Quality Manual 9001-2015 06-10-2021

PPC Flexible Packaging LLC- Buffalo Grove, IL Page 1 of 27
ISO 9001:2015
Quality Manual Revision Date:
Approved: Darshit Shah 06/10/2021
TABLE OF CONTENTS:
POLICY CONTENTS PAGE PROCEDURE

Table of Contents 1
Manual status 3
Page revision status 4
Introduction 4
0.1 General 4
0.2 Principles 4
0.3 Process Approach 4
0.3.1 General
0.3.2 Plan-Do-Check-Act
0.3.3 Risk Based Thinking
1.0 Activities, Scope and Permissible Exclusions 5
2.0 Normative reference 5
3.0 Terms and definitions 6
4.0 Context of the Organization 6
4.1 General QMS requirements 6
4.2 Needs & Expectations (Quality Manual) 7
4.3 Scope of the QMS 8
4.4 QMS & Processes 9
4.4.1 The processes
4.4.2 Maintain / Retain Documented Information QP-7.5; Doc & Data
5.0 Leadership 12 QP-7.6 Quality Records
5.1 Leadership & Management commitment 12
5.1.1 General QP-5.1; QP-6.3 Quality
Plan
5.1.2 Customer Focus QP-10.2 Corrective Action
5.2 Quality Policy 13
5.3 Roles; Responsibility & Authority 15
6.0 Planning Quality Objectives 16
6.1 Addressing Risk & Opportunities 16
6.1.1 Quality Management System Plan
6.1.2 Organizational Plan
6.2 Quality Objectives and Planning 16 QP-8.0; Sales Order
6.2.1 Establishing Objectives QP-7.5 Doc & Data
6.2.2 Achieving Objectives
6.3 Planning of Changes 17 QP-7.2 Training
7.0 Support 17 QP-7.0 Job Descriptions
7.1 Resources 17
7.1.1 General
7.1.2 People
7.1.3 Infrastructure WI-7.1 P/M
7.1.4 Environment of Processes
7.1.5 Monitoring and Measuring QP-7.5; QP-9.0 Inspect /
Test
7.1.5.1 General QP-7.1 Calibration
7.1.5.2 Measurement Traceability
7.1.6 Organization knowledge QP-7.0; QP-7.2 Training
7.2 Competence 18 QP-9.1; Inspect & Test
QP-7.2
7.3 Awareness 19
7.4 Communication 19 QP-8.0; Sales Order Entry
7.5 Documented Information 19 QP-7.5 Doc & Data
information
7.5.1 General
7.5.2 Creating and Updating QP-7.5 Doc & Data
Control
ISO 9001:2015
7.5.3 Control of Documented Information QP-8.0; QP-7.5; QP-7.6

7.5.3.1 Methods and Activities QP-9.0; 7.1; 9.1; 8.7
8.0 Operation 20
8.1 Planning and Control 20 QP-6.3 Quality Planning
8.2 Requirements of Products and Services 20
8.2.1 Communication and Product Requirements WI-8.5-6 General specs;
QP-8.0
8.2.3 Review of requirements and product
8.2.4 Changes to requirements and product QP-8.0 Sales Order Entry
8.3 Design and Development 22
8.4 Control of External Documents 22 QP-7.5 Doc & Data
Control
8.4.1 General
8.4.2 Types and Extent of (Purchasing) Control
8.4.3 Information from External Providers
8.5 Products and Service Provision 22
8.5.1 Control of Product and Services WI-8.5; WI-8.13; WI-7.1
P/M
8.5.2 Identification and Traceability
8.5.3 Customer Property QP-8.5 Customer Supplied
8.5.4 Preservation of Product
8.5.5 Post Delivery Activities QP-6.3. Quality Plan; WI-
9.16
8.5.6 Control of changes
8.6 Release 24 QP-9.0; 9.1; 9.2; QP-8.5.1
8.7 Control of Non-conforming outputs QP-8.7 QC in Process &
N/C
8.7.1 Identification and Control
8.7.2 Documentation
9.0 Performance Evaluation
9.1 Monitoring, Measurement and Evaluation
9.1.1 General
9.1.2 Customer Satisfaction
9.2 Internal Audits 25 QP-9.2 Internal Audits
9.2.1 Internal Audits
9.2.2 Audit Program
9.3 Management Review 26 QP-9.3 Management
Review
9.3.1 General
9.3.2 Inputs
9.3.3 Outputs
10.0 Improvement 26
10.1 General 26
10.2 Non-conformity and Corrective Action 26
10.2.1 Action to Control and Correct
10.2.2 Documented Information
10.3 Continual Improvement 27 QP-10.3
ISO 9001:2015
Details of Changes Date Authorized By

