2. ISO 9000 Definitions
• Quality Control: “A part of quality management focused on fulfilling quality
requirements”.
• Quality Assurance : A part quality management focused on providing
confidence that quality requirements will be fulfilled.”
3. IS QC = QA?
• Quality Control –
• What: The activities or techniques used to achieve and maintain the product quality, process
and service. –
• How: Finding & eliminating causes of quality problems through tools & equipment so that
customer’s requirements are continually met. •
• Quality Assurance –
• What: Prevention of quality problems through planned and systematic activities including
documentation. –
• How: Establish a good quality management system and the assessment to fits adequacy&
conformance audit of the operation system & the review of the system itself
4. Comparative analysis
Quality control
• Product Reactive
• Line Function
• Find the defects
• Walk through
• Testing
• Inspection
• Checkpoint Review
Quality Assurance
• Pro-active
• Staff Function
• Prevent the defects
• Quality Audit
• Defining Process
• Selection of tools
• Trainings
5. Objectives of quality control
• 1. To establish the desired quality standards which are acceptable to the customers?
• 2. To discover flaws or variations in the raw materials and the manufacturing processes in order to
ensure smooth and uninterrupted production.
• 3. To evaluate the methods and processes of production and suggest further improvements in their
functioning.
• 4. To study and determine the extent of quality deviation in a product during the manufacturing
process.
• 5. To analyse in detail the causes responsible for such deviation.
• 6. To undertake such steps which are helpful in achieving the desired quality of the product.
6. Functions of quality control programme
• Physical and chemical evaluation of raw materials and processed products.
• Control of
• a) Raw materials, ingredients and packaging supplies.
• b) Processing parameters.
• c) Finished products.
• Microbiological analysis and control of raw materials and finished products.
• Control of storage and handling conditions.
• Sanitation and waste products control.
• Assurance that final products are within the legal and marketing standards established.
7. Quality control procedures
• Ingredient Specifications
• Approved Supplier List
• Product Formulas p Product Standards (Specifications)
• Manufacturing Procedures
• Critical Control Point Identification/Sampling Program
• In-Process Analysis, Records and Reporting Packaging Specifications
• Label Specifications
• Cleaning and Sanitizing Program
• Good Manufacturing Practices (GMP) Requirements
• Recall Program Warehousing, Shipping and Receiving Program
• Laboratory Analysis
8. Quality Assurance procedures
• Compliance with specifications. Legal requirements, industry standards, internal company
standards, shelf-life tests, customers’ specifications.
• Test procedures. Testing of raw materials, finished products, in process tests.
• Sampling procedures and schedules. Suitable sampling schedules should be used to
maximize the probability of detection while minimizing workload.
• Record-keeping and reporting procedures. Maintenance of all QA records so that customer
complaints and legal problems can be dealt with.
• Troubleshooting. Solution of problems caused by poor quality raw materials, erratic
supplies, malfunctioning process equipment; investigation of reasons for poor quality
product to avoid repetition.
• Special problems. Customer complaints, production problems, personnel training, short
courses, etc.
9. • Education
• Training
• Special projects
• Standards
• Consulting
• Auditing the quality program
10. Class Activity:
• 1.Frame the quality control procedures for a milk processing plant
• 2. Correlate the QA procedures sampling, special programs and audit
planning
11. The specific responsibilities of quality control assigned to a department or to an individual include:
• Standardizing procedure for sampling and examining raw materials.
• Development of test procedures.
• Establishment and implementation of quality standards for fresh and processed products.
• Setting up preventive quality control methods for in-plant liaison between manufacturing section and test laboratories.
• Examination of finished products.
• Storage controls.
• Sanitation inspection
• Conformance to food regulations
• Waste disposal control
• Research and development into new products and their packaging.
