Upload
lamthien
View
221
Download
3
Embed Size (px)
Citation preview
Page 2Flowserve Corporation Proprietary and Confidential
SPACER• Safety
• Purpose
• Agenda
• Conduct
• Expectations
• Roles
Agenda
15:00 – 15:20 Introductie Flowserve RSD15:20 – 16:25 Hoe doen ze dat bij…..?
a) Control of externally provided…b) Internal/supplier audits
16:30 – 17:25 Rondgang (productie & logistiek)
Roosendaal plant overview
• Facility size : 5,800 m2• Shop floor : 3,600 m2• Headcount : 215; 72 direct, 143 indirect• Shop Capacity : 116,000 hours, 3 shifts• Warehouse : 2 shifts
• Core capabilities:– Knowledge center for pump seals & systems in EMA (technology & logistics)– Test facility completely refurbished in 2013/2014– Hub for all EMA Quick Response Centers (manufacturing & distribution)– QMS certified:
• ISO 9001 by Lloyd’s Register (since 1989)• ASME NQA-1 by AIB Vinḉotte
Scope QMSEngineering and manufacturing
ofmechanical seals, sealing systems and components for
rotating equipment for use in
petroleum, chemical, power, pulp and paper, mining and other industries.
Renewal CertificationISO 9001:2015 Implementation
Gap Analysis & StrategyPre-Implementation
20-22 Sept 2016May 20164Q15 1Q16Since 2013
5 – Implementation (level off) Process- and Risk Management
7 – Implement actions according to RAIL and update QMS documentation. For example Relationship managementRisk-based thinkingProcess approach
Start ISO Transition Roadmap. ISO 9001:2015 certified
High Level ISO Transition Roadmap
4 – Training InternalISO Audit team
Steering team to agree on transition approach, resources and timeline
3 – Deploy GAP Analysis tool and execute GAP analyze (QA), create RAIL and resources.
8 – Review, maintain, develop and improve QMS.
Half yearly QMS reviews and Surveillance Visits LRQA
Frequent Progress / Awareness/ Reporting to Management Team, auditors LRQA and internal ISO Audit Team.
1 – Knowledge QA by trainings, workshops, seminars, etc.
2 – Benchmark withother FLS Companies
6 – Align and verify approach with LRQA (Focus visit)
GAP Analyze tool
Page 8
FINDINGS SETTING
COM
PLIA
NCE
RAN
KIN
G [%
]
RISK
RAN
KIN
G[1
up
to 1
0]
ACTUAL QMSInitials
Responsible Individual
Date Assigned Status First Due
DateActual
Due DateClose Date Comments / Result / Status / Update
1
2
3
4
5
6
7
8
9
10
Executed by:Title:
Site GAP ANALYSIS
XXX SECTION(S): xxxxxxxxxxxx REFERENCE: ISO 9001:2015
No ISO
CLAU
SERE
F. Identified changes or new issued requirements of ISO 9001:2015 (compared to ISO 9001:2008)
GAP ANALYSISN.B. Provide references to documentation where necessary
ACTIONS REQUIRED
Notes:
Revision:Updated:
0DD-MM-YY
Date of execution GAP ANALYZE this section: DD-MMM-YYYY Name(s)xxx & xxx
Analysis RAIL
Example
Page 9
FINDINGS SETTING
COM
PLIA
NCE
RAN
KIN
G [%
]
RISK
RAN
KIN
G[1
up
to 1
0]
ACTUAL QMSInitials
Responsible Individual
Date Assigned Status First Due
DateActual
Due DateClose Date Comments / Result / Status / Update
1Term "product" changed to "Product and or Service" in the scope of the ISO9001 standard.
70 1QA Manual and ISO9001 Certificate. Actual Q Policy describes "products and service".
WG 1-Feb-16 Open 1-Mar-16Ask for impact during transition training FLS in March
2 Exclusions of QMS no longer limited within clause 7: Product realization 100Clause 8.3 Design and development for products and services remain excluded from scope QMS RSD.
3 Fundamentals and vocabulary (ISO 9000) changed to 2015 version 100Dutch and English ISO9001:2015 available
WG 26-Jan-16 Open 1-Mar-16 27-01-2016: Not in NEN Contract RSD.
4 Terms and definitions (ISO 9000) changed to 2015 version 100 Idem 3
5Are external and internal issues determined that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system?
100SWOT executed by MT mid 2015, risks are translated into improvements projects and ranked for priority
6Does the organization monitor and review information about these external and internal issues?
