2. Quality objectives and planning to achieve them:

The organization has established quality objectives at relevant functions, levels and processes needed for the QMS.

The quality objectives are:

• Consistent with the quality policy
• Measurable
• Taking into account applicable requirements.
• Relevant to conformity of products and services to enhancement of customer satisfaction.
• Monitored.
• Communicated.
• Updated as appropriate

Quality objective:

• Improve customer satisfaction
• Improve delivery performance
• Reduce internal process rejections and reworks
• Provide trainings to employees and motivate them to enhance their skills
• Continual improvement in products and processes by total employee involvement

The organization ensures to maintain documented information on the quality objectives.

While planning how to achieve its quality objectives, the organization determines action plans with responsibility and target for the completion of tasks. The plan includes resources required and evaluation techniques

3. Understanding Organization and its context:

The organization has determined external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system. The organization ensures to monitor and review information about these external and internal issues. These issues include positive and negative factors or conditions for consideration. Understanding the external context is facilitated by considering issues arising from legal, technological, competitive, market, cultural, social and economic environments, whether international, national, regional or local. Understanding the internal context is facilitated by considering issues related to values, culture, knowledge and performance of the organization.

4. Risk and opportunity management (ROM)

Is a systematic process for identifying, analyzing, and controlling potential risks and opportunities? The goal of ROM is to achieve long-term and short-term objectives while maximizing opportunities

5. Organizational Roles, responsibilities and Authorities:

Top management ensures that the responsibilities and authorities for relevant roles are assigned, communicated and understood within RMD. Top management assigns the responsibility and authority for:

• ensuring that the quality management system conforms to the requirements of QMS
• ensuring that the processes are delivering their intended outputs;
• reporting on the performance of the quality management system and an opportunities for Improvement in particular to top management;
• ensuring the promotion of customer focus throughout the organization;
• Ensuring that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

6. Management procedures

Are a set of rules that outline how to take actions to achieve management goals. They are important for ensuring that tasks are completed consistently and efficiently.

7. The seven basic quality control (QC) tools are:

• Check sheet: A structured way to collect and analyze data
• Cause-and-effect diagram: Also known as the "fishbone diagram" or Ishikawa diagram
• Control chart: A statistical tool that compares current data to historical control limits
• Histogram: A bar graph that shows how often each value in a set of data occurs
• Pareto chart: A graphical tool that shows the relative importance of problems
• Scatter diagram: A correlation chart that shows the relationship between two variables
• Stratification: Also known as a flow chart or run chart, this technique separates data into groups to identify patterns

8. Quality management system (QMS)

Is a set of policies, procedures, and processes that help an organization consistently meet customer expectations. A QMS helps ensure that products and services are safe, effective, and meet regulatory requirements.

Benefits of a QMS :

• Helps a business protect its reputation
• Helps a business accelerate change
• Helps a business meet customer needs
• Helps a business demonstrate governance, risk, and compliance best practices
• Helps a business protect itself in the face of litigation
• QMS components quality planning, quality control, quality assurance, and quality improvement.
• QMS examples ISO 9001, Six Sigma, Total Quality Management (TQM), and ISO 13485:2016 for medical device manufacturing.

9. An internal auditor

Is an employee who assesses a company's operations, financial reporting, and risk management. They work to ensure that the company is running effectively and that it complies with laws and regulations.

Responsibilities

• Evaluate the effectiveness of internal controls and risk management systems
• Review financial records and processes
• Assess compliance with laws and regulations
• Identify potential issues and risks
• Develop recommendations to improve risk management
• Investigate fraud
• Provide evidence to present to stakeholders
• Advise management on how to improve systems and processes Key skills
• Strong interviewing and communication skills
• Knowledge of industry requirements, regulations, and company policies
• Ability to identify and assess risks
• Ability to evaluate the adequacy of internal control systems
• Ability to identify areas of potential threats Role in the organization

Internal auditors help management achieve the organization's objectives by identifying and assessing risks. They also help safeguard the organization's assets and prevent fraud.

