Kurita America Inc. Chemical Operations ISO 9001:2015 Audit Issued Non-Conforming Findings Report Summary - duplicate

Section 1: Audit Finding General - Info

• Issue Date

  Date

• Audit Type

  P1

  P2

  RC

  Kurita America Internal Audit

• Finding ID

• Finding Current Status

  Open

  Closed

• Category of Finding

  Select CAT1 (Major) CAT2 (Minor) Observation Opportunity For Improvement (OFI)

  • CAT1 (Major)
  • CAT2 (Minor)
  • Observation
  • Opportunity For Improvement (OFI)

• Finding Title

Section 2: Description of Finding (DOF)

• ISO 9001:2015 requirements clause - Scope (choose all that apply)

  Select 4 Context of the organization 4.1 Understanding the organization and its context 4.2 Understanding the needs & expectations of interested parties 4.3 Determining the scope of the QMS 4.4 Quality management system and its processes 4.4.1 Kurita America shall establish, implement, maintain and continually improve a QMS, including processes needed and their interactions, in accordance with ISO 9001:2015 requirements. 4.4.2 To the extent necessary, Kurita America shall 5 Leadership 5.1 Leadership and commitment 5.1.1 General 5.1.2 Customer focus 5.2 Policy 5.2.1 Establishing the quality policy 5.2.2 Communicating the quality policy 5.3 Organizational roles, responsibilities and authorities 6 Planning 6.1 Actions to address risks and opportunities 6.1.1 When planning for the QMS, Kurita America shall consider issues referred to in 4.1 & requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed. 6.1.2 Kurita America shall plan 6.2 Quality objectives and planning to achieve them 6.2.1 Kurita America shall establish quality objectives at relevant functions, levels & processes needed for the QMS. 6.2.2 When planning how to achieve its quality objectives, Kurita America shall determine. 6.3 Planning of changes 7 Support 7.1 Resources 7.1.1 General 7.1.2 People 7.1.3 Infrastructure 7.1.4 Environment for the operation of processes 7.1.5 Monitoring and measuring resources 7.1.5.1 General 7.1.5.2 Measurement traceability 7.1.6 Organizational knowledge 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information 7.5.1 General 7.5.2 Creating & updating 7.5.3 Control of documented information 7.5.3.1 Documented info required by the QMS & ISO 9001 shall be controlled to: 7.5.3.2 For the control of documented information, Kurita America shall address the following activities: 8 Operation 8.1 Operational planning & control 8.2 Requirements for products & services 8.2.1 Customer communication 8.2.2 Determining requirements for products & services 8.2.3 Review of the requirements for products & services 8.2.3.1 Kurita America shall ensure it's ability to meet requirements for products & services to be offered to customers. 8.2.3.1 Kurita America shall conduct a review prior to committing to supply products & services to customers. 8.2.3.2 Kurita America shall retain documented info, as applicable. 8.2.4 Changes to requirements for products & services 8.3.1 General 8.3.2 Design & development planning 8.3.3 Design & development inputs 8.3.4 Design & development controls 8.3.5 Design & development outputs 8.3.6 Design & development changes 8.4 Control of externally provided processes, products & services 8.4.1 General 8.4.2 Type & extent of control 8.4.3 Information for external providers 8.5 Production & service provision 8.5.1 Control of production & service provision 8.5.2 Identification & traceability 8.5.3 Property belonging to customers or external providers 8.5.4 Preservation 8.5.5 Post-delivery activities 8.5.6 Control of changes 8.6 Release of products & services 8.7 Control of nonconforming outputs 8.7.1 Kurita America shall ensure outputs that do not conform to their requirements are identified & controlled to prevent their unintended use or delivery. 8.7.2 Kurita America shall retain documented info that: 9 Performance evaluation 9.1 Monitoring, measurement, analysis, & evaluation 9.1.1 General 9.1.2 Customer satisfaction 9.1.3 Analysis & evaluation 9.2 Internal audit 9.2.1 Kurita America shall conduct internal audits at planned intervals to provide info on whether the QMS: 9.2.2 Kurita America shall: 9.3 Management review 9.3.1 General 9.3.2 Management review inputs 9.3.3 Management review outputs 10 Improvement 10.1 General 10.2 Nonconformity & corrective action 10.2.1 When a nonconformity occurs, including any arising from complaints, Kurita America shall: 10.2.2 Kurita America shall retain documented info as evidence of: 10.3 Continual improvement

