1.

1 Quality Management Systems

No. Question Evidence Required Look For

1.11 • Quality Manual

Manual to ISO9001/TS 16949 or
Mandatory Does the organization have a certified quality system? • Procedures
conversion matrix.
• Certificates

IIs a quality policy established and communicated throughout the Quality policy approved by CEO.
organization?
1.12 l Quality Policy
Correlation between Quality policy
l Quality Operating System
Requirement: ISO 9001 -2015 5.2.1 and Quality objectives
ISO 9001 - 2008 5.3

Does the organization compare trends in quality and operational * Comparison of trends to goals.
performance towards goals and objectives? * Actions to trend analysis.
1.13
Is Top management a part of the review? lQuality Metrics/KPI with action plans * Prioritization of action.
Mandatory
and follow up * Management review meeting
Requirement: ISO 9001 - 2015 6,2 & 9 minutes,
ISO 9001 - 2008 5.4.1 & 8 * Action Plans and follow-up
1.2 Quality Audits
Audits planned
Are Internal audits planned, conducted and carried out according to Audits conducted.
1.21 Audit plan ? Audit actions closed and verified.
Mandatory l Audit plan
Requirement: ISO 9001 -2015 9.2 & 10
ISO 9001 - 2008 8.2.1

Are audits results brought to the attention of personnel in charge of the

audited area ? Do records indicate review and verification of the Time between implementation of
1.22
effectiveness of action(s) ? action and time for closing. Has it
Mandatory * Audit reports
been time to verify effectiveness of
Requirement: ISO 9001 -2015 9.2 & 10 implemented action?
ISO 9001 - 2008 8.2.1
1.3 Document Management
 Has the organization established a document control procedure, Document control master list or
equivalent.
a) to approve documents before release?
b) to ensure changes and current document revision are clearly Availability of documents in
identified? various locations.
c) to assure relevant documents are available at point of use?
d) to assure documents remain legible and identifiable? Process for notification/distribution
e) to ensure documents of external origin are identified and their of documents from internal and
1.31 distribution controlled? l Document Control Procedure external origins.
f) to prevent unintended use of obsolete documents,

Requirement: ISO 9001 - 2015 7.5

ISO 9001 - 2008 4.2.3

Process for
l
notification/distribution of customer
Does the organization have a process to assure timely review, engineering
distribution and implementation of all customer engineering standards/specifications.
standards/specifications and changes? Does this take place in a Customer and Regional Standards/specs l Process for implementation of
1,32 customer initiated change.
timely manner?
Mandatory l Document changes triggered by
Customer change notifications
Requirement: ISO 9001 - 2015 8.3.6 & 8.5.6 engineering changes.
ISO 9001 - 2008 7.3.7 l Records of engineering changes
implemented.

Has the organization established a documented procedure to define l Quality Management System l Quality Manual according to
the controls needed for the identification, storage, protection, retrieval, l Record maintenance system ISO/TS 16949:2002./ISO 9001
retention time and disposition of records? l Defined record retention time
compared to customer/regulatory
1.33 Requirement: ISO 9001 - 2015 7.5.3 requirements.
ISO 9001 - 2008 4.2.4

1.4 Resource Management

 Does the organization l Job Description l Training records complementing
a) determine the necessary competence of person(s) doing work under l Training records the type of work that the personnel
its control that affects the performance and effectiveness of the quality l Personnel records perform on the product.
management system; l Training Plan l Personnel records.
b) ensure that these persons are competent on the basis of l Interviews with personnel.
appropriate education, training, or experience;
c) where applicable, take actions to acquire the necessary
1.41 competence, and evaluate the effectiveness of the actions taken;
d) retain appropriate documented information as evidence of
competence.

Requirement: ISO 9001 - 2015 7.1 & 7.2

ISO 9001 - 2008 6

Does the organisation determine, provide and maintain the

infrastructure for the operation of it's processes and to achieve
conformity of products and services ?
Infrastructure can include ;
a) Building(s) and associated utilities
b) Equipment incl hardware and software
1.42 c) Transportation resources
d) Information and communication technology

Requirement: ISO 9001 - 2015 7.1.3

ISO 9001 - 2008 6.3

Does the organisation provide and maintain the work environment Verification thru walk about in the
necessary to achieve conformity of products and services ? premises

a) Social (e.g. non-discrimunatory, calm) Interviews with personnel.

b) Psychological (e.g. stress-reducing, burn-out preventiv, emotionally
1.43 protective)
Mandatory c) Physical (e.g. temperature, heat, humidity, light, airflow, hygiene,
noise)

Requirement: ISO 9001 - 2015 7.1.4

ISO 9001 - 2008 6.4

2. Environmental Management
Does the organization have a certified Environmental system? l Environmental Manual l Manual to ISO14001.
2.11 l Procedures
l Process Maps
 Has the organization done an analysis of its environmental aspects & l Aspect & impact analysis. lContent of analysis, last review
impacts ? and update of analysis

