This document provides a supplier audit checklist covering various quality management system processes. It includes scoring criteria for audit findings, questions to consider for different processes like customer relations, design and development, and procurement. Sections provide guidance on what to look for as evidence and include diagrams of process flows. The goal is to evaluate whether a supplier's management system and processes meet customer and regulatory requirements.
Firstly, it will be clarify some of the misunderstandings of some of the fundamental audit concepts and principals that are implemented during the audit or planning of the audit program, focusing on audit guidelines, auditor principles, audit process principles and types of audits. Furthermore, gaining understanding of the management and preparation of an ISO 9001 audit through audit program pillars, good audit practices and prepared work documents and checklists. Outline how to conduct and close an ISO 9001 audit in a professional manner with the precise audit review.
Main points covered:
• Fundamental audit concepts and principles
• Managing an ISO 9001 audit program
• Preparation of an ISO 9001 audit
• Conduct of an ISO 9001 audit & Closing the audit
Presenter:
This webinar was presented by Kefah El-Ghobbas, PECB Certified Trainer and Organizational Development expert and operations manager at TURBO CARBO.
Link of the recorded session published on YouTube:https://youtu.be/kK8pAc3QM5E
The webinar covers:
• Misconceptions about management reviews
• Evaluating performance of the organization
• How performance reviews affects the bottom line
• How to improvement management ownership of the review process
Presenter:
This webinar was presented by Sheryl Anderson, Managing Director for Quality Systems Solutions & Initiatives (QSSI) and certified trainer for HACCP ISO 9001 & ISO 22000.
Link of the recorded session published on YouTube: https://youtu.be/dGdxT5fyUoc
How to Perform a Successful Internal Quality AuditGreenlight Guru
You already know internal quality audits are required by both FDA 21 CFR Part 820 and ISO 13485.
You also probably already know they are a big hassle to conduct.
What you might not know is that they are one of the most powerful weapons at your disposal for preventing 483's and observations.
Why?
Because they are one of the most effective and efficient ways to make sure you and your team are always prepared if FDA or NB decided to show up unexpectedly.
So how do you “establish” the right procedures? How do you ensure your auditor is competent and properly qualified? And what do you do if you find non-conformances?
View this presentation by our guest Kyle Rose, President at Rook Quality Systems, where you will find the answers to all those questions and more.
Specifically, you will learn:
- How to conduct an effective internal quality audit based on process identification, sampling and questioning
- How to plan a internal quality audit and develop an audit schedule
- How to find and use competent and qualified auditors
- Why certain auditors shouldn’t audit certain areas
- How to properly report the findings of your internal quality audit
- How to concisely document non-conformances
- How to determine what needs corrective actions and how to follow up on them
ISO 9001 2015 ASQ Workshop by Colin GrayColin Gray
The current and expected development of ISO 9001 - Annex SL reviewed. Gain insight into the ISO 9001 Draft International Standard (DIS) of ISO 9001 which has recently been released.
ISO 9001:2015 DIS Changes, Requirements and ImplementationGovind Ramu
This presentation discusses new requirements to ISO 9001 based on the Draft International Standard (DIS). Guidance for transition to new revision is proposed for planning, communication and execution.
Firstly, it will be clarify some of the misunderstandings of some of the fundamental audit concepts and principals that are implemented during the audit or planning of the audit program, focusing on audit guidelines, auditor principles, audit process principles and types of audits. Furthermore, gaining understanding of the management and preparation of an ISO 9001 audit through audit program pillars, good audit practices and prepared work documents and checklists. Outline how to conduct and close an ISO 9001 audit in a professional manner with the precise audit review.
Main points covered:
• Fundamental audit concepts and principles
• Managing an ISO 9001 audit program
• Preparation of an ISO 9001 audit
• Conduct of an ISO 9001 audit & Closing the audit
Presenter:
This webinar was presented by Kefah El-Ghobbas, PECB Certified Trainer and Organizational Development expert and operations manager at TURBO CARBO.
