ISO 9001:2015 QualityManagementSystem AuditChecklist
Clause4:CONTEXT OF OUR ORGANIZATION
4.1 Understandingourorganizationanditscontext
1 Has our organization determined the external and internal
issues that are relevant to its purpose and its strategic
direction and
that affectour ability to achieve the intended result(s) of our
quality management system?
(Are documents available like Business Plans, SWOTAnalysis,
Stakeholder Analysis, etc…)
Yes. Name, number and Location of
documented information:
a) Hard copy
b)Electron(linkto thefolderto beinserted
here)
Needs improvement
2 Is our organization monitoring and reviewing information
about these external and internal issues? How is it done?
No Last changes in the
regulatory
requirements has not
been captured in the
document
4.2 Understandingtheneedsand expectationsofinterestedparties
1 Due to their effector potential effecton our organization’s ability to
consistently provide products and services that meet our customer and
applicable statutory and regulatory requirements, has our organization
determined in documented format...
a) the interested parties that are relevant to our quality management
system?
b) the requirements of these interested parties that are relevant to our
quality management system? (Any documentation available as
evidence for that?)
NO. Regulatory
requirements of
external interested
parties has not been
provided
2 Whether and how our organization monitors and reviews information
about these interested parties and their relevant requirements?
No
4.3 Determiningthescopeofourqualitymanagementsystems
1 Has our organization determined the boundaries and applicability of
our quality management system to establish its scope? (Scope
Statement available?)
Yes. AZO-QMS-MAN-001
Quality Manual Rev1.
Soft and hard copy available
in Server and Folder
Need to Improve due to
new Service provided to
UBOC Waste Management
Service
2 When determining this scope, did our organization consider:
a) the external and internal issues referred to in 4.1?
b) the requirements of relevant interested parties referred to in 4.2?
c)the products and services of our organization.
Yes. AZO-QMS-MAN-001
Quality Manual Rev1.
Softand hard copy available in
Server and Folder
Need to Improvedue to
new Service provided to
UBOC Waste Management
Service. Requirements,
needs and expectations
must be considered.
3 Did our organization apply all the requirements of the ISO9001:2015
standard if they were applicable within the determined scope of our
QMS?
4 Is the scope of our organization’s quality management system visually
available and maintained as documented information somewhere?
Yes. AZO-QMS-MAN-001
Quality Manual Rev1.
Soft and hard copy available
in Server and Folder
5 Does the scope state the types of our products and services covered,
and provide justification forany requirement of the ISO 9001:2015
standard that our organization determines as not applicable to the
scope of our quality management system?
Yes Waste Management
Service is omitted
6 Are weaware that conformity to the ISO 9001:2015 standard may only
be claimed if the requirements determined as not applicable do not
affectour organization’s ability or responsibility to ensure the
conformity of our products and services and the enhancement of
customer satisfaction?
No exclusion and non-
applications are not
included
4.4 Determiningthescopeofourqualitymanagementsystems
1 (4.4.1) Has our organization determined the main QMS related
processes needed for our quality management system and their
application throughout our organization?
Yes. AZO-QMS-MAN-001
Quality Manual Rev1.
Soft and hard copy available
in Server and Folder
Waste Management Service
is omitted in Quality
Manual
2 (4.4.1)
Has our organization ...
a) determined the inputs required and the outputs expected from these
processes?
b) determined the sequence and interaction of these processes? (Flow
charts?)
c)determined and applied the criteria and methods (including
monitoring, measurements and related performance indicators)
needed to ensure the effectiveoperation and controlof these
processes?
d) determined the resources needed forthese processes and ensured
their availability?
e) assigned the responsibilities and authorities forthese processes?
f)addressed the risks and opportunities as determined in accordance
with the requirements of 6.1 (planning)?
Yes.
1. AZO-LMP-QMS-
PRO-001 rev1
Manufacturing of
driling fluids
2. AZO-LMP-QMS-
PRO-003 rev1
Shipping Procedure
3. AZO-LMP-QMS-
PRO-002 Material
Receiving, Storage,
Handling and
Preservation
Procedure
4.
a) Need to determine
Inputs
b)Need to draw flow charts
for each processes
f) need to determine risks
and opportunities foreach
processes
g) all processes need to be
evaluated. Achievement of
the intended results need
to be ensured
g) evaluated these processes and implemented any changes needed to
ensure that these processes achievetheir intended results?
h) tried to improve these processes and also our entire quality
management system?
