6sigma绿带项目报告模版

全球500强某美国医疗器材公司内部最专业,最具条理性,最系统的6sigma报告模版

Title of DMAIC Project

DMAIC Green Belt Plant Date

全球500强某美国医疗器材公司内部最专业,最具条理性,最系统的6sigma报告模版

Overview

Project Title Project Number (1st, 2nd, 3rd) Instantis Project ID# Project Leader Name Project Leader Job Title Segment/GBU/Division/Plant/Region

1- Add a team photo where appropriate –

2 | Covidien | June 13, 2012 | Confidential

全球500强某美国医疗器材公司内部最专业,最具条理性,最系统的6sigma报告模版

Template Guidelines1. 2. 3. 4. 5. Used for final report of DMAIC GB or DMAIC BB DOE or DMAIC BB Non DOE Project Completed report is uploaded in Instantis. Removing slides from the template is not permitted Additional slides may be added Project evaluation criteria for GB, BB Non-DOE and BB DOE are included in the slides. The criteria listed here are minimum criteria for project approval.

Purpose: summarize your project results and accomplishments

3 | Covidien | June 13, 2012 | Confidential

全球500强某美国医疗器材公司内部最专业,最具条理性,最系统的6sigma报告模版

SignaturesInstructions 1. Once the project is completed, obtain signatures and scan them into this page. 2. Save the file as PDF, using the Save As option in PowerPoint 2007. This saves space, and prevents any further changes to your work. 3. Upload this file to the project s Documents folder in Instantis using the following file naming convention:01 – DMAIC XX– Extrusion OD Scrap Reduction XX= GB , BB DOE, BB Non DOE For example: 01 – DMAIC GB– Extrusion OD Scrap Reduction.pdfPRINTED NAME Candidate Project Champion: OpEx Manager / Leader: (Plant / Country) OpEx Director / Manager: (Divisional / Business Unit) Local Finance Representative: SIGNATURE DATE

4 | Covidien | June 13, 2012 | Confidential

全球500强某美国医疗器材公司内部最专业,最具条理性,最系统的6sigma报告模版

Financial ResultsInclude: Hard and Soft savings A general description of how they were achieved (labor, material, overhead absorption etc.) Summarize the results in $ State all financial metrics for the project

Name of MetricA. DPMOB. Cpk/Ppk

Baseline35,0001.2 / 0.7

Goal<5,000>.3 / 1.3

Entitlement10,0001.5 / 1.5

Actual (A) or Projected (P)12,000 (A)1.5 (A) / 1.2 (P)

C. Scrap (%)D. Cycle time (mins)

13%15

<5%<8

3%5

5.5% (A)10 (A)

5 | Covidien | June 13, 2012 | Confidential

全球500强某美国医疗器材公司内部最专业,最具条理性,最系统的6sigma报告模版

Operational Excellence – Team CharterProgram Name: Team Leader: Team Champion: Business Unit: Start Date: Element 1. Process: Stock Reduction in Scrub Warehouses Jessie Zhuo Con Crighton Inventory-Operations November 2008 Description The process in which the opportunity exists. Describe the problem that needs to be solved, or the opportunity to be addressed. Total Savings Identified ($ value)

Product or Service Impacted MBB: Target Completion Date:

All Products September 2009

Team Charter Stock Transfer Request, Personal Demonstration Request, Stock Return Transfer, Inventory value in Scrub locations are continuously increasing. It has made certain SKU s “scarce” in main warehouse, which causes loss of sales and also adds pressure to cash flow. Meanwhile, excess or non-moving stock became expired in Scrub locations, which causes waste. Improve the process of requesting stock transfers to Scrub warehouses. Better control of the

stock being transferred to Scrub warehouses. Regular review of excess/non-moving stock in Scrub warehouses. Visibility to Sales of the stock on hand situation. Name of Metric Baseline Goal Entitle Units of ment* Measure Stock on Hand AUD$600K AUD$500K AUD Value (Consumables only) Total Cost

2. Problem Description:

3. Objective:

What improvement is targeted?

Project CharterProblem Statement and Objective This is a Manufacturing Example - Insert your charter word document, Problem Statement Objective (from charter)

4. Metrics:

What are the measurements that quantify program progress and success? *W hat is the best the processis expected to produce ?