  • 4 Context of the organization
  • 4.1 Understanding the organization and its context
  • 4.2 Understanding the needs & expectations of interested parties
  • 4.3 Determining the scope of the QMS
  • 4.4 Quality management system and its processes
  • 4.4.1 Kurita America shall establish, implement, maintain and continually improve a QMS, including processes needed and their interactions, in accordance with ISO 9001:2015 requirements.
  • 4.4.2 To the extent necessary, Kurita America shall
  • 5 Leadership
  • 5.1 Leadership and commitment
  • 5.1.1 General
  • 5.1.2 Customer focus
  • 5.2 Policy
  • 5.2.1 Establishing the quality policy
  • 5.2.2 Communicating the quality policy
  • 5.3 Organizational roles, responsibilities and authorities
  • 6 Planning
  • 6.1 Actions to address risks and opportunities
  • 6.1.1 When planning for the QMS, Kurita America shall consider issues referred to in 4.1 & requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed.
  • 6.1.2 Kurita America shall plan
  • 6.2 Quality objectives and planning to achieve them
  • 6.2.1 Kurita America shall establish quality objectives at relevant functions, levels & processes needed for the QMS.
  • 6.2.2 When planning how to achieve its quality objectives, Kurita America shall determine.
  • 6.3 Planning of changes
  • 7 Support
  • 7.1 Resources
  • 7.1.1 General
  • 7.1.2 People
  • 7.1.3 Infrastructure
  • 7.1.4 Environment for the operation of processes
  • 7.1.5 Monitoring and measuring resources
  • 7.1.5.1 General
  • 7.1.5.2 Measurement traceability
  • 7.1.6 Organizational knowledge
  • 7.2 Competence
  • 7.3 Awareness
  • 7.4 Communication
  • 7.5 Documented information
  • 7.5.1 General
  • 7.5.2 Creating & updating
  • 7.5.3 Control of documented information
  • 7.5.3.1 Documented info required by the QMS & ISO 9001 shall be controlled to:
  • 7.5.3.2 For the control of documented information, Kurita America shall address the following activities:
  • 8 Operation
  • 8.1 Operational planning & control
  • 8.2 Requirements for products & services
  • 8.2.1 Customer communication
  • 8.2.2 Determining requirements for products & services
  • 8.2.3 Review of the requirements for products & services
  • 8.2.3.1 Kurita America shall ensure it's ability to meet requirements for products & services to be offered to customers.
  • 8.2.3.1 Kurita America shall conduct a review prior to committing to supply products & services to customers.
  • 8.2.3.2 Kurita America shall retain documented info, as applicable.
  • 8.2.4 Changes to requirements for products & services
  • 8.3.1 General
  • 8.3.2 Design & development planning
  • 8.3.3 Design & development inputs
  • 8.3.4 Design & development controls
  • 8.3.5 Design & development outputs
  • 8.3.6 Design & development changes
  • 8.4 Control of externally provided processes, products & services
  • 8.4.1 General
  • 8.4.2 Type & extent of control
  • 8.4.3 Information for external providers
  • 8.5 Production & service provision
  • 8.5.1 Control of production & service provision
  • 8.5.2 Identification & traceability
  • 8.5.3 Property belonging to customers or external providers
  • 8.5.4 Preservation
  • 8.5.5 Post-delivery activities
  • 8.5.6 Control of changes
  • 8.6 Release of products & services
  • 8.7 Control of nonconforming outputs
  • 8.7.1 Kurita America shall ensure outputs that do not conform to their requirements are identified & controlled to prevent their unintended use or delivery.
  • 8.7.2 Kurita America shall retain documented info that:
  • 9 Performance evaluation
  • 9.1 Monitoring, measurement, analysis, & evaluation
  • 9.1.1 General
  • 9.1.2 Customer satisfaction
  • 9.1.3 Analysis & evaluation
  • 9.2 Internal audit
  • 9.2.1 Kurita America shall conduct internal audits at planned intervals to provide info on whether the QMS:
  • 9.2.2 Kurita America shall:
  • 9.3 Management review
  • 9.3.1 General
  • 9.3.2 Management review inputs
  • 9.3.3 Management review outputs
  • 10 Improvement
  • 10.1 General
  • 10.2 Nonconformity & corrective action
  • 10.2.1 When a nonconformity occurs, including any arising from complaints, Kurita America shall:
  • 10.2.2 Kurita America shall retain documented info as evidence of:
  • 10.3 Continual improvement

