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Global Standard for Consumer Products Issue 3: February 2010
Audit Report / Scorecard
Auditors should select yes or no for each question. Some questions also allow for a Not Applicable (N/A) answer. No questions shall be left blank. Additionally auditors shall write a summary of findings for all fundamental clauses
For each clause, the auditor shall summarise the detail of all non conformities found and indicate whether they are Critical (C) , Major (M) or Minor (Min) There is a space at the end of each section to allow auditor to include comments if they wish to do so. Auditors shall not write observations unrelated to the Standard or any recommendations in this space but may record aspects audited but not covered by the questions relating to the section
Section 1
Senior Management Commitment and Continual Improvement
Fundamental
The company's senior management shall demonstrate that they are fully committed to the implementation of the
Clause
requirements of the Global Standard for Consumer Products (referred to as The Standard). This shall include
provision of adequate resources, effective communication, systems of review, and actions taken to identify and
effect opportunities for improvement.
Summary of
auditor
findings
Clause
Prod
Group
1.1
All
The companys senior management shall ensureNon conformity details
that product safety and quality objectives are
established, documented, monitored, and
reviewed at least annually.
1.1 a
All
Are product safety and quality objectives
Yes
No
established, documented, and monitored?
1.1 b
All
Are product safety and quality objectives
Yes
No
reviewed by senior management at least
annually?
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Global Standard for Consumer Products Issue 3: February 2010
Audit Report / Scorecard
1.2
All
The senior management review process shall beNon conformity details
documented and shall include an evaluation of:
Internal, customer, and external (third party)
audits; previous management review documents,
corrective action plans, and timeframes;
customer performance indicators, complaints,
and feedback; incidents, non-conforming
materials and corrective actions; an assessment
of process performance; a review of the product
risk assessment system; a review of the results
of monitoring and testing; developments in legal
requirements or scientific information associated
with the products in scope; resource
requirements.
1.2 a
All
Is the senior management review process
Yes
No
documented, and does it include an
evaluation of internal, customer, and external
(third party) audits?
1.2 b
All
Are previous management review documents,Yes
No
corrective action plans, and timeframes
available and documented?
1.2 c
All
Are customer performance indicators,
Yes
No
complaints, and feedback reviewed and
documented?
1.2 d
All
Are incidents, non-conforming materials, andYes
No
corrective actions reviewed and
documented?
1.2 e
All
Is an assessment of process performance
Yes
No
conducted, reviewed, and documented?
1.2 f
All
Is there review and documentation of the
Yes
No
product risk assessment system?
1.2 g
All
Is there review and documentation of the
Yes
No
results of monitoring and testing?
1.2 h
All
Is there review and documentation of
Yes
No
developments in legal requirements or
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Global Standard for Consumer Products Issue 3: February 2010
Audit Report / Scorecard
scientific information associated with the
products in scope?
1.2 i
All
Is there review and documentation of
Yes
No
resource requirements?
1.3
All
The decisions and actions agreed shall be
Non conformity details
effectively communicated to appropriate staff and
the actions implemented within the agreed
timescales. Records should be updated to show
when actions have been completed.
1.3 a
All
Are agreed decisions and actions effectivelyYes
No
communicated to appropriate staff?
1.3 b
All
Are actions implemented within the agreed
Yes
No
timescales?
1.3 c
All
Are records updated to show when actions
Yes
No
have been completed?
1.4
All
The company's senior management shall provideNon conformity details
the human and financial resources required to
implement and improve the processes of the
quality management system, the product risk
assessment plan, and to address legal, product
safety, and product quality matters.
1.4 a
All
Has the company's senior management
Yes
No
provided adequate human and financial
resources to implement and improve the
processes of the quality management
system?
1.4 b
All
Has the company's senior management
Yes
No
provided adequate human and financial
resources to implement and improve the
product risk assessment plan?
1.4 c
All
Has the company's senior management
Yes
No
provided adequate human and financial
resources to address legal, product safety,
and product quality matters?
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1.5All
There shall be clear communication and regularNon conformity details
reporting of the functioning of, and compliance
with, the Standard to senior management by the
staff responsible. This shall include suggestions
for improvement.
1.5 aAll
Is there clear communication and regularYesNo
reporting of the functioning of, and
compliance with, the Standard to senior
management by the responsible staff,
including suggestions for improvement?
1.6All
The company shall have a current, original copyNon conformity details
of the Standard available on site.
1.6 aAll
Does the company have a current, originalYesNo
copy of the Standard available on site?
1.71 & 2
Where required by legislation, the site shall beNon conformity details
registered with or approved by the appropriate
government agency and evidence of this shall be
available.
1.7 a1 & 2
Where required by legislation, is the siteYesNoN/A
registered with or approved by the
appropriate government agency and is
evidence of this available?
Auditor remarks
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Section 2
Risk Management
Fundamental
he company shall have a management process in place to assure product safety, legality and quality, based on
Clause
risk assessment principles. Sites must be aware of and refer to up-to-date legislation, product standards, codes of
practice, and developments in science or technology that may impact risk concerning their products and
packaging where these exist in the regions of intended sale.
Auditor
findings
ClauseProd
Audit Questions
Group
2.1
Product Scope and group determination
2.1.1All
The company shall identify the range of productsNon conformity details
it wishes to include in the scope of certification
and the countries/states or regions for which the
products are to be made available for sale.
2.1.1 aAll
Has the company identified the range of
YesNo
products it wishes to include in the scope of
certification and the countries/states or
regions for which the products are to be made
available for sale?
2.1.1 bAll
Is there evidence that the company is
YesNo
manufacturing products that are contained
within the scope of the audit?
2.1.2All
The company shall establish and document theNon conformity details
product group(s) assigned to the products in
scope, derived from application of the questions
indicated in the decision tree (see The Standard
Section II, 3.4).
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2.1.2 a
All
Has the company established and
YesNo
documented the product groups assigned to
the products in scope, derived from
application of the questions indicated in the
decision tree?
2.2
Legislative and safety requirements
2.2.1
All
The company shall have and use a system, whichNon conformity details
may comprise internal and/or external resources,
to demonstrate knowledge of all legislation,
product standards, product safety issues,
scientific and technical developments, and
industry/customer codes of practice in the regions
of intended sale relevant to the products in scope.
2.2.1 a
All
Does the company have and use a system,
YesNo
which may comprise both internal and
external resources, to demonstrate knowledge
of all legislation, product standards, product
safety issues, scientific and technical
developments, and industry/customer codes
of practice in the regions of intended sale
relevant to the products in scope?
2.2.2
All
If the company relies on information concerningNon conformity details
product safety, quality, and legality provided by
their customer or related party, it shall validate the
information received and document the validation
process.