Conversion to ISO 9001:2015 Standard
1/8/16 Bob Roach
Management rep change from Bob
Roach to Vince Maltese 10/17/17 Vince Maltese
Company name change 2/23/18 Vince Maltese
Addition of Interested parties to section
4.1 11/28/18 Vince Maltese
Management representative changed
from Vince Maltese to Darshit Shah,
Changed Format of Manual index,
adjusted manual format, Added COO
and GM position in section 5.1, Changed
Quality Policy Statement to Food safety
and Quality Policy Statement in section
5.2, Obsoleted Performance Appraisals
Form F-7.2-11 from section 5.3 and
section 7.2, Changed position mentioned
of VP of Marketing to General Manager 06/03/2020 Darshit Shah
and added Plant Manager in section 6.1
and section 7.1.3, Changed Axapta to
Radius ERP in section 7.5.3, Changed
Customer/Supplier Credit Form to
Customer credit form in section 8.5.4,
Obsoleted Form F-9.1-3 and F-9.1-4
from section 9.1.2, Changed reaction
point from “B” to Fair.
Section 4.1- Obsoleted key principles
from this section as it is covered in
following section, changed Interested
parties, obsoleted neighbours and
financial institutions.
Section 4.2 – Obsoleted Neighbours and
Financial institutions from interested
parties
Section 4.4.1 – Adjusted 8 key process
to 7 key processes by integrating
Contract review and Customer
Satisfaction into one and defined all key 12/01/2020 Darshit Shah
process in detail.
Section 5.0 – Changed Top
Management Responsible Person for
QMS.
Section 6.0 – Defined section 6.1.1 and
section 6.1.2
Section 4.2 – Corrected Statutory and
Regulatory agencies names for
Reference Standards.
Section 5.2 – Changed Quality Policy to 06/10/2021 Darshit Shah
comply with SQF Requirements.
Section 9.1.2 Customer Satisfaction –
replaced form with customer surveys.
ISO 9001:2015
INTRODUCTION
0.1 General
The Quality Management System is a strategic system for an organization that can help to improve its overall
performance and provide a sound basis for sustainable development initiatives.
The design and implementation of an organization’s QMS is influenced by its business environment, changes in that
environment, or risk associated with that environment, its varying needs, its particular objectives, the products it
provides, the process it employs, its size and organizational structure.
This International Standard can be used by internal and external parties, including certification bodies, to assess the
organizations ability to meet customer statutory and regulatory requirements applicable to the product, and the
organizations own requirements.
The potential benefits to an organization of implementing a quality management system based on this International
Standard are:
a) the ability to consistently provide products and services that meet customer and applicable
statutory and regulatory requirements;
b) facilitating opportunities to enhance customer satisfaction;
c) addressing risks and opportunities associated with its context and objectives;
d) the ability to demonstrate conformity to specified quality management system requirements.
0.2 Quality Management Principles
This International Standard is based on the quality management principles described in ISO 9000. The descriptions
include a statement of each principle, a rationale of why the principle is important for the organization, some examples
of benefits associated with the principle and examples of typical actions to improve the organization's performance
when applying the principle.
The 7 quality management principles are:
a) customer focus;
b) Leadership;
c) engagement of people;
d) process approach;
e) improvement;
f) evidence-based decision making;
g) relationship management.
0.3 Process Approach
This International Standard promotes the adoption of a process approach when developing, implementing and
improving the effectiveness of the quality management system, to enhance customer satisfaction by meeting
customer requirements.
To function effectively the organization has to determine and manage numerous linked activities. An activity or set of
activities using resources, and managed in order to enable the transformation of inputs into outputs, are considered a
process. Often the output from one process directly forms the input into the next.
The application of a system of processes within the organization, together with the identification and interactions of
these processes and their management to produce the desired outcome are referred to as the “process approach”.
An advantage of the process approach is the ongoing control that it provides over the linkage between the individual
processes within the system of processes, as well as over their combination and interaction.
ISO 9001:2015
0.3.1 General
When used within the quality management system, such an approach emphasizes the importance of:
a. Understanding and meeting requirements
b. The need to consider processes in terms of added value
c. Obtaining results of process performance and effectiveness
d. Continual improvement of processes based on objective measurement.
0.3.2 Plan-Do-Check-Act Cycle
The methodology known as “Plan-Do-Check-Act” can be applied to all processes and can be briefly described as
follows:
Plan: Establish the objectives and processes necessary to deliver results in accordance with customer requirements
and the organization’s policies.
Do: Implement the processes
Check: Monitor and measure processes and service against policies, objectives and requirements for the service and
report the results
Act: Take actions to continually improve process performance.
0.3.3 Risk Based Thinking
Risk-based thinking enables an organization to determine the factors that could cause its processes and its quality
management system to deviate from the planned result, to put in- place preventive controls to minimize negative
effects and to make maximum use of opportunities as they arise.
1.0 ACTIVITIES, SCOPE AND PERMISSABLE EXCLUSIONS
PPC Flexible Packaging is the leading manufacturer of Clean Room bags and packaging materials. We customize
bags and packaging programs to fit our customers’ needs.
The success and reputation of the company may be measured by the high standing of its customers. A policy of
continuous self-appraisal and attention to detail has ensured the expansion of its customer base.
The company has implemented a quality management system to demonstrate its ability to provide consistent products
and service that meet customer and applicable statutory and regulatory requirements.
This will enable the company to address and achieve customer satisfaction through the effective application of the
system, including processes for continual improvement and the prevention of nonconformity and applicable statutory
and regulatory requirements.
The scope of the quality management system applies to the Quality Management System for the manufacturing of
plain and flexographic printed, Precision Clean cleanroom bags, pouches and packaging materials, with
warehousing and distribution coordinated from 1700 Leider Lane, Buffalo Grove, Illinois, USA, 60089-4504
2.0 NORMATIVE REFERENCE
This quality manual defines the policies and principles applied against each of the requirements of ISO 9001:2015 and
relates to all activities carried out in the organization that determine quality, and lays down guidelines within which the
organization can operate.
Each section of the manual is related to an identified section of ISO 9001:2015.
DISTRIBUTION
The Quality Representative is responsible for the Master Copy of the QM and ISO system list.
ISO 9001:2015
UNCONTROLLED MANUALS
Uncontrolled manuals are up-to-date at issue and are only issued to outside organizations, customers, etc. Such
uncontrolled manuals will be clearly marked ‘Confidential’ and ‘Uncontrolled’.
3.0 TERMS AND DEFINITIONS
The following terms and definitions are provided to assure a uniform understanding of selected terms as they are used
in these requirements.
 ORGANIZATION means PPC Flexible Packaging
 SUPPLIER means the party to whom an order has been placed by the organization for the purchase of
supplies, or the execution of a specific part of a particular order.
 CUSTOMER means firm or person having a contractual agreement with, or the recipient of a product and
service the organization.
 PRODUCT means the result of a process, which is the combination of some of the four generic product
categories, services and processed materials.
4.0 CONTEXT OF THE ORGANIZATION
4.1 GENERAL QMS REQUIREMENTS
PPC Flexible Packaging, LLC has identified the external and internal issues relevant to its purpose, strategic
direction, and those that affect our ability to achieve the intended results of our quality management system
as:
Potential and Actual Issues from the Interested Parties may

Interested Parties
include but are not limited to:
End Users  NC Products (Field Failures)
 Not complying with Customer Specific Requirements (NC
Customers Product or Service related issues)
 Poor Customer Satisfaction Survey Results
 Supplier Performance as it relates to On Time Delivery and
Suppliers Quality Issues affecting PPC FLEXIBLE PACKAGING, LLC
or its Customers
 Business Growth
 Competition in Marketplace
 Economic Environments
 Producing NC Products
 Late Deliveries
Staff & Employees
 Safety Related Issues
 Injuries on the Job
 Not having appropriate information on how to process jobs
 Lack of training
 Lack of Qualified Workforce – difficulties in finding
employees willing to work
Statutory and/or Regulatory  Not complying with applicable Legal and / or Regulatory
Agencies requirements
Morgan Stanley  Profitable
ISO 9001:2015
 Growth
 Comply with applicable Statutory and Regulatory
requirements
 Safety
 Organizational collaboration
4.2 UNDERSTANDING NEEDS & EXPECTATIONS
The quality management system based on the requirements of ISO 9001:2015 describes how the organization’s
program is designed to ensure that customer’s quality requirements are recognized and that consistent and uniform
control of these requirements are adequately maintained. This manual describes how effective control is established
by the use of formal written procedures, and also as required by contract.
The quality management system documentation includes:
 Documented procedures and records required in this International Standard including a quality manual,
quality policy and quality objectives
 Documents, including records, determined by the organization to be necessary to ensure the effective
planning, operation and control of its processes in the form of written or visual reference standards of
acceptability and verification methods at various stages of the process which may arise from:
 Contractual requirements from the customer or other interested parties.
 Acceptance of international, national, regional and industry sector standards.
 Relevant standards, statutory and regulatory requirements; such as KSC-C-123J; ISO 14644-1 & 2
Cleanroom operations & validation; Mil Specs; IEST Std-CC-1246D; OSHA and FDA regulations as
shown in the Letter of Continuous Guarantee.
 Decisions by the organization.
a) the requirements of these interested parties that are relevant to the quality management system have
been identified as follow:
Requirements of the Interested Parties may include, but are not

Interested Parties
limited to…
 Products that meet agreed upon specifications
 Timely delivery of products to their intended destination
 Timely resolution of any issues which do not conform to customer
Customers & End Users requirements
 Competitive Pricing
 Instructions for Safe and Proper Use
 Safety and Technical Information
 Adequate planning information in order to enable suppliers to meet
PPC Requirements for quality and delivery
Suppliers
 Timely payment for products and/or services
 Accurate Purchase Order Information and Lead Times
 Safety
 Quality
 Delivery
 Cost
 Profitability
Management Team
 Efficiency
 Staffing
 Business Growth
 Product and/or System Certifications
 Timely payment for products and/or services
ISO 9001:2015
 Safe Working Environment

Employees  Effective Training
 Competitive Wages
Statutory and/or  Product Registration
Regulatory Agencies
 ASTM
 Clean Room Certification to ISO 14644; Class 4 (Formerly
Federal Standard 209E) and ISO 14644; Class 7
 Kennedy Space Center standard KSC-C-123J for particle counts
 Johnson Propulsion Group Standard (JPG 5322.1)
 Institute of Environmental Standards (IEST STD-CC-1246E) -
Product Cleanliness Standard
 Institute of Environmental Standards (IEST RP CC0018.4) for
General Practices for Clean Room Housekeeping
 System Registration
 SQF (Food Safety Registration)

 ISO 9001
 Transportation Requirements
 DOT
 USMX / USCA
 FAA
 NELMA
 Federal Regulations
 EEOC
 Minimum Wage Act
 IRS
 OSHA / SDS (Global Harmonization)
 EPA / HAZMAT
 NFPA
 Local Regulations
 Building Codes
 Fire Marshall
 IEPA (Illinois EPA)
 Hand Gun Regulations
 Smoke Free Workplace
 And any additional requirements stipulated by PPC Flexible

Packaging, LLC Customers
 Conflict Mineral - Have recently had Customers inquire about

Conflict Minerals, which is believed to be Not Applicable to
PPC. PPC still provides Declaration Letters to these Customers
 EU- European Union and RoHS Restrictions on Hazardous
Substances (Mercury Free Initiatives - European Directive
2002/95/EC)
 California Proposition 65 compliance has been requested by
certain Customers. PPC has provided them with Declarations of
Compliance. No product markings at this time.
 REACH (Coneg - Heavy Metal Customer requirement for <
300ppm of heavy metals)
 BSE TSE for diseases that could be communicated in beef
ISO 9001:2015
packaging and additives from bovine