NOTE:
Environmental aspect - element of the organisations activities,
products or services that can interact with the environment.(both
threats and opportunities)
2.12
Environmental impact -
any changes to the environment whether adverse or benificial, wholly
or partially resulting from the aspects

Requirement: ISO 14001 -2015 6.1.2

ISO 14001 - 2004 4.3

Has the organization established environmental objectives and targets

* Comparison of trends to goals.
at relevant functions and levels within the organization?
* Actions to trend analysis.
2.13
* Prioritization of action.
Mandatory Are the environmental objects and targets maintained and up-to-date? l Environmental Metrics
* Management review meeting
minutes,
Requirement: ISO 14001 - 2015 6.2
* Action Plans and follow-up
ISO 14001 - 2004 4.3.3

Has the organization as a minimum established Wallboards

2.14
waste management system inch segregation of waste? Bins
Mandatory p hysical evidence as bins, etc.
Agreements with 3'rd part
Requirement: ISO 14001 3.2.7 Local Government reports

2.2 Rosh & WEE

Is the organization compliant with Rosh II Directive 2011/65/EU? *Are components registered in Bo
check/Silicon expert with Rosh II
Ref: Rosh II Directive 2011/65/EU (replaced Rosh I from jan3, 2013) Declaration of Compliance
documents in databases?
2,21 l Rosh compliance declarations
Mandatory *Are testing done to evaluate the 6
substances in RoHS2?
(EN62321:2009) XRF
In house? / External lab?
 Is the organization compliant with WEEE , directive 2012/19/EU?
If applicable, (electronic
2.22 Ref: directive 2012/19/EU Compliance documents equipment)
Decision making documents as
reports, minutes of meeting etc.
Does the organization have Harmonized standard EN 50 581
(Technical File) available for the assembled product? Knowledge about EN50581
2.23 I. (Module A of decision 768/2008/EC) Techincal file
Techical file for actual assembly

Does the organization have WEEE document of the assembled If applicable ( electronic equipment)
product ? WEEE documents, WEEE documents for assembled
2.24
parts

Is the organization compliant with REACH Directive? If applicable ( Manufacturing, sales into
Europe only) - Official registrations with
Ref: Regulation of the EU: (EC) No. 1907/2006 the European Chemicals Agency Chemical/Substance amount per
2.25
• Went into effect on 1st June 2007 (ECHA). year

Does the supplier organization comply with the "Black & Grey list"
2,26 (Banned and Restricted Substances) Black and Grey list
Existens of a Black and Grey list
Mandatory

Is there any proof of how the organization ensures that they are
If applicaple, (electronic
meeting the obligations under ROHS?
2,27 equipment)
E.g if bought from outside the EU ? Procedure/instruction
Mandatory Decission making documents as
reports, minutes of meeting etc.

2.3 Environmental audits

Are Internal audits planned, conducted and carried out according to
2.31 Audit plan ?
Audits planned
Mandatory l Audit plan Audits done.
Requirement: ISO 14001 - 2015 9.2
ISO 14001 - 2004 4.5.5.
Are audits results brought to the attention of personnel in charge of the
audited area ? Do records indicate review and verification of the Time between implementation of
2.32 effectiveness of action(s) ? action and time for closing. Has it
Mandatory * Audit reports
been time to verify effectiveness of
Requirement. ISO 14001 - 2015 9.2.2, 10.2 & 10.3 implemented action?
ISO 14001 - 2004 4.5.5
 Are an audit programme planned and taking into consideration the
importance of the processes and areas to be audited as well as the
Criteria
results of previous audits ?
Scope
2.33 Audit plan
Method
The audit criteria, scope, frequency and methods shall be defined. Audit reports
Impartiality
Requirement. ISO 14001 - 2015 9.2.2, 10.2 & 10.3
ISO 14001 - 2004 4.5.5
Does the Audit programme identify potential emergency situations and
potential accidents that can have impact on the environment ?
2.34 Audit plan Existence of procedure
Procedure Part of audit plan
Requirement: ISO 14001 - 2015 8.2
ISO 14001 - 2004 4.4.7
3.0 Labour & Human Rights, Fair business & Ethics (SA8000, ISO26000)
3.1 Labour & Human Rights
a) Has the organization established a policy and implemented
procedures for the company's social accountability/responsility? Policies and procedures translated
3,11 b) Is the policy and procedures according to SA 8000? Policy, Certificate in major languages spoken by
Mandatory c) Is the company certified to SA 8000? employees

Does the policy cover employees'

3.12 Does the company have a policy that supports health and safety, working
Mandatory international human rights or with reference to National laws ? Policy/Procedure conditions, labor relations, child
and forced labor, career
management, discrimination?

