Quality Management Plan Template

DRAFT Template

QUALITY MANAGEMENT PLAN

[PROJECT NAME]

Tetra Pak Processing Solutions

DATE

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INTRODUCTION
The Quality Management Plan is an integral part of any project management plan. The purpose
of the Quality Management Plan is to describe how quality will be managed throughout the
lifecycle of the project. It also includes the processes and procedures for ensuring quality
planning, assurance, and control are all conducted. All stakeholders should be familiar with how
quality will be planned, assured, and controlled.

The Quality Management Plan for the [Project Name] project will establish the activities,
processes, and procedures for ensuring a quality product upon the conclusion of the project. The
purpose of this plan is to:
 Ensure quality is planned
 Define Project Quality KPI’s
 Secure Quality & Process capability
 Define Supplier Validation activities
 Define External Product Validation activities (PPAP)
 Define Internal Product Validation activities
 Define acceptable quality standards & validation levels

Key Points in defining the Quality Management Plan are

 What is the mission, vision and scope
 What is in scope – Whati is out of Scope
 What in existing systems needs update (Focus on change needs)
 How to validate quality prior to producing commercial units?

QUALITY MANAGEMENT APPROACH

[Quality must always be planned into a project in order to prevent unnecessary rework, waste,
cost, and time. When planned, Quality should be considered from both product and process
perspective. The organization must have a standardized approach to quality and it must be
defined and communicated to all project stakeholders.]

Vision & Mission

[Define the Overall Quality targets (KMI) of the transfer.]

Scope
[Define the Overall Scope of the Quality activities in the project:
 Internal External Activities
 Products
 Parts

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 Tests
 Systems
 Etc.]

Key Performance Indicators

Key Performance Indicators (KPI) are established and used to measure quality throughout the
project life cycle to monitor both product and process compliance. These product and process
measurements will be used as criterion in determining the success of the project and shall be
reviewed regularly by Project Management and by the project steering group.

Product Metrics used in the project are:

– Cost of Customer Claims /equipment measured up until 2 months after
delivery/commissioning
– Number of Technical Issues (TI) /equipment measured up until 2 months after
delivery/commissioning
– Number of INC/delivered machine
– Number of Rework hours/delivered machine
– Product Yield
– Material Yield
– Supplier First Time Right rate (FTR)

Process Metrics used in the project are:

– % Correct Specifications/drawings at drawing review
– % of INC eradicated through SEA or WCM Teams
– % of Engineering Change Requests (ECR) submitted by Production/SM
implemented
– % of Audit Plan performed
– % of suppliers reaching CSM compliance level before production start up
– % of sourced articles covered by Product Validation process

Targets and subtargets are defined in the Quality Validation Plan: [Link]

Competence & Training Plan

A skills matrix have been created and filled out by all Project Team members to assess gaps in
critical competence areas (Project Management, Quality, Finance etc) [Link to Skills Matrix]

A Training Plan for all staff involved in Quality activities such as KPI reporting, Supplier
Validation, Product Validation, Process mapping, FMEA, Control Plan creation etc, has been set
up and shall be executed accordingly. This training plan also covers all technical trainings
planned for all staff in order to produce the machinery (New Processes, New Methods & New
tools)

Items covered by the Training Plan:

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– Secure correct use of systems and routines for handling Claims, TI,I NC's &
ECR/ECM
– Supplier Validation & Supplier Auditing
– Product Validation Tools
– PFMEA
– Control Plans
– Technical aspects & new Production Processes
– New Tools & Systems

[Link to Training Plan]

SUPPLIER VALIDATION
The Supplier Validation follows the Global Process for Supplier validation as described in
POINT: http://pointprocesses.tetrapak.com/Processes/TPPS/Base%20configuration/
BusinessProcessNetwork/4ce94290-d672-45fc-861b-265bcf310a75.html

And in the Supplier validation Guideline:

https://teamsite.tetrapak.com/sites/004084/Supplier%20validation%20process/Supplier
%20Validation%20Process%20guideline.pptx

Supplier Development Audits:

Global Supplier Management shall together with and with guidance of the Supply Chain Quality
Team, perform Supplier Assessments and Audits at each potential supplier before supplier
selection, to ensure that necessary information is available before supplier selection is done.

The table below provides the high level Supplier Audit plan for the [Project Name] Project.

Material Supplier Date for Date for Targeted CSM

Assessment CSM Approval Level

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After Supplier Assessment and Supplier Audit the SC Quality lead Auditor shall present findings
for the project team and recommend path forward. After a Supplier Selection the Lead Auditor
shall facilitate the set up of an improvement plan with the supplier to close and prioritized gaps
found during the audit. The assigned Supply Manager is responsible to report the progress on the
improvement plan to the Project Manager.

The table below provides the key Supplier improvements for the [Project Name] Project.

Material Supplier Improvement Area Date for

Compliance

EXTERNAL PRODUCT VALIDATION

The External Product Validation follows the Global Process for Product Validation as described
in POINT:
http://pointprocesses.tetrapak.com/Processes/TPPS/Base%20configuration/
BusinessProcessNetwork/35531bca-54a7-4b9a-ab41-d364d4c6fe1f.html

And in the Product Validation Guideline:

https://teamsite.tetrapak.com/sites/004084/Product%20validation%20process/Product
%20Validation%20Process%20guideline.pptx

Product Validation Tool Kit:

https://teamsite.tetrapak.com/sites/004084/Product%20validation%20process/Product
%20Validation%20Tool%20kit,%20rev%20%201.0.xlsx

First Article Inspection:

All parts in first time buy shall be inspected by Incoming Quality Control. (IQC) Resources for
IQC has been secured with responsible Line Manager.

Product Validation:
Product Validation process shall be run on all parts sourced with new suppliers, or when the part
is new to the supplier. Detailed Product validation Plans shall be set up for each supplier and be

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governed by Supplier Management. These plans shall contain necessary Supplier training needed
both on Technical Product aspects, as well as How to run the Product validation process

Overall Plan for External Product Validation:

Process step Date Comment

Item Risk Analysis done
Critical & Additional Product Requirements defined
Drawing Reviews conducted
Authorized Engineering Changes made
Process Charts/Sequence Schedules done
PFMEAs performed
Control Plans created
WPS done
Checking Aids and Master Samples Produced
SOP’s made
Production Start
Goods Dispatch
IQC & Product Validation completed

INTERNAL PRODUCT VALIDATION

The Internal Product Validation follows the Global Process for Product Validation. The Internal
Product Validation includes:

Process step Date Comment

Product Risk Analysis done Sending Site
Critical & Additional Product Requirements defined Sending Site
Drawing Reviews conducted Sending & Receiving Site
Authorized Engineering Changes made Sending Site
Process Charts/Sequence Schedules done Receiving Site
PFMEAs performed Receiving Site
Control Plans created Receiving Site
WPS done Receiving Site
Pressure Vessel Requirements Clarified Receiving Site
mpFC requirements Clarified Receiving Site
Checking Aids and Master Samples Produced Sending & Receiving Site
Test Procedures Transfered Sending & Receiving Site
SOP’s made Sending & Receiving Site

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Production Start Receiving Site

QUALITY VALIDATION PLAN

The Quality Validation defines what targets need to be achieved in order to validate the Quality
Processes for the Production.

[Link to Quality Validation Plan]

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