Link of the recorded session published on YouTube:https://youtu.be/kK8pAc3QM5E
The webinar covers:
• Misconceptions about management reviews
• Evaluating performance of the organization
• How performance reviews affects the bottom line
• How to improvement management ownership of the review process
Presenter:
This webinar was presented by Sheryl Anderson, Managing Director for Quality Systems Solutions & Initiatives (QSSI) and certified trainer for HACCP ISO 9001 & ISO 22000.
Link of the recorded session published on YouTube: https://youtu.be/dGdxT5fyUoc
How to Perform a Successful Internal Quality AuditGreenlight Guru
You already know internal quality audits are required by both FDA 21 CFR Part 820 and ISO 13485.
You also probably already know they are a big hassle to conduct.
What you might not know is that they are one of the most powerful weapons at your disposal for preventing 483's and observations.
Why?
Because they are one of the most effective and efficient ways to make sure you and your team are always prepared if FDA or NB decided to show up unexpectedly.
So how do you “establish” the right procedures? How do you ensure your auditor is competent and properly qualified? And what do you do if you find non-conformances?
View this presentation by our guest Kyle Rose, President at Rook Quality Systems, where you will find the answers to all those questions and more.
Specifically, you will learn:
- How to conduct an effective internal quality audit based on process identification, sampling and questioning
- How to plan a internal quality audit and develop an audit schedule
- How to find and use competent and qualified auditors
- Why certain auditors shouldn’t audit certain areas
- How to properly report the findings of your internal quality audit
- How to concisely document non-conformances
- How to determine what needs corrective actions and how to follow up on them
ISO 9001 2015 ASQ Workshop by Colin GrayColin Gray
The current and expected development of ISO 9001 - Annex SL reviewed. Gain insight into the ISO 9001 Draft International Standard (DIS) of ISO 9001 which has recently been released.
ISO 9001:2015 DIS Changes, Requirements and ImplementationGovind Ramu
This presentation discusses new requirements to ISO 9001 based on the Draft International Standard (DIS). Guidance for transition to new revision is proposed for planning, communication and execution.
Measure Customer and Business Feedback to Drive ImprovementTechWell
Companies often go to great lengths to collect metrics. However, even the most rigorously collected data tends to be ignored, despite the findings and potential for improving practices. Today, one metric that cannot be ignored is customer satisfaction. Customers are more than willing to share their thoughts in a manner that can impact your bottom line. Social media gives consumers a stronger voice than ever, and damage to your brand is only one tweet away. The question is: Are you listening to your customers? Paul Fratellone helps you break down current process metrics so you can build them back up with business and customer value at the forefront. With feedback on how well you are attaining your objectives, you can create a powerful action plan for change that will receive the attention it deserves. If you are serious about improving the value of your projects to the business, join this session and let the right data drive your improvement actions.
[To download this presentation, visit: https://www.oeconsulting.com.sg/training-presentations]
ISO 22301:2019, Security and Resilience - Business Continuity Management System (BCMS), is the latest international standard for implementing and maintaining effective business continuity plans, systems and processes. This new standard replaces the old ISO 22301:2012.
This ISO 22301:2019 (BCMS) awareness PPT training presentation can be used to brief management and staff, new hires and potential auditees so as to create awareness of the ISO 22301:2019 standard. Alternatively, the presentation may be used to supplement your materials for the training of BCMS professionals and internal auditors.
LEARNING OBJECTIVES
1. Provide background knowledge of ISO 22301
2. Gain an overview of ISO 22301 structure and the certification process
3. Gather useful tips on handling an audit session
SSCG Business Efficiency - Achieving Superior Performance, Bottom Line and Cu...SSCG Consulting
It is vital businesses to optimise internal efficiency, increase the speed and standard of execution, and make and deliver quality products on time and at the right price.