Are the employees free to join or not to join trade

3.13 unions or similar external organizations, and to Is this right fully granted? Any
Mandatory bargain collectively? Policy/Procedure restrictions?

a) Do the employees have contracts according to

national laws and regulations? Does the organization fulfil local
b) Are the employees free to leave their employment after reasonable law or
3.14
Mandatory notice and not bound by bonding arrangements? (I.e. leave deposits of Contracts (examples) regulations?
money or other belongings with the employer) Employee files Check employee files for
contracts, money, passport,
deposits, etc
 a) Does the company comply with international standards for minimum
age of employment? (15 years) ?

b) Does the company have a policy for child labor, considering the best
of the child?
Engagements or measures taken
3.15 c) Does the company comply to the United Nations Convention of the Employee records to prevent or eradicate child or
Mandatory Rights of the child for persons under 18, regarding hazardous work or Policy forced labor?
work that is inconsistent with the child's development? Random checks of persons under 18

a) Has the company defined employment conditions and do the

employees understand their contract?
b) Are payment and terms fair and reasonable and comply with with
national laws and industry standards? Official measures to compensate a
c) Do working hours comply with national laws ? typical working hours?
d) Are dormitory, canteen & kitchen (where available) as well as Rest periods or vacations in
3.16
workers toilet/rest room in an acceptable conditions ? (cleanliness, Contracts (examples) accordance with legal
Mandatory
smell etc) Working hours records requirements?
working hours, time off, wages and
compensations, disciplinary
practices, forced labor,

a) Does the company have a policy that ensures the employees to be

treated with respect and dignity? Public commitment to avoid
b) Does the company state rules or policies to avoid physical and discrimination (e.g. color, race,
3.17 verbal punishment? gender, religion, ethnic, social)
Mandatory c) Does the company have a policy to prohibit discrimination? Policy/Procedure Proactive measures to avoid
discrimination during recruitment
phase (please specify)

Does the company require their suppliers to meet SA8000 or Code of

3.18 Conduct requirements similar to those mentioned above ? Requirement included in
Policy
contract/agreement?
Requirement : Observation only
3.2 Fair business and ethics
 Communication of Code of Ethics
Has the organization formalized its policy/ policies on fair business policy to all employees
practices? Policy/policies
3.21 Communication of Code of Ethics
Communication
business partners (e.g. suppliers)

Does the company have a policy that states clearly that bribery or
improper payments to or from employees or organizations are
3,22 prohibited? Policy/Procedure Policy statement
Mandatory

Signature acknowledgement of
anti-corruption policy required for
all concerned employees
Structured mechanisms to deal
with policy violations (e.g. potential
Are there actions in place against corruption, bribery and anti- sanctions)
3,23 competitive practices? Signed documents. Secure communication channel for
Mandatory Policy employees to seek advice or voice
concerns
Training program on anti-
corruption and anti-competitive
practices

Does the company require their suppliers to meet requirements similar

3,24 to those mentioned above ? Supplier agreements
Signed agreements
Mandatory Policy Procedures
Requirement : Observation only

4. Health & Safety (OHSAS 18000) & Security

4.1 OHSAS18001
a) Has the organization established and communicated policies for
health and safety?

b) Has the organization established, documented and implemented Policies and procedures translated
4,11 Policy
procedures for health and safety? in major languages spoken by
Mandatory Procedures
employees

If certified: OHSAS 18001 4.2

 Are the policy and procedures according to OHSAS 18001?
Policy a) policy
4.12 Is the company certified according to OHSAS 18001?
Certificates b) certificate
Requirement: Observation only"
Health and safety risk assessment
Has the organization established, and responsibilities defined
documented and implemented
procedures for; Provision of protective equipment
to all impacted employees
a) hazard identification,
b) risk assessment, Specific procedures for handling of
4,13 c) determination of necessary controls, chemicals or hazardous
Documented procedures
Mandatory d) identifying and accessing the substances
legal and other health and safety
requirements that are applicable Training of all relevant employees
to it?? on health and safety

If certified: OHSAS 18001 4.3.1

Has the organization established procedures for identifying emergency

situations and to respond to such emergency situations?
Procedures translated in major
4.14
languages spoken by employees
Mandatory Documented procedures
Procedures easily available in an
If certified: OHSAS 180011 4.4.7
emergency situation

a) Has the organization established procedures for monitoring and

measuring health and safety performance on a regular basis?
4.15 b) Has the organization established procedures for recording, KPIs and measurements
Mandatory investigating and analyzing incidents? Documented procedures Incident handling; root cause
analyze, actions, verification
If certified: OHSAS 18001 4.5

a) Does the organization conduct internal audits of the health and

safety management system?
b) Does top management review the organization's health and safety Audit plans
4,16 management system? Audit plans
Audit reports
Mandatory Audit reports
Management review
Requirement: Observation if not certified
If certified: OHSAS 18001 4.5.5

4.2 Security
 Has the organization established a production recovery plan including
4.21
timelines? Timeframes
Mandatory Up to date Production Recovery plan

Has the organization established a confidentiality agreements policy

Signed agreements.
4,22 and confidentiality agreements with its employees? Policy/procedure
If customer documents are re-used
Mandatory Agreements
in copy machine

Has the organization established liability insurance?