Difference from external auditors

Internal auditors are different from external auditors, who are independent auditors hired to review and confirm the accuracy of financial statements.

10. Management review meeting (MRM)

Is a formal meeting where senior management evaluates an organization's performance and effectiveness. The purpose of the meeting is to make operational decisions and promote continuous improvement.

Who attends

• CEO, VP, and other senior management
• Department heads
• Subject matter experts
• Production manager
• Quality auditor
• Product development manager
• Engineer What's discussed
• Performance of the management system
• Status of issues from previous meetings
• Changes to internal and external issues
• Availability of resources
• Effectiveness of actions taken
• Identification of opportunities for improvement How often
• MRMs are usually held at least once a year, but larger organizations may hold them more frequently
• The frequency of MRMs should be defined in the management system processes

How to prepare Create an agenda that covers all relevant topics, Encourage active participation, Invite all relevant participants, and Set a deadline for actions.

11. Cost of Poor Quality (COPQ)

Is the total financial loss a company incurs due to poor-quality products or services. It includes the cost of defects, nonconformities, and errors.

Examples of COPQ

Scrap: Defective products or materials that can't be used, repaired, or sold

Rework: Correcting defective products or materials before delivery to the customer

Waste: Unnecessary work or stockholding due to poor organization or communication

Warranty failure: Costs associated with warranty claims

Lost opportunities: Churned customers or reputational damage

12. The seven types of waste in lean manufacturing are:

• Transportation: Moving parts or materials from one place to another
• Inventory: Having too many products or parts, or not having parts that are needed
• Motion: Unnecessary movement of people or machinery
• Waiting: Waiting for goods to be delivered, or for equipment to be ready
• Overproduction: Producing too many items "just in case"
• Overprocessing: Spending too much time on a task, or adding features that don't add value
• Defects: Having broken or defective parts that need to be reworked These seven types of waste are also known by the acronym TIMWOOD.

How to reduce waste

The TIMWOOD framework was developed by Toyota to help organizations identify and reduce waste.

How to identify waste

To identify waste, you can consider how work is done. Value-creating work is directly necessary for making products, while incidental work is not directly value-creating. Waste is work that doesn't create value and can be eliminated.

Benefits of reducing waste

Reducing waste can help organizations improve efficiency and operational performance.

The seven types of waste are:

• Overproduction: Producing more than what is demanded
• Waiting: Idle time caused by a lack of synchronization between processes
• Transportation: Moving equipment and processes, which can be costly
• Inventory: Keeping more inventory than is needed, which can tie up capital and increase logistics costs
• Motion: Unnecessary movement of people, machines, or materials
• Defects: Producing defective products that need to be reworked
• Processing: Inefficient processes that don't add value These types of waste are also known as muda in Japanese. Toyota engineer Taiichi Ohno developed the concept.

13. Kaizen

Is a Japanese word that means "good change" or "continuous improvement". It's a business philosophy that encourages employees to work together to make small changes that add up to big results over time.

How Kaizen works

• Identify the problem: Identify the issue that needs to be addressed
• Analyze the problem: Use data to understand the root cause of the problem
• Develop solutions: Brainstorm ideas to address the problem
• Implement solutions: Put the best solution into action
• Review and standardize: Make the solution part of regular operations Kaizen benefits
• Kaizen can make manufacturing processes more efficient, cost-effective, and quality-oriented
• It can lead to significant long-term benefits
• It can help organizations achieve breakthroughs that lead to swift process improvements
• Kaizen principles Know your customer, Let it flow, Go to Gemba, Empower people, and Be transparent.
• Kaizen is associated with lean methodology and principles. It has its origins in post-World War II Japanese quality circles.

14. OEE

Overall Equipment Effectiveness (OEE) is a measurement of how productive a manufacturing process is. It's an industry standard that's used to identify losses and improve productivity.

How is OEE calculated?