5. Business Results:

6. Program Scope:

What is the improvement in business performance? Please list any other improvements on a separate sheet as needed. Which parts of our business processes will be considered? Which customer segments, organizations, geographies, and timeframe? Names and roles of team members

Cost Reduction

Cost Avoidance

WIP/ Inventory Reduction X

Cash Flow X

Labor Savings

Inc. Sales

Included Excluded Both Australia and New Zealand Metrics excludes Capital Scrub warehouses Equipment Both Consumable Goods and Capital Equipment Bevan Allchurch- Product Manager - Laparoscopic Lisa Olding- Sales Support Coordinator Gloria Ng – Accounts Receivable Officer Kai Liu- Inventory Coordinator Stock availability to end customers.

7. Team Members:

8. Benefit to External Customers:

Who are the final customers, what are their most critical requirements/measurements, and what benefits do we expect to deliver to them? Give the key milestones and dates.

8. Schedule:

Define Measure Analyze Improve Control

Key Project Dates 28 February 2009 31 March 2009 30 April 2009 31 July 2009 25 September 2009

6 | Covidien | June 13, 2012 | Confidential

DEFINE

全球500强某美国医疗器材公司内部最专业,最具条理性,最系统的6sigma报告模版

SIPOC Map

Example of SIPOC – Insert yours – what is the purpose of performing a SIPOC?

7 | Covidien | June 13, 2012 | Confidential

DEFINE

全球500强某美国医疗器材公司内部最专业,最具条理性,最系统的6sigma报告模版

Voice of the Customer/BusinessVoice of Customer/Business Input Actual customer statements and comments “This TV remote should be easy to use.” “I can’t reach all the connectors in the back.” “I want to talk to the right person and don’t want to wait on hold too long.” “Our margins on this product are too low!? Key Customer Issue The real customer concerns, values or expectations Customer Requirement The specific, precise and measurable characteristic

Wants to understand the remote Each function should be understood without Wants to reach around back of TV from the instruction manual front and feel connectors Connectors should be accessible from front of TV within 1 second Wants to talk to the right person quickly Phone tree has less than 6 branches Customer reaches correct person the first time within 30 seconds Cost should represent 70% of product’s price. Product cost should be benchmarked with competi

tion to be within +/- 5%.

Cost is too high Sales price is too low.

Insert your VOC/VOB and describe how this project affects the business CTQs (Sales, Quality, Service, Cost, etc.) as well as the end customer. This is only required for at least one project before certification for each GB/BB.

8 | Covidien | June 13, 2012 | Confidential

DEFINE

全球500强某美国医疗器材公司内部最专业,最具条理性,最系统的6sigma报告模版

Key Process Output Variables – Project Y’sThe high-level customer requirements were broken down into their measurable components as follows:System Project YReduce Compliance Nonconformities # NC % missing DPU Survey Scale 1-5 Survey Scale 1-5 Survey Scale 1-5 DPU Minutes Days Survey Scale 1-5 Survey Scale 1-5 Survey Scale 1-5 Ensure that standards available when needed Ensure that standards are correctly identified in QMS High rating by users regarding satisfaction on communication of standards changes

Units

Control

Selection

Satisfaction on guidance for selecting the best standard High confidence level on selection of the best standard Sufficient detail for selecting critical standards Timely retrieval Timely purchase Good availability of critical standards

AccessConvenient/easy to use system for accessing and retrieving needed standards High satisfaction level of overall system

Insert the KPOVs of your project.9 | Covidien | June 13, 2012 | Confidential

DEFINE

全球500强某美国医疗器材公司内部最专业,最具条理性,最系统的6sigma报告模版

Understand the Process – Process MapsStandards Retrieval Process (Access)Procedure/Training Related (duration 5-15 minutes)

Process Flowchart Current State to Access process

How do I retrieve a standard?

Is worker familiar with the process?

Yes

Check iSOP

Is it referenced?

No

Initiate purchase order (wait 2-4 weeks for standard) DELAY FRUSTRATION

CONFUSION

Contact Regulatory or Quality Consultant No

Yes Note the format and control number

Yes

No

Ask a local coworker

Coworker knows the process?

DELAY

Location Related (duration ~20 minutes)

Initiate purchase order (wait 2-4 weeks for standard)

Check out copy (standard not available for others)

Travel to Regulatory department (10 minute walk) DELAY Return to office (10 minute walk) Review the standard and print needed parts Call to be allowed into building G2

DELAY No ~90% Is worker in building G2?

Yes FRUSTRATION Missing or checked out?

No

Ask Regulatory to help

Format Related (duration – no affect)

Yes

No CONFUSION Is worker familiar with the process?

No FRUSTRATION Is Quality Consultant available?