 Compliance with, but not regulated to FDA (21 CFR 177.1520)
for Plastic and Polyethylene
 Be responsible neighbour
 Meet Covenants
Morgan Stanley  Compliance with applicable Statutory (Legal) and / or Regulatory
requirements
4.3 SCOPE OF THE QUALITY MANAGEMENT SYSTEM
The organization has determined the boundaries and applicability of the quality management system to establish its
scope. The organization has determined the scope by considering:
a) the external and internal issues referred to in 4.1:

b) the requirements of relevant interested parties referred to in 4.2;
c) the products and services of the organization.
The organization has applied all the requirements of this International Standard applicable within the determined
scope of its quality management system.
Not applicable requirements currently include:
Section 8.3 Design and Development

Section 8.5.1 Servicing portion only
Section 8.5.5 Post Delivery Actions
The scope of the organization quality management system is available and maintained as documented information.
The scope states the types of products and services covered, and provides justification for any requirement of this
International Standard that the organization determines is not applicable to the scope of its quality management
system. Conformity to this International Standard may only be claimed if the requirements determined not applicable
do not affect the organizations ability or responsibility to ensure the conformity of its products and services and the
enhancement of customer satisfaction.
Organization: PPC Flexible Packaging LLC

Organization Abbreviation: PPC
SIC Code: 2673
Physical Address: 1111 Busch Parkway
Buffalo Grove, IL 60089
Phone: 847-541-0000
Fax: 847-541-0075
4.4 QUALITY MANAGEMENT SYSTEM & PROCESSES
4.4.1 PPC Flexible Packaging, LLC has established, documented, implemented, maintains, and continually
improves their quality management system. This includes the identification of QMS Processes and their
interactions in accordance with the requirements of this International Standard.
PPC Flexible Packaging, LLC has determined and identified the processes needed for the quality
management system and their application throughout the organization as:
1) Top Management
2) Contract Review (Customer Service)
3) Purchasing
4) Product Realization
5) Measurement, Analysis and Improvement
6) Document and Data Control
7) Resource Management
ISO 9001:2015
As part of the identification and continued management of these Key Processes, PPC Flexible Packaging,
LLC …
a) has determined the inputs required and the outputs expected from these processes via the System
Process Model Diagram (F 4.4.1) as well as the documented information defined below:
Inputs may include, but are not Outputs may include, but are not
Identified Key Processes
limited to… limited to…
 Management Review Meeting
Minutes
 Development of new and/or
Receive Organized Information
updates to…
and Data with respect to…
 Quality Planning Projects
 Customer Satisfaction,
 Key Process Risk
 Internal Audits,
Assessment Matrix
 Corrective Actions,
Top Management  Continual Improvements
 Customer Complaints,
 Corrective Actions
 Continual Improvement,
 Goals and Objectives
 Quality Objectives,
 Action associated with Goals
 NC Data,
and Objectives
 Resource Needs
 Nonconformances
 Application of resources to be
applied back into the QMS
 Requests for Quotes from
 Quotations o the Customers
the Customers
 Acceptable Contracts between
 Customer Purchase
the Customer and PPC
Orders
Contract Review FLEXIBLE PACKAGING, LLC
 Customer Part Prints
 Risk Assessments
 Customer Specific
(Customer Service)  Quality Planning Checklists
Requirements
 Sales / Work Orders to initiate
 Customer Report Cards
Production Activities
and other Satisfaction
 Customer Satisfaction Data
Data
 Information to qualify new  Quotations from Suppliers
Suppliers  Supplier Qualification Documents
 Data regarding Quality and  Purchase Orders
Delivery performance to  Receiving Records
Purchasing monitor existing Suppliers  Communication Records with the
 Information related to Material Customer regarding damaged,
and / or Service Demands lost, or unsuitable for use
 Receipt of materials needed Customer Supplied Property
to complete Customer Orders
Product Realization  Production Cards  In Process and Finished Goods
 Raw Materials  Completed Inspection
 Components Documentation and Records
 Part Prints  Calibration Records
 Customer Specific  Preventative Maintenance
Requirements Records
 Quality / Inspection Records  Nonconformance Reports
 QMS Documents  Corrective Actions
 New Measurement Devices  Updated Calibration Records
 Calibration Schedule displaying complying results
 Employee Communications  Out of Tolerance Investigations
with respect to device issues  Updated Calibration Stickers
or loss  Certificates of Calibration from
 Preventative Maintenance external calibration sources
Schedule  Updated Preventative
ISO 9001:2015
Maintenance Records
 Evidence of completed Work
 Unscheduled Work Order
Order Requests
Requests
 Copies of External Service PM
Reports
 Internal Audit Schedule
 Scope of Internal Audits
 Internal Audit Note and
 Completed Internal Audit
Record Sheets
Reports
 Customer Complaints
 Corrective Actions (as
 Customer Satisfaction Data
necessary)
 Audit Schedules
 Updated Internal Audit Schedule
 Inspection Requirements and
Measurement, Analysis, and  Completed Inspection
associated documents
Improvement Documentation and Records
 Initiated Nonconformance
 Completed Nonconformance
Reports
(Internal Audits, Corrective Reports
 Initiated Corrective Actions
Action, Continual  Completed Corrective Actions
 Initiated Continual
Improvement)  Completed Internal Audit
Improvements
Reports
 Raw Data for analysis
 Completed Continual
 Management Team
Improvement Projects
Directives
 Continual Improvement Projects
 Employee Recommendations
 Improved Performance
 Customer Feedback
 Projects derived from Best
Practice evaluations
 Document Change Forms  Updated Quality Management
 Corrective Actions System Documents
 Continual Improvements  Completed Document Change
Forms
Document and Data Control  Updates to the Document Master
List
 Updates to the Records Matrix
 Release of Controlled Copies of
applicable QMS Documents
 Top Management feedback
with respect to resource
 Quality Planning Checklists
needs
 Training Records
 Employee Requests for
Resource Management  Employee Competencies
Training
 Training Effectiveness
 Equipment needs based on
Evaluations
PM Data and Customer
Orders
a) Organization has determined the sequence and interaction of these processes via the System Process Model
Diagram (F-4.4.1)
b) Organization has determined and have applied the criteria and methods (including monitoring, measurements and
related performance indicators) needed to ensure the effective operation and control of these processes
throughout the documented QMS (i.e. Quality System Manual, Quality System Procedures, Work Instructions, and
Controlled Reference Documents)
c) Organization has determined the resources needed for these processes and ensure their availability through
conversations and actions resulting from Management Review Meetings, Contract Review activities, Corrective
Actions (including Customer Complaints, Internal Nonconformances, Internal and External Audit results,
Documentation Changes, and any Quality Planning activities
d) Organization has assigned responsibilities and authorities for these processes via the Organizational Chart (F-5.3-
1) and the Responsibilities Matrix (F-5.3-2)
ISO 9001:2015
e) The key processes of the system are managed by representatives of Top Management who provide information,
instruction, and support to their employees.
f) Continually addresses the risks and opportunities as identified and determined in accordance with the
requirements of section 6.1 of this Quality System Manual
g) Continually evaluates the Key Processes and implements any changes needed to ensure that these processes
achieve their intended results via the review of the Goals and Objectives Matrix (F-6.2), Internal Audit activities,
Customer Feedback, Management Review Meeting discussions, and day to day activities;
h) Continually applies methodologies to improve the processes and the quality management system. Actions are
taken as necessary when planned results are not achieved.
4.4.2 PPC Flexible Packaging, LLC has:
a) maintained documented information to support the operation of its processes;
The Quality Management System Documentation structure has been defied as follows…
Tier I Quality Manual

The governing document that defines the scope and processes of the Quality
Management System.
Tier II Quality Procedures

Documents that define Who, What, and When
Tier III Work Instructions / Control Plans

Documents that specifically define how to complete an assigned task
Tier IV Forms
Documents that promote the recording of data and information.
Tier V Quality Records