2.2.2 a
All
Where the company relies on information
YesNoN/A
concerning product safety, quality, and
legality provided by their customer or related
party, does it validate the information received
and document the validation process?
2.2.3
All
A documented process shall exist for
Non conformity details
incorporating changes in legislation, standards,
etc. into the companys procedures in a timely
fashion, which shall be before any official
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implementation date of the relevant change.
2.2.3 a
All
Does a documented process exist forYesNo
incorporating changes in legislation,
standards, etc. into the companys procedures
in a timely fashion?
2.2.4
All
Copies of applicable legislation, standards, codesNon conformity details
of practice, and similar documentsshall be
available to relevant staff.
2.2.4 a
All
Are copies of applicable legislation,YesNo
standards, codes of practice, and similar
documents available to relevant staff?
2.3
Risk assessment - prior to production
2.3.1
All
A design specification covering each product shallNon conformity details
be documented, dated, and authorized. This shall
include all relevant information. As a guide, this
may include the following, although this is not an
exhaustive list: composition, size, color; bills of
materials; assembly diagrams; primary packaging;
intended shelf life; warnings or instructions for
use; use, misuse, usage patterns; productions
volumes. Any changes to the product design shall
be documented and dated.
2.3.1 a
All
Is there a documented design specification toYesNo
cover each product?
2.3.1 b
All
Are design specifications and revisions toYesNo
specifications dated?
2.3.1 c
All
Do design specifications include all relevantYesNo
information?
2.3.2
All
The company shall determined and list the legalNon conformity details
statutes and mandatory standards applicable to
each product and to the materials from which it is
made, relevant in the regions of intended sale.
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2.3.2 a
All
Has the company determined and documentedYesNo
the legal statutes and mandatory standards
applicable to each product and to the
materials from which it is made, relevant in the
regions of intended sale?
2.3.3
All
The company shall ensure that a product hazardNon conformity details
and risk assessment is available and clearly
identifies: the hazards, the risk level for each
hazard and whether the risk is acceptable; the
person responsible for the assessment; the date
performed and the evidence (for example, sample
drawings, computer graphics) from which the
assessment was derived. This risk assessment
may be provided by internal or external resources.
If the product requires modification, a new risk
assessment shall be completed on the modified
design.
2.3.3 a
All
Is a product hazard and risk assessment
YesNo
available that clearly identifies the hazards,
the risk level for each hazard and whether the
risk is acceptable?
2.3.3 b
All
Is the person responsible for the assessmentYesNo
clearly identified?
2.3.3 c
All
Is the date on which the assessment was
YesNo
performed and the evidence on which it is
based identified?
2.3.3 d
All
If the product requires modification, is a
YesNoN/A
product hazard and risk assessment available
that clearly identifies where products have
been modified, and is a new risk assessment
available?
2.3.4
All
No products deemed to present an unacceptableNon conformity details
risk by the assessment described in clause 2.3.3
shall be produced.
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2.3.4 aAllThe audit does not result in evidence that
YesNo
product has been produced that had been
identified as being of an unacceptable risk
during the risk assessment process?
2.4
Verification of the Product Risk Assessment
2.4.1AllThe company shall ensure that risk assessmentsNon conformity details
have been carried out by competent staff (internal
or external) and shall document the way in which
this is assessed.
2.4.1 aAllDoes the company ensure that risk
YesNo
assessment is carried out by competent staff
(internal or external), and do they document
the way in which this is assessed?
2.4.2AllThe risk assessment shall be regularly, and at
Non conformity details
least annually, reviewed (while the products are
still in production) to ensure that the assessment
remains up to date, takes account of complaints
or incidents with the product or similar products,
and reflects any changes in legislation.
2.4.2 aAllWhile the products are in production, is thereYesNo
a regular review of the risk assessment, at
least annually?
2.4.2 bAllDoes the review ensure that the assessmentYesNo
remains up to date, takes account of
complaints or incidents with the product or
similar products, and reflects any changes in
legislation?
2.4.31 & 2The risk assessment shall be carried out beforeNon conformity details
production begins, and completion shall be
verified by a designated responsible person. If
customer sign-off is part of the contract of sale,
this shall be obtained.
2.4.3 a1 & 2Are risk assessments carried out before
YesNoN/A
production begins, and is completion verified
by a designated responsible person?
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2.4.3 b1 & 2If customer sign off is part of the contract ofYesNoN/A
sale, is this obtained?
2.4.41 & 2Where there is legal requirement to do so or whenNon conformity details
it is necessary to confirm its safety or legality, a
representative product should be submitted for
testing to a suitably qualified and accredited
laboratory (internal or external). The results of the
test should form part of the risk assessment.
2.4.4 a1 & 2Where product testing is required, either
YesNoN/A
legally or on safety or quality grounds, are
products submitted to a suitably qualified and
accredited laboratory (internal or external)?
2.4.4 b1 & 2Do the results of the test form part of the riskYesNoN/A
assessment?
2.4.51 & 2Aspects of the product design/materials that areNon conformity details
critical to safety and which must be maintained in
production shall be established with the risk
assessment provider and the control limits set on
these features or materials.
2.4.5 a1 & 2Are all aspects of the product design/materialsYesNoN/A
maintained in production that are critical to
safety established with the risk assessment
provider?
2.4.5 b1 & 2Are control limits set on these features or
YesNoN/A
materials?
2.4.61 & 2Where legally required, the identity, qualifications,Non conformity details
and/or license of the person producing the safety
review or risk assessment shall be documented
and verified.
2.4.6 a1 & 2Where legally required, is the identity,
YesNoN/A
qualifications, and/or license of the person
producing the safety review or risk
assessment documented and verified?
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Auditor remarks
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Section 3Management System
ClauseProd
Audit Questions
Group
3.1
Policy statement
AllThe policy shall state the company's intention toNon conformity details
produce safe and legal products to the specified
3.1.1
quality (and to meet its responsibility to its
customers). This shall include the commitment for
review and continual improvement.
AllHas the company's senior managementYes
No
3.1.1 a
developed, documented, and implemented a
policy statement?
3.1.1 bAllIs the policy statement authorized, regularlyYes
No
reviewed, signed, and dated?
AllDoes the policy state the company's intentionYes
No
3.1.1 c
to produce safe and legal products to the
specified quality and to meet its responsibility
to its customers?
3.1.1 dAllDoes the policy include the commitment forYes
No
review and continual improvement?
AllThe company's senior management shall ensureNon conformity details
3.1.2
the policy statement is communicated to and
understood by all staff involved with activities
relating to product safety, legality, and quality.
AllIs the policy statement communicated to andYes
No
3.1.2 a
understood by all staff involved with activities
relating to product safety, legality, and quality?
General Documentation requirement
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3.2.1
Documentation Control
Statement of
The company's senior management shall
Non conformity details
Intent
ensure that all documents records, and data
critical to the management of product safety,
legality and quality are in place and effectively
controlled.
