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Module 2 QMS

This document provides an overview of quality standards, management systems, and regulations for the chemical industry. It discusses key quality standards like ISO 9000, ISO 14001, ISO 17025, and ISO 22000. It also covers quality management systems and approaches like Total Quality Management, Hazard Analysis and Critical Control Point, and Good Manufacturing Process which are important for ensuring product and process quality. The document emphasizes that standards are important for businesses, the global economy, and consumers to ensure safety, compatibility, and satisfaction.

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guzman.regina.lauria
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22 views

Module 2 QMS

This document provides an overview of quality standards, management systems, and regulations for the chemical industry. It discusses key quality standards like ISO 9000, ISO 14001, ISO 17025, and ISO 22000. It also covers quality management systems and approaches like Total Quality Management, Hazard Analysis and Critical Control Point, and Good Manufacturing Process which are important for ensuring product and process quality. The document emphasizes that standards are important for businesses, the global economy, and consumers to ensure safety, compatibility, and satisfaction.

Uploaded by

guzman.regina.lauria
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
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Module 2:

Quality Standards, Management


Systems and Regulations for
Chemical Industries
Industrial Chemistry
2nd semester, 2020 - 2021
Quality Standards: Overview
• documents that provide:
• Requirements
• Specifications
• Guidelines, or
• Characteristics
that can be used consistently to ensure that materials, products,
processes, and services are fit for their intended purpose.
Quality Standards: Principles
Quality Standards: Importance
For businesses:
• Standards are important to the bottom line of every
organization.
• Standards are business tools that should be managed
alongside quality, safety, intellectual property, and
environmental policies.
• Standardization leads to lower costs by reducing redundancy,
minimizing errors or recalls, and reducing time to market.
Quality Standards: Importance
For the global economy:
• Businesses and organizations complying to quality standards
helps products, services, and personnel cross borders and also
ensures that products manufactured in one country can be sold
and used in another.
Quality Standards: Importance
For consumers:
• Serves as safeguards for users of products and services
• Standardization can also make consumers’ lives simpler.
• A product or service based on an international standard will be
compatible with more products or services worldwide, which increases
the number of choices available across the globe.
Quality Management: Overview
• End goal:
• ensure that quality standards were met in all aspects of the finished
product
• ensuring satisfaction of the buyer / end-user

• From the middle ages:


• Involved evaluation & inspection of the finished work

• Up to the present:
• Involved measurement, examination and testing of the products,
processes and services
Total Quality Management (TQM)
• inspections were carried out by production personnel

• inspections were conducted during specific production intervals

• The focus is not just simply inspecting the end product, but
rather to actually preventing end product problems through
early detection on the production line.
Quality Management Systems
• ISO
• 9000 series: 9001 (Quality Management)
• 14000 series: 14001 (Environmental Management)
• 17025 (Testing & Calibration)
• 22000 (Food Safety)
• HACCP
• GMP
ISO 9000 series & ISO 9001:2015
➢ General quality management system

➢ Latest version: ISO 9001:2015

➢Adoption is voluntary

➢ Ultimate goal:
• Ensure customer and stakeholder satisfaction within statutory and regulatory
requirements related to a product or service
ISO 9000 series & ISO 9001:2015
➢Certification does not involve grades of competency
• i.e., either one is ISO-certified or not

➢ Certification is achieved thru auditing


• Internal audits – conducted trained staff / employees of the
organization
• External audits – conducted by external certification bodies eg. TUV
Rheinland, SGS, Intertek
ISO 9001:2015 Principles
• Principle 1 – 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.

• Principle 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.
ISO 9001:2015 Principles
• Principle 3 – Engagement 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.

• Principle 4 – Process approach


A desired result is achieved more efficiently when activities and related
resources are managed as a process.
ISO 9001:2015 Principles
• Principle 5 – Improvement
Improvement of the organization's overall performance should be a permanent
objective of the organization.

• Principle 6 – Evidence-based decision making


Effective decisions are based on the analysis of data and information.

• Principle 7 – Relationship management


An organization and its external providers (suppliers, contractors, service
providers) are interdependent and a mutually beneficial relationship enhances the
ability of both to create value.
ISO 14000 series & ISO 14001:2015
➢ Environmental management system

➢ Latest version: ISO 14001:2015

➢Adoption is voluntary

➢ Ultimate goals:
• Minimize a business operation’s negative impacts to the environment
• Comply with EMS regulations:
• Sustainable resource use
• life cycle assessment and end-of-life scenarios
• climate change mitigation
• Continual improvement
ISO / IEC 17025
➢ General requirements for the competence of testing and calibration
laboratories

➢ for any organization that performs testing, sampling or calibration


and wants reliable results

➢ Two main clauses:


• Management requirements
• Operation & effectiveness of QMS within the lab (similar to ISO 9001)
• Technical requirements
• Staff competence
• Testing methodologies
• Equipment
• Reporting of test and calibration results
ISO / IEC 17025
ISO 22000
➢ Food safety management systems - Requirements for any
organization in the food chain

➢ Ultimate goal:
• control, and reduce to an acceptable level, any safety hazards identified for
the end products delivered to the next step of the food chain.

➢Key elements:
• Good manufacturing practices (GMP) or prerequisite programs
• HACCP
• Management system
• Interactive communication between suppliers, customers, and regulatory
authorities
Hazard Analysis and Critical Control
Point (HACCP)
• identification and control of potential hazards (biological,
chemical or physical hazards) at specific points in the process
of manufacturing, processing or handling of food products
Hazard Analysis and Critical Control
Point (HACCP) Principles
1. Conduct of hazard analysis
• Evaluate processes & identify where hazards can be introduced
• Eg. metal contamination, toxin contamination, bacterial contamination
• Two steps:
• Hazard identification
• Hazard evaluation – determining the degree of risk to the user of the identified hazard

2. Identification of critical control points


• At what steps in the process can controls be applied to prevent or eliminate
the hazards that have been identified?
• How will the hazard be prevented?: Indicate specific temperature, pH, time,
procedures
• Establish maximum or minimum limits that will control the hazard
• temperature, time, pH, salt level, chlorine level or other processing characteristics
Hazard Analysis and Critical Control
Point (HACCP) Principles
3. Establish critical limits
• What criteria must be met to control the hazard at that point? Eg. minimum
temperature?

4. Establish monitoring procedures


• What will you measure and how will you measure it?
• How often will the measurements need to be performed to show that the process is
under control?

5. Establish Corrective Actions


• What actions need to be taken if a critical limit is not met?
• The action must make sure that no unsafe product is released
• two purposes:
• control any nonconforming product resulting from the loss of control, and
• identify the cause, eliminate it and prevent the situation from reoccurring.
Hazard Analysis and Critical Control
Point (HACCP) Principles
6. Establish record-keeping procedures
• determine what records are needed to show that the critical limits have
been met, and the system is in control.
• include records from the development of the system and the operation
of the system.

7. Establish verification procedures


• HACCP plan must be validated and audited.
• Ensure HACCP plan is effective in preventing the hazards identified.
• Test the end product, verify that the controls are working as planned.
Good Manufacturing Process (GMP)
• Roadmap of all the steps necessary to ensure high-quality products
are produced every time.

• Elements:
• Documentation
• Standard Operating Procedures
• Specification sheets for ingredients, end-products and packaging materials
• Critical criteria (ensures product / consumer safety)
• Major criteria (avoid poor quality product)
• Minor criteria (minimum product quality that should be met)
• Ingredient & material batch / lot numbers, product batch numbers
• Master formulas
• Batch records
• Quality control

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