Documents that provide information on how to complete tasks but do not require the
recording of any data.
Other documents that are controlled but are not considered part of this five-tier structure include
Documents of External Origin.
External Documents are those documents that PPC Flexible Packaging, LLC has no authority
to update or revise.
These documents may include, but are not limited to documents such as…
 the ISO 9001 Standard,

 applicable Industry Specifications,
 Text Books,
 Reference Manuals, and/or
 Drawings
b) Retained documented information in order to support compliance with external and internal requirements,
and to provide PPC Flexible Packaging, LLC confidence that the processes are being carried out as
planned. See the associated Document and Data Control Matrix (F-7.5.1-5)
5.0 LEADERSHIP
5.1 LEADERSHIP & MANAGEMENT COMMITMENT
5.1.1 General
ISO 9001:2015
PPC Flexible Packaging, LLC has defined the Leadership Team / Top Management as the following staff
members:
 Plant Manager
 Quality Manager
Additional staff members may provide input as deemed necessary to assure adherence to the Quality Policy,
the documented Quality Management System, and the Goals and Objectives Matrix (F-6.2-1)
Top Management demonstrates their leadership and commitment with respect to the quality management
system by:
a) Taking accountability for the effectiveness of the quality management system by taking or assigning
actions as a result of Internal and External Audits, as well as any action items generated during
Management Review Meetings;
b) Ensuring that the quality policy and quality objectives are established for the quality management system
and are compatible with the context and strategic direction of the organization (see section 5.2 of this
Quality System Manual)
c) Ensuring the integration of the quality management system requirements into the organization’s business
processes via the documented Quality Management System
d) Promoting the use of the process approach and risk-based thinking per section 6.1 of this Quality Manual
e) Ensuring that the resources needed for the quality management system are available per section 7.1 of
this Quality Manual
f) Communicating the importance of effective quality management and of conforming to the quality
management system requirements via postings and various meetings.
g) Top Management has established and maintains appropriate communication channels as defined in the
System Process Model Diagram (F 4.4.1) and the Organizational Chart (F 5.3-1) to support the
effectiveness of the Quality Management System.
h) Ensuring that the quality management system achieves its intended results via the Goals and Objective
Matrix, Customer Feedback, and Internal and External Audit Results;
i) Engaging, directing, and supporting persons to contribute to the effectiveness of the quality management
system by providing training and assistance with various tasks;
j) Promoting improvement during conversations and application of resources during the Management
Review Meetings.
k) Supporting other relevant management roles to demonstrate their leadership as it applies to their areas of
responsibility.
5.1.2 CUSTOMER FOCUS
The top management have ensured that customer needs and expectations are determined through customer
contact and application, enhancing and maintaining customer satisfaction, manufacturing capability and
contract review and that specifications developed are converted into requirements and fulfilled as measured
by satisfaction surveys, complaints, returns, and Corrective Actions. Statutory and regulatory requirements are
considered when determining these needs and expectations along with risks and opportunities that can affect
conformity of products and services. Related documents include: F-9.1-2, QP-10.2 and F-10.2-2.
5.2 QUALITY POLICY
5.2.1 & 5.2.2 ESTABLISHING & COMMUNICATING -
It is the policy of the organization to provide a range of products, which meet the requirements of its
customers and quality standard parameters, and that orders are maintained on schedule and at the agreed
price. All work is carried out in a cost effective and timely manner, and in accordance with the highest
professional standards aiming for continual improvement and customer satisfaction through the involvement
and participation of all levels of management, staff and other interested parties.
A policy for quality conforming to the requirements of ISO 9001:2015 has been established to ensure that it:
 Is appropriate to the purpose of the organization, the expected level of customer satisfaction as
determined during Management Review
ISO 9001:2015
 Includes a commitment to meeting requirements and to continual improvement

 Provides a framework for establishing and reviewing quality objectives through use of the Key
Process Quality Policy Objective Matrix
 Demonstrates top management commitment and ensures the quality objectives are
communicated, understood and implemented at appropriate levels of the organization
 Is regularly reviewed at the Management Review Meetings for suitability and effectiveness
addressing continual improvement.
Being a small but highly efficient and quality cost conscious organization, and due to its size, a number of
personnel have a dual role within multiple functions to carry out the policy. It is, the organizations intent that
this dual role shall not deter, in any manner, personnel from their prime objective of providing quality products
and service through an adequately controlled quality management system. The initial function of all
management and employees shall be to meet the corporate Food Safety and Quality Policy Statement:
1. PPC Flexible Packaging, LLC Buffalo Grove, IL. is committed to providing safe, quality products that continually
meet or exceed our customer’s expectations for cost control, timelines of response to customer needs, added
product value through partnership practices and continuous customer satisfaction while complying with all
applicable regulations.
2. The company will ensure food safety and quality culture are a priority within the site. Employees are
empowered to “Do the right thing” regarding product safety and quality and are encouraged to communicate
issues to management.
3. Employee and management communication systems are established and include shift-meetings as well as
confidential reporting systems.
4. We will meet these commitments through establishing and monitoring clear objectives, and implementation of
food safety and quality management systems that promote continuous improvement.
a. This will include: Management Meetings, HACCP Plan, Internal Audits, and Corrective Action
Management.
5. Objectives will be reviewed as part of the management review process and include corrective actions when the
objectives aren’t met.
Management is ultimately responsible for making balanced judgements, assessing the significance of
variations in this sphere and taking decisions. In arriving at such decisions, the quality and personal integrity
of staff are of fundamental importance. In this context, all effort is made to ensure that each person in the
organization understands that quality assurance is important to their future, to know how they can assist in the
achievement of adequate quality and are stimulated and encouraged to do so.
This policy is approved by the undersigned and is supported by all the levels of management within the
organization. All personnel shall be guided by the contents of the quality management system and no
deviation from the methods and procedures set down shall be permitted.
Signed: ………………………………… Plant Manager Date: ………………
5.3 ORGANIZATIONAL ROLES, RESPONSIBILITY & AUTHORITY
The responsibilities, authority and the interrelation of all personnel who manage, perform and verify work
affecting quality are defined and communicated in order to facilitate effective quality management via the
Responsibilities Matrix F-5.3-2 and Organizational Chart F-5.3-1
All people have been given authorities and responsibilities to enable them to assist in the achievement of the
quality objectives. This assignment of authority and responsibility helps to establish involvement and
commitment of people throughout the organization.
The responsibility of personnel is given. An individual may be appointed with a dual role, in such cases he /
she will be responsible for fulfilling the tasks assigned to both roles.
ISO 9001:2015
Full written Job Descriptions QP-7.2-1; F-7.2-9 is issued to all personnel and maintained with the Orientation
Check List F-7.2-10.
The top management is responsible for identifying and providing all the necessary resources to meet the
requirements of the quality system and the organization’s customers. These resources include trained
personnel QP-7.2 for the management and performance of work, including system audits and verification
activities.
The top management has responsibility for the overall performance and operation of the organization,
developing the strategy in the short term and long term, ensuring resources are available for the successful
implementation of the strategy. Duties include the future direction of the organization, maintaining customer,
supplier and outsourced liaisons as required.
Top management has responsibility for determining the criteria for recruitment against each of the categories
of staff employed and thus ensuring adequate resources are available.
Management Review minutes and Internal Communication Memo F-5.1 brief staff on product performance,
customer requirements, any recurring problems and obtaining feedback as necessary. Review of staffing and
arrangement for the preparation of any training plans and implementation is carried out by top management at
the Management Review Meetings held twice annually.
Management is responsible for ensuring that organizational performance can be adequately measured to
meet the requirements of its customers and has nominated a Quality Representative with the authority and
responsibility for ensuring that the requirements of the latest issue of ISO 9001:2015 are implemented and
maintained by internal quality audits.
6.0 PLANNING QUALITY OBJECTIVES
6.1 Actions to address risks and opportunities
6.1.1 As part of planning for the continued development of the quality management system, the
organization will consider the issues referred to in Section 4.1 and the requirements referred to in Section 4.2
of this Quality System Manual, and determine the risks and opportunities that need to be addressed to:
a) give assurance that the quality management system can achieve its intended result(s);
b) enhance desirable effects;
c) prevent, or reduce, undesired effects;
d) achieve improvement.
6.1.2 PPC Flexible Packaging, LLC has incorporated Risk Assessment Methodologies in order to:
a) identify actions in order to address identified risks and opportunities;

