5. Quality assurance in food industry

What is food quality control (QC)?

The core mechanism of quality control is to maintain desired quality in product and production process by:

• Measuring product and process properties

• Comparing measurement outcomes with the standard

• Taking necessary corrective action(s)

What is food quality assurance (QA)?

• The objective to quality assurance is to guarantee that quality requirements are realized

• Quality assurance should provide confidence to government, customers, consumers

• Quality assurance is especially important for the food industry to ensure that food is safely produced.

• Critical product quality points and critical process quality points are regularly audited (internal and external)

The core mechanism of quality assurance

• The translation of assurance requirements of stakeholders into the company-specific quality management system

• Its implementation

• Verifying if the system is executed well

What are key quality assurance activities?

• Setting requirements on quality (and safety)

• Implementation of the requirements

• Validating the effectiveness (in advance)

• Verify and audit whether the system works

• Documenting and record-keeping of all steps above.

Interaction between quality control and quality assurance

Quality assurance depends on quality control

Is it possible to have quality assurance without quality control?

• No, quality control focuses on specific points in the process

• Quality assurance focuses on the whole process.

Quality management (QM)

• Refers to all activities that companies use to direct, control, and coordinate the quality

Quality management system (QMS)

• Quality management system (QMS) includes the organizational structure, responsibilities, processes, procedures, and resources that QM needs.

Food safety management system (FSMS)

• Part of QMS

• Is specifically aimed at realizing and ensuring product safety

How is a QMS or FSMS designed?

• Designed by the use of quality assurance guidelines and standards

  • QA guidelines support in designing a companies’ own specific QMS/FSMS

  • QA standard has a similar function, but in addition a company can be certified against the predefined requirements of the standard (e.g. ISO)

QMS certification

Once a company decides for certification of its QMS (e.g. ISO certification) and independent certification agent is coming to check the QMS on its compliance with the procedures.

Typical QMS decisions

• Critical product properties, critical parameters, critical points in the production process

• Capability of processes, equipment and buildings

• Critical decisions and action points of people

• Responsibilities and procedures in quality systems and auditing

Order of QC, QA and QMS

Primary QA standards and guidelines

• Production environment

• Production system

• Organization

Remember not the different topics but what they entail and what their differences are.

Similarities of QA standards/guidelines:

• Aims for safe and/or high-quality foods

• Describe how to control, monitor, and document activities

Differences of QA/guidelines:

• Regulated by law, retailer or company initiative

• Focus on production environment, food production itself, and/or the complete organization

• Degree of detail and way of structuring

• Focus on one actor of the supply chain, part(s) of the supply chain, or the full supply chain

Principles of codex alimentarius

• The purpose of codex alimentarius is to establish a set of international standards, guidelines and codes of practice for food quality and safety to protect the health of consumers and ensure fair pratices in the internation food trade

  • Designed to ensure international acceptance in terms of quality and economic interest of consumer and to ensure fair trade practices

  • Hygiene guidelines based on scientific principles such as HACCP

Structure of codex alimentarius

• The general principle is an elementary document for production of safe food in agri-food chains, foundation for ensuring food hygiene

• Must be combined with specific codes of hygiene practice and guidelines for microbiological criteria

• Codex General principles of Food hygiene contains:

  • General practical principles of food hygiene

  • Guidelines HACCP application

  • Principles for establishment and guidelines of microbiological criteria for foods

  • Principles for establishment and guidelines to conduct microbial risk assessment

Food labelling requirements of codex

• Name of the food

• List of ingredients (in descending order)

• Net content and drained weight

• Name and address of manufacturer

• Country of origin

• Lot identification

• Date marking and storage instructions

• Instructions for use

Principles of Good manufacturing practice

• Good manufacturing practice is a set of regulations, codes, and guidelines for the manufacture of drug substances and drug products, medical devices, in vivo and in vitro diagnostic products, and foods

GMP for the food industry

Prerequisite programmes (PRPs)

• Objective: prevention of hazards that are not controllable as critical control point (CCP)

  • e.g. contamination by poor equipment design

• Necessary foundation for functional HACCP

• Focus: independent systems not specifically linked to process but applicable to whole company

• Content of detailed description to achieve PRP goals:

  • What? How? When? Who? Where?

Comparison Codex, GMP and PRP

• Codex: general principle of safe food production

• Good manufacturing practices: guidelines of hygienic food production

• Prerequisite programs: necessary foundation for a functional HACCP system (focus on control)

Principles of hazard analysis critical control points (HACCP)

• A systematic approach to the identification, evaluation and control of those steps in food production that are critical to food safety

• Basic aim is assuring production of safe food products by prevention instead of by quality inspection.

Seven core principles of HACCP

4. = Quality control

7. = Quality Assurance

Principles of well known ISO standards

• ISO 9001 and ISO 22000 are among ISO’s most well-known standards in food industry

• ISO 9001 helps organizations to implement quality management

• ISO 22000 helps food productio nchains to ensure food safety

Principles of ISO 9001

• It is generic:

  • For any organization, large or small, whatever its product or service, in any sector (private, public)

• It is a quality management standard with focus on finding and preventing nonconformities during production and supply process and preventing their recurring appearance

7 core principles of ISO

Structure ISO 9001:2015

• ISO 9001:2015 deals with managing all processes with a company to research high product and/or service:

  • It is not a product/service standards

  • It is a process standard

  • It can be sued by product manufacturers and serivce providers

• Processes affect final products or services

• ISO 9001:2015 gives the requirements for what the organization must do to manage processes affecting quality of its products and services

• Major change to ISO 9001:2008 is ‘risk based thinking’ in stead of ‘preventative thinking’

ISO certification

• Certification means that an independent, external
  body has audited an organization's management system and verified that it conforms to the requirements specified in the standard

• ISO does not carry out certification and does not issue or approve certificates; national certification bodies do

• Certification is not a requirement of ISO 9001, an
  organization can implement and benefit without having it certified

ISO Certification as a business decision

• Certification is a decision to be taken for business
  reasons

• if it is a contractual, regulatory, or market
  requirement

• if it meets customer preferences

• it is part of a risk management programme

• if it will motivate staff by setting a clear goal

Principles of ISO 22000

• Objective: integrity of food supply chain by minimzing hazards throughout the chain by ensuring there are no weak links

• It specifies how:

  • To carry out the hazard analysis

  • To design the prerequisite programmes

  • to decide which are operational prerequisite programmes

  • to design the HACCP plan

• Based on 9001 and includes HACCP

• Mix of management and process approach rather than a product approach

QA trends in food supply chains

1. Complex international food production chains

When a product comes and goes to so many places, then who is responsible?: the company from which the product is bought.

2. Integrated food production chains

3. Shorter food production chains