Yes CONFUSION Electronic Is format paper or electronic? Yes ~10%

Paper

Discuss why you decided to dig deeper into a portion of the process. If you do not need to go further, simply state N/A and continue10 | Covidien | June 13, 2012 | Confidential

MEASURE

全球500强某美国医疗器材公司内部最专业,最具条理性,最系统的6sigma报告模版

Cause and Effects MatrixCause and Effect Matrix (Access and Use)Rating of Importance to Customer Access = light yellow Guidance/selection = turquiose Control = pale blue 9 1 10 2access to electronic version (search text)

8 3detailed procedure for how to access standards

10 4

9 5

system for accessing standards is simple to use

8 6training on how to access standards allows multiple users to simultaneously access standards

8 7

10 8

10 9useful Information on choosing and using standards

9 10training on how to choose and use standards

8 11changes to standards communicated

6 12accountability for final selections of standards

9 13consistent advice on how to choose and use standards

10 14compliance to global requirements

8 15written requirements on how to apply a standard are clearly communicated

9 16assistance for interpretation of the standard

9 17good documentation of compliance to the standard

10 18

10 19Standards used by EBD are available for users

9 20Changes to standards are identified and communicated

8 21

An SOP exists for controlling standards and is communicated

ability to make personal copies

standards are easy to find (and retreive)

Withdrawn standards are still available

timely access to standards

Total

Process Step Use the 13 standard/ Use the 14 standard/ 15 Use the standard/ Use the standard/

Process Input Quality Consultant Regulatory team member protocol/test report template protocol/test report procedures standards training Quality Consultant standards control system Quality Consultant Regulatory department user's experience, skills, knowledge Regulatory team member format of standard (electronic or paper) previous product examples/docu ments RA Admin 9 9 9 9 3 1 0 3 9 9 9 0 9 9 9 9 9 9 9 9 9 9 3 1 3 9 9 576 546 504

16 17

9 9 9

1 9 3

9 1 3

0 3 9

9 9 9

9 3 9

9 9 9

1 9 3

9 3 1

504 488 474

Use the standard/ Select Most 18 Applicable Standards/ 1 7 6 Locate Standard/ Locate Standard/ Locate Standard/ Use the standard/

1 3 3

3 9 3

9 3 9

9 3 3

9 9 9

1 3 3

9 9 9

9 9 9

452 438 426

24

9

9

1

3

3

9

0

1

9

404

Select Most 19 Applicable Standards/ Use the 12 standard/

9

3

3

9

9

9

3

1

0

399

9

0

0

9

3

9

0

9

360

Use the 20 standard/ Need for a standard is Communicated / Standard is Processed/ Standard is Processed/ Electronic Version Delivered/ Hardcopy Delivered/ Locate Standard/ Locate Standard/ Need for a standard is Communicated / Need for a standard is Communicated /

9

3

0

0

9

3

1

3

9

344

39

9 Procedure GP142 RA Admin RA Admin 9 RA Admin training procedure (GP142) standards access system 0 1 0 0 9 9 9 9 9 9 0 0 9 3 1 3 9

9

9

9

333

47 48 50 54 3 4

9 9

9 9 9 9

9 9 9 9

9 9 9 9

333 333 333 333 325 306

Cut and paste your C&E Matrix with a Pareto. Again, discuss the high points from the exercise and any ah has and conclusions. Discuss which variables will be evaluated, and which key variables are derived from VOC and VOB.

36

9

9

9

3

285

40

Quality Consultant

9

9

3

9

279

Regulatory Select previous Strategy 21 product (as model)/ 22 Use the standard/ Regulatory Guidance/Tools Engineer's experience/skill s/knowledge IOVV Matrix

9

0

0

9

3

3

9

0

0

273

9

1

3

0

1

9

3

3

0

273

Select

Most 23 Applicable Standards/ Select previous 25 product (as model)/ 46 52 Standard is Processed Electronic Version Delivered/ Electronic Version Delivered/ Electronic Version Delivered/ Hardcopy Delivered/

9

9

0

9

3

1

0

1

0

271

9 iSOP Requestors

0

0

3

0

3

9

0

3

237

9 9

3 3

9 9

3 3

225 225

51

Software/metho d of filing I.H.S. Global

9

9

1

3

213

49 53

9 Hardcopy filing system 9

9 9

0 0

3 3

204 204

11 | Covidien | June 13, 2012 | Confidential

MEASURE

全球500强某美国医疗器材公司内部最专业,最具条理性,最系统的6sigma报告模版

Evaluate Risks on Process Inputs - FMEAStanadards SystemFailure Modes and Effects Analysis (FMEA) Process Name: Standards System Responsible: Core Team Prepared by: David Horton FMEA Date: 2/26/2008 (original) Rev. A Process StepStep of the process under investigation

InputInput under investigation?