In the current business environment, IT Suppliers have become integral part of the Customer organization and the IT environment and processes of IT Suppliers have a direct impact on the Customer Organization. Even though Operational responsibility might have got transferred to Supplier, but legal and regulatory responsibility will still be with Customer. Hence it is Customer’s responsibility to verify that appropriate controls are in effect to ensure that the organization fulfills its contractual obligations. This topic focuses on some of the key components and the best practices in auditing IT Suppliers for Compliance. It is aligned with one of the ISACA Research paper (Outsourced IT Environments Audit/Assurance Program) with additional information.
20210113 Lean In Government Harrisburg Conf Agile Governance at Scale Craeg S...Craeg Strong
Traditional duties of IT governance and oversight include auditing timely completion of milestones and phase gates and tracking progress versus spend. They place heavy emphasis on correctness and completeness of documentation, managing risks and tracking metrics such as earned value and escaped defect counts. With the adoption of agile methods comes the need to adjust governance and oversight accordingly. But what does agile governance look like? How does it differ from traditional governance? Given the lack of detailed plans up-front, the reduced emphasis on documentation, and the eschewing of traditional metrics such as earned value, one might assume that governance and oversight is more challenging in the agile space. Looking at governance and oversight through a traditional lens reveals relatively few effective tools and the necessity of relying upon vaguely defined metrics such as “story points.” However, we will show that, in fact, agile methods offer governance and oversight a wealth of new tools and capabilities, enabling a more proactive and collaborative approach—which could ultimately lead to improved outcomes.
How to Automate Clinical, Safety, and Business Processes with Innovative Tech...Perficient, Inc.
The deployment of business process management (BPM) strategies in a digital world revolves heavily around leveraging software platforms to automate pieces of or even complete processes. Whether you’re in clinical operations, safety and pharmacovigilance, or a back-office department, BPM technology solutions can be used to address virtually any business challenge that involves a process.
Experts from Perficient and Appian discussed why and how sponsors and contract research organizations (CROs) can leverage BPM technology to streamline processes while maintaining compliance.
FCB Partners Webinar: Measure What Matters FCBPartners
Join Steve Stanton, Managing Director of FCB Partners, as he leads a roundtable discussion on the challenge of managing metrics. This 30-minute webinar is an introduction to our new Master Class on Measurement (premiering November 18 in Boston).
Without question, measurement is the most difficult aspect of process management. With so many choices it’s tough to select the right measures and create an actionable scorecard. Too often, organizations measure what they can, measure what they can measure easily, or measure what they can measure easily that produces a positive number.
But, without a great measurement architecture, organizations can flounder with too many measures or misleading data, or just lagging indicators.
In this practical webinar, Steve will focus on the following themes:
Why is measurement so tough?
How can we find the right few measures for a process?
How to use measures effectively
How to improve the process of measurement itself
QMS Effectiveness: Tracking and Trending Quality Data - OMTEC 2017April Bright
What measurements are useful, and which metrics’ baseline makes sense to show the effectiveness of your quality management system? This presentation takes an ISO 13485 and 21 CFR, Part 820 approach to deciding what measurements are important, how trending makes an impact on risk-based decision-making, and why management review is just one of the ways to discuss and document your Quality Data activities.
Ambiguity Reviews: Building Quality RequirementsTechWell
Are you frustrated by the false expectation that we can test quality into a product? By the time an application is delivered to testing, our ability to introduce quality principles is generally limited to defect detection. So how do you begin to shift your team’s perceptions into a true quality assurance organization? Susan Schanta shares her approach to Shift Quality Left by performing ambiguity reviews against requirements documents to reduce requirement defects at the beginning of the project. By helping the business analyst identify gaps in requirements, you can help build quality in and improve the team’s ability to write testable requirements. Learn how to review requirements to identify ambiguities and document the open questions that need to be addressed to make requirements clear, concise, and testable. Susan demonstrates her approach to ambiguity reviews and how she turned lessons learned into a Business Analyst Style Guide to drive quality into the requirements gathering process.