3 (4.4.2)
To the extent necessary, does our organization ...
a) maintain documented information to support the operation of our
QMS related processes? Please cite some examples like Core Process
Map, Quality Manual, etc...
b) retain documented information to have confidence that all QMS
related processes are being carried out as planned? Records keeping?
Please cite some examples.
Yes.
AZO-QMS-MAN-001 Quality
Manual Rev1.
Softand hard copy available in
Server and Folder
Process map needs to be
developed
Clause5:LEADERSHIP
5.1 Leadershipandcommitment
1 (5.1.1 - General)
In order to demonstrate its leadership and commitment with respect to our
quality management system, is our top management “Hands on”...
a) taking accountability forthe effectivenessof our quality management
system? Please cite some examples.
b) ensuring that our quality policy and quality objectivesare established for
our quality management system and are compatible with the context and
strategic direction of our organization? Please cite some examples (Quality
Policy signed, etc…?).
c) ensuring the integration of our quality management system requirements
into our organization’s business processes? Please cite some examples.
d) promoting the use of the process approach and risk-based thinking? Please
cite some examples. (Quality training, E-newsletter, any other documented
evidence, etc…)
e) ensuring that the resources needed for our quality management system are
available? Please cite some examples. Is there are EmployeeHandbook
available?
f)communicating the importance of effectivequality management and of
conforming to our quality management system requirements? Please cite
some examples.
g) ensuring that our quality management system achieves its intended
results? Please cite some examples. Is there a List of
authorities/Responsibilities, Org-Chart available?
h) engaging, directing and supporting persons to contribute to the
effectivenessof our quality management system? Please cite some examples.
Yes.
AZO-QMS-POL-001
Quality policy-Azorel
LLC
AZO-LMP-QMS-F-017
Azorel OrgChart
AZO-LMP-QMS-F-001
MASTER LIST
Org chart needs to be
updated
Would be a good idea to
train each department a
relative standard
top management should
communicate the
importance of the QMS to
all staff
2 (5.1.2 - Customer focus)
In order to demonstrate its leadership and commitment with respect to
customer focus, is our top management ensuring that ...
a) customer and applicable statutory and regulatory requirements are
determined,
Yes
AZO-LMP-QMS-F-027
Customer Satisfaction
Questionnaire
1.develop a list of internal
and external interested
parties. And todefine needs
and expectations in this list
2.develop process mapping
understood, monitored and consistently met?
b) the risks and opportunities that can affectconformity of products and
services and the ability to enhance customer satisfaction are determined and
addressed? (Risk plan?)
c)the focuson enhancing customer satisfaction is maintained?
AZO-LMP-QMS-F-030
Continual
Improvement Register
3.develop strategy of the
organization
5.2 Policy
1 Has our top management established, implemented and maintaining a quality
policy that ...
a) is appropriate to the purpose and context of our organization and supports
its strategic direction?
b) provides a frameworkforsetting our quality objectives?
c)includes a commitment to satisfy applicable requirements?
d) includes a commitment to continual improvement of the quality
management system?
Yes
AZO-QMS-POL-001
Quality policy-Azorel
LLC
2 (5.2.2 - Communicating the quality policy)
Whether the quality policy ...
a) is available and is maintained as documented information?
b) is communicated, understood and applied within our organization?
Posters, e-newsletter?
c)is available to relevant interested parties, as appropriate?
Yes,
All places where the
staff attends it was
posted on the wall
5.3 Organizational roles,responsibilitiesandauthorities
1 Does our top management ensure that the responsibilities and authorities for
relevant QMS related process roles are assigned, communicated and
understood within our organization? (Responsibility Charts, Org-Chart, etc…)
Yes
AZO-LMP-QMS-F-017
Azorel OrgChart
2 Has our top management assigned the responsibility and authority for...
a) ensuring that our quality management system conformsto the
requirements of the ISO9001:2015 standard?
b) ensuring that all QMS related processes are delivering their intended
outputs?
c)reporting on the performance of our quality management system and on
opportunities for improvement, in particular to our top management?
d) ensuring the promotion of customer focusthroughout our organization?
e) ensuring that the integrity of our quality management system is maintained
when changes to our quality management system are planned and
implemented?