b) determine the most effective methods to:
1) integrate and implement the actions into the quality management system processes, and
2) evaluate the effectiveness of these actions.
Actions taken to address risks and opportunities will be proportionate to the potential impact on the
conformity of products and services.
See QP 6.1 for further information on Risk Assessment activities
6.2 Quality objectives and planning to achieve them
6.2.1 PPC Flexible Packaging, LLC has established quality objectives at relevant functions, levels, and
processes needed for the quality management system.
The Goals and Objectives Matrix (F 6.2-1) is the primary document that is populated and maintained
with respect to Quality Objectives.
The quality objectives will be:
ISO 9001:2015
a) consistent with the quality policy;

b) measurable;
c) consider applicable requirements;
d) relevant to conformity of products and services and to enhancement of customer satisfaction;
e) monitored;
f) communicated;
g) updated as appropriate.
6.2.2 As part of the Management Review Meetings, Top Management will review existing and define new
objectives that will be utilized to measure the continued suitability and effectiveness of the Quality
Policy.
When planning on how to achieve the identified quality objectives, Top Management personnel will
determine:
a) what will be done;

b) what resources will be required;
c) who will be responsible;
d) when it will be completed;
e) how the results will be evaluated.
Evidence of these actions will be documented semi-annually on the Goals and Objectives Matrix and
reviewed in detail during the Management Review Meetings as a basis for continual improvements (QP 9.3).
6.3 PLANNING OF CHANGES (see 4.4)
When the organization determines the need for changes to the quality management system, the changes will
be carried out in a planned manner consistent with the existing Quality Management System.
This level of planning (Systems Level Planning) is normally initiated during Management Review Meetings in
which potential new or revised programs are introduced (i.e. plans for integrated accounting, manufacturing
software, or updated ISO requirements).
Systems Level Quality Planning activities will be assigned to responsible individuals and be re-reviewed
during Internal Audits and Management Review Meetings to ensure their effective implementation.
 Internal Auditors and Top Management Staff will ensure that the project(s) are being carried out in
accordance with the general quality management system requirements (section 4.4) and the established
quality objectives (section 6.2).
Quality Management System Planning activities will typically be documented on a Quality Planning Checklist
(F 6.3-1), which is the same document utilized for related Product / Process Level Quality Planning activities
(see section 8.1).
Personnel responsible for each Planning Project will consider:
a) the purpose of the changes and their potential consequences;

b) the integrity of the quality management system;
c) the availability of resources;
d) the allocation or reallocation of responsibilities and authorities.
Upon completion of each Systems Level Planning activity and to ensure the integrity of the quality
management system, Top Management will evaluate the effect on the overall adequacy and effectiveness of
the new/updated systems and either officially close the project or provide direction with respect to additional
actions necessary. This is typically performed during the Management Review Meeting.
7.0 Support
7.1 RESOURCES
ISO 9001:2015
7.1.1 GENERAL
The resources needed to develop, implement and continually improve the processes of the quality
management system and to address and enhance customer satisfaction have been determined and
provided in a timely manner to ensure requirements are met.
7.1.2 PEOPLE
Personnel performing work affecting conformity to product requirements defined in the Quality
Management System shall be competent on the basis of applicable education, training, skills and
experience.
The top management has appointed a member of the organizations management with the authority
and responsibility for the development, overall implementation and maintenance of the quality
management system together with the control and issue of all quality documentation.
The Management Representative is responsible for monitoring the system and in particular for
advising and training other personnel in the system, continually looking for improvements. The
Management Representative ensures that internal quality audits are carried out as detailed on the
schedule and that all corrective and preventive actions arising from audits are closed out.
The Management Representative reports quality performance during Management Review, including
needs for improvement and on the awareness of customer needs and requirements throughout the
organization. Awareness of customer needs review, includes supplier performance review, raw
material performance data, shipping performance summary; Supplier and Customer C/A; P/A;
Customer Survey -- analysis of data, Customer Audit summary, continual improvement
accomplishments and goals, Customer Contact Log entries; and Raw Material / Finished Goods reject
list trends and results.
7.1.3 INFRASTRUCTURE
General Manager and Plant Manager has determined via opportunity for growth and the quality plan,
provided and arranged maintenance and improvement for the infrastructure needed to achieve
conformity of requirements including buildings, workspace and associated facilities, process
equipment, computer hardware and software, communication media, shipping / receiving,
warehousing and supporting operations.
The appropriateness of the building, work environment, utilities, process and computer with
supporting systems such as transport, communication or information systems are discussed and
documented twice yearly during the Management Review Meetings.
A maintenance program WI-7.1 specifies the type and frequency of needed maintenance, the
methods for maintenance and the verification of its completion.
7.1.4 ENVIRONMENT FOR OPERATION OF PROCESSES
It is ensured that the working environment in the factory, offices, and site areas is suitable at all times
to achieve conformity to requirements.
Programs maintaining a suitable work environment include, but are not limited to:
- The company supplied uniforms.

- The company supplied Safety Shoe program.
- Positive air flow
- Solvent incineration
- Adherence to EPA and OSHA requirements including maintenance of the MSDS
- Adequate and advanced lighting
- Internal Safety Programs and training
These and associated topics may be discussed, and documented during Management Review and
action taken for continuous improvement as necessary and when opportunity permits.
7.1.5 MONITORING & MEASURING RESOURCES