3.2.1.1
All
All documents in use shall be the current versions,
Non conformity details
authorized and dated, and a procedure shall be in
place to ensure that obsolete documentation is
removed from use.
3.2.1.1
All
Is there a procedure in place that defines how
Yes
No
a
documentation is controlled?
3.2.1.1
All
Is there a "Master List" of controlled
Yes
No
b
documents or another means of identifying
which documents are controlled?
3.2.1.1
All
Are documents in use the current version and
Yes
No
c
are they authorized and dated?
3.2.1.1
All
Is there a procedure in place to ensure obsolete
Yes
No
d
documentation is removed from use?
3.2.1.2
All
Documents shall be clearly legible, unambiguous,
Non conformity details
in appropriate languages, and sufficiently detailed
to enable their correct application by staff. They
shall be readily accessible to relevant staff at all
times.
3.2.1.2
All
Are documents clearly legible, unambiguous, in
Yes
No
a
appropriate languages, and sufficiently detailed
to enable their correct application by staff?
3.2.1.2
All
Is the documentation readily accessible by
Yes
No
b
relevant staff at all times?
3.2.1.3
All
Changes or amendments to documents shall be
Non conformity details
authorized and dated and the reason for the
change recorded.
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3.2.1.3
All
Are all changes or amendments to documents
Yes
No
a
authorized and dated and is the reason for the
change recorded?
3.2.1.3
All
Are the most recent customer provided
Yes
No
N/A
b
specifications available to the appropriate
personnel, and being utilized by
manufacturing?
3.2.1.3
All
Are drawings and manufacturing documents
Yes
No
c
updated when product changes are made?
3.2.2
Record Completion and Maintenance
3.2.2.1
All
The records shall be legible, genuine, appropriately
Non conformity details
authorized, and retained in good condition for a
period which takes account of the product lifetime
and is consistent with the legal requirements in the
country of manufacture or sale. Customer-specific
requirements relevant to record retention shall be
respected.
3.2.2.1
All
Does the company maintain records to
Yes
No
a
demonstrate the effective control and
achievement of product safety, legality, and
quality?
3.2.2.1
All
Are receiving inspection records, inline
Yes
No
b
inspection records, final inspection records
and nonconforming material records which
show date of inspection, item number, item
description, lot size, AQL and inspection
results maintained?
3.2.2.1
All
Are the quality records available sufficient to
Yes
No
c
verify conformity to specifications, operating
procedures, and evidence for problem solving?
3.2.2.1
All
Are these records legible, genuine,
Yes
No
d
appropriately authorized, and retained in good
condition for a period of time which takes into
account product lifetime, customer
requirements, and the legal requirements in the
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country of manufacture or sale?
3.2.2.2
AllThe company's senior management shall ensureNon conformity details
that procedures are operated for the collation,
review, maintenance, storage, and retrieval of all
records relating to product safety, legality, and
quality.
3.2.2.2
AllDoes the company's senior management
YesNo
a
ensure that procedures are operated for the
collation, review, maintenance, storage, and
retrieval of all records relating to product
safety, legality, and quality?
3.2.2.3
AllAny alterations to records shall be visible and
Non conformity details
authorized, and the justification for alterations shall
be recorded.
3.2.2.3
AllAre alterations to records visible and
YesNo
a
authorized, and is a justification for alterations
recorded?
3.2.3
Specification & Technical information dossiers
Statement ofThe company shall ensure that specifications
Non conformity details
Intent
exist for raw materials, components, and
bought-in components including packaging,
intermediate/semi-processed, and finished
products and any product or service that could
affect the integrity of the finished product. A
technical folder shall be established for each
product.
3.2.3.1
AllSpecifications shall be adequate and accurate, and
Non conformity details
shall ensure compliance with relevant safety,
legislative, and customer requirements. They shall
be accessible to relevant staff.
3.2.3.1
AllDo adequate and accurate specifications exist
YesNo
a
to ensure compliance with relevant safety,
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legislative, and customer requirements?
3.2.3.1AllAre the specifications accessible to relevant
Yes
No
b
staff?
3.2.3.2AllCompanies shall maintain a technical folder
Non conformity details
containing all relevant data (or details of where
such data is located) to ensure that products meet
the requirements of the Standard. For example:
detailed product specification (see clause 2.3.1);
bill of materials; safety data sheets on all chemicals
used where relevant to the safety, legality, or
quality of the product; risk assessment(s);
description of the conformity assessment
procedure; test reports, inspection reports; list of
the legislation, product standards with which the
products are manufactured to comply; production
control procedures and charts; approvals by any
government body (if applicable); declarations of
conformity to legal requirements (if applicable).
3.2.3.2AllDoes the company maintain a technical folder
Yes
No
a
for each product containing relevant data to
ensure the products meet the requirements of
the standards?
3.2.3.31 & 2The company shall seek formal agreement of
Non conformity details
specifications with relevant parties. Where
specifications are not formally agreed, then the
company shall be able to demonstrate that they
have taken steps to seek formal agreement.
3.2.3.31 & 2Does the company seek formal agreement of
Yes
No
N/A
a
specifications with relevant parties?
3.2.3.31 & 2Where specifications are not formally agreed,
Yes
No
N/A
b
can the company demonstrate that they have
taken steps to seek formal agreement?
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3.2.3.41 & 2There shall be a documented procedure for the
Non conformity details
amendment and approval of specifications for all
parts of the process including regular reviews to
ensure adequacy and status.
3.2.3.41 & 2Is there a documented procedure for the
Yes
No
N/A
a
amendment and approval of specifications for
all parts and materials of the process including
regular reviews to ensure adequacy and
status?
3.3
Organizational structure, responsibility, and management authority
Statement ofThe company shall have a clearly defined and
Non conformity details
Intentdocumented organizational structure that
ensures the awareness of job function,
responsibilities, and reporting relationships of
key staff.
3.3.1AllThe company shall have an organization chart
Non conformity details
demonstrating the structure of the company.
3.3.1 aAllDoes the company have an organization chart
Yes
No
demonstrating the structure of the company?
3.3.2AllDocumented, clearly defined responsibilities shall
Non conformity details
exist and be communicated to key staff with
responsibility for product safety, legality, product
quality, and management systems.
3.3.2 aAllDo documented, clearly defined responsibilities
Yes
No
exist for key staff with responsibility for
product safety, legality, product quality, and
management systems?
3.3.2 bAllHave these responsibilities been clearly
Yes
No
communicated to the appropriate staff?
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3.3.3
All
A named individual with relevant experience and
Non conformity details
qualifications shall be responsible for the
management of the legal, quality, and safety
requirements laid out in this Standard. This
responsibility should not present a conflict of
interest with any other responsibilities.