• OEE is calculated by multiplying three factors: availability, performance, and quality
• A score of 100% means that all production is good quality, fast, and without downtime
• An OEE score above 85% is considered world-class What do the OEE factors measure?
• Availability: The amount of time that machinery is running
• Performance: How fast the machinery is running compared to its designed capacity
• Quality: The number of good units produced compared to the total number produced

How can OEE be used?

• Measuring OEE can help identify losses and improve the manufacturing process
• The "Six Big Losses" are a way to categorize equipment-based losses that can be targeted for improvement

15. MTBF & MTTR

(Mean Time Before Failure vs Mean Time To Repair) The terms “MTBF” and “MTTR” are used to describe separate steps in a broader process. The time between failures for devices that need to be repaired is measured by MTBF, while the time it takes to repair those devices is measured by MTTR.

16. TPM can stand for Total Productive Maintenance.

Total Productive Maintenance (TPM)

• A method of ensuring that equipment is well-maintained and lubricated, and that production processes run smoothly
• Involves operators cleaning, lubricating, and inspecting their equipment
• Involves operators taking responsibility for their equipment
• Involves operators identifying issues before they become failures
• Involves scheduling maintenance tasks based on predicted failure rates
• Involves documenting changes and performing regular audits

17. 5S

17. 5S is a methodology that helps create a clean, organized, and efficient workplace. It's a lean management tool that can help reduce waste and improve productivity.

The five S's

• Sort: Remove unnecessary items from the workspace
• Set in Order: Organize items into labeled and color-coded storage locations
• Shine: Clean the workspace, including sweeping, mopping, dusting, and wiping down surfaces
• Standardize: Create consistent work practices across different offices and shifts
• Sustain: Maintain the organized and clean workspace Benefits of 5S
• Reduces waste and unplanned downtime
• Improves employee morale and safety
• Helps build a quality work environment
• Helps customers have a good first impression
• Improves production process efficiency and safety
• Prevents errors and defectsHow to implement 5S
• Use visual cues to achieve more consistent operational results
• Create "kits" that contain just what is needed to perform a task
• Standardize work practices
• Mark frequently used tools to make them easily accessible
• Encourage workers to improve their working conditions

18. PPAP

PPAP, or Production Part Approval Process, is a quality assurance plan used in manufacturing to ensure that parts meet customer specifications. It's a key process in the automotive and aerospace industries.

How PPAP works

Design:
Use Design Failure Mode and Effects Analysis (DFMEA) to identify potential failures and mitigate causes

Planning:
Create a quality plan that includes a process flow diagram, initial process studies, and a control plan

Production:
Ensure that the manufacturing process and inspection process are in place

Approval:
Get customer approval for the part's appearance, functionality, and other specifications

PPAP levels:
There are five levels of PPAP submission:

• Level 1: Part Submission Warrant (PSW) only
• Level 2: PSW with product samples and limited supporting data
• Level 3: PSW with product samples and complete supporting data
• Level 4: PSW and other requirements as defined by the customer PPAP documents

• Product description
• Samples of the part
• Manufacturing process
• Inspection process
• Quality plan
• Part history
• Supplier approval form

19. MSA

Measurement System Analysis (MSA) is a statistical process that evaluates the accuracy of a measurement system. It's a key part of quality management systems and Six Sigma methodologies.

How MSA works

• MSA is a series of experiments and analyses that assess a measurement system's performance and capability.
• It can be used to assess data quality from surveys, experiments, and observational studies.
• MSA can help improve the quality of decisions and product quality.
• It can also help identify sources of error and ensure that data collection and evaluation are not affected by measurement error.
Why MSA is important


• MSA can help prevent wasted time, labor, and scrap in a manufacturing process.
• It can help ensure that the system of collecting data is appropriate to the process.
• It can help ensure that all data collection and evaluation are not affected by measurement error.
MSA certification


• The AIAG offers a certification exam for MSA that verifies an individual's proficiency in measurement systems analysis techniques.

20. SPC

Statistical process control (SPC) is a quality control method that uses statistical analysis to monitor and control manufacturing processes.