70 7 Yearly review of SWOT with MT EK 1-Feb-16 Open 1-Sep-16
7Are the interested parties that are relevant to the quality management system determined?
100Stakeholderanalyse executed by man assistant with MT mid 2015
8Are the requirements of these interested parties that are relevant to the quality management system determined?
100 Part of Stakeholderanalyse
9Is the information about these interested parties and their relevant requirements monitored and reviewed?
10 7 Only annual identified. EK 1-Feb-16 Open 1-Sep-16
10Are the boundaries and applicability of the quality management system to establish its scope determined (and available and maintained as documented information)?
100Scope QMS in RSD-PR-GEN-000E QA manual
11Are the processes and their interactions, needed for the QMS and their application throughout the organization, determined?
100See appendix A of RSD-PR-GEN-000E QA manual
12Are the inputs required and the outputs expected from these processes determined?
10 10 Not all in- and outputs determined EK 1-Feb-16 Open 1-Sep-16
13 Are the sequence and interaction of these processes determined? 100See appendix A of RSD-PR-GEN-000E QA manual
14Are methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes determined and are the criteria applied?
100Outputs of processes by KPI/PI measurement
16 Are the responsibilities and authorities for these processes assigned? 100 Assigned by each QMS document WG 1-Feb-16 Open 1-Mar-16
17Are the risks and opportunities for these processes addressed? (according 6.1)
10 10Risk and opp per process not part of GAP analyse MT.
EK 1-Feb-16 Open 1-Sep-16
18Are these processes evaluated and are any changes implemented needed to ensure that these processes achieve their intended results?
Monitoring by KPI/PI's of processes WG 1-Feb-16 Open 15-Mar-16 To be asked in transition training FLS
19 Are the processes and the quality management system improved? 100See MoM periodical QMS review, Plant AC and departmental AC's.
20Is documented information to support the operation of the processes maintained?
10 3Process of maintenance is described in RSD-PR-QAC-149E, but structural periodical review is missing.
WG 15-Jan-16 Open 1-Sep-16
21Is documented information retained to have confidence that the processes are being carried out as planned?
100DI available as KPI's, Internal Audit reports and MoM Man. Review
Executed by:Title:
Level of process approach and their in- and outputs to be defined.
4.4.1 b)
4.4.1 c)
4.4.1 h)
4.4.2 a)Implement periodical review process of (critical) QMS documents and changes of process owners
4.4.1 e) Add resp and auth per process in QA manual
4.4.1 f) Identify risk and opp per process as defined in ISO9001
4.4.1 g) What is definition of evaluation?
Section 2: Normative references
Section 1
4.3
Notes:No 10, 20 & 21 allready identified by section "Documented information".
Revision:Updated:
001-Feb-16
Date of execution GAP ANALYZE this section: 01-Feb-2016 E. Kepers & W. GeukeManager QA/QC/CIP & QA Engineer
4.2.b)
4.2 Periodical review to be implemented in strategic MT meetings
4.4.2 b)
4.4.1
4.4.1 a)
4.1
4.1 Periodical review to be implemented in strategic MT meetings
4.2 a)
Section 1Check and or update (text) content of RSD-PR-GEN-000E and ISO9001 Certificate on "Product and or Service"
Section 2 Check if ISO9000:2015 is available (contract NEN or Techstreet)
Section 3 Idem 3
Section 1: Scope
Section 3: Terms and definitionsSection 4: Context of the organization
No ISO
CLAU
SERE
F. Identified changes or new issued requirements of ISO 9001:2015 (compared to ISO 9001:2008)
GAP ANALYSISN.B. Provide references to documentation where necessary
ACTIONS REQUIRED
Site GAP ANALYSIS
RSD SECTIONS: 1, 2, 3 and 4 REFERENCE: ISO 9001:2015
ISO 9001:2015 requirementsfor “Process approach”
1) Intended result2) Input and output3) Sequence and interaction4) Performance indicators5) Planning, implementation and control 6) Resource management7) Responsibilities/Ownership 8) Risk based thinking9) Evaluation, change and improvements10) Trends in process performance(s)
Defined processes of RSD(According RSD-PR-GEN-000E: QA Manual)
