability: Designated personnel available around the clock to manage the recall process promptly. Comprehensive Documentation: Ensuring all personnel understand how to initiate and execute a recall effectively. Regular Mock Recalls: Recommended at least annually to test the effectiveness of the recall procedure, identify potential communication issues, and verify the reliability of support systems. Method of halting distribution: products not yet on the market but in transit must also be considered. Method of informing regulatory bodies e.g. HPRA – will then follow up review and and subsequently audit the facility to check GMP system.Details of a batch · Full details should be made available to include product names, strengths, nature of defect, actions to be taken, urgency etc.
    Monitored: Progress of the recall