4.23
(Covering damage on 3'rd parts property)
Mandatory Insurance document Value, coverage

Has the organization established procedures for

document and data safety?
4.24 Back up schedule
Procedure
Storage of back up
Requirement: ISO 9001 - 2015 7.5.3
ISO 9001 - 2008 4.2.3
Are emergency equipment as fire extinguisher, emergency light,
4.25 emergency exit signs etc. available and in a condition that prevent Check during walk around.
Mandatory personal hazard ? Percent at site Percent, Functional, service
agreements
Requirement: National law, approval of premises

5.0 Product Planning (NPI, DPR etc)

5.1 Product Realization

l Quality plan and Design Record,

Control Plan, Operator
Instructions, Product Approval
Is a well documented NPI process in place and l Timelines records, resources/facilities and
followed? l Customer standards/specifications any plans to enhance them.
5.11 Are the staff involved properly defined? l Customer change notifications l Design validation at various
Are documentation requirements properly defined in a development l Floor plan stages of design.
project? l Planning documents l Link between process changes
and updates in the quality plan(s).
l Gantt charts, Action plans,
Meeting minutes.
 l Engineering change request.
l Change in FMEAs.
l Change records.
l Test specification.
Is a procedure in place for production process l Change management process
5.12 l Evidence of design and
feedback during NPI? l Impact studies
production validation tests
conducted for product changes.
l Design and production test
report.

Is there a process to identify and/or comply with End of Life

requirements? l Material data sheets
5.13 l Policy Statement
l Banned substances list

Can the organization communicate (language and electronically) in l Language of documents

Riellos directed formats/languages (English)? submitted.
5.14 l English speaking personnel
l CAD format.
Requirement: Observation only l Electronic data transfer protocol.

5.2 Design and Development Planning, Verification and Validation

( only where GPRO_39 and/or GFORM_252 are required)
Does the organization have a prototype process that includes:
a) a prototype program and control plan? l Prototype facilities.
b) use of the same suppliers, tooling and manufacturing process that l Prototype records.
will be used in production? l Prototype control plan.
5.24 l Prototype Procedure or Process
c) monitoring all performance testing activities for timely completion l Prototype tooling.
and conformance to requirements? l Prototype test records.
d) maintenance of responsibility for subcontracted services, including l Subcontractor management.
technical leadership?

5.25 Does the organization have detailed capacity planning documents? l Standard production hour scheduling l Documentation

Is first time quality used to determine capacity?

5.26 (FTQ = Calculation of the percentage of good parts at the beginning of l Shop floor plans vs. Actual l Documentation
a production run)
l Formulas
Are elements of TAKT used to establish and improve capacity? l Pace Studies
5.27 l Documentation
(Available time for production / required units of production) l Run at Rate
l Projections

Does the organization have plans established to address sudden lComparison of customer planning
5.28 l Procedure or Policy
increases in volume or to replace rejected material? vs. releases to shipped material.

5.3 Advanced Product Quality Planning

( Except Mandatory, only where GPRO_39 and/or GFORM_252 are required)
 Does the organization use a multidisciplinary approach to prepare for l Functions represented in product
product realization, including: development teams.
a) development/finalization and monitoring of special characteristics? l Personnel involved in definition of
b) development and review of FMEAs including actions to reduce l Product Development Teams
5.31 special characteristics, FMEA, and
potential risks? l APQP Development Teams
Control Plan.
c) development and review of Control Plans? l Prior SLP Creation and
Execution
Does the organization identify special characteristics and:
a) include all on the Control Plan? l Procedure of process map for
b) comply with customer specifications and symbols? drawing review.
l Review of customer requirements
c) identify process control documents including drawings, FMEAs, l Process to identify special
control plans and operator instructions with the customer's special for special characteristics,
characteristics.
characteristic symbol or an equivalent symbol/notation? definitions and symbol
5.32 l Design records.
identification.
l Drawing review.
l Process FMEA.
l APQP documents.
l Control Plan.
l Product drawings.
l Operator instructions.

Does the Process Flow Diagram show the start of the process at the l Receiving Dock
5.33 receiving dock and the stop point the shipping dock? l Documentation vs. Floor
l Shipping Dock
Is the Process FMEA
a) created and are improvement measures l Improvements based on high
established? RPN numbers.
b) updated when amendments are made during launch and the l New items or changes in RPN
established measures implemented? numbers.
5.34 l PFMEA
c) cover items of past concerns? l Correlation between Process
d) developed to include all the steps in the Process Flow Diagram? Flow Diagram and Process FMEA.
e) used to drive the Continuous Improvement Process? l Update due to customer
complaint.

Does the organization

a) Develop a process Control Plan for the products produced by the Control plans for different levels.
organization.
Controls identified on PFMEA are
b) Use a PFMEA used to prepare it? on Control Plan.
5,35 l Procedure
c) Do they review and update control plans when any changes occur Control Plan requirements in
Mandatory l Control Plan
affecting product, manufacturing process, measurement, logistics, operator instructions, Gage
supply sources, or FMEA? Control, Maintenance, etc.

d) Ensure that the control plan and process flow diagram are Evidence of implementation of
followed? Control plan
 l PFMEA
Are Mistake Proofing devices well defined for purpose and intent? Are l Customer complaints.
Mistake Proofing devices checked initially and regularly per an l Lessons learned.
l Control Plan
established procedure? l Operator Instructions.
5.36 l Devices
(Mistake-proofing is the use of process or design features to prevent l Preventive maintenance.
l Good/Bad Masters
errors or the negative impact of errors. Mistake-proofing is also known l Set-up Instructions.
as poka-yoke (pronounced pokayokay) l Documentation of test or
calibration.

