Republic of the Philippines

PALOMPON INSTITUTE OF TECHNOLOGY

Palompon, Leyte

COLLEGE OF TECHNOLOGY AND ENGINEERING

Industrial Engineering Department

IT311
MANUFACTURING
TECHNOLOGY

IT311 Manufacturing Technology 1st Semester 2021-2022

 Introduction

Manufacturing is the creation, through one or several processing operations, of

components or products from basic raw materials. The effectiveness of process
selection will be based on the inter-related criterion of design parameters, material
selection and process economies. This course provides introduction to students to the
theory and operation of manufacturing including manufacturing processes and
equipment overview, manufacturing design, production process and flow, materials,
machine operations and logistics.

Course Description: The course will comprise introduction to theory and operation of
manufacturing including manufacturing processes and equipment overview,
manufacturing design, production process and flow, materials, machine operations and
logistics.

Goals and Objectives

1. Introduce the student to processes and equipment utilized in the manufacturing
environment.
2. Compare and contrast different material types and their application.
3. Introduce the concepts of production monitoring and control processes.
4. Explain different forms of production logistics in a manufacturing process.

Learning Outcomes
1. Ability to examine data, ideas, issues and arguments; understand and evaluate
assumptions and evidence; and reach logically valid conclusions.
2. Develop knowledge about technological processes and distinct understanding of
the concepts and outlines of manufacturing technology to be able to assess the
potential for mechanization in manufacturing companies.
3. Ability to confidently communicate and coherently for a specific purpose, while
using and acknowledging sources effectively.

IT311 Manufacturing Technology 1st Semester 2021-2022

Modular Lesson VII – Product and Process Development and
Validation

Objectives:
1. To comprehend the general implications about Product and Process
Development and Validation
2. To develop familiarity of series of activities and operations depicted to Product
and Process Development and Validation
3. To apply the acquired knowledge in the future purpose by using appropriate
sources.

Lesson Content:
7.1 Product and Process Development and Validation

IT311 Manufacturing Technology 1st Semester 2021-2022

7.1 Product and Process Development and Validation
Products should be designed to ensure that the end product meets consumer
expectation within the intended and anticipated circumstances of use, and to ensure
that product design and performance have been fully evaluated for the required function
in respect of microbiological safety, chemical safety, physical safety and sensory
quality.

1.CUSTOMER REQUIREMENTS
Before commencing the design procedure, it is advisable to define the customer
and/or consumer expectations of the new product or process. These should be
established by market research or by direct agreement with the customer. It is also
important to consider whether the food is targeted at a section of the population that is
deemed as a vulnerable group with regard to food safety, for example the elderly, the
young, pregnant women or immunocompromised individuals, and the possible
implications in terms of product design.

Customer requirements may include the utilization of recognized food safety

hazards, for example allergens in the product formulation, a formulation packaging
design or manufacturing process that may lead to higher risk of pathogen survival, or
the use of packaging that in itself presents a food safety hazard,

Due account should be taken of any specific standards that are to be met to
justify special claims (including those related to packaging), specified requirements such
as suitability for a specific nutritional or health purpose, or other particular expectations,
for example:

✔ provenance and geographic location;

✔ environmental benefits, e.g., recycling,
✔ use of novel technology;
✔ claims of being free from specific ingredients, e.g. sugar free;
specific production method: halal, kosher, organic, vegan,
vegetarian;
✔ animal welfare friendly;
✔ diabetic or other health‐related product; or
✔ low‐carbohydrate, low‐fat or suitable for a low‐calorie diet.
Those claims that could be attributed to the product should be
agreed before beginning the design process.

2. DESIGN OBJECTIVES
Before commencing the design of a new product, design objectives should be
established clearly, having due regard to the following requirements:

(i) customer/consumer expectations;

IT311 Manufacturing Technology 1st Semester 2021-2022

(ii) product safety;
(iii) product integrity, including the need for authenticity
markers;
(iv) regulatory requirements for the intended market; and
(v) minimizing operating costs while remaining consistent with the fulfilment of (I), (ii)
and (iii). Design objectives should include acceptance criteria and tolerances.
Establishing tolerances is crucial to achieving customer expectations at a realistic cost.
They may be established by past precedent or by agreement with the customer (e.g.,
the retailer, caterer or distributor).