No.
Internal Audit was not
completed,
MRM was not held to
be ensured of intended
outputs
Developa reporting system
for process owners to
monitor status of intended
results
customer expectations
should be communicated
to all emloyees
clause 6.3 should be
considered when QMS
planned and implemented
Clause6:PLANNING
6.1 Actionsto addressrisksandopportunities
1 (6.1.1)
When planning for our quality management system, did our
organization consider the issues referred to in 4.1 and the requirements
referred toin 4.2 and determine all risks and relevant new opportunities
that need to be addressed to:
a) give assurance that our quality management system can achieve its
intended result(s)? Global Risk plan if needed? Inclusive Supplier risk
evaluation?
b) enhance desirable effects?
c)prevent, or reduce, undesired effects?(FMEA,or any other Risk
planning tool?)
d) achieve improvement?
Yes.
AZO-LMP-HSE-PRO-004-Risk
Management
AZO-LMP-QMS-F-024Risk
Register
AZO-LMP-QMS-F-030
Continual Improvement
Register
Risk Management
procedure should be
reviewed.
COTO log should be
developed for risk and
opportunities register
2 (6.1.2)
Has our organization planned ...
a) actions to address these risks and opportunities?
(Continuity/Contingency plan?)
b) how to:
1) integrate and implement the actions into its quality management
system processes (see 4.4)? Do we have a Risk and/or Safety
Committee?
2) evaluate the effectivenessof these actions? Regular Risk status
meetings?
Yes.
Job Safety Analysis
Continual Improvement
AZO-LMP-QMS-F-030
AZO-LMP-QMS-F-024Risk
Register
1.Planning and
implementing risk
management activities
were not identified and
appointed from
appropriate team of
parties
2.Not determined
sequence of processes,
process diagram or
process map
3. Leadership and
commitment in planning of
the processes (risk based
thinking)
4.Risk assessment and
controlneeded for
purchased products,
ordered processes,
products, or services,
delivery or provision (201)
5.Purchasing of material
6. Consequences of a
change in QMS aspects
must be assessed(97)
7.Assessment of reaction of
external providers to
nonconformities in order
to prevent reoccurrence of
them has not included in
risk assessment (274)
8.Risks are not assessed
for Post-delivery of
products activities(327)
3 (6.1.2)
Whether the actions taken to address risks and opportunities shall be
proportionate to the potential impact on the conformity of products
and services? Global and local?
4 (6.1.2)
Do the options to address all to our organization relevant risks include
avoiding risk, taking risk in order to pursue an opportunity, eliminating
the risk source, changing the likelihood or consequences, sharing the
risk, or retaining risk by informed decision?
Yes.
Risk Management Procedure
AZO-LMP-HSE-PRO-014
6.2 Qualityobjectivesandplanningto achievethemSl. #
1 (6.2.1)
Has our organization established and connected our quality objectiveswith
relevant functions, levels and processes needed to achieve our quality
management system objectives?
Yes,
AZO-LMP-QMS-F-009
Quality Objectives
2 (6.2.1)
Whetherthe chosenqualityobjectives...
a) are consistentwith ourqualitypolicy? AnySOP forQMS planning?
b) are measurableandbrokendown visibleinour QMS processes?
c) take into accountapplicablerequirements?KeyPerformanceIndicator(KPI)
Plan?
d) are relevantto conformityof ourproductsand servicesandfocus on
enhancementof customersatisfaction?
e) are monitored?Do wehavea Recordskeepingplan?
f) are communicatedthroughoutourorganization?
g) are updated,asappropriate?
Yes.
AZO-LMP-QMS-F-009
Quality Objectives
AZO-QMS-PLC-001
Quality Policy
Need to develop SOP for
QMS planning
3 (6.2.1)
DoesourorganizationmaintaindocumentedinformationontheQMS quality
objectives?
No
4 (6.2.2)
When planninghowto achieve ourqualityobjectives,doesourorganization
determine...
a) what will bedone?Do we collect andtrack monthlyKPI Recordsforstatus
update?
b) what resourceswillbe required?
c) who will beresponsible?Processownersresponsiblefortrackingprocess
interruptions?
d) when it will becompleted?Quarterly,Monthly,weekly?
e) how theresultswill be evaluated?IstheQuality teamtracking/analyzingKPI
trends?