ISO 9001:2015
7.1.5.1 GENERAL
Monitoring and measurements to be made are identified on the In-process Quality Sheet F-8.6-6
The organization shall determine the monitoring and measurement to be undertaken and the
monitoring and measurement equipment needed to provide evidence of conformity to determined
requirements as controlled through Procedures QP-8.6. Inspection & Testing, Work Instructions,
Document & Data Control QP-7.5-1 and Calibration QP-7.1-5 to ensure that measurement capability
is consistent with the monitoring and measurement requirements.
7.1.5.2 MEASUREMENT TRACEABILTY (Calibration)
Where necessary to ensure valid results, measuring equipment is:
 Calibrated or verified or both at specified intervals and adjusted periodically or prior to use,
against measurement standards traceable to international or national measurement standards.
Where no such standards exist, the basis used for calibration shall be recorded,
 Adjusted or re-adjusted as necessary
 Have identification in order to determine its calibration status
 Safeguarded from adjustments that would invalidate the measurement result
 Protected from damage and deterioration during handling, maintenance and storage
 Recorded with the results of their calibration
 Required to have the validity of previous results re-assessed if they are subsequently found to be
out of calibration.
When used in the monitoring and measurement of specified requirements, the ability of computer
software to satisfy the intended application is confirmed, prior to initial use and reconfirmed as
necessary.
Documented procedures have been established and maintained to monitor and measure the
characteristics of the product to verify that requirements for the product are met. This is carried out at
appropriate stages of the product realization process in accordance with the planned arrangements
(see 7.1).
Evidence of conformity with the accepted criteria is maintained and records indicate the person(s)
authorizing release of the product for delivery to the customer. The release of product and delivery to
the customer does not proceed until the planned arrangements (7.1) have been satisfactorily
completed, unless otherwise approved by a relevant authority and, where applicable, by the customer.
7.1.6 ORGANIZATIONAL KNOWLEDGE
The organization has determined the knowledge necessary for the operation of its processes and
achieved conformity of products and services through an excess of 45 years in business. This
knowledge is maintained and available to the extent necessary. When addressing changing needs
and trends, the organization has considered its current knowledge and determined how to acquire or
access any necessary additional knowledge such as through Contract Review and the External
Documents Log F-8.4 requiring periodic updates.
ISO 9001:2015
7.2 COMPETENCE (Training)
It is policy for QC and/or HR to determine the necessary competence for personnel performing work affecting
conformity to product requirements, training and competency as it pertains to job functions and where
applicable, to provide training or take other actions to achieve the necessary competence. This is
accomplished via the Employee Competency Profile Matrix F-7.2-2; QP-7.2. Employee Job Description
F-7.2-9 and QP-7.2-2 Training all making one aware of the relevance and importance of their activities and
how they contribute to the achievement of quality objectives. Job Descriptions set the foundation for function,
competency requirements to start the position and establishes required future training needs.
A Training Procedure QP-7.2 and New Employee Orientation Check List F-7.2-10 are mandatory as quality
system elements and for the training needs of existing staff in order to achieve its objectives. Each employee
completes a written exam on subjects, where applicable, and office employees complete a Training
Effectiveness Survey F-7.2-8 for review immediately after the training by the trainer for evaluation and
discussion as part of competency awareness and training.
7.3 AWARENESS
Cleanroom staff affecting quality via daily activities are trained yearly on selected QP’s; WI’s; Forms and
changes affecting quality. Each, complete a written exam covering the subject and a general exam covering a
broad base of daily production activities. Office personnel are trained annually in systems and subjects
ranging from lSO Procedures, Sales techniques, computer navigation; to concerns regarding product
performance, customer applications and typical, but complex customer technical questions often asked of
Sales and Customer Service. Training may include internal or external seminars. Training on the same
subject may be repeated at a later date in the same or greater depth to re-evaluate knowledge gained.
Training results, subjects, methods and needs are discussed and documented in the Management Review
Meetings. Each employee is required to re-sign their job description yearly as a reminder of their position and
importance within the organization. Records are maintained of education, experience, and training in separate
departmental training logs and on Departmental Training Matrices F-7.2-1 through F-7.2-4.
7.4 COMMUNICATION
Top management has defined and implemented processes for the communication of quality requirements,
objectives and accomplishments including, but not limited to the implementation of Management Review; the
Internal Communication Memo F-5.1 used to summarize and post the results twice yearly. Yearly Goals &
Objectives F-6.2; Continual Improvement F-10.3-2; Cleanroom meetings and electronic media. The
Customer Satisfaction Surveys F-9.1-2-1; Quality Planning F-6.3; yearly Supplier Evaluations F-8.4-2;
Internal Audits QP-9.2 and associated manufacturing QP’s; Work Instructions and Forms further
communicate current status. The Customer Complaint Log (SQF F 2.1.4.4) Corrective Actions QP-10.2
and Training Effectiveness F-7.2-8 provide information that becomes a resource for improvement and the
involvement of people in achieving established quality objectives.
Methods and procedures have been identified and implemented to communicate with customers on
information about the product and service QP-8.2-1 Sales Order Entry and amendments, to deal with
inquiries, contracts or order handling, including amendments, Customer Satisfaction F-9.1.1-2 and
representative forms include F-10.2-5 Credit and Return Authorization F-10.2-4.
7.5 DOCUMENTED INFORMATION (Doc & Data Control)
7.5.1 GENERAL
The organization’s Quality Management System includes documented information required by the
ISO 9001:2015 Standard and that which is determined by the organization as being necessary for the
effectiveness of the QMS. Sufficient records are maintained to demonstrate conformance to
requirements and verify effective operation and provide knowledge for maintenance and improvement
of the quality management system.
ISO 9001:2015
Documentation & Data Control QP-7.5 has been defined and implemented to ensure that correct
documents are used. All obsolete documents are promptly removed from all points of issue, therefore
prevented from unintended use. Documents to be retained, and records of quality performance, are
controlled, maintained and protected.
Controls are imposed to ensure that the latest copies of all documentation relevant to the
accomplishment of work are available at the time and place of work to ensure effective functioning of
the organization’s quality management system. Quality records are analysed to provide inputs for
corrective and preventive action, improvements to process control and the quality management
system. Documents defined as quality records are controlled. A documented procedure has been
established to:
 Approve documents for adequacy prior to use
 To review, update as necessary and re-approve documents
 Identify the current revision status of documents
 Ensure that relevant versions of applicable documents are available at point of use
 Ensure that documents remain legible, readily identifiable and retrievable
 Ensure that documents of external origin determined by the organization to be necessary
for the planning and operation of the Quality Management System are identified and their
distribution controlled
 Prevent the unintended use of obsolete documents, and to apply suitable identification to
them if they are retained for any purpose.
7.5.2 CREATING & UPDATING
The organization has identified, described via title, date, author or reference number appropriate
documented information which may be held in Log books and/or electronically on the company ‘G’
Drive all of which are reviewed, approved with signatures, stamps and combinations for suitability and
adequacy in the QM; QP; WI and Forms Log books. Updating and Training occur by following QP-7.5.
7.5.3 CONTROL OF DOCUMENTED INFORMATION
7.5.3.1 & .2 CONTROL METHODS & ACTIVITIES
Records required for the quality management system are controlled per QP-7.5-1 QC Records and
maintained in Log books; on the company public ‘G’ drive and on the Radius ERP system per QP-8.2-
1 Sales Order Entry with continuous back-up storage to provide evidence of conformance to
requirements and of effective operation of the quality management system.
The organization has established a documented procedure to define the controls needed for
identification, storage, protection, retrieval, retention and disposition of records in QP-7.5
Documentation & Data Control and QP-7.5-2 Quality Records & Maintenance / Control &
Retention; Documentation and records may be in any form or type of medium suitable for the needs
of the organization.
Records remain legible, readily identifiable and retrievable for a period of two years. Orders are
indefinitely retrievable to the extent of the Radius ERP system.
8.0 OPERATION
8.1 OPERATION PLANNING & CONTROL (Quality Planning)
In planning of product and services the organization has determined the need to establish processes (4.4)
and documents and to provide resources specific to the product, determined the sequence of processes and
sub-processes required to achieve the end product. Planning of the processes is consistent with the other
requirements of the organization’s quality management system along with risk assessment and mitigation
ISO 9001:2015
(6.0) via the Quality Manual; Quality Procedures; Work Instructions and Forms to support and manage the
processes including:
 Quality objectives and requirements for the product as determined during contract review as provided by
the customer and / or under General Product Specifications WI-8.5-6
 Activities within the processes, including documents QP-9.0; 7.1; 9.1; 8.7 associated Forms and Work
instructions) and to provide resources specific to the product.
 Required verification, validation, monitoring, measurement, inspection and test activities specific to the
product and the criteria for acceptance of the product as spelled out in documents listed above.
 Records are completed and kept to provide evidence that the processes and resulting service meet
requirements. Ref-QP-7.6
 Any processes where outsourced, i.e.: calibration, are identified and controlled. Control of outsourced
processes is identified within the quality management system through the Purchasing process. The type
and extent of control to be applied to these outsourced processes shall be defined within the Quality
Management System.
8.2 REQUIREMENTS FOR PRODUCTS & SERVICES (Contract Review)
8.2.1 and 8.2.2 CUSTOMER COMMUNICATION & PRODUCT REQ’s
The organization shall determine statutory and regulatory requirements applicable to the
product and any additional requirements considered necessary by the organization. Product
requirements specified by the customer are determined through direct communication.
Particular consideration is given to:
 The extent to which customers have specified the requirements of the product.
 Customer requirements, availability of materials, product specifications, and delivery
 Requirements not specified by the customer, but necessary for fitness and purpose as shown
in the Work Instruction, WI-8.5.6.
 Obligations related to product quality including statutory and legal requirements are met by
means of information contained on the Process and QC Data Sheets F-8.6-6 (converted
products) and (Cleanroom jobber rolls) F-8.6-7.
 Any additional requirements determined by the organization, using our own intuition,
experience and understanding of the customer application. We may ‘leak test’ or engage in a
procedure not specifically requested by the customer in order to assure quality in use and
assure customer satisfaction.
 Establishing specific requirements for contingency actions, when relevant. A contingency plan
has been prepared to reasonably protect the customers supply of product in the event of an
emergency, such as service interruptions, labour shortages and key equipment failures. This
contingency plan will be reviewed once annually at a Management Review Meeting.
8.2.3 REVIEW OF THE REQUIREMENTS / PRODUCT
In order to establish and maintain customer satisfaction, a formal system is in place and
maintained to ensure that each commitment to supply a product is formally reviewed and
controlled. This review QP-8.0 is conducted prior to the commitment to supply and shall
ensure that in 8.2.3.1:
 The requirements are adequately defined, documented and planned QP-8.0
 Where the customer provides no written statement of requirement, the order
requirements are confirmed verbally before acceptance and are made per PPC
minimum acceptance specifications per WI-8.5.6
ISO 9001:2015
 The organization shall determine statutory and regulatory requirements applicable to

