Annual Training 2023

TOPIC: Training on Internal Auditing

Training Objectives

° To Develop an Understanding of What is Required of

a ‘Quality’ System Auditor

° To Review the Guidelines for Auditing ‘Quality’ Systems

° To Develop Auditing Techniques

° To Utilize these Concepts through Actual

Audits

° Understanding How to Respond to an Auditor

° Understanding Auditing Techniques
Planning Schedules
Creating Check Lists Audit
Plan
Audit Findings/Observations
Preparing Audit Reports

° Team Audits
 BASIC TYPES OF AUDITS
° Internal (First Party, Self)
• This type includes audits by your company employees,
consultants and contractors.

° External
• Supplier Audit
 Second Party
• This is where: 1. Customer employee(s) audit your company or
where 2. Your employee(s) audit a company which supplies your
company with a product or service.

• Independent Organization
 Third Party - Registrar
• 1.- A customer wants an audit of your company but wants your
company to pay for it. 2.-Your company wants to be certified even
if it is not a customer requirement but rather a business strategy.
• This type of audit is described as independent.
 AUDIT SUB TYPES
° Compliance (do we comply with the standard)

° System (the theory)

• Example: Audit of Document Control

° Process (the practice)

• ’Example: printing, lamination ,curring, slitting

° Product (the result)

• Example: Alu-Alu , blister , tropical foil
 A breakdown of the final product. Verify paperwork trail,inspection and test
results, for each item of the product. Verify key characteristics meet
dimensional requirements.
 PHASES OF AUDITING
° Planning and Preparing for the audit
° Reporting the audit results
° Close out of corrective actions
THE PART PEOPLE SEE
° Opening Meeting
° Collection of Information
° Record and Grade Nonconformances
° Evaluation of Number and Significance of
Nonconformances
° Assessment of Compliance to Requirements
° Preparation of Findings
° Closing Meeting Review
 QUALITY AUDIT
One Definition
A systematic and independent examination to determine
whether quality activities and related results comply with
planned arrangements and whether these arrangements
are implemented effectively and are suitable to achieve
the stated objectives.
 THE INTERNAL AUDIT

The Systematic Investigation of the Intent, Implementation,

and Effectiveness of Selected Aspects of the Systems of an
Organization or One or More of It’s Departments
INTERNAL AUDIT SYSTEM BASE REQUIREMENTS
There are several very important features to bear in mind:

• It is important to consider whether the identified

nonconformance is a ‘repeater’ (recurrent).
• Particularly in internal auditing, disagreements arise which
must be resolved by the audit program manager (or
equivalent).
the
• Not every nonconformance identified requires a
formal corrective action.
• Some require a ‘minimum’ corrective action.
• Some require a serious, in-depth investigation following the
8-D format or any other method specified by customer or
the organization itself.
 SYSTEMS AUDIT

° Is an audit where high level company systems are reviewed.

In general terms we are talking about Level II procedures
which form the backbone based upon the Quality Systems
Manual.
° It usually probes the interactivity (communication) of the
related company systems and as such often cross ‘functional’
inter-
area ‘boundaries’.

° Typical Systems
Audits:
• Nonconformance
Document Control
• Control of Measuring and Test Equipment

° Thus, it is very common to carry them out in multiple

departments. For example, if one decides to audit Document
Control, one must audit a number of departments where that
function is executed.
 PROCESS AUDIT
° A Process Audit is where the company’s procedures are validated and also is a
requirement of ISO 9001 and GMP

1.Printing Department: Objective:

To ensure the printing process meets quality standards and specifications.
Audit Checklist:
•Verify the availability and accuracy of job orders and printing specifications.
•Inspect the condition and cleanliness of printing cylinders.
•Check the ink mixing process for accuracy and consistency.
•Evaluate the color matching process against approved samples.
•Examine the printing setup, including registration and impression settings.
•Assess the print quality by inspecting samples for color accuracy, sharpness, and clarity.
•Review the maintenance and calibration records of printing equipment.
•Check the adherence to standard operating procedures and safety guidelines.
2.Lamination Department: Objective
: To verify the lamination process for adherence to quality requirements and
efficiency.
Audit Checklist:
•Verify the availability and accuracy of lamination job orders.
•Check the cleanliness and condition of lamination rollers and cylinders.
•Evaluate the alignment and tension control of the lamination machine.
•Inspect the adhesive application process and verify the correct type and amount of
adhesive used.
•Examine the lamination setup, including temperature, speed, and pressure settings.
•Assess the bond strength and uniformity of laminated samples.
•Review the maintenance and cleaning procedures for the lamination machine.
•Check the proper handling and storage of raw materials and finished laminated
products.
3.Slitting Department: Objective: To
ensure the slitting process produces accurate and consistent product dimensions.
Audit Checklist:
•Verify the availability and accuracy of slitting job orders.
•Check the condition and sharpness of slitting blades.
•Evaluate the alignment and tension control of the slitting machine.
•Inspect the slitting setup, including width adjustment and alignment of cutting
guides.
•Measure and record the dimensions of slit rolls using calibrated measuring
instruments.
•Assess the quality of slit edges for cleanliness, smoothness, and uniformity.
•Review the maintenance and blade replacement schedule for the slitting machine.
•Check the proper labeling and identification of slit rolls for traceability.
4.Curing Objective:
To verify the curing process to ensure proper drying and curing of printed and
laminated materials.
Audit Checklist:
•Verify the curing parameters (temperature, humidity, time) specified in the job orders.
•Monitor and record the temperature and humidity levels during the curing process.
•Inspect the curing equipment for proper functioning and calibration.
•Assess the curing setup, including the arrangement of printed or laminated materials.
•Measure the moisture content of cured materials to ensure proper drying.
•Evaluate the adhesion and durability of cured prints or laminations.
•Review the maintenance and cleaning procedures for the curing equipment.
•Check the documentation of curing parameters and results for traceability.
These examples demonstrate how process audits can be conducted in
different departments such as printing, lamination, slitting, and curing to
ensure compliance with quality standards, identify areas for improvement,
and maintain consistent and efficient operations.