3.3.3 a
All
Is there a named individual with relevant
Yes
No
experience and qualifications responsible for
the management of the legal, quality, and safety
requirements laid out in this Standard?
3.3.3 b
All
Is it verified that there is no a conflict of interest
Yes
No
in this person's responsibilities?
3.3.4
All
There shall be appropriate documented
Non conformity details
arrangements in place to cover for the absence of
key staff.
3.3.4 a
All
Are there appropriate documented
Yes
No
arrangements in place to cover for the absence
of key staff?
3.3.5
All
The company's senior management shall ensure
Non conformity details
that a description of general duties or work
instructions is in place and communicated to all
staff involved with activities relating to product
safety, legality, and quality.
3.3.5 a
All
Has the company's senior management
Yes
No
ensured a description of general duties or work
instructions and communicated to all staff
involved with activities relating to product
safety, legality, and quality?
3.4Internal Audit
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Statement of
The company shall audit the management
Non conformity details
Intent
system to ensure that it is complied with and
appropriate.
3.4.1
All
Internal audits shall cover all aspects associated
Non conformity details
with the Standard. They shall be scheduled and
their scope and frequency shall be established
commensurate with the risks associated with the
activity. Audits of aspects that directly affect
safety, legality, or quality shall be conducted at
least annually. Exceptions resulting in audit
intervals of more than one year shall be justified by
documented risk assessment.
3.4.1 a
All
Does the company have internal audits that
Yes
No
cover all aspects associated with the Standard?
3.4.1 b
All
Are the internal audits scheduled and is their
Yes
No
scope and frequency commensurate with the
risks associated with the activity?
3.4.1 c
All
Are audits of aspects that directly affect safety,
Yes
No
legality, or quality conducted at least annually,
and if greater than annually is it justified by
documented risk assessment?
3.4.2
All
Internal audits shall be carried out by competent
Non conformity details
auditors, who shall be independent of the area of
operation being assessed. Auditors shall not audit
their own work.
3.4.2 a
All
Are internal audits carried out by competent
Yes
No
auditors who are independent of the area of
operation being assessed?
3.4.3
All
Corrective actions shall be formally agreed by the
Non conformity details
person responsible for the action and implemented
within appropriate and agreed timescales.
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3.4.3 a
All
Are corrective actions formally assigned to
Yes
No
persons responsible for the action and
implementation within appropriate and agreed
timescales?
3.4.4
All
A record of all programmed internal audits and
Non conformity details
associated corrective actions shall be maintained
with both conformity and nonconformity with the
requirements documented. All corrective actions
shall be verified to ensure satisfactory completion.
3.4.4 a
All
Is a record of all programmed internal audits
Yes
No
and associated corrective actions maintained?
3.4.4 b
All
Do these records list both conformity and
Yes
No
nonconformity with requirements documented?
3.4.4 c
All
Are all corrective actions verified to ensure
Yes
No
satisfactory completion?
3.5
Purchasing, Supplier Approval and performance Review
Statement of
The company shall control all purchasing
Non conformity details
Intent
processes which are critical to product safety,
legality, and quality to ensure that procured
products and services conform to defined
requirements. In this context suppliers shall
include subcontractors and home workers.
3.5.1
All
The site shall have a documented supplier-
Non conformity details
approval procedure, including a list of approved
suppliers for products, materials, and services
impacting product safety, legality, or quality.
Procedures shall be established which include
clear criteria for ongoing assessment and the
standards of performance required. Ongoing
assessment may take the form of monitoring
performance through one or more of the following,
although there may be other acceptable methods:
in-house checks; certificates of analysis; certificate
of conformity; supplier audits; traceability checks.
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Records of this monitoring shall be retained for at
least the lifetime of the product.
3.5.1 a
All
Does the company have a documented supplier
Yes
No
approval procedure, including a list of
approved suppliers for products, materials and
services impacting product safety, legality, or
quality?
3.5.1 b
All
Does the supplier approval procedure include
Yes
No
clear criteria for ongoing assessment and the
standards of performance required?
3.5.1 c
All
Are supplier approval records kept for the
Yes
No
lifetime of the product?
3.5.1 d
All
Does the company maintain a list of critical
Yes
No
materials?
3.5.2
All
The company shall review the performance of new
Non conformity details
suppliers against defined criteria within a specified
"trial" period and thereafter at a specified frequency
to decide the level of ongoing supplier performance
monitoring.
3.5.2 a
All
Does the company review the performance of
Yes
No
new suppliers against defined criteria within a
specified 'trial' period and thereafter at a
specified frequency to decide the level of
ongoing supplier performance monitoring?
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3.5.3
All
The procedure shall identify whether the use of
Non conformity details
unapproved suppliers is acceptable under any
emergency or unusual situations. If this is the
case, the procedure shall define how exceptions
are recorded and how they are handled to maintain
safety, legality, and quality of the products.
3.5.3 a
All
Is there a procedure for the use of suppliers,
Yes
No
not on the approved list, under any emergency
or unusual situations?
3.5.3 b
All
Does the procedure define how exceptions are
Yes
No
recorded and how they are handled to maintain
safety, legality, and quality of the products?
3.6
Customer supplied property
Statement of
The company shall exercise care customer
Non conformity details
Intent
property (including intellectual property) while
it is under the company's control or is being
used by the company.
3.6.1
All
The company shall identify, verify, protect and
Non conformity details
safeguard customer property including software,
intellectual property, tooling, fixtures, test
equipment and products. If any customer property
is lost, damaged or otherwise found to be
unsuitable for use, this shall be reported to the
customer and records maintained.
3.6.1 a
All
Does the company identify, verify, protect and
Yes
No
safeguard customer property including
software, intellectual property, tooling, fixtures,
test equipment and products?
3.6.1 b
All
If any customer property is lost, damaged or
Yes
No
otherwise found to be unsuitable for use, is this
reported to the customer and records
maintained?
3.7
Corrective and Preventive Action
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FundamentalThe company's senior management shall
Non conformity details
Clauseensure that procedures exist to record,
investigate, analyze, and correct the cause of
nonconforming products or failure to meet
standards, specifications, and procedures
which are critical to product safety, legality,
and quality.
Auditor findings
3.7.1
AllThe company shall operate an effective system for
Non conformity details
the capture, recording, and timely investigation of
nonconformities or matters reported as possible
nonconformities critical to product safety, legality,
or quality.
3.7.1 a
AllDoes the company operate an effective system
Yes
No
for the capture, recording, and timely
investigation of nonconformities or matters
reported as possible nonconformities critical to
product safety, legality, or quality?
3.7.2
AllCustomer complaints concerning actual or potential
Non conformity details
product nonconformity shall be included in the
system.