Potential Failure Mode

Potential Failure Effects

S E VHow Severe is the effect to the cusotmer?

Potential CausesWhat causes the Key Input to go wrong?

O C CHow often does cause or FM occur?

Current ControlsWhat are the existing controls and procedures (inspection and test) that prevent either the cause or the Failure Mode? Should include an SOP number.

D E THow well can you detect cause or FM?

R P N

Actions Recommended

Resp.

In what ways does the Key Input go What is the impact on the Key Output Variables wrong? (Customer Requirements) or internal requirements?

What are the actions for reducing the occurrance of Who's Responsible for the recommended action? the Cause, or improving detection? Should have actions only on high RPN's or easy fixes.

Standard is Processed after it is received (identification of status, add ref to iSOP, VL number issued) Need for a standard is communicated (either from I.H.S or internal requestor)

RA Admin function Incorrect identification of the Standards that should not be used are standard's status still being used (i.e. obsolete standard is still being used) 9

Lack of understanding or training on standards and their status 8

Regulatory team member's input (IOVV, Regulatory Strategy, etc.) (2) Expect Quality Consultant's input. These are only effective for development teams

8

576

(1) Establish process/tool that identifies status of standards and then relays the information effectively. (2) Have designated experts and trained individuals identify the status.

Regulatory

RA Admin function RA not notified of the need (receives notice of and doesn't purchase new the need for a standard standard)

The standardard is unavailable for use

I.H.S. global doesn't send notification because standard is not on their list 8 7

None

Perform quarterly comparison of their list Either Regulatory or of standards to ours. Update them on Quality Consultant (differences) as needed. Add to SOP 10 560

Application of the standard

User (experience, Previous product's Delayed registration/license in global skills, knowledge, documentation / protocols market training) are not adequate to today's standards

User refers to and uses p

revious product (as model) 9 8

Application/ access of the standard Select most appropriate standards for global market

Application of the standard

User (experience, Users cannot study the skills, knowledge, standard and make training) personal notes to remember interpretation Regulatory team Not recommending the use member of a critical standard. (missing standard completely, not just harmonized/ version/ revision of a standard) User (experience, User applies the standard skills, knowledge, insufficiently or incorrectly training)

Delayed registration/license in global market due to increase time in developing suuport documents Delayed registration/license in global market

7

Users do not have access to a copy of the standard for personal use (paper or electronic). Not knowledgeable on all standards (knowledge range)

Regulatory review of final supporting documentation. Expectation that user will ask coworkers and Quality Consultant on how to apply the standard None

7

504

Revise GP-142 to add caution statement Regulatory to review standard revision before use. Not to rely wholly on previous product application of standard.

Provide electronic access to all users 10 490

Regulatory

7 (1) Regulatory strategy, (2) IOVV inputs; however, Regulatory is in charge of writing these, so if the mistake is made, it's too late.

10

5

9

450

(1) Designate standards experts for each Regulatory genre (2) Training and central location for standards information

Delayed registration/license in global market 8

User or expert has limited knowledge of standards/lack of training

8

Select most appropriate standards for global market Application/ access of the standard

Regulatory team member

Recommendation of the incorrect version/ revision

Delayed registration/license in global market 9

Not knowledgeable on all standards (knowledge range) 5

Regulatory review of final supporting documentation. Expectation that user will ask coworkers and Quality Consultant on how to apply the standard (1) Regulatory strategy, (2) IOVV inputs; however, Regulatory is in charge of writing these, so if the mistake is made, its too late. None

7

448

(1) Designate standards expert/contact info. (2) Formal external standards training for each genre/functional expectations

Regulatory and Quality Consultant

9

405

(1) Designate standards experts for each Regulatory genre (2) Training and central location for standards information

User (experience, Users cannot find applicable Ineffective use of resources (time). skills, knowledge, parts within a standard (e.g. Frustration with not finding what to do training) keywords, etc.) quickly.

5

Standards not available in a format that enables searchable text Reliance on the purchasing system (PO placed, purchasing, accounts payable, I.H.S. order fulfillement, mail, etc.)

Provide electronic access to all users 9 405 Provide electronic access to all users. This would make access to standards available at user's computer.