• Determined ISO 9001:2015 scope clauses - Description's

• Description of Non-conformity (relevant to ISO 9001:2015 clauses chosen)

• Description of Objective Evidence (relevant to audit identified non-conformity)

• Finding identified - Location
  Address

• Focus area - Comments

• "Accountable" - Process area / department

  Select Accounting Analytical Services Applied Technology Chemical Purchasing Customer Service Environmental Executive Facilities Fleet Health Human Resources Improvement Kurita Water Inc. - CSR Initiatives Manufacturing Marketing Marketing Communications Master Data Process Technologies Product Management Quality Regulatory R&D Innovation Center Safety Sales Enablement Sales Operations Sales Support Strategic Corporate Business Training Transportation Warehousing Quality Control Testing Shipping Receiving

  • Accounting
  • Analytical Services
  • Applied Technology
  • Chemical Purchasing
  • Customer Service
  • Environmental
  • Executive
  • Facilities
  • Fleet
  • Health
  • Human Resources
  • Improvement
  • Kurita Water Inc. - CSR Initiatives
  • Manufacturing
  • Marketing
  • Marketing Communications
  • Master Data
  • Process Technologies
  • Product Management
  • Quality
  • Regulatory
  • R&D Innovation Center
  • Safety
  • Sales Enablement
  • Sales Operations
  • Sales Support
  • Strategic Corporate Business
  • Training
  • Transportation
  • Warehousing
  • Quality Control Testing
  • Shipping
  • Receiving

• "Accountable" person(s) - Name(s) & Title(s)

• "Responsible" process area / department - Interested Parties (choose aLL that apply)

  Select Accounting Analytical Services Applied Technology Chemical Purchasing Customer Service Environmental Executive Facilities Fleet Health Human Resources Improvement Kurita Water Inc. - CSR Initiatives Manufacturing Marketing Marketing Communications Master Data Process Technologies Product Management Quality Regulatory R&D Innovation Center Safety Sales Enablement Sales Operations Sales Support Strategic Corporate Business Training Transportation Warehousing Quality Control Testing Shipping Receiving

  • Accounting
  • Analytical Services
  • Applied Technology
  • Chemical Purchasing
  • Customer Service
  • Environmental
  • Executive
  • Facilities
  • Fleet
  • Health
  • Human Resources
  • Improvement
  • Kurita Water Inc. - CSR Initiatives
  • Manufacturing
  • Marketing
  • Marketing Communications
  • Master Data
  • Process Technologies
  • Product Management
  • Quality
  • Regulatory
  • R&D Innovation Center
  • Safety
  • Sales Enablement
  • Sales Operations
  • Sales Support
  • Strategic Corporate Business
  • Training
  • Transportation
  • Warehousing
  • Quality Control Testing
  • Shipping
  • Receiving

• Designation of "Responsibility" person(s) - Name(s) & Title(s)

• ISO 9001:2015 Clause - Focus Area (choose all that apply)

  Select Accounting Analytical Services Applied Technology Chemical Purchasing Customer Service Environmental Executive Facilities Fleet Health Human Resources Improvement Kurita Water Inc. - CSR Initiatives Manufacturing Marketing Marketing Communications Master Data Process Technologies Product Management Quality Regulatory R&D Innovation Center Safety Sales Enablement Sales Operations Sales Support Strategic Corporate Business Training Transportation Warehousing Quality Control Testing Shipping Receiving

  • Accounting
  • Analytical Services
  • Applied Technology
  • Chemical Purchasing
  • Customer Service
  • Environmental
  • Executive
  • Facilities
  • Fleet
  • Health
  • Human Resources
  • Improvement
  • Kurita Water Inc. - CSR Initiatives
  • Manufacturing
  • Marketing
  • Marketing Communications
  • Master Data
  • Process Technologies
  • Product Management
  • Quality
  • Regulatory
  • R&D Innovation Center
  • Safety
  • Sales Enablement
  • Sales Operations
  • Sales Support
  • Strategic Corporate Business
  • Training
  • Transportation
  • Warehousing
  • Quality Control Testing
  • Shipping
  • Receiving