3.7.2 a
AllAre customer complaints concerning actual or
Yes
No
potential product nonconformity included in the
system?
3.7.2 b
AllAre inspection records used included in
Yes
No
determining use of corrective action?
3.7.2 c
AllDo adequate procedures exist to record,
Yes
No
investigate, analyze and correct the cause of
nonconforming products?
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3.7.3AllAn appropriate staff member shall be identified andNon conformity details
allocated the responsibility and accountability for
each corrective action. This shall be documented.
3.7.3 aAllDoes documentation support that anYes
No
appropriate staff member was identified and
allocated the responsibility and accountability
for each corrective action?
3.7.4AllThe company shall ensure that effective correctiveNon conformity details
actions are taken to prevent recurrence of the
problem and shall monitor and record their
completion within an appropriate timescale.
3.7.4 aAllDoes the company ensure that effectiveYes
No
corrective actions are taken to prevent
recurrence of the problem and does it monitor
and record their completion within an
appropriate timescale?
3.7.4 bAllIs the corrective action system closed loop?Yes
No
3.7.5AllThe company shall review its processes at leastNon conformity details
annually, incorporate industry best practice, and
adopt preventative measures as they become
available.
3.7.5 aAllDoes the company review their processes atYes
No
least annually, incorporate industry best
practice, and adopt preventive measures as
they become available?
3.7.5 bAllAre the results of preventative actionsYes
No
monitored and analyzed by management?
3.8
Traceability
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FundamentalThe company shall have a system to identify
Non conformity details
Clauseand trace product lots/batches including raw
materials, components, and packaging
materials and follow this from the source of the
incoming material through all stages of
processing to supply of the product to the
primary customer, and vice versa, in a timely
manner. ( Materials identified as low risk to the
safety, legality, or quality of the final product may
be exempted from lot traceability)
Auditor findings
3.8.1
AllCompanies shall be able to identify the immediate
Non conformity details
source of all raw materials, components, and
packaging materials.
3.8.1 a
AllIs the source of all raw materials, components,
Yes
No
and packaging materials identifiable?
3.8.2
AllThe products that constitute a lot/batch shall be
Non conformity details
defined and documented. This shall include
products made by continuous production methods.
3.8.2 a
AllAre products that constitute a lot/batch defined
Yes
No
and documented, including products made by
continuous production methods?
3.8.3
AllIdentification of lots/batches of raw materials
Non conformity details
including packaging, processing aids,
intermediate/semi-processed products, part-used
materials, finished products and materials pending
investigation, shall be adequate to ensure
traceability.
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3.8.3 a
All
Is the identification of lots/batches of raw
Yes
No
materials including packaging, processing aids,
intermediate/semi-processed products, part-
used materials, finished products and materials
pending investigation, adequate to ensure
traceability as necessary?
3.8.4
All
Final products shall be suitably marked, at least on
Non conformity details
their outer packaging, to allow adequate
identification and traceability.
3.8.4 a
All
Are final products suitably marked, at least on
Yes
No
their outer packaging, to allow adequate
identification and traceability?
3.8.5
All
Traceability must, in all cases, be available for
Non conformity details
each lot/batch from source of raw material to
supply to the primary customer.
3.8.5 a
All
Is traceability available for each lot/batch from
Yes
No
source of raw material to supply to the primary
customer?
3.8.6
All
The traceability system shall be maintained when
Non conformity details
rework or any reworking operation is performed.
3.8.6 a
All
Is the traceability system maintained when
Yes
No
rework or any reworking operation is
performed?
3.8.7
All
The company shall test the traceability system to
Non conformity details
ensure traceability can be determined from raw-
material receipt to finished product and vice versa.
This shall occur at a predetermined frequency, at
least annually, and results shall be retained. The
time taken to complete the exercise shall be
measured and recorded.
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3.8.7 aAllDoes the company test the traceability systemYes
No
to ensure traceability can be determined from
raw material receipt to finished product and
vice versa?
3.8.7 bAllDoes this occur at a predetermined frequency,Yes
No
at least annually, and are results retained?
3.8.7 cAllIs the time taken to complete this exerciseYes
No
measured and recorded?
3.8.8AllWhen the same component or raw material isNon conformity details
sourced from more than one supplier, the
traceability system shall ensure that the
lots/batches from each supplier can be identified if
the component/material is identified as critical to
safety, quality, or legality.
3.8.8 aAllIn the case that the same component orYes
No
N/A
material is sourced from more than one
supplier, does the traceability system ensure
that the lots/batches from each supplier can be
identified if the component/material is identified
as critical to safety, quality, or legality?
3.8.9AllChanges in materials, processes, or componentsNon conformity details
shall be traceable if they could affect the safety,
quality, or legality of the product and formally
agreed by the customer if contractually required.
3.8.9 aAllAre changes in materials, processes orYes
No
components traceable if they could affect the
safety, quality, or legality of the product?
3.8.9 bAllIs there evidence that changes in materials,Yes
No
processes or components that could affect
safety, quality, or legality are formally agreed to
by the customer?
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3.8.10AllSubcontracted manufacture of products or
Non conformity details
components (including homeworking) must be
traceable to a level appropriate to the risk.
3.8.10AllIs subcontracted manufacture of products or
Yes
No
N/A
a
components (including homeworking) traceable
to a level appropriate to the risk?
3.8.111 & 2The need for further traceability through the chain
Non conformity details
should be established, based on the risk
assessment and any legal or specific customer
requirements.
3.8.111 & 2Has the need for further traceability through the
Yes
No
N/A
a
chain been established, based on the risk
assessment and any legal or specific customer
requirements?
3.8.121 & 2For continuous production processes, methods of
Non conformity details
defining traceability levels must be documented
and based on the risk assessment.
3.8.121 & 2For continuous production processes, are the
Yes
No
N/A
a
methods of defining traceability levels
documented and based on the risk
assessment?
3.9
Management of Product withdrawal and productrecall
Statement ofThe company shall have a plan and system in
Non conformity details
Intentplace to effectively manage product withdrawal
and product recall procedures.
3.9.1AllThe company shall have a product recall procedure
Non conformity details
in place to effectively manage product withdrawals
and recalls. Procedures shall exist to ensure that
customers are notified immediately on issues of
significance to the customer or consumer in terms
of product safety, quality, or legality.
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3.9.1 aAllDoes the company have a product recall
Yes
No
procedure in place to effectively manage
product withdrawals and recalls?
3.9.1 bAllDo procedures exist to ensure that customers
Yes
No
are notified immediately on issues of
significance to the customer or consumer in
terms of product safety, quality, or legality?
3.9.2AllThe company shall have written agreements in
Non conformity details
place with distributors and other parties in the
supply chain where these are necessary to ensure
effective withdrawal/recall.