12. ISO 9000
• Set of standards Quality mgmnt
• Customers quality requirements
• Meet the applicable regulatory
requirements
• To enhance customer satisfaction
• Continual improvement
Note:Known as generic management
15. ISO 9000
• 8 Principles of QMS
• 12 Fundamentals of QMS
• 84 terms and definitions
16. 12
fundamentals
Rationale for QMS
Requirements for QMS and products
Approach of QMS
Process approach
Quality policy and quality objective
Role of top mgmnt within QMS
Documentation
Continual improvement
Role of Statistical techniques
Qms and other mgmnt system focuses
QMS and excellence models
18. STEPS FOR IMPLEMENTING QMS
• Identify the goals
• Identify the expectation from others
• Obtain information from ISO 9000 family
• Apply the standards
• Obtain guidance within QMS
• Establish current status,analyze the gaps and requirements
• Determine the process
• Develop a plan
• Carry out a plan
• Undergo periodic assessment
• Demonstrate the conformance
• Audit /improvement
20. Quality manual
• Establishments and evolution
• Position in the supply chain
• Suppliers and customers in chain
• Site related details
• Quality policy and related objectives
• Applicable statutory and regulatory requirements
• Structure of QMS documentation
21. Mandatory procedures
• Control of documents
• Control of records
• Internal audit
• Control of NC
• Corrective action
• Preventive action
22. 6 compulsory documents
Control of
documents
1
Control of
records
2
Internal audits
3
Control of Non
conforming
product
4
Corrective action
5
Preventive action
6
23. Standard Operating Procedures
• Procedure for training
• Procedure for maintainance
• Identification and traceability
• Purchase
• Handling potential NC
• Verification for raw material stores,finished products,
• For dispatch
• Handling customers
24. Formats and records
• Current competence of all records
• Calibration of instruments
• Outcome of internal audits
• Output of management review
• Corrective actions
• Training and its effectiveness
• Product design review.verification,validation,
• Corrections of NC
• Release of end product
25. Miscellaneous documents
• Statutory and regulatory requirements
• Quality policy
• Quality objectives
• List of available resources
• Customer requirements
• Technical documents
26. ISO 9001:2000-CLAUSES
• SCOPE
• NORMATIVE REFERENCE
• TERMS AND DEFINITIONS
• QMS
• MANAGEMENT RESPONSIBILTY
• RESOURCE MANAGEMENT
• PRODUCT REALIZATION
• MEASUREMENTS ANALYSIS AND IMPROVEMENT
28. Clause 4:Quality management system
4.1 general requirements
4.2 Documentation requirements
4.2.1 general
4.2.2. quality manual
4.2.3 Control of documents
4.2.4 control of records
30. 5.5 responsibility authority
and communication
• 5.5.1 Responsibilty and
authority
• 5.5.2Management representative
• 5.5.3Internal communication
5.6 Management review
• 5.6.1 general
• 5.6.2 review input
• 5.6.3review output
31. CLAUSE 6:Resource management
6.1 Provision of
resources
6.2 human resources
• 6.2.1.general
• 6.2.2 Competence,
Awareness and Training
6.3 infrastructure
6.4 Work
environment
32. CLAUSE 7:Product realization
7.1Planning of product realization
7.2 Customer related processes
7.2.1 determination of requirements related to product
7.2.2 review of requirements related to product
7.2.3.customer communication
33. • 7.3 design and development
• 7.3.1 design and development planning
• 7.3.2 design and development inputs
• 7.3.3 design and development output
• 7.3.4 design and development review
• 7.3.5 design and development verification
• 7.3.6 design and development validation
• 7.3.7 control of design and development changes
34. • 7.4 Purchasing
• 7.4.1 purchasing process
• 7.4.2 purchasing information
• 7.4.3 verification of purchased product
35. • 7.5 production and service provision
7.5.1 control of production and service provision
7.5.2 validation of processes for production and service
7.5.3 Identification and traceability
7.5.4 Customer property
7.5.5 preservation of product
36. Clause 8 Measurement analysis and
Improvement
• 8.1 General
• 8.2 monitoring and measurement
8.2.1Customer satisfaction
8.2.2 internal audit
8.2.3 monitoring and measurement of processes
8.2.4 monitoring and measurement of product
37. • 8.3 control of NC
• 8.4 Analysis of data
• 8.5 Improvement
8.5.1 continual improvement
8.5.2 corrective action
8.5.3 preventive action