Yes
Management Review
Protocol
AZO-LMP-QMS-F-032
6.3 Planningofchanges#
1 When our organization determines the need for changes to our quality
management system, are the changes carried out in a planned manner?
Any SOP for that available?
Does our organization consider ...
a) the purpose of the changes and their potential consequences?
b) the integrity of our quality management system?
c)the availability of resources to coverthe changes?
d) the allocation or reallocation of responsibilities and authorities?
No
AZO-LMP-QMS-F-025
Change request form
AZO-LMP-QMS-PRO-
007
Management of Change
procedure
Allocation of
employees and
equipment(forklift)
whichaffected
Process environment
in LMP due to the
change
There is no evidence for
consideration of
estimation of Potential
Consequences
Quality Objectivesare not
considered while changes
are done
Process outputs are not
considered
Customer requirements
and satisfaction were not
considered
Risks are not considered
Gap analysis between
conditions, situations and
results before and after
changes must be done
Changes did not submitted
to PDCA cycle(98)
Clause7:SUPPORT
7.1 Resources
(7.1.1 – General)
Has our organization determined and is providing the resources needed for
the establishment, implementation, maintenance and continual improvement
of our quality management system? Is that a constant item line of our QMS
Management Reviews?
Has our organization considered ...
a) the capabilities of, and constraints on, existing internal resources?
b) what needs to be obtained from external providers?
Yes,
Raw material and
equipment are
determined and
provided by partner
company
Truckand forklist by
the org.
Correct volume and
quality are provided by
the organization
Regulatory
requirements are also
by the organization.
Such as transport,
storage, handling and
dispose
Storage, handling,
transportation regulatory
requirements forraw
materials are not
controlled by competent
employee
Raw materials must be
comformed of adequate
quality and quantity with
COA and QR
Diezel as a fuel for
equipment does not have a
method to ensure adequate
criteria for safe use in
equipment.
Better to arrange
awareness presentation
for each department
relevant QMS aspects
No proper training on
storage, handling for
warehouseman
No awareness of msds
(7.1.2 - People)
Does our organization determine and provide the persons necessary for
the effective implementation of our quality management system and for the
operation and control of its relevant processes? Job Skill Matrix? Annual
Training plan in place? etc...
Yes,
Competency sheet
Organization chart
Quality policy should have
statement about human
resources.And reference to
organization diagram
(7.1.3 - Infrastructure)
Does our organization determine, provide and maintain the infrastructure
necessary for the operation of its processes and to achieve conformity of
products & services?
What is the status of the following infrastructure (if applicable) ...
a) buildings and associated utilities?
b) equipment, including hardware and software?
c) transportation resources?
d) information and communication technology?
Yes,

Internal audit checklist.docx

  • 1.
    ISO 9001:2015 QualityManagementSystemAuditChecklist Clause4:CONTEXT OF OUR ORGANIZATION 4.1 Understandingourorganizationanditscontext 1 Has our organization determined the external and internal issues that are relevant to its purpose and its strategic direction and that affectour ability to achieve the intended result(s) of our quality management system? (Are documents available like Business Plans, SWOTAnalysis, Stakeholder Analysis, etc…) Yes. Name, number and Location of documented information: a) Hard copy b)Electron(linkto thefolderto beinserted here) Needs improvement 2 Is our organization monitoring and reviewing information about these external and internal issues? How is it done? No Last changes in the regulatory requirements has not been captured in the document
  • 2.
    4.2 Understandingtheneedsand expectationsofinterestedparties 1Due to their effector potential effecton our organization’s ability to consistently provide products and services that meet our customer and applicable statutory and regulatory requirements, has our organization determined in documented format... a) the interested parties that are relevant to our quality management system? b) the requirements of these interested parties that are relevant to our quality management system? (Any documentation available as evidence for that?) NO. Regulatory requirements of external interested parties has not been provided 2 Whether and how our organization monitors and reviews information about these interested parties and their relevant requirements? No 4.3 Determiningthescopeofourqualitymanagementsystems 1 Has our organization determined the boundaries and applicability of our quality management system to establish its scope? (Scope Statement available?) Yes. AZO-QMS-MAN-001 Quality Manual Rev1. Soft and hard copy available in Server and Folder Need to Improve due to new Service provided to UBOC Waste Management Service 2 When determining this scope, did our organization consider: a) the external and internal issues referred to in 4.1? b) the requirements of relevant interested parties referred to in 4.2? c)the products and services of our organization. Yes. AZO-QMS-MAN-001 Quality Manual Rev1. Softand hard copy available in Server and Folder Need to Improvedue to new Service provided to UBOC Waste Management Service. Requirements, needs and expectations must be considered. 3 Did our organization apply all the requirements of the ISO9001:2015 standard if they were applicable within the determined scope of our QMS? 4 Is the scope of our organization’s quality management system visually available and maintained as documented information somewhere? Yes. AZO-QMS-MAN-001 Quality Manual Rev1.