• Finding by auditor - Name(s) & Title(s)

Section 3: Corrective Action (CA) to eliminate the "Non-conformity" (NC) - Plans

• CA's determined to eliminate "NC" - Details

• Correction(s) to eliminate "NC" actions designated to - Name(s) & titles

• Defined CA's to eliminate "NC" - Due Date

  Date

• Defined CA's to eliminate "NC" - Status

  Initiated

  Working

  Completed

• Defined CA's to eliminate "NC" status - Date

  Date

• CA's to eliminate "NC" general & completed - Comments

Section 4: Root Cause Analysis (RCA) of Non-conformity (NC) - Fishbone Ishikawa Cause & Effect

• RCA - Due date

  Date

• RCA conducted by name(s) & title

• NC "Primary" root - Causes (choose all that apply)

  Select Authorization Communication Competency Documentation Environment Leadership Objectives Management Materials Method People Policy Process Risk Quality Resources Risk Safety Services Systems Training Vendor

  • Authorization
  • Communication
  • Competency
  • Documentation
  • Environment
  • Leadership
  • Objectives
  • Management
  • Materials
  • Method
  • People
  • Policy
  • Process
  • Risk
  • Quality
  • Resources
  • Risk
  • Safety
  • Services
  • Systems
  • Training
  • Vendor

• NC "Sub" root - Causes descriptions (list for each determined "Primary" root cause)

• RCA conducted - date

  Date

Section 5: Corrective Action (CA) to eliminate the "Root Cause" (RC) of identified Non-Conformance (NC) - Plan

• CA's to eliminate NC "Root Cause" - Current Status

  Initiated

  Working

  Completed

• What CA's will be done to eliminate NC "Root Cause" - Details

• CA's to eliminate NC "RC" designated to - Name & Title

• CA"s to eliminate NC "RC" - Due date

  Date

• CA's taken to eliminate NC "RC" general & completed - Comments

• Corrective actions to eliminate NC "RC" - Completed date

  Date

Section 6: Kurita America Effectivity Check of Corrective Actions (CA) taken to eliminate NC "Root Cause"

• Effectivity Checks to be conducted by - ISO Quality & as designated by Kurita America Leadership

  Drawing

• RC effectiveness verification - Date

  Date

• RC Effectiveness verification conducted by - Name & Title

• RC effectiveness - Found As

  Effective

  Non-Effective

• RC effectiveness verification - Comments

• RC Effectiveness Objective Evidence

  Drawing

• RC effectiveness - Found as "Non-Effective": ISO Quality, designated Accountable and responsible key-stakeholders to collaboratively re-evaluate to define new CA's conducted are appropriate & effective in eliminating the Root Cause" (RC) of identified Non-Conformance (NC) . * All actions taken and results of evaluations shall be documented, analyses to include, actions taken to address risk and opportunities.

  Drawing

• RC Effectiveness verification conducted by - Signature

  Sign

Section 7: ISO 9001:2015 Certified QMS DNV Registrar Auditor - Verification of Kurita America's audit finding responses.

• Verification - Due Date

  Date

• Verification conducted by - Name & Title

• Verification - Found as

  Open

  Closed

• Found as verified - Date

  Date

Section 8: ISO 9001:2015 Certified QMS DNV Registrar Auditor - Closure Verification of Kurita America's Finding

• To be conducted by during Kurita America's next annual ISO 9001:2015 QMS audt.

  Drawing

• Closure verification - Date

  Date

• Closure verification conducted by - Name & Title

• Closure verification - Found As

  Effective

  Non-Effective

• Closure verification found as - Comments

• RC Effectiveness verification - Objective Evidence

  Drawing

• Closure verification - Found as "Non-Effective": ISO Quality, designated Accountable and responsible key-stakeholders to collaboratively re-evaluate to define new CA's conducted are appropriate & effective in eliminating the Root Cause" (RC) of identified Non-Conformance (NC) . * All actions taken and results of evaluations shall be documented, analyses to include, actions taken to address risk and opportunities

  Drawing

• RC Effectiveness verification by - Signature

  Sign