the product and any additional requirements considered necessary by the
organization.
 The requirements comply with the enquiry and any differing requirements are
satisfactorily resolved through contract review, faxed and signed confirmation.
 The organization has the ability to meet those defined requirements
8.2.4 CHANGES to REQUIREMENTS of PRODUCTS & Services
The results of the review and subsequent follow-up actions are recorded. Where product or
service requirements are changed, and agreed with the customer or their representative the
documentation is amended, and all relevant personnel made aware of the changed
requirements via QP-8.0.
8.3 DESIGN & DEVELOPMENT - 8.3.6
There is currently no true design and development occurring with the heat sealing of generic
polyethylene bag material, therefore exclusion to the Design and Development clause is deemed
appropriate.
8.4 CONTROL OF EXTERNAL PROCESSES
8.4.1 GENERAL (Supplier Selection & Evaluation)
All purchasing processes are controlled to ensure purchased product or services conform to
requirements. The type and extent of control will be dependent upon the effect on subsequent
processes and their output. A system for the evaluation and selection of suppliers is operated,
based on their ability to supply a product or service in accordance with the organization’s
requirements.
Evaluation and selection criteria for suppliers, is based on QP-8.4.
 A supplier’s previous and continuous record of providing product and / or services

to satisfactory standards.
 An evaluation of a supplier’s quality management system, to determine their ability to satisfy
the purchase requirements. (Supplier Survey F-8.4-3).
 An “Approved List” F-8.4-5 of those suppliers affecting the final product or service is maintained
to show they have been evaluated and successfully selected.
8.4.2 TYPES & EXTENT OF CONTROL (Purchasing)
Purchasing documents contain information clearly describing the product or service ordered,
including where appropriate:
 Requirements for approval or qualification of product, procedures, processes, service,

equipment and personnel QP-8.0; QP-08.4; & QP-8.2
 Quality management system requirements QP-6.1; QP-6.3
The practice reviews and approves purchasing documents for adequacy of the
specified requirements prior to release.
8.4.3 INFORMATION FOR EXTERNAL PROVIDERS
The activities necessary for verification of purchased product QP-8.4 Part# Designation are identified
and implemented. (See Receiving Inspection Reporting WI-9.1.5 Receiving Inspection). Where the
ISO 9001:2015
organization or its customer proposes to perform verification activities at the supplier’s premises, the
organization shall state the intended verification arrangements and the method of product release in
the purchasing documentation as shown on the PO. Verification by the customer neither absolves the
organization of responsibility to provide product which is acceptable to the customer, nor does it
preclude subsequent rejection by the customer.
8.5 PRODUCTION & SERVICE PROVISION
8.5.1 CONTROL OF PRODUCTION (Product Realization)
Operations are controlled through:

 Any production processes where the resulting output cannot be verified by subsequent
monitoring and measurement and as a consequence, deficiencies may become apparent
only after the product is in use or has been delivered. Validation demonstrates the ability
of the processes to achieve planned results and include the following arrangements:
 Defined criteria for review and approval of processes as illustrated by quality planning
QP-6.3 and the Quality Planning Check List, F-6.3
 Approval of equipment and qualification of personnel
 Use of specific methods and procedures
 Requirements for records
 Revalidation. The continued suitability of processes, procedures and test methods is
based on product performance, customer satisfaction and opportunities for
improvement, as discussed during Management Review. Where validation is
destructive to the product, but information critical, spot testing and sacrifice of product
is warranted as in seal leak testing WI-9.18 Seal Integrity tests and WI-9.16
Sampling Plan.
 The availability of information that specifies the characteristics of the product as shown on
the Process Sheets F-8.6-6 rolls & Jobber Materials; F-8.6-7 In Process QC or customer
supplied specifications.
 The availability of Work Instructions, as necessary WI-8.5 – WI-8.13
 The use of suitable equipment as determined by the trade; Preventive Maintenance
Schedule & Work Instruction WI-7.1; capability studies and quality planning.
 The availability and use of suitable monitoring and measuring equipment QP-9.0; 7.1
 The implementation of monitoring and measuring activities QP-8.6 Description of
Inspection & testing
 The implementation of product release, delivery, packaging, or on-site activities such as
inventory and storage. QP-8.6. Outside service does not apply.
8.5.2 IDENTIFICATION & TRACEABILITY
The organization identifies the product by suitable means throughout product realization, via
exclusive raw material purchase order numbers, exclusive job and lot numbers for every
custom production run identifying the product with respect to monitoring and measurement
requirements throughout product realization.
Where traceability is a requirement, the organization controls the unique identification of the
product and maintains records (4.2.4) via raw material purchase orders, certificates of
conformance on raw material, a unique job and lot number, labelling containing this
information and trace of product to supplier raw material ID on the In-Process Quality Control
Data Sheet. (F-9.16)
8.5.3 CUSTOMER PROPERTY
Loaned printing plates, are the only current application.

ISO 9001:2015
The organization exercises care with customer property while it is under our control or being
used by us. We identify, verify and protect and safeguard customer property provided for use
or incorporation into the product. The customer is notified and records are maintained in the
Plate Mounting Log of any lost, damaged or customer property found unsuitable for use, the
organization shall report this and maintain records. Credit is provided if necessary via the
Customer Credit Form F-10.2-5.
8.5.4 PRESERVATION OF PRODUCT
Conformity of product with customer requirements is preserved during storage, during internal
processing and while in transit to the intended destination in order to maintain conformity to
requirements per QP-8.6. As applicable, preservation shall include identification, handling,
packaging, storage and protection.
8.5.5 POST DELIVERY ACTIVITIES
“Servicing” is not applicable to the current business operations and QMS.
8.5.6 CONTROL OF CHANGES
The organization reviews and controls change for production or service provision, to ensure
continuing conformity with requirements via section 6.0 of QP-8.0 Sales Order Entry. The
organization retains documented information describing the results of the review of changes,
on signed confirmations by the persons authorizing the change, and any necessary actions
arising from the review.
8.6 RELEASE
The organization plans and implements the monitoring, measurement, analysis and improvement processes
needed to:
 Demonstrate conformity to product requirements through inspection and testing WI-9.0 / QP-9.1 and
analysis of data.
 Ensure conformity of the quality management system through Internal Quality Audits QP-9.2 and
Management Review QP-9.3.
 Continually improve the effectiveness of the quality management system QP-6.3. This includes
determination of applicable methods, including statistical techniques QP-9.1-1, and the extent of their use.
8.7 CONTROL OF NON-CONFORMING OUTPUTS
8.7.1 ID & CONTROL and 8.7.2 DOCUMENTATION
A documented procedure QP-8.7 Quality Control for In-Process Goods is in place to define the controls
and related responsibilities and authorities for dealing with non-conforming product. Product, service and
procedures which do not conform to requirements are identified and controlled to prevent recurrence or its
unintended use or delivery.
Where applicable the organization shall deal with non-conforming product in one of the following ways:
 By taking actions appropriate to the effects, or potential effects, of the non-conformity

when non-conforming product is detected to eliminate the detected nonconformity in the
short run and in the long run after delivery or use has started.
 By authorizing its use, release or acceptance under concession by a relevant authority
and, where applicable, by the customer
 By acting to preclude its original use or application.
ISO 9001:2015
When non-conforming product or service is corrected it is subject to re-verification to demonstrate conformity

to the requirements.
Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained,
are maintained.
When non-conforming product or service detected after receiving, delivery, or use has started, the
organization acts appropriate to the effects, or potential affects, of the nonconformity.
9.0 PERFORMANCE EVALUATION
9.1 MONITORING, MEASUREMENT, ANALYSIS & EVALUATION
9.1.1 GENERAL
The organization has determined what needs to be monitored and measured; the methods for monitoring,
measurement, analysis and evaluation needed to ensure valid results; when the monitoring and measuring
shall be performed and when the results from monitoring and measurement shall be analyzed and evaluated.
The organization evaluates the performance and the effectiveness of the quality management system twice
yearly in Management Review.
The organization retains, shares and reviews appropriate documented information as evidence of the results.
The organization applies suitable methods for monitoring and, where applicable, measurement of the quality
management system processes to demonstrate the ability of the processes to achieve planned results through
Internal Quality Audits QP-9.2. The organization has considered the type and extent of monitoring and
measurement appropriate to each of its eight Key Processes in relation to their impact on the conformity of
product requirements and on the effectiveness of the QMS. See yearly Goals & Objectives F-6.2. When
planned results are not achieved, correction and corrective action is taken, as appropriate, to ensure
conformity of the product or service via QP-10.2
All data is effectively collected and analysed to determine the suitability and effectiveness of the quality
management system and to evaluate where continual improvement of the effectiveness of the quality
management system can be made. This includes data generated as a result of monitoring and measurement
of quality on incoming raw materials and finished goods.
Data is analysed to provide information on customer satisfaction, conformance to customer product

characteristics and trends of processes and products including opportunities to mitigate risk, and supplier
improvements. Cleanroom air quality is monitored and recorded weekly; particle count trends are monitored
and recorded for each raw material type monthly, leachable and extractables are tested for each raw material
type periodically for comparison and trend analysis, production scrap levels are monitored by machine, and
tallied monthly. Six-month totals are presented in Management Review, twice yearly to indicate consistency
and show continuous improvement where applicable.
9.1.2 CUSTOMER SATISFACTION
PPC will monitor customer’s perception of the degree of their needs and expectations fulfilled by customer
survey held annually and customer feedback on delivered products.
9.2 INTERNAL AUDITS
9.2.1 & 9.2.2 INTERNAL AUDITS & AUDIT PROGRAM