Welcome to the Program Your Destiny course. In this course, we will be learning the technology of personal transformation, neuroassociative conditioning (NAC) as pioneered by Tony Robbins. NAC is used to deprogram negative neuroassociations that are causing approach avoidance and instead reprogram yourself with positive neuroassociations that lead to being approach automatic. In doing so, you change your destiny, moving towards unlocking the hypersocial self within, the true self free from fear and operating from a place of personal power and love.
Ethical_dilemmas_MDI_Gurgaon-Business Ethics Case 1.pptx
Supplierr audit checklist
1. GUIDANCE
S U P P L I E R A U D I T C H E C K L I S T
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2. SCORING CRITERIA
Minor Non-conformance
• not likely to result in the
failure of the management
system or reduce its ability
to assure controlled
processes or products
• failure in some part of the
supplier's management
system relative to a
specified requirement
Opportunity for
Improvement
• Management system
• weak
• cumbersome
• redundant
• overly complex
offer an opportunity for an
organization to improve its
current status
Major Non-conformance
• absence (omission, not
addressed) or total
breakdown (commission,
failure, not implemented)
of a system to meet a
specified requirement
• failure of or materially
reduce the usability of the
products or services for
their intended purpose
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3. CUSTOMER
RELATED
PROCESSES
· Determine whether
the process conforms to
planned arrangements
· Determine whether
the process is properly
implemented and maintained
· Provide information
on process performance to
Top Management
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4. ISTHE PROCEDURE
RIGHT?
I S T H E R E
C O N T I N U I T Y
B E T W E E N T H E
VA R I O U S
S U P P O R T
P R O C E S S E S ?
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5. I S T H E TA S K D O N E
C O N S I S T E N T LY O N
A P E R S O N - TO -
P E R S O N O R D AY-
TO - D AY B A S I S ?
D O T H E I N T E R F A C E S B E T W E E N T H E
D E P A R T M E N T S O P E R AT E S M O O T H LY ?
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6. DOES PRODUCT
INFORMATION FLOW
FREELY?
D O E S I T M E E T T H E R E Q U I R E M E N T S O F T H E
S TA N D A R D O R S P E C I F I C AT I O N ?
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7. IS IT HELPING THE ORGANIZATION
EFFECTIVELY?
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8. BEGIN WITH
THE
PROCESS
OWNER
how the process interacts with
the other process inputs
outputs
suppliers
and/or customers
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10. P R O C E S S
N A M E / D E S C R I P T I O N :
P R O C E S S I N P U T S :
E Q U I P M E N T & F A C I L I T I E S :
I N S T R U C T I O N S & P R O C E D U R E S :
P E R S O N N E L :
S U P P O R T P R O C E S S E S :
P R O C E S S O U P U T S :
C O N T R O L P R O C E S S E S :
K E Y P E R F O R M A N C E I N D I C A T O R S :
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11. PROCESS NAME/DESCRIPTION:
What steps are involved in the process?
What happens at each step in the process?
What documents and records are generated?
Is the process implemented in accordance with procedures, instructions or plans?
Are controls applied as described?
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12. PROCESS
INPUTS:
What triggers the
process?
What inputs are
required?
Where do the inputs
come from?
Are they received in a
timely manner?
Are they fit for
purpose?
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13. EQUIPMENT & FACILITIES:
What equipment
and resources are
required?
01
Is equipment
suitable and
properly
maintained?
02
Is the work
environment
maintained?
03
Is there evidence
of appropriate
maintenance of all
equipment used
by this process?
04
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14. INSTRUCTIONS &
PROCEDURES:
Review the documents that describe
and control the process.
Review all the important steps and
activities of the process being audited.
This info must be documented within
the QMS.
Evaluate how effectively the process
flows through the steps.
Do you see roadblocks or issues?
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15. PERSONNEL:
Review employee
skill lists for the
process.
Are there lists of
skills for each
position?
Do they show
enough detail?
This is often a
finding, where lists
are generic with
inadequate detail.
Training is a key
process of any
system.
Are there
particular skills you
want to evaluate?
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16. SUPPORT
PROCESSES:
• As you audit, you will see how it connects and
interacts with other processes.