3.9.2 aAllDoes the company have written agreements in
Yes
No
place with distributors and other parties in the
supply chain where these are necessary to
ensure effective withdrawal/recall?
3.9.3AllIn the event of a product recall, the certification
Non conformity details
body issuing the current certificate and the
appropriate enforcement authorities shall be
informed in a timely manner. The company shall be
aware of and adhere to any legal reporting
obligations in the countries of sale.
3.9.3 aAllIn the event of a product recall, is the
Yes
No
certification body issuing the current certificate
and the appropriate enforcement authorities
informed in a timely manner?
3.9.3 bAllDid the company demonstrate awareness of
Yes
No
and adhere to any legal reporting obligations in
the countries of sale?
3.9.41 & 2The product recall and withdrawal procedures shall
Non conformity details
be documented and regularly tested, at least
annually, in a way that ensures their effective
operation. Results of the test shall include timings
of key activities and shall be retained.
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3.9.4 a1 & 2Are the product recall and withdrawalYes
No
procedures documented and regularly tested,
at least annually, in a way that ensures their
effective operation?
3.9.4 b1 & 2Do results of the test include timings of keyYes
No
N/A
activities and are they retained?
3.9.51 & 2The company's senior management shall ensureNon conformity details
that results of this test shall be used to implement
improvements as necessary?
3.9.5 a1 & 2Does the company's senior managementYes
No
N/A
ensure that results of this test are used to
implement improvements as necessary?
Management of incidents and business continuity
Statement ofThe company shall have procedures in place to
Non conformity details
Intent
identify methods of ensuring business
continuity in the case of incidents and/or
informing their customers when incidents
occur.
3.10.1
AllThe company shall provide written guidance to
Non conformity details
relevant staff regarding the type of event that would
constitute an incident or emergency situation that
impacts product safety, legality, or quality, and a
documented reporting procedure shall be in place
which shall include informing their customers in a
timely manner.
3.10.1
AllDoes the company provide written guidance to
Yes
No
a
relevant staff regarding the type of event that
would constitute an incident or emergency
situation?
3.10.1
AllDoes the company have a documented
Yes
No
b
reporting procedure in place that includes
informing their customers in a timely manner?
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3.10.21 & 2The company shall develop contingency planning
Non conformity details
for business continuity in the event of major
incidents such as: disruption to key services - e.g.
water, energy, staff availability; events such as
flood, fire, or natural disaster; malicious
contamination or sabotage.
3.10.21 & 2Has the company developed contingency
Yes
No
N/A
a
planning for business continuity in the event of
major incidents such as: disruption to key
services, flood, fire, or natural disaster, or
malicious contamination or sabotage?
3.10.31 & 2The procedures shall include as a minimum:
Non conformity details
identification of key staff constituting the incident
management team and their key responsibilities;
an up-to-date list of key contacts, with details of
agencies providing advice and support.
3.10.31 & 2Does the business continuity plans include
Yes
No
N/A
a
identification of key staff and their
responsibilities?
3.10.31 & 2Does the business continuity plans include an
Yes
No
N/A
b
up-to-date list of key contacts?
3.10.31 & 2Does the business continuity plans include
Yes
No
N/A
c
details of agencies providing advice and
support?
3.11
Contract review and customer focus
Statement ofThe company's senior management shall
Non conformity details
Intentensure that processes are in place to determine
any customer requirements and expectations
with regard to product safety and quality, and
ensure that these are fulfilled.
3.11.1AllCustomer requirements shall be documented,
Non conformity details
reviewed, and confirmed on a suitable
predetermined frequency. Any resulting changes
shall be documented and communicated to
relevant departments.
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3.11.1AllAre customer requirements documented,Yes
No
a
reviewed, and confirmed on a suitable
predetermined frequency?
3.11.1AllAre resulting changes documented andYes
No
b
communicated to relevant departments?
3.11.2AllIn the case where customers have set particularNon conformity details
performance indicators to be monitored, these
requirements shall be communicated, adhered to,
and reviewed at least annually.
3.11.2AllIn the case where customers have set particularYes
No
N/A
a
performance indicators to be monitored, are
these requirements communicated, adhered to,
and reviewed at least annually?
3.11.31 & 2The company shall clearly identify those individualsNon conformity details
responsible for communication with customers and
shall have an effective system for communication.
3.11.31 & 2Has the company identified those individualsYes
No
N/A
a
responsible for communication with
customers?
3.11.31 & 2Is there an effective system for thisYes
No
N/A
b
communication?
3.11.41 & 2Performance indicators relating to customerNon conformity details
satisfaction shall be established and communicated
to relevant staff, and performance reviewed against
these targets.
3.11.41 & 2Have performance indicators relating toYes
No
N/A
a
customer satisfaction been established and
communicated to relevant staff, and is
performance reviewed against these targets?
3.12
Complaint handling
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Statement ofThe company shall operate an effective system
Non conformity details
Intentfor the capture, recording, and investigation of
product complaints.
3.12.1AllA system shall be in place to capture, record, and
Non conformity details
investigate all complaints relating to product safety,
legality, and unusual or critical quality defects, and
the results of the investigation shall be recorded.
3.12.1AllIs there a system in place to capture, record,
Yes
No
a
and investigate all complaints relating to
product safety, legality, and unusual or critical
quality defects?
3.12.1AllAre the results of the investigation recorded?
Yes
No
b
3.12.2AllWhere complaints are investigated externally on
Non conformity details
behalf of the company, the responsibilities of the
parties shall be defined and the process shall be
documented. Companies shall seek to obtain the
results of any investigations carried out by such
parties.
3.12.2AllWhere complaints are investigated externally
Yes
No
a
on behalf of the company, are the
responsibilities of the parties defined and are
all the processes documented?
3.12.3AllActions appropriate to the seriousness and
Non conformity details
frequency of the problems identified shall be
carried out promptly and effectively by trained staff.
3.12.3AllAre actions appropriate to the seriousness and
Yes
No
a
frequency of the problems identified, carried
out promptly and effectively by trained staff?
3.12.41 & 2Complaint data shall be analyzed and used to
Non conformity details
implement ongoing improvements to product
safety, legality, and quality, and to avoid
recurrence. This analysis shall be made available
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to relevant staff.
3.12.41 & 2Is complaint data analyzed and used toYes
No
N/A
a
implement ongoing improvements to product
safety, legality, and quality, and to avoid
recurrence?
3.12.41 & 2Is this complaint analysis data made availableYes
No
N/A
b
to relevant staff?
Auditor
remarks
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Section 4
Site Standards
ClauseProduct
Audit Questions
Group
4.1
Location, Perimeter and Grounds
Statement of
Sites used for manufacturing, storage or
Non conformity details
Intent
distribution shall be of suitable size, location,
construction and design to facilitate
maintenance, prevent contamination, and
enable the production of safe and legal
products.