3. REGULATORY REQUIREMENTS
Were regulatory requirements including statutory maxima or minima for particular
parameters, the design targets should provide at least sufficient margin below the
maxima or above the minima to allow for ingredient composition variation, within and
between batch variation and process variation.

4. PLANNING
Planning for a new process or product should include clear identification of
responsibilities for the design activities, agreed actions and timescales. This is best
achieved through a multidisciplinary project team, which could comprise technical,
production, engineering, marketing, and purchasing and distribution expertise.

In the event of changes to existing products, packaging or processing methods,

the existing HACCP plan(s) and food safety management system (FSMS), quality
management system (QMS) and food integrity management system (FIMS) needs to be
reviewed by the HACCP team and/or project team if they are the same group of
individuals.

Any proposed changes should be validated. Validation should include a range of

trials as applicable to the situation. Validation is the collection and evaluation of
scientific and technical information to determine whether the HACCP plan, when
properly implemented, will effectively control the identified food hazards

5. QUALITY, SAFETY, AND INTEGRITY PLANNING

At each critical stage in the design process (e.g., kitchen, pilot scale, pre‐
production factory trials, first production, packaging trial, distribution (transit) trial, retail
trial) it is essential to verify that the product meets its agreed design criteria and agreed
tolerances, and that the HACCP study has been successful in effectively managing food
safety hazards. This can be achieved in a number of ways, including:

• shelf‐life testing;
• quality control testing of microbiological, chemical and sensory
parameters and packaging;

IT311 Manufacturing Technology 1st Semester 2021-2022

• market trials;
• process monitoring; and
• checks for compliance with regulatory requirements.

The trials should be undertaken in accordance with documented procedures and

the results of the trials should be documented and retained. If the factory trials and
associated testing form part of the validation process for the HACCP plan and general
FSMS and FIMS, these should be referenced within the HACCP documentation. The
FSA
publication E. coli O157 – Control of cross‐contamination:

Guidance for food business operators and enforcement authorities (2014) stress
the importance of not only validating the HACCP plan, but also focusing on validating
the control measures in place to ensure that bacterial loading on fresh produce is
reduced on receipt, that physical separation of materials is effective and that
disinfectants are purchased and used in compliance with validated dilution levels and
contact times.

Nutrition analysis should be undertaken to ensure that at the end of the shelf life,
nutrient values comply with the product label, especially where the original design
phase involved calculation of nutrition content from standard sources. This is critical
where nutritional claims are made for the product, for example ‘Free from ‘high in and
low in claims. A food crime risk assessment needs to be undertaken to deter mine the
potential vulnerabilities associated with the new products and any potential integrity risk,
or areas where transparency is weak or there are potential threats that need to be
adequately controlled

A quality plan needs to be developed to manage key product quality parameters.

Guidance on the development of quality plans can be accessed in ISO 10005:2005
Quality management systems – Guidelines for quality plans.

Failure to achieve the design objectives can be caused by three factors: unrealistic
initial design objectives, an inadequate HACCP study, risk assessment or quality plan,
or failure to implement the requirements properly within the product development
process. In all cases the entire new product development procedure should be revisited,
although revision of the initial objectives and design criteria may be considered if the
end result is demonstrably acceptable to the manufacturer and their customers in all
respects despite the failure to meet an original design objective that is no longer
deemed necessary. If the
objectives are changed at any point during the design and development process, a
thorough re‐evaluation of the implications of the changes in terms of food safety,
integrity and quality must be made.

6. LABELLING

IT311 Manufacturing Technology 1st Semester 2021-2022

 Checks should be undertaken to ensure that the labelling of the new product is
legal and in accordance with the formulation and product specification. These checks
should include weight control and volume control information, nutrition information,
allergen information, customer storage instructions, cooking and preparation methods
and other instructions for use, and product durability information

IT311 Manufacturing Technology 1st Semester 2021-2022