  • 3.
    Soft and hardcopy available in Server and Folder 5 Does the scope state the types of our products and services covered, and provide justification forany requirement of the ISO 9001:2015 standard that our organization determines as not applicable to the scope of our quality management system? Yes Waste Management Service is omitted 6 Are weaware that conformity to the ISO 9001:2015 standard may only be claimed if the requirements determined as not applicable do not affectour organization’s ability or responsibility to ensure the conformity of our products and services and the enhancement of customer satisfaction? No exclusion and non- applications are not included 4.4 Determiningthescopeofourqualitymanagementsystems 1 (4.4.1) Has our organization determined the main QMS related processes needed for our quality management system and their application throughout our organization? Yes. AZO-QMS-MAN-001 Quality Manual Rev1. Soft and hard copy available in Server and Folder Waste Management Service is omitted in Quality Manual 2 (4.4.1) Has our organization ... a) determined the inputs required and the outputs expected from these processes? b) determined the sequence and interaction of these processes? (Flow charts?) c)determined and applied the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effectiveoperation and controlof these processes? d) determined the resources needed forthese processes and ensured their availability? e) assigned the responsibilities and authorities forthese processes? f)addressed the risks and opportunities as determined in accordance with the requirements of 6.1 (planning)? Yes. 1. AZO-LMP-QMS- PRO-001 rev1 Manufacturing of driling fluids 2. AZO-LMP-QMS- PRO-003 rev1 Shipping Procedure 3. AZO-LMP-QMS- PRO-002 Material Receiving, Storage, Handling and Preservation Procedure 4. a) Need to determine Inputs b)Need to draw flow charts for each processes f) need to determine risks and opportunities foreach processes g) all processes need to be evaluated. Achievement of the intended results need to be ensured
  • 4.
    g) evaluated theseprocesses and implemented any changes needed to ensure that these processes achievetheir intended results? h) tried to improve these processes and also our entire quality management system? 3 (4.4.2) To the extent necessary, does our organization ... a) maintain documented information to support the operation of our QMS related processes? Please cite some examples like Core Process Map, Quality Manual, etc... b) retain documented information to have confidence that all QMS related processes are being carried out as planned? Records keeping? Please cite some examples. Yes. AZO-QMS-MAN-001 Quality Manual Rev1. Softand hard copy available in Server and Folder Process map needs to be developed
  • 5.
    Clause5:LEADERSHIP 5.1 Leadershipandcommitment 1 (5.1.1- General) In order to demonstrate its leadership and commitment with respect to our quality management system, is our top management “Hands on”... a) taking accountability forthe effectivenessof our quality management system? Please cite some examples. b) ensuring that our quality policy and quality objectivesare established for our quality management system and are compatible with the context and strategic direction of our organization? Please cite some examples (Quality Policy signed, etc…?). c) ensuring the integration of our quality management system requirements into our organization’s business processes? Please cite some examples. d) promoting the use of the process approach and risk-based thinking? Please cite some examples. (Quality training, E-newsletter, any other documented evidence, etc…) e) ensuring that the resources needed for our quality management system are available? Please cite some examples. Is there are EmployeeHandbook available? f)communicating the importance of effectivequality management and of conforming to our quality management system requirements? Please cite some examples. g) ensuring that our quality management system achieves its intended results? Please cite some examples. Is there a List of authorities/Responsibilities, Org-Chart available? h) engaging, directing and supporting persons to contribute to the effectivenessof our quality management system? Please cite some examples. Yes. AZO-QMS-POL-001 Quality policy-Azorel LLC AZO-LMP-QMS-F-017 Azorel OrgChart AZO-LMP-QMS-F-001 MASTER LIST Org chart needs to be updated Would be a good idea to train each department a relative standard top management should communicate the importance of the QMS to all staff 2 (5.1.2 - Customer focus) In order to demonstrate its leadership and commitment with respect to customer focus, is our top management ensuring that ... a) customer and applicable statutory and regulatory requirements are determined, Yes AZO-LMP-QMS-F-027 Customer Satisfaction Questionnaire 1.develop a list of internal and external interested parties. And todefine needs and expectations in this list 2.develop process mapping
  • 6.