4.1.1All
The site to be included in the audit shall be clearly
Non conformity details
defined, and shall be located and maintained so
as to allow the production of safe and legal
products.
4.1.1 aAll
Is the site to be included in the audit clearly
Yes
No
defined, and is it located and maintained so as
to allow the production of safe and legal
products?
4.1.2All
Consideration shall be given to local activities and
Non conformity details
the site environment, which may have an adverse
impact on product integrity. Measures adopted at
the site to protect the product from any potential
contaminants shall be regularly reviewed to
ensure that they continue to be effective.
4.1.2 aAll
Has consideration been given to local
Yes
No
activities and the site environment which
would have an adverse impact on finished
product integrity and where necessary, are
measures taken to prevent contamination?
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4.1.2 b
All
Is there a regular review of the measures
Yes
No
adopted to protect the site from any potential
contaminants?
4.1.3
All
The external areas and surroundings shall be
Non conformity details
maintained in good order.
4.1.3 a
All
Are the external areas and surroundings
Yes
No
maintained in good order?
4.1.4
All
External traffic routes that are under site control
Non conformity details
shall be maintained in good repair to avoid
contamination of the product.
4.1.4 a
All
Where there are external traffic routes under
Yes
No
site control, are they maintained in good repair
to avoid contamination of the product?
4.1.5
All
There shall be no evidence of facility damage due
Non conformity details
to inadequate drainage.
4.1.5 a
All
Is there no evidence of facility damage due to
Yes
No
inadequate drainage?
4.2
Internal Site: Factory layout, Product Flow and Segregation
Fundamental
Premises and plant shall be suitably designed,
Non conformity details
Clause
constructed, and maintained so as to control
the risk of product contamination and to
comply with all relevant legislation.
Auditor findings
4.2.1
All
The building shall be maintained to minimize
Non conformity details
potential for product contamination.
4.2.1 a
All
Is the building designed and constructed to
Yes
No
minimize potential for product contamination?
4.2.1 b
All
Is the building maintained to minimize
Yes
No
potential for product contamination?
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4.2.2
All
The machinery and equipment shall be positioned
Non conformity details
to allow an efficient product flow from incoming to
outgoing and shall be arranged to minimize the
risk of product contamination and damage.
4.2.2 a
All
Does the placement of machinery and
Yes
No
equipment allow an efficient product flow and
minimize the risk of product contamination,
loss of traceability and damage?
4.2.3
All
A process flow diagram shall be available.
Non conformity details
4.2.3 a
All
Is a process flow diagram available?
Yes
No
4.2.4
All
Premises shall allow sufficient working space and
Non conformity details
storage capacity to enable all operations to be
carried out under safe and, if necessary, hygienic
conditions.
4.2.4 a
All
Do the premises allow sufficient working
Yes
No
space and storage capacity to enable all
operations to be carried out under safe and if
necessary hygienic conditions, including
areas such as raw material storage,
component storage, production floor, packing
or finishing area, finished product storage,
etc?
4.2.5
All
There shall be effective segregation to minimize
Non conformity details
the risk of product cross-contamination taking into
account the flow of product, nature of materials,
equipment, personnel, waste, airflow, air quality,
and utilities. When critical to product safety,
legality, quality, or customer requirements,
controls shall be in place to ensure that raw
materials, work in progress, rework, packaging,
and finished products of different specifications
are not inadvertently mixed.
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4.2.5 a
All
Is there effective segregation to minimize the
Yes
No
risk of product cross-contamination taking
into account the flow of product, nature of
materials, equipment, personnel, waste,
airflow, air quality, and utilities?
4.2.5 b
All
Are controls in place to ensure that raw
Yes
No
materials, work in progress, rework,
packaging, and finished products of different
specifications are not inadvertently mixed?
4.2.6
1 & 2
The location of facilities and services, including
Non conformity details
toilets, cleaning facilities, and catering facilities,
shall not jeopardize the integrity of the product.
4.2.6 a
1 & 2
Is the location of facilities and services,
Yes
No
N/A
including toilets, cleaning and catering
facilities such that it does not jeopardize the
integrity of product?
4.3
Building interiors
Statement of
The internal site, buildings, and facilities shall
Non conformity details
Intent
be suitable for the intended purpose. All
utilities to and within the production and
storage areas shall be designed, constructed,
maintained, and monitored to effectively
control the risk of product contamination.
4.3.1
All
The quality and finish of site buildings and
Non conformity details
facilities, including drainage when required, shall
be suitable for the intended purpose with due
regard to the risk of product safety, legality, and
quality, and shall be maintained to an appropriate
standard. This shall include: A clean, tidy and
clutter-free factory; adequate lighting; suitable and
sufficient removal of any by-products and
contaminants; impervious floors, in good repair,
and able to withstand cleaning procedures.
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4.3.1 a
All
Is the quality and finish of site buildings and
Yes
No
facilities, including drainage, suitable for the
intended purpose with due regard to the risk
of product safety, legality, and quality and is it
maintained to an appropriate standard?
4.3.1 b
All
Is there sufficient lighting in the factory,
Yes
No
including the production floor, inspection
areas, test areas, storage areas, maintenance
areas, finishing and packing areas, etc?
4.3.1 c
All
Is the facility clean, tidy, and clutter free,
Yes
No
including the production floor, inspection
areas, test areas, storage areas, maintenance
areas, finishing and packing areas, etc?
4.3.2
1 & 2
Potential contamination risk from buildings and
Non conformity details
overhead structures, including building voids, shall
be controlled through regular documented
inspections, and corrective action shall be taken
to prevent the risk of production contamination.
4.3.2 a
1 & 2
Is potential contamination risk from buildings
Yes
No
N/A
and overhead structures, including building
voids, controlled through regular documented
inspections?
4.3.2 b
1 & 2
Are corrective actions taken to prevent the
Yes
No
N/A
risk of product contamination?
4.3.3
1 & 2
The site shall be assessed for any particular
Non conformity details
requirements relevant to the products being
produced, such as temperature, humidity,
electrostatic discharge. Any identified
requirements shall be adopted, documented,
monitored, and regularly reviewed.
4.3.3 a
1 & 2
Has the site been assessed for any particular
Yes
No
N/A
requirements relevant to the products being
produced, such as temperature, humidity,
electrostatic discharge?
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4.3.3 b
1 & 2
Are the identified requirements adopted,
Yes
No
N/A
documented, monitored and regularly
reviewed?
4.3.3 c
1 & 2
Is the ventilation adequate to maintain product
Yes
No
N/A
safety, legality, and quality at the production
floor, inspection areas, test areas, storage
areas, maintenance areas, finishing and
packing areas, etc.?