• Interactions with other processes are always
important.
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17. PROCESS
OUPUTS:
What is the product produced by
this process?
Are product measures in place to
ensure that product meets
requirements?
How are processes measured?
Are product and process
measures achieved?
What feedback is received from
customers?
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18. CONTROL PROCESSES:
HOW IS THE
PROCESS DEFINED
AND WHO IS
RESPONSIBLE?
HOW ARE
CUSTOMER
REQUIREMENTS
DEFINED?
WHAT
SPECIFICATIONS
APPLY DEFINED?
WHAT OBJECTIVES
AND TARGETS
APPLY PROCESS?
WHAT
CONTROLS/CHECK
POINTS ARE THERE?
WHAT ACCEPTANCE
CRITERIA EXIST?
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19. KEY PERFORMANCE
INDICATORS:
Review metrics and
performance with
Managers,
01
Supervisors and
operators.
02
They should know
how things are
running, objectives,
customer issues,
problem areas.
03
If they do not, the
requirements were
not met.
04
Is there evidence
that quality
objectives and
targets affected by
this process are
being achieved?
05
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20. S U P P L I E R
A U D I T
Q U E S T I O N S
AUDIT QUESTION
FINDINGS
AUDIT EVIDENCE
WHAT TO LOOK FOR
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21. QUALITY MANAGEMENT
s the quality system
documented, controlled
and maintained to clearly
describe current practice?
Quality manual and all procedures
show revision control (sign-offs &
dates), history of changes
Do quality reports, trend
charts and data analysis
identify areas of
opportunity and are used
by management on a
routine basis?
Product quality yield data, problems
and corresponding improvement
actions, status of preventive/
corrective/audit results
Are quality-performance
targets clearly defined,
included in the business
plan and monitored for
improvements?
Strategic and tactical objectives,
goals, action plans, etc.
Does executive
management participate
in periodic quality system
reviews that address
quality related feedback
from customers and
internal quality metrics?
Analysis of field failures, inspection
yields, resource needs, internal
audit results, corrective action
status, etc.
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22. CONTINUOUS IMPROVEMENT
re preventive actions
taken based on the
analysis of significant
business trends, design
reviews, customer
satisfaction surveys or
other meaningful inputs?
Management review meetings, goal
setting, performance measurement,
internal audits, action plans,
customer survey
is there a formal approach
used to actively pursue
cost containment and
other continual
improvement activities
throughout the
organization?
Employee involvement/recognition
program, Lean, Six Sigma, kaizen,
SPC, 5-S, cost reduction
programme
Is a corrective action
system in place that
provides root cause
analysis and takes timely
and effective action to
prevent recurrence?
Corrective actions, trend charts,
meeting minutes, non-conformance
frequency & cost analysis
Does the corrective action
system cover customer,
internal and supplier
issues?
Management review meetings and
corrective actions
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23. DESIGN &
DEVELOPMENT
SUPPORT
• Market studies, customer/end-user surveys,
technical design reviews
are customer needs and
requirements incorporated into
product designs processes?
• Process capability studies, process plan,
manufacturing verification tests
Are Critical-to-Quality (CTQ)
characteristics are identified,
understood and records
retained?
• roduct characteristics, application requirements and
other information for safe and proper use and
disposal
are product specifications and
drawings generated, controlled
and maintained for new or
changed product designs?
• Design results, manufacturability, productivity and
cost studies, confirmation that product fulfils its
specified requirements or intended use or
applications
is design validation is an integral
part of the design process and
occurs prior to production
release?
• Qualification of technical staff. Equipment/software
capabilities, CAD
Are human and technical
resources aradequate to meet
the requirements for design
collaboration, tooling design and
electronic drawing and data
exchange?
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24. QUALITY PLANNING
Are customer production
requirements and quality
specifications are
reviewed to ensure they
can be met on a
consistent basis?
rocedures, design/process review,
capacity plans, resource plans,
product test, storage, packaging
and shipment requirements
Are reliability test plans
developed and routinely
followed?