Core Processes: Supporting FunctionsOrder Entry & Booking
OE Customers(Customer Service Order
Fulfillment OE)
Order Engineering(Seal / System
Engineering & ATS)
Order Scheduling & Inventory Management(MRP Planning)
Project & (Nuclear) Order Management
(Seals & Systems)
Production Engineering & preparation
(Industrial Engineering)
Assemble, testing & Inspection
Seals / Standard Systems
(Manufacturing, Testlab &
Warehouse)
Produce Components(Manufacturing/Tool Crib)
Inspect Components /
Seals / Engineered Systems
(Quality Control)
Store Components / Seals / Systems
(Warehouse)
Pick, Pack & Ship Components /
Seals / Systems incl. Documentation
(Shipping & Export)
Human Resources Finance
Continuous Improvement
Program
Safety, Health and Environmental
Affairs
Maintenance(Facility
Management)
Information Technology
Supporting FunctionsOrder Entry & BookingAM Customers
(Customer Service Order Fulfillment AM)
Outsource Operations & Component Production
(Shop Planning)
Order Engineering (Chennai Engineering
Cell)
NC programming & 3D modelling
(Chennai Engineering Cell)
Quality Assurance
Production Planning(Shopplanning)
Purchase Components / Seals / Engineered Systems
(Purchasing)
Internal Audits
• Each defined process minimum each 3 year;• Nuclear process(steps) yearly;
Order Entry & BookingOE Customers
(Customer Service Order Fulfillment OE)
Order Engineering(Seal / System
Engineering & ATS)
Order Scheduling & Inventory Management(MRP Planning)
Project & (Nuclear) Order Management
(Seals & Systems)
Production Engineering & preparation
(Industrial Engineering)
Assemble, testing & Inspection
Seals / Standard Systems
(Manufacturing, Testlab &
Warehouse)
Produce Components(Manufacturing/Tool Crib)
Inspect Components /
Seals / Engineered Systems
(Quality Control)
Store Components / Seals / Systems
(Warehouse)
Pick, Pack & Ship Components /
Seals / Systems incl. Documentation
(Shipping & Export)
Human Resources Finance
Continuous Improvement
Program
Safety, Health and Environmental
Affairs
Maintenance(Facility
Management)
Information Technology
Supporting FunctionsOrder Entry & BookingAM Customers
(Customer Service Order Fulfillment AM)
Outsource Operations & Component Production
(Shop Planning)
Order Engineering (Chennai Engineering
Cell)
NC programming & 3D modelling
(Chennai Engineering Cell)
Quality Assurance
Production Planning(Shopplanning)
Purchase Components / Seals / Engineered Systems
(Purchasing)
Internal Audits
• Each defined process minimum each 3 year;• Nuclear process(steps) yearly;• Yearly audit plan (approved & priorities by MT);
Internal Audits
• Each defined process minimum each 3 year;• Nuclear process(steps) yearly;• Yearly audit plan (approved & priorities by MT);• Feedback/results: Every 6 months by MR;
Total % 0.86 0.90 0.69 1.35 -0.05 0.74 0.87Warranty % 0.40 0.55 0.24 0.70 -0.46 0.35 0.32Scrap % 0.39 0.30 0.30 0.34 0.31 0.32 0.21Rework % 0.07 0.04 0.05 0.05 0.05 0.03 0.06LDs % 0.00 0.00 0.10 0.23 -0.11 0.02 0.26CARs # 37 - 45 13 13 9 10
Manufacturing FTR Rate MFG parts % 95.2 96.0 96.2 96.1 96.1 96.4 96.0Management Review # 2 2 2 1 0 1 0QMS Transitie ISO9001 % - 100 90 80 65 90 100Completed # 12 12 10 2 4 0 4CARs # 23 - 33 6 11 2 14Accurancy % 90 100 83 80 100 67 83
Inte
rnal
Pro
cess
es
Cost of Poor Quality (as % of Sales YTD)
Audits
QMS
Internal Audits
• Each defined process minimum each 3 year;• Nuclear process(steps) yearly;• Yearly audit plan (approved & priorities by MT);• Feedback/results: Every 6 months by MR;• Qualified auditors;
Internal Audits
• Each defined process minimum each 3 year;• Nuclear process(steps) yearly;• Yearly audit plan (approved & priorities by MT);• Feedback/results: Every 6 months by MR;• Qualified auditors;• Corrective/preventive actions of findings;
- Best practices : Shared with Process owner(s)- OFI : Input for CIP- NC : Global CAR-System
Internal Audits
• Each defined process minimum each 3 year;• Nuclear process(steps) yearly;• Yearly audit plan (approved & priorities by MT);• Feedback/results: Every 6 months by MR;• Qualified auditors;• Corrective/preventive actions of findings;• 6x year internal audit team meetings;