    understood, monitored andconsistently met? b) the risks and opportunities that can affectconformity of products and services and the ability to enhance customer satisfaction are determined and addressed? (Risk plan?) c)the focuson enhancing customer satisfaction is maintained? AZO-LMP-QMS-F-030 Continual Improvement Register 3.develop strategy of the organization 5.2 Policy 1 Has our top management established, implemented and maintaining a quality policy that ... a) is appropriate to the purpose and context of our organization and supports its strategic direction? b) provides a frameworkforsetting our quality objectives? c)includes a commitment to satisfy applicable requirements? d) includes a commitment to continual improvement of the quality management system? Yes AZO-QMS-POL-001 Quality policy-Azorel LLC 2 (5.2.2 - Communicating the quality policy) Whether the quality policy ... a) is available and is maintained as documented information? b) is communicated, understood and applied within our organization? Posters, e-newsletter? c)is available to relevant interested parties, as appropriate? Yes, All places where the staff attends it was posted on the wall
  • 7.
    5.3 Organizational roles,responsibilitiesandauthorities 1Does our top management ensure that the responsibilities and authorities for relevant QMS related process roles are assigned, communicated and understood within our organization? (Responsibility Charts, Org-Chart, etc…) Yes AZO-LMP-QMS-F-017 Azorel OrgChart 2 Has our top management assigned the responsibility and authority for... a) ensuring that our quality management system conformsto the requirements of the ISO9001:2015 standard? b) ensuring that all QMS related processes are delivering their intended outputs? c)reporting on the performance of our quality management system and on opportunities for improvement, in particular to our top management? d) ensuring the promotion of customer focusthroughout our organization? e) ensuring that the integrity of our quality management system is maintained when changes to our quality management system are planned and implemented? No. Internal Audit was not completed, MRM was not held to be ensured of intended outputs Developa reporting system for process owners to monitor status of intended results customer expectations should be communicated to all emloyees clause 6.3 should be considered when QMS planned and implemented
  • 8.
    Clause6:PLANNING 6.1 Actionsto addressrisksandopportunities 1(6.1.1) When planning for our quality management system, did our organization consider the issues referred to in 4.1 and the requirements referred toin 4.2 and determine all risks and relevant new opportunities that need to be addressed to: a) give assurance that our quality management system can achieve its intended result(s)? Global Risk plan if needed? Inclusive Supplier risk evaluation? b) enhance desirable effects? c)prevent, or reduce, undesired effects?(FMEA,or any other Risk planning tool?) d) achieve improvement? Yes. AZO-LMP-HSE-PRO-004-Risk Management AZO-LMP-QMS-F-024Risk Register AZO-LMP-QMS-F-030 Continual Improvement Register Risk Management procedure should be reviewed. COTO log should be developed for risk and opportunities register 2 (6.1.2) Has our organization planned ... a) actions to address these risks and opportunities? (Continuity/Contingency plan?) b) how to: 1) integrate and implement the actions into its quality management system processes (see 4.4)? Do we have a Risk and/or Safety Committee? 2) evaluate the effectivenessof these actions? Regular Risk status meetings? Yes. Job Safety Analysis Continual Improvement AZO-LMP-QMS-F-030 AZO-LMP-QMS-F-024Risk Register 1.Planning and implementing risk management activities were not identified and appointed from appropriate team of parties 2.Not determined sequence of processes, process diagram or process map 3. Leadership and commitment in planning of the processes (risk based thinking)
  • 9.