Reliability test plans, test reports
s testing is used to verify
the design specifications,
drive design
improvements and
provide an on-going
check of materials and
workmanship?
mprovement/corrective actions
taken, design changes implemented
s product reliability test
data is available upon
request and historical test
performance data shows a
highly stable process and
product design?
Reliability test summary
reports/charts
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25. PROCESS CONTROL
re key part
characteristics and
process parameters are
reviewed and statistically
based controls and/or
problem solving tools are
used to control variation?
01
re written improvement
plans are implemented to
reduce sources of
variation?
02
s process capability is
measured and actions
are taken to maintain
established minimum
Cpk/Ppk targets?
03
Are out of control
conditions are noted on
charts and documented
corrective action is taken
to bring the process back
into control?
04
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26. AUDIT
EVIDENCE
Histograms, run charts, SPC charts, pareto
analysis, cause and effect diagrams, mistake
proofing, reaction plan & process corrections.
Documented reaction plan and process
corrections. SPC trend charts showing current
status vs. goals, improvement plans
Documented process capability studies and
results (actual vs target Cpk/Ppk)
Control charts
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27. PROCUREMENT
s there a formal
process used for the
selection, qualification
and re-qualification of
suppliers?
01
Are purchases from
unapproved suppliers
prevented by a properly
controlled and available
approved supplier list?
02
Are preventive actions
taken to continuously
improve performance of
the supplier base?
03
Does the supplier
assurance system
ensure that all
purchased product or
material conforms to
defined specifications
and applicable
regulatory or customer
requirements?
04
Does a system exist for
the identification,
verification and
protection of customer
supplied product that
includes notifying the
customer if product is
damaged or lost?
05
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28. WHAT TO
LOOK
FOR
Supplier quality audits and
corrective actions, engineering
testing, approval records,
production trials
Approved supplier list,
procedures, production
material receipt records
Supplier quality performance
analysis, performance trends,
supplier audit reports
Receiving inspection, supplier
audits, source inspection,
qualification testing, Certificate
of Compliance, component
marking, labelling, etc.
Procedures, segregation
during storage, limited and
controlled access to stored
inventories
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29. EDUCATION & TRAINING
• s the skill and education level required for each job
documented and appropriate training provided?
• s employee qualification/certification maintained
where the quality outcome of the process cannot be
verified and is strongly dependent upon operator
skill?
• re suitable methods used to verify training
effectiveness?
• re suitable records of maintained?
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30. WHAT TO LOOK
FOR
• use of training aids and work instructions at work
stations
• Qualification records, certification history
• Records of testing, production quality records, audit
records, interview workers to validate training
records
• Job descriptions, job skills assessment, training
records, training manuals
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31. NONCONFORMING MATERIAL
TAGS, MARKING,
CONTROLLED STAGING
AREAS
NSPECTION RECORD,
TAG AND STAMP
WRITTEN PROCEDURE,
WAIVER OR
CONCESSION RECORDS
SERIAL NUMBER
RECORDS, LOT NUMBER,
DATE OF
MANUFACTURE,
LABELLING AND
MARKING OF
CONTAINERS OR
PRODUCT
DOCUMENTED
PROCEDURE AND
REVIEW OF SYSTEM
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32. ENVIRONMENT
ENVIRONMENTAL POLICY
STATEMENT DOCUMENT
RECORDS OF
AGENCY/GOVERNMENT
INSPECTION, PROCEDURES
FOR MEASURING AND
MONITORING
ENVIRONMENTALLY
SENSITIVE ACTIVITIES.
RECORD OF PURCHASES,
WASTE STREAM AND
CONSUMPTION; INVENTORY
CONTROL PROCEDURES.
RECORDS/USE OF;
BIODEGRADABLE
MATERIALS, RETURNABLE
CONTAINERS OR
PACKAGING, RECYCLING
PROGRAM, PACKAGING
MATERIALS MADE OF
RECYCLED MATERIALS.
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