4.3.4
1
Walls, floors, ceilings, pipework, and overhead
Non conformity details
structures shall be designed, constructed,
finished, and maintained to reduce condensation
and mold growth, and shall have access to
facilitate cleaning.
4.3.4 a
1
Are walls, floors, ceilings, pipework, and
Yes
No
N/A
overhead structures designed, constructed,
finished, and maintained to reduce
condensation and mold growth, and are they
accessible to facilitate cleaning?
4.3.5
1
All water used as an ingredient of the products or
Non conformity details
preparation of the products where it may come
into direct contact with the product shall be
potable (as defined in the region of intended
product sale), or suitably treated to prevent
contamination, and shall be regularly monitored.
4.3.5 a
1
Is all water used as an ingredient of the
Yes
No
N/A
products or preparation of the products where
it may come into direct contact with the
product potable (as defined in the region of
intended product sale), or suitably treated to
prevent contamination?
4.3.5 b
1
Is the water tested regularly?
Yes
No
N/A
4.3.6
1
Water in the form of water, ice, or steam used for
Non conformity details
cleaning or in connection with any operation in the
manufacture of products shall comply with legal
requirements in the country of use and present no
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risk to the safety, legality, or quality of the
products.
4.3.6 a
1
Does all water in the form of water, ice or
Yes
No
N/A
steam used for cleaning or in connection with
any operation in the manufacture of products
comply with legal requirements in the country
of use and present no risk to the safety,
legality, or quality of the products?
4.4
Staff Facilities
Statement of
Staff facilities shall be sufficient to
Non conformity details
Intent
accommodate the required number of
personnel, and shall be designed and
operated to minimize the risk of product
contamination. Such facilities shall be
maintained in good and clean condition.
4.4.1
All
Staff facilities such as washrooms, canteens, and
Non conformity details
break areas shall be designed and operated so as
to minimize the risk of product contamination.
4.4.1 a
All
Are staff facilities such as washrooms,
Yes
No
canteens, and break areas designed and
operated so as to minimize the risk of product
contamination?
4.4.2
1 & 2
Where smoking is allowed under national law,
Non conformity details
designated controlled smoking areas shall be
isolated from production areas to an extent that
ensures smoke cannot reach the product.
Adequate arrangements for dealing with smokers'
waste shall be provided both internally and
externally.
4.4.2 a
1 & 2
Are workers not allowed to have food, drink,
Yes
No
N/A
or smoke at their work areas?
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4.4.2 b
1 & 2
Where smoking is allowed under national law,
Yes
No
N/A
are designated controlled smoking areas
isolated from production areas to an extent
that ensures smoke cannot reach the product?
4.4.2 c
1 & 2
Are adequate arrangements provided both
Yes
No
N/A
internally and externally for dealing with
smokers' waste?
4.4.3
1 & 2
Storage facilities of sufficient size to
Non conformity details
accommodate all reasonable personal items shall
be provided for all personnel who work in areas
where they are unable to keep possessions with
them.
4.4.3 a
1 & 2
Are storage facilities of sufficient size
Yes
No
N/A
available, to accommodate all reasonable
personal items for all personnel who work in
areas where they are unable to keep
possessions with them?
4.4.4
1
Where specific workwear is required, designated
Non conformity details
changing facilities shall be provided for all
personnel: staff, visitor, or contractor. These shall
be sited to allow direct access to the production,
packing, or storage areas without recourse to any
external area. Where this is not possible, a risk
assessment shall be carried out and procedures
implemented accordingly.
4.4.4 a
1
Where specific workwear is required, are
Yes
No
N/A
designated changing facilities provided for all
personnel such as staff, visitors, or
contractors?
4.4.4 b
1
Are the changing facilities located to allow
Yes
No
N/A
direct access to the production, packing, or
storage areas without recourse to any external
area?
4.4.4 c
1
Where this is not possible, is a risk
Yes
No
N/A
assessment carried out and procedures
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implemented accordingly?
4.4.5
1
Outdoor clothing and other personal items shall
Non conformity details
be stored separately from workwear within the
changing facilities.
4.4.5 a
1
Are outdoor clothing and other personal items
Yes
No
N/A
stored separately from workwear within the
changing facilities?
4.4.6
1
Suitable and sufficient hand-cleaning facilities
Non conformity details
shall be provided at access to, and at other
appropriate points within, production areas.
Information on how to clean hands shall also be
provided near hand-cleaning points.
4.4.6 a
1
Are suitable and sufficient hand-cleaning
Yes
No
N/A
facilities provided at access to, and at other
appropriate points within, production areas?
4.4.6 b
1
Is information on how to clean hands provided
Yes
No
N/A
near hand-cleaning points?
4.4.7
1
All food brought into manufacturing premises by
Non conformity details
staff shall be stored in a clean and hygienic state.
No food shall be taken into storage, processing, or
production areas.
4.4.7 a
1
Is all food brought into manufacturing
Yes
No
N/A
premises by staff stored in a clean and
hygienic state?
4.4.7 b
1
Are storage, processing, and production areas
Yes
No
N/A
free of any non-production food?
4.5
Cleaning procedures
Fundamental
Housekeeping and cleaning systems shall be in place which ensure that
Non conformity details
Clause
adequate standards of cleanliness and tidiness are maintained at all times
and the risk of contamination is minimized.
Auditor findings
4.5.1
All
Cleaning practices shall be completed so as to
Non conformity details
minimize risk of contamination.
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4.5.1 a
All
Are cleaning practices completed so as to
Yes
No
minimize risk of contamination?
4.5.2
All
Cleaning and, where necessary, disinfection
Non conformity details
procedures shall be revalidated following building
or maintenance work, changes to equipment, or
introduction of new product types.
4.5.2 a
All
Are cleaning and, where necessary,
Yes
No
disinfection procedures revalidated following
building or maintenance work, changes to
equipment, or introduction of new product
types?
4.5.3
All
Cleaning, pest control, and process-aid chemicals
Non conformity details
shall be suitably identified and controlled to
prevent the risk of product contamination. They
must be clearly labeled and no chemicals shall be
decanted unless into properly labeled and
identified containers. Adequate storage facilities
shall be provided and sited so as not to
compromise the safety, legality, and quality of the
product.
4.5.3 a
All
Are cleaning, pest control, and process-aid
Yes
No
chemicals suitably identified and controlled to
prevent the risk of product contamination?
4.5.3 b
All
Are they clearly labeled and no chemicals
Yes
No
decanted unless into properly labeled and
identified containers?
4.5.3 c
All
Are adequate storage facilities provided and
Yes
No
sited so as not to compromise the safety,
legality, and quality of the product?
4.5.4
All
If cleaning services are outsourced, the service
Non conformity details
providers shall have signed a contract which
identifies the scope and frequency of the work,
and a logbook shall be maintained as a record of
work done. A defined