6.0 Supplier Management

6.1 Supply Chain Management
Has the supplier ensured that conflict minerals, in particular gold (Au),
tantalum (Ta), tungsten (W) or tin (sn), are sourced from conflict-free
zones and according to international laws and regulations?
Is there any declaration available in in Bomcheck/Silicon expert with
Emails and/or Letters to suppliers
6,11 up-to-date Conflict mineral Declaration of Compliance documents ? Requests to supplier
requesting infor and replies from
Mandatory Replyfrom supplier
suppliers

Has the supplier ensured that counterfeit and fraudulent materials are
not utilized in product or material provided to Riello? Emails and/or Letters to suppliers
6,12 Request to supplier
requesting infor and replies from
Mandatory Reply from supplier
suppliers

Are supplier performance monitoring processes established, executed

and followed up properly? Including:
- Key Performance Indicators
- Supplier agreements - KPI with targets set, do they
- Buffer stock levels meet
- Key Performance
- Supplier audits target ? What do they do if not ?
Indicators
6.13 - Content of Supplier agreements
- Supplier agreements
Requirement: ISO 9001 - 2015 9.1.3 - Buffer stock levels in ERP
- Buffer stock levels
ISO 9001 - 2008 8.4 - updated Supplier
- Supplier audits/plans/reports
audits/plans/report
with closed loop
 Are proper material expediting processes in place?

- Critical material lists ?

Escalation path (a clear
management chain) pr supplier
6,14 - Escalation path (a clear management chain) pr supplier and Escalation path pr supplier and distributor
and distributor
Mandatory distributor delivering critical material ? - Critical material lists
Critical material lists
Requirement : Observation only

Are purchase orders and forecast to suppliers managed to meet

operational requirements? E.g. lead-time and monitoring and tracking
6,15 of confirmation. ERP set up or other tracking lists
Mandatory
Requirement : Observation only
Are rescheduling and cancellation processes with suppliers in place
and actively followed up (including partial cancellation)? Procedure
6.16 Examples of how it has been used
ERP process
Requirement : Observation only

6,2 Incoming Inspection, Layout and Functional Testing

Doest the organization have a process to ensure the quality of
purchased product utilizing one of the following:
Incoming inspection.
a) receipt of and evaluation of statistical data?
Source inspection.
b) receiving inspection and /or testing such as sampling based on
6,21 performance?
l Procedure Audits of supplier sites.
Mandatory c) assessments or audits of suppliers sites,
d) part evaluation by a designated laboratory?
Independent evaluation of
e) another method agreed with the customer?
acceptability of product by a
designated 3rd party.
Requirement : ISO 9001 - 2015 8.4.2
ISO 9001 - 2008 7.4.3

Are there measures in place to avoid material contamination, handling

damage and degradation during storage? l Raw materials and components
6,22
l Storage procedure storage
Mandatory
Requirement : ISO 9001 - 2015 8.5.4 l Containers
ISO 9001 - 2008 7.5.5
Are all goods, from receipt of incoming materials through shipment
stored, and identified, for efficient use and retrieval?
6,23
l Receiving Inspection Process Controls l FIFO system
Mandatory
Requirement : ISO 9001 - 2015 8.5.2
ISO 9001 - 2008 7.5.3
 Where applicable, are all materials with a shelf life properly identified
and still useable?
6,24
l Process Controls l Expired Material on shelves
Mandatory
Requirement : ISO 9001 - 2015 8.5.2
ISO 9001 - 2008 7.5.3

7. MANUFACTURING
7.1 Identification and Traceability
Does the organization identify the product by a suitable means
7.11 throughout product realization? l Check for positive recall.
Mandatory l Lot Traceability System l Suitable product identification
Requirement : ISO 9001 - 2015 8.5.2 throughout the facility.
ISO 9001 - 2008 7.5.3
Does the traceability originate with raw material and purchased
7.12 components, i.e., nuts, screws, etc.?
l Procedure l Documentation vs. Floor

Does the lot control reflect the last value added process? lLot control should reflect batch
l Procedure
7.13 breakdown at value added
l Process Flow Diagram
Requirement : Observation only processes
Is material identification, traceability and test status maintained and
recorded at all production stages? Does this also include process
7.14
traceability? lIdentification at different process
Mandatory l Procedure
stages
Requirement : ISO 9001 - 2015 8.5.2
ISO 9001 - 2008 7.5.3
Are customer requirements part of the identification procedure?
7.15 l Procedure l Documentation

Will Riello production lots be defined as a maximum of one shift of

production (8hrs)?
7.16 l Procedure l Documentation
Requirement : Observation only