How it works

• SPC collects data from product and process measurements
• The data is plotted on a graph with control limits
• Data that falls within the control limits is considered normal variation
• Data that falls outside the control limits indicates a problem that needs to be fixed

• SPC can reduce variability and scrap
• It can improve productivity and reduce costs
• It can help uncover process issues
• It can help make real-time decisions
• It can help promote a culture of quality and excellence SPC tools run charts, control charts, and design of experiments.

• X-R chart
• X-s chart
• Xm-R chart
• I-MR chart
• p chart
• np chart
• c chart
• u chart

SPC is often used interchangeably with statistical quality control (SQC). However, SQC includes acceptance sampling, which SPC does not.

21. Corporate policies

Corporate policies, also known as company policies, are written guidelines that govern how a company's employees and managers act in certain situations. They can be internal or external.

Examples of corporate policies:

• Code of conduct: Defines how employees should behave, including dress code, social media use, and acceptable behavior
• Health and safety: Ensures workplace safety and prevents accidents
• Equal opportunity: Ensures that employees are treated equally and fairly, regardless of race, caste, gender, or age
• Attendance: Sets rules for employee schedules, including how to request time off and the consequences for missing work
• Disciplinary action: Defines corrective measures that managers can take, such as verbal warnings, counseling sessions, and dismissals
• Anti-harassment and anti-discrimination: Protects employees from harassment and discrimination
• Privacy: Protects employees, customers, and the company by establishing trust and transparency with customers
• Payment: Sets terms for customers and vendors, including payment time

The policies a company needs depends on its industry, corporate culture, and the legislative environment.

22. Measure of process

Process measurement is the method of collecting and analyzing data to assess how well a process is performing. It can help identify areas for improvement and optimize processes.

Process measurement methods :

Process metrics:
Quantitative measures that evaluate process quality and efficiency. They can be static, dynamic, or process evolution metrics.

Key performance indicators (KPIs):
Quantifiable measures of performance over time. KPIs can help teams set goals, track progress, and make better decisions.

Measurement System Analysis (MSA):
Analyzes the capability of the measurement system, rather than the process itself. Process performance measurement tools Process mapping, Statistical Process Control (SPC), Six Sigma Methodology, Benchmarking, and Process Mining and Task Mining. Process measurement cycle measure the current process metrics performance, make improvements to your cycle, and measure it again to check for changes. Process measurement examples cycle time, throughput, yield, and waste.

23. Continual Improvement

Continuous improvement is a key part of quality management systems (QMS). It's a systematic, ongoing process of improving products, services, or processes.

Benefits of continuous improvement:

Meet customer expectations
By consistently improving products and services, organizations can meet and exceed customer requirements.

Adapt to market conditions
Continuous improvement helps organizations quickly adapt to changing market conditions.

Reduce waste
By optimizing processes, organizations can reduce waste and increase efficiency.

Improve quality
By regularly questioning and challenging the status quo, organizations can improve overall quality and productivity.

Steps of continuous improvement

1. Plan: Identify an opportunity and plan for change.
2. Do: Implement the change on a small scale.
3. Check: Use data to analyze the results of the change.
4. Act: If the change was successful, implement it on a wider scale.

Examples of QMS that use continuous improvement ISO 9001 is a quality management system that uses continuous improvement.

24. Leadership skills

Leadership skills include communication, decision-making, empathy, integrity, conflict resolution, active listening, problem-solving, and relationship-building.

Communication Articulate your vision, Listen actively, Ensure mutual understanding, and Minimize misunderstandings.

Decision-making

• Gather and analyze data
• Weigh pros and cons
• Make a choice that aligns with your team's goals and values

Empathy understand and share the feelings of others, see things from another person's perspective, and build strong relationships.

Integrity :

• Be honest
• Rely on your own moral compass and values to make decisions
• Be motivated to do what is right Conflict resolution solve conflict constructively and maintain healthy relationships.

Active listening Build trust, Understand your team, and Foster a supportive work environment.

Problem-solving Stay calm, Identify a step-by-step solution, Make quick decisions, Resolve obstacles with your team, and Ensure projects are completed on time.