    4.Risk assessment and controlneededfor purchased products, ordered processes, products, or services, delivery or provision (201) 5.Purchasing of material 6. Consequences of a change in QMS aspects must be assessed(97) 7.Assessment of reaction of external providers to nonconformities in order to prevent reoccurrence of them has not included in risk assessment (274) 8.Risks are not assessed for Post-delivery of products activities(327) 3 (6.1.2) Whether the actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products and services? Global and local? 4 (6.1.2) Do the options to address all to our organization relevant risks include avoiding risk, taking risk in order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decision? Yes. Risk Management Procedure AZO-LMP-HSE-PRO-014
  • 10.
    6.2 Qualityobjectivesandplanningto achievethemSl.# 1 (6.2.1) Has our organization established and connected our quality objectiveswith relevant functions, levels and processes needed to achieve our quality management system objectives? Yes, AZO-LMP-QMS-F-009 Quality Objectives 2 (6.2.1) Whetherthe chosenqualityobjectives... a) are consistentwith ourqualitypolicy? AnySOP forQMS planning? b) are measurableandbrokendown visibleinour QMS processes? c) take into accountapplicablerequirements?KeyPerformanceIndicator(KPI) Plan? d) are relevantto conformityof ourproductsand servicesandfocus on enhancementof customersatisfaction? e) are monitored?Do wehavea Recordskeepingplan? f) are communicatedthroughoutourorganization? g) are updated,asappropriate? Yes. AZO-LMP-QMS-F-009 Quality Objectives AZO-QMS-PLC-001 Quality Policy Need to develop SOP for QMS planning 3 (6.2.1) DoesourorganizationmaintaindocumentedinformationontheQMS quality objectives? No 4 (6.2.2) When planninghowto achieve ourqualityobjectives,doesourorganization determine... a) what will bedone?Do we collect andtrack monthlyKPI Recordsforstatus update? b) what resourceswillbe required? c) who will beresponsible?Processownersresponsiblefortrackingprocess interruptions? d) when it will becompleted?Quarterly,Monthly,weekly? e) how theresultswill be evaluated?IstheQuality teamtracking/analyzingKPI trends? Yes Management Review Protocol AZO-LMP-QMS-F-032
  • 11.
    6.3 Planningofchanges# 1 Whenour organization determines the need for changes to our quality management system, are the changes carried out in a planned manner? Any SOP for that available? Does our organization consider ... a) the purpose of the changes and their potential consequences? b) the integrity of our quality management system? c)the availability of resources to coverthe changes? d) the allocation or reallocation of responsibilities and authorities? No AZO-LMP-QMS-F-025 Change request form AZO-LMP-QMS-PRO- 007 Management of Change procedure Allocation of employees and equipment(forklift) whichaffected Process environment in LMP due to the change There is no evidence for consideration of estimation of Potential Consequences Quality Objectivesare not considered while changes are done Process outputs are not considered Customer requirements and satisfaction were not considered Risks are not considered Gap analysis between conditions, situations and results before and after changes must be done Changes did not submitted to PDCA cycle(98)
  • 12.
    Clause7:SUPPORT 7.1 Resources (7.1.1 –General) Has our organization determined and is providing the resources needed for the establishment, implementation, maintenance and continual improvement of our quality management system? Is that a constant item line of our QMS Management Reviews? Has our organization considered ... a) the capabilities of, and constraints on, existing internal resources? b) what needs to be obtained from external providers? Yes, Raw material and equipment are determined and provided by partner company Truckand forklist by the org. Correct volume and quality are provided by the organization Regulatory requirements are also by the organization. Such as transport, storage, handling and dispose Storage, handling, transportation regulatory requirements forraw materials are not controlled by competent employee Raw materials must be comformed of adequate quality and quantity with COA and QR Diezel as a fuel for equipment does not have a method to ensure adequate criteria for safe use in equipment. Better to arrange awareness presentation for each department relevant QMS aspects No proper training on storage, handling for warehouseman No awareness of msds
  • 13.
    (7.1.2 - People) Doesour organization determine and provide the persons necessary for the effective implementation of our quality management system and for the operation and control of its relevant processes? Job Skill Matrix? Annual Training plan in place? etc... Yes, Competency sheet Organization chart Quality policy should have statement about human resources.And reference to organization diagram (7.1.3 - Infrastructure) Does our organization determine, provide and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products & services? What is the status of the following infrastructure (if applicable) ... a) buildings and associated utilities? b) equipment, including hardware and software? c) transportation resources? d) information and communication technology? Yes,