7.2 Production Control

 Do instructions for running the process exist (operator instructions) for
all employees having responsibilities for the operation of processes?
Are they available in the language necessary for Riello personnel to
7,21 read and understand? l Availability of work instructions at
l Visual
Mandatory the workstation.
Requirement: ISO 9001 - 2015 8.5.1
ISO 9001 - 2008 7.5.1
Note : language is only Observation

Do instructions
a) have the correct content?
b) list the bill of materials, production tools, and safety equipment
needed at each operation?
c) address stop/start or line down procedures?
d) identify the critical and significant characteristics at the stations that l Complete Standardized Work l Operator vs. Instructions.
7.22 product them? l Visual l Documentation.
Mandatory e) take into account the literacy and language of all operators? l Control Plan l Floor data.
f) identify who is authorized to do what? l Speak to Operator l Can operators read and
l Identification understand instructions.
Requirement : ISO 9001 - 2015 8.5.1
ISO 9001 - 2008 7.5.1 , 7.5.2

Are visual aids and/or boundary samples required? If so, are they
available to the operator?
7,23
l Visual equipment/aids/boundary samples
Mandatory
Requirement : ISO 9001 - 2015 8.5.1
ISO 9001 - 2008 7.5.1 , 7.5.2

7.3 Manufacturing Monitoring & Measurement

l PFMEA
7,31 Are quality requirements effectively monitored during serial production lEffectiveness of controls of avoid
l Control Plan
Mandatory with the implemented inspection, measuring and test equipment? quality issues
l Quality History

7,32 Are defined and separate containers available for good, rework, and l Control Plan l Containers
Mandatory scrap product? l Visual l Disposition documents

l Customer or product based

production units.
Are concepts of lean production, cellular manufacturing, JIT
7.33 l Floor Plan l Material management system.
implemented throughout the facility?
l Allot storage for incoming
materials.
 l Dry mark boards
Are production goals monitored by the operator(s) using visual l Requirements vs. Actual
7.34 l Production vs. Scrap Data
management tools? Production Report
l Downtime Records

Are the operators given responsibility and authority of the production

l Job Descriptions
7.35 equipment and environment? l Operators job responsibilities
l Procedure
Are operators authorized to shut down the line?
7,36 Are Inspection Instructions available for operators at each production l Posted or readily referenced
l Inspection Instructions
Mandatory station? Are they being followed? inspection requirements
Does each item on the control plan have inspection instructions
7,37 lControl Plan vs. Instructions vs.
associated with it? l Production Control Plan vs. Instructions
Mandatory Floor
Does this include final audit?
7,38 Does the procedure for non-conforming material prevent it from lInternal rejections vs. Customer
l Containment Plan
Mandatory reaching the customer? rejections
l Logs
If there is more than one shift, how does information get passed across
7.39 l Procedure l Interviews
shifts?
l Pre-shift/Handover Meetings

7,310 For appearance items, does the supplier have the appropriate lEquipment required to qualify l Light booths
Mandatory resources in place, i.e., lighting for evaluation? appearance items l Color Analysis Machines, etc.

For appearance items, does the supplier have masters for color, grain, Masters Proper storage area with masters
gloss, texture, etc., as appropriate? Color Testing Authorized personnel must be
7,311 Mandatory
For appearance items, are authorized personnel properly qualified and Training Records capable to review appearance
trained? Vision Testing items and have proper training

7.312 Does the organization release product only after all the requirements
lMaterial is released only if all
Mandatory have been satisfactorily completed, unless otherwise approved by a l Control Plan
requirements are met.
relevant authority, and where applicable by the customer?

7.4 Inventory and Storage

Does packaging and material handling protect parts from damage and
contamination:
7.41 a) during internal processing? l Packaging reviews.
Mandatory b) during delivery to the intended destination? l Procedure
l Proper utilization.
l PFMEA
l Plant tour.
Requirement : ISO 9001 - 2015 8.5.4
ISO 9001 - 2008 7.5.5
 Is the raw material/finished goods stored in specific locations? Is
storage appropriate to prevent damage and deterioration?
7,42
l Documentation vs. Floor l Plant Layout
Mandatory Requirement : ISO 9001 - 2015 8.5.4
ISO 9001 - 2008 7.5.5

l Compare dates to assure oldest

7.43 Is First In/First Out maintained at each operation? l Part Container dates material is processed first
l WIP Dates

Are customer requirements for shipping methods, routings, and l Assembly plant
7.44 l Assigned carriers
carriers observed? l Shipping Instructions

Are system and procedures in place to ensure effective delivery l Shipping Records l Past Due
7.45
performance? Are corrective actions taken? * On time Delivery measurement ( KPI) l Premium Freight

7.5 Preventive Maintenance

Does the organization determine, provide and maintain the l Buildings, workspace and
infrastructure needed to achieve conformity to product requirements? associated facilities.
l Process equipment, both
7,51 Requirement : ISO 9001 - 2015 7.1.3 l Plant Tour hardware and software.
Mandatory ISO 9001 - 2008 6.3 l Supporting services, e.g.,
transportation, communication,
etc.
Is the organization's plant layouts optimized for material travel,
handling and value-added use of floor space and shall facilitate l Process flow analysis.
synchronous material flow? l Plant layout (current and
7.52 l Plant Tour planned).
Requirement: SO 9001 - 2015 7.1.3 l Delivery point/Shipping point.