ISO 9001:2015
A documented procedure has been established to define the responsibilities and requirements for planning
and conducting internal audits of the quality management system establishing records and reporting results.
Records of the audits and their results shall be maintained as in QP-9.2. The purpose of the internal audit is to
determine whether:
 The quality management system conforms to the requirements of this International

Standard by conducting yearly internal quality audits of key processes per QP-9.2.
 The quality management system has been effectively implemented and maintained
as verified during Management Review.
A planned audit program has been put in place taking into consideration the status and importance of the
activities and areas to be audited as well as the results from previous audits. The audit criteria, scope,
frequency and methodologies are defined. Audits are conducted by personnel other than those who perform
the activity being audited.
The documented procedure includes the responsibilities and requirements for conducting audits, ensuring
their independence, recording results and reporting to management
The management responsible for the area being audited shall ensure that any necessary corrections and
corrective actions are taken without undue delay found during the audit to eliminate detected nonconformities
and their causes. Follow up action includes the verification of the implementation of corrective action, and the
reporting of verification results.
9.3 MANAGEMENT REVIEW
9.3.1 GENERAL
The top management, Management Representative and appropriate staff, review the quality management
system at intervals of twice a year to ensure its continuing suitability, adequacy and effectiveness. The review
shall include assessing opportunities for improvement and the need for changes to the system and to verify
that quality policy and objectives are being satisfied.
9.3.2 INPUTS
The management reviews the inputs (5.6.2 a-e Internal Audits; Customer Feedback; Process Performance;
C/I; C/A; follow up from previous Management Review on the Action Items Register; Quality Planning Check
Lists, potential changes to the QMS; Recommendations for Improvement; reviewing improvements made to
the QMS; product improvements and new resources. By analysing these activities, we determine required
changes to the QMS and opportunities for improvement, including quality policy changes and quality
objectives. Ref. QP-9.3
The meeting is arranged by the Management Representative and attended by top management, and
supervisory personnel having responsibility for the quality management system. Other personnel attend
including Customer Service and others, where necessary, to provide relevant input.
9.3.3 OUTPUTS
The Management Representative is responsible for minutes including observations, conclusions and
recommendations issued as a result of such review. Minutes of the meeting are signed as approved by top
management and retained as a quality record with all agreed actions monitored and results recorded.
Summary minutes are issued to all people as a way of internal communication.
10.0 IMPROVEMENT
ISO 9001:2015
10.1 GENERAL
The process necessary for the continual improvement of the quality management system is planned and
organized along with responding to identified risk and opportunities to mitigate.
Continual improvement of the quality management system is facilitated through the use of the quality policy,
Quality objectives, Key Process Goals & Objectives Matrix, audit results, analysis of data (such as reduction in
scrap, customer credits; improvement in customer satisfaction, Shipping Summary results) corrective and
preventive actions and management review.
10.2 NON-CONFORMITY & CORRECTIVE ACTION
10.2.1 TAKING ACTION TO CONTROL / CORRECT
A corrective action program is established and maintained to eliminate the causes of nonconformities in order
to prevent recurrence. Corrective action appropriate to the impact of the problems encountered is
appropriately carried out.
10.2.2 DOCUMENTED INFORMATION
The documented procedure for corrective action QP-10.2 defines requirements for:
 Identifying and reviewing nonconformities including customer complaints
 Determining the causes for nonconformities with short term and long-term action plans
 Evaluating the need for actions to ensure that nonconformities do not recur
 Determining and implementing the corrective action needed
 Recording results of action taken
 Reviewing the effectiveness of the corrective action taken.
10.3 CONTINUAL IMPROVEMENT
Top management id responsible to continually improve the suitability, adequacy and effectiveness of the
quality management system by establishing continuous improvement projects and tracking them using
Continuous Improvement Log Form F-10.3-1.

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PPC Flexible Packaging LLC- Buffalo Grove, IL Page 1 of 27

POLICY CONTENTS PAGE PROCEDURE

7.5.3 Control of Documented Information QP-8.0; QP-7.5; QP-7.6

Details of Changes Date Authorized By

0.2 Quality Management Principles

The 7 quality management principles are:

0.3 Process Approach

0.3.2 Plan-Do-Check-Act Cycle

0.3.3 Risk Based Thinking

1.0 ACTIVITIES, SCOPE AND PERMISSABLE EXCLUSIONS

2.0 NORMATIVE REFERENCE

Each section of the manual is related to an identified section of ISO 9001:2015.

3.0 TERMS AND DEFINITIONS

 ORGANIZATION means PPC Flexible Packaging

4.0 CONTEXT OF THE ORGANIZATION

4.1 GENERAL QMS REQUIREMENTS

Potential and Actual Issues from the Interested Parties may

4.2 UNDERSTANDING NEEDS & EXPECTATIONS

The quality management system documentation includes:

Requirements of the Interested Parties may include, but are not

 Safe Working Environment

 SQF (Food Safety Registration)

 And any additional requirements stipulated by PPC Flexible

 Conflict Mineral - Have recently had Customers inquire about

packaging and additives from bovine

4.3 SCOPE OF THE QUALITY MANAGEMENT SYSTEM

a) the external and internal issues referred to in 4.1:

Not applicable requirements currently include:

Section 8.3 Design and Development

Organization: PPC Flexible Packaging LLC

4.4 QUALITY MANAGEMENT SYSTEM & PROCESSES

4.4.2 PPC Flexible Packaging, LLC has:

a) maintained documented information to support the operation of its processes;

Tier I Quality Manual

Tier II Quality Procedures

Tier III Work Instructions / Control Plans

Tier V Quality Records

 the ISO 9001 Standard,

5.1 LEADERSHIP & MANAGEMENT COMMITMENT

5.1.2 CUSTOMER FOCUS

5.2.1 & 5.2.2 ESTABLISHING & COMMUNICATING -

 Includes a commitment to meeting requirements and to continual improvement

Signed: ………………………………… Plant Manager Date: ………………

5.3 ORGANIZATIONAL ROLES, RESPONSIBILITY & AUTHORITY

6.0 PLANNING QUALITY OBJECTIVES

6.1 Actions to address risks and opportunities

a) identify actions in order to address identified risks and opportunities;

See QP 6.1 for further information on Risk Assessment activities

6.2 Quality objectives and planning to achieve them

a) consistent with the quality policy;

a) what will be done;

6.3 PLANNING OF CHANGES (see 4.4)

Personnel responsible for each Planning Project will consider:

a) the purpose of the changes and their potential consequences;

7.1.4 ENVIRONMENT FOR OPERATION OF PROCESSES

- The company supplied uniforms.

7.1.5 MONITORING & MEASURING RESOURCES

7.1.5.2 MEASUREMENT TRACEABILTY (Calibration)

Where necessary to ensure valid results, measuring equipment is:

7.1.6 ORGANIZATIONAL KNOWLEDGE

7.2 COMPETENCE (Training)

7.5 DOCUMENTED INFORMATION (Doc & Data Control)

7.5.2 CREATING & UPDATING

7.5.3 CONTROL OF DOCUMENTED INFORMATION