ISO 9001 - 2008 6.3, l Material staging areas.

Has the organization prepared contingency plans to satisfy the

customer requirements in the event of an emergency such as utility l Key equipment identified.
interruptions, labor shortages, key equipment failure, and field returns? l Material and component supplier
7.53 l Contingency plans profiles.
l Identification of critical
suppliers/services.
 l Facility Tour, including office
areas.
Does the organization maintain its premises in a state of order, l Cleanliness.
cleanliness and repair consistent with the product? l Lighting.
7,54
l Policy Statement l Housekeeping instructions.
Mandatory
Requirement : ISO 9001 - 2015 7.1.3 & 7.1.4 l Floor markings and signs.
ISO 9001 - 2088 &.3 & 6.4 l Material flow from one end to the
other.
l Visual management tools.

Does the preventive maintenance system minimally include:

a) planned maintenance activities?
b) packaging and preservation of equipment, tooling, gauging?
c) availability of replacement parts for key manufacturing equipment? l Key equipment list.
7.55 d) documenting, evaluating and improving maintenance objectives? l Maintenance records.
Mandatory l Preventive Maintenance process l Predictive maintenance
Requirement: ISO 9001 - 2015 7.1.3 examples.
ISO 9001 - 2008 6.3 l Plant tour.

Does the facility have defined Product Maintenance responsibilities

(maintenance, operator, etc.)? l Operator instructions.
7,56
l Documentation l Set-up/shut down procedures.
Mandatory
l PM procedure.
Requirement : Observation only
Does the organization have resources available for tool and gauge
7,57 design, fabrication and verification activities? l Procedure lTool/gage design staffing and
Mandatory l Organization Charts qualification.
Requirement : Observation only
Does the facility have resources available for the maintenance and
repair of tooling/gauging? l Tool room staffed with
7,58
l Tool Management process appropriate personnel.
Mandatory
Requirement : Observation only * 3'rd part

Is there a system to manage revisions to tools based on customer

engineering changes? l Records.
7,59 Is there evidence that the supplier properly notifies their customers l Customer Notification
when tooling undergoes refurbishment? l Procedure
Mandatory communications.
Is the tool properly requalified? l PPAP.
 In regard to customer property, does the organization:
a) exercise care while under its control?
b) identify, verify, protect and safeguard the property provided for use
or incorporation into the product?
c) report and maintain records for property that is lost, damaged or l Identification.
7,60
otherwise found unsuitable for use? l Procedure l Storage environment.
Mandatory
l Damage reports.
Requirement: ISO 9001 - 2015 8.5.3
ISO 9001 - 2008 7.5.4

8.0 Quality Control

8.1 Quality Control
Are records of final inspection and test
maintained?
Is there a record of first article inspection for
new test fixture?
8,11 Do inspection records show that product has Test/inspection reports
Test/inspection reports
Mandatory passed or failed? FAI report

Requirement: ISO 9001 - 2015 8.6

ISO 9001 - 2008 8.2.4

Can inspection and test status of products be

readily identified?
Traceability procedure
8,12 Is complete part/lot traceability maintained? ID tags
Traveler
Mandatory
ID tags with status
Requirement: ISO 9001 - 2015 8.6
ISO 9001 - 2008 8.2.4

Are there documented procedures for non-

conforming product found during production? Procedure
*Is non-conforming product identified and Process flow
segregated? Segregation of non-conforming
"red" bins
*Are reworked, repaired or modified product re- material into bins etc. and/or
8,13 Non-conforming material tag
inspected or re-tested? Locked areas
Mandatory Inspection label
*Are corrective action reviewed to ensure they are CA review of effectiveness ( is it
effective? reasonable time between
implementation and verification of
Requirement. ISO 9001 - 2015 8.7 effectiveness of the action ?)
ISO 9001 - 2008 8.3
 Is there an effective process for handling customer
complaints?
Procedure
Is information on actions taken submitted for
8,14 8D reports / Customer complaint forms Process description
management review?
Mandatory with closed loop Register of customer complaints
KPI's
Requirement : ISO 9001 - 2015 8.2.1, 8.6, 8.7
ISO 9001 -2008 7.2.3, 8.2.4, 8.3

8.2 Statistical Process Control

l Review of control plan.
8,21 Does the organization determine the appropriate statistical tools for l Procedure
l Review of quality plan.
Mandatory each process and include them in the control plan? l Control Plan
l Plant floor.

Are short-term capability studies conducted on new or changed lCapability studies for parts
8.22 processes and equipment according to requirement in PQP ? l Procedure recently validated and new
production equipment.
8,23 Does the supplier calculate long term capability? lCapability studies for parts in
l Procedure
Mandatory production.
l Blackbelts.
Does the supplier have a statistically based Continuous Improvement l Documentation
8.24 l CIP reports.
Process (CIP), e.g., Six Sigma? l Organization Charts
l Posted charts/graphs.

l Contents of reaction plan for

Does the organization's reaction plans for unstable or non-capable
8,25 l Control Plans unstable and noncapable
characteristics include containment and 100% inspection as
Mandatory l Reaction Plans processes.
appropriate?
l Records.

Does the organization establish a corrective action following the

lCorrective actions for initiated
8.26 initiation of reaction plans, indicating specific timing and assigned l Corrective Action Reports
reactions.
responsibilities?
Are the organization's corrective action plans reviewed with and
8.27 l Corrective Action approval process l Corrective action reports.
approved by the customer when so required?
Does the organization maintain records of the effective dates of
process changes? l Records of process change
8,28 dates.
l Process change management process
Mandatory Requirement : ISO 9001 - 2015 8.5.1 l Instructions for proper product
ISO 9001 - 2008 7.5.2 identification

8.3 Control of Monitoring & Measurement Devices

 Are all inspection and test equipment affecting product quality: lTest equipment inventory.
a) identified enabling calibration status to be determined? lCertifications for calibration
b) calibrated at prescribed intervals, or prior to use, against masters and their traceability to
measurement standards traceable to international or national international national recognized
measurement standards? standard.
c) adjusted or readjusted as necessary? l Calibration results records.
d) safeguarded from adjustments that would invalidate the l Method of control of calibration
measurement result? l Procedures settings.
8.31
e) protected from damage and deterioration during handling, l Documentation l Calibration status identification.
Mandatory
maintenance, and storage? l Calibration Instructions for each type of l Type, Identifier, Location,
equipment Calibration frequency, method,
Requirement : ISO 9001 7.1.5.1 & 7.1.5.2 Gage R&R status, Acceptance
ISO 9001 - 2008 7.6 criteria, results, actions
l Gage/Test Equipment Control
System

8.4 Non-Conforming Product

Is there a formal system to determine the disposition of rejected
material?
8.41
Does this include rework processes? lMaterial Review Board with
Mandatory l Procedure
dispositions.
Requirement: ISO 9001 - 2015 8.7
ISO 9001 - 2008 8.3

Does the organization ensure that product which does not conform to
requirements is identified and controlled to prevent its unintended use l Follow one or more
8.42 or delivery? nonconforming case and verify the
Mandatory l Procedure flow (identification, segregation,
etc.).
Requirement: ISO 9001 - 2015 8.7 l Obsolete parts.
ISO 9001 - 2008 8.3

Do repair/rework materials return through the normal production

controls? l Flow or repair/rework in the
8.43 Does supplier obtain customer approval for rework process? lProcedure stating point of return to production system.
production flow l Closed loop re-entry into
Requirement: ISO 9001 - 2015 8.7 production system
ISO 9001 - 2008 8.3
 Does the organization:
l Examples.
a) maintain a record of the expiration date or quantity authorized by l Record of authorization with
the customer concession or deviation? expiration date.
8,44
b) ensure compliance with the original or superseding specifications l Procedure l Inspection results for material
Mandatory
and requirements when the customer concession or deviation expires? shipped under concession.
c) properly identify on each shipping container material shipped on the l Proper label/identification for
concession authorization? material shipped on authorization.

Is there a process in place to notify customers of suspect material

either at the customer location or in route?
8,45
l Procedure l Examples.
Mandatory
Requirement: ISO 9001 - 2015 8.2.1
ISO 9001 - 2008 7.2.3

Does the organization have a system established to evaluate returned

parts from their customer's and do they know requirements of the
l Records of analysis.
controlled shipping process ?
l List of returned parts.
8,46
l Procedure l Minimalization of cycle time.
Mandatory Requirements : ISO 9001 - 2015 8.5.5
l Review product/test analysis.
ISO 9001 - 2008 7.5.1
l Records.
(if agreed in contract, if not -
Observation)

8.5 Improvement Processes

Does the supplier have a Continuous Improvement Process they apply
l Six Sigma program.
to their processes and products? Does the organization use the
l Procedure l Continuous Improvement
PFMEA as part of this process?
8.51 l Organization Chart Process reports.
Is there a focus on reduction of product and process variation?
l Reduction in process variation l Posted charts/graphs.
l RPN Improvement l PFMEA
Requirement: ISO 9001 - 2015 10.3
l Quality Improvement Plans
ISO 9001 - 2008 8.5.1

Is there a documented plan to address nonconforming material in

8.52 order to prevent recurrence?
Mandatory l Procedure l Procedure vs. Practice
Requirement: ISO 9001 - 2015 10.0
ISO 9001 - 2008 8.5.2
 Does the organization have a system to determine the severity of the
problem in terms of cost penalties both internally and to the customer?
lCost of Quality System.
Are these cost penalties measured and tracked as part of the l Procedure.
8.53 lMonthly Financial reports of cost
supplier's monthly operating plan? l Management Documentation
vs. plan
Requirement: Observation only
Is 100% Sort implemented as a containment action until permanent
8,54 corrective action is implemented and verified? l Sort records.
l Sorting area
Mandatory l Paynter Charts.
Requirement: Observation only