Regula

tory

9 Electronic copies are ordered when available

RA Admin function The purchase order takes a Standard not available in a timely Standard is (PO long time to process manner Delivered (PO process/receive/file processed, ) standard is filed if hardcopy, electronic version link sent to Quality Consultant) User (experience, User applies the standard skills, knowledge, insufficiently or incorrectly training) Ineffective use of resources (money, time)

5

9

9

405

Application of the standard

Limited knowledge of standards/lack of training 6 8

Locate standard Select most appropriate standards for global market Select most appropriate standards for global market

GP-142/ training

Personnel don't know that there is a formal method for locating standard. Quality Consultant Recommendation of a nonFunction harmonized or nonrecognized standard Regulatory team member

difficult to find standards (frustration), delays access time because of search Delayed registration/license in global market

8

lack of training on how to access standards Not knowledgeable on regulatory status of standards (knowledge range) Not knowledgeable on regulatory status of standards (knowledge range)

Informal reliance on user, user's coworkers, and other project documentation. Consulting these additional resources is not a requirement GP-142 and training SOP

8

384

(1) Designate standards expert/contact info. (2) Formal external standards training for each genre/functional expectations

Regulatory and Quality Consultant

8 (1) Regulatory strategy, (2) IOVV inputs

6

384

9

9

4

324

(1) Revise SOP to give more detail or Regulatory clarify (2) Add annual training to compliancewire (1) Designate standards experts for each Regulatory and Quality genre (2) Training and central location for Consultant standards information (1) Designate standards experts for each Regulatory genre (2) Training and central location for standards information

Recommendation of a non- Delayed registration/license in global harmonized or nonmarket recognized standard

9

4

(1) Regulatory strategy, (2) IOVV inputs; however, Regulatory is in charge of writing these, so if the mistake is made, it's too late. None

9

324

Barrier to access of standard (harcopy in G2, dependant on Quality Consultant to be present, interoffice mail) User (experience, Users cannot study the Application/ skills, knowledge, standard and make access of the training) personal notes to remember standard interpretation Need for a RA Admin function RA not notified of the need standard is (receives notice of and doesn't purchase new communicated the need for a standard (either from standard) I.H.S or internal requestor) Retrieve standard

Personnel

Frustration and delayed access to standard 4

Remote location/building locked 9

Provide electronic access to all users 9 324

Regulatory

Frustration for not having confidence in how they use the standard.

4

The standardard is unavailable for use

Users do not have access to a

copy of the standard for personal use (paper or electronic). I.H.S. global's notification is missed or overlooked by RA

None 8 None 10 320

Provide electronic access to all users

Regulatory

What were the key input variables identified from the C&E Matrix? How are you going to address the high RPN values for these input variables?

Perform quarterly comparison of their list Either Regulatory or of standards to ours. Update them on Quality Consultant (differences) as needed. Add to SOP 10 320

8

4

Cut and paste your FMEA with Pareto. Discuss the high points from the exercise and any ah has and conclusions. Remember this is a working document. Paste the first draft here with recommended actions for improvement. In the control phase you are required to post the final FMEA with actions taken completed12 | Covidien | June 13, 2012 | Confidential

MEASURE

全球500强某美国医疗器材公司内部最专业,最具条理性,最系统的6sigma报告模版

Measurement System AnalysisObjectiveDefine measurement variation Define accuracy, bias, and precision Define repeatability and reproducibility Define the precision to tolerance ratio Describe the importance of the precision to tolerance ratio Define the % R & R Describe the importance of % R & R Define number of distinct categories

GB

Describe the importance of number of distinct categories Define the steps in completing a Measurement Systems AnalysisUse Minitab to calculate the statistics of an MSA: repeatability, reproducibility, %R&R, P/T ratio for a set of data Interpret Minitab output to determine if the measurement process is adequate

Interpret Minitab output to determine if an attribute measurement process is adequate

This is only required for at least one project before certification (Minitab session window output has all of these elements) You should be able to interpret the above output from an MSA and if the gage is acceptable for the measurement at hand.

13 | Covidien | June 13, 2012 | Confidential

MEASURE

全球500强某美国医疗器材公司内部最专业,最具条理性,最系统的6sigma报告模版

Measurement System Analysis

An example of the Minitab session window output that should be present in the template.

14 | Covidien | June 13, 2012 | Confidential

MEASURE

全球500强某美国医疗器材公司内部最专业,最具条理性,最系统的6sigma报告模版

Gage R&R

Specify what you are gauging, how you performed the test, and what conclusions did you draw from the results. In other words, what does the output mean, is the gage acceptable for your process? If not what actions will you take? Cut and Paste the Minitab Session window including the graphs above into the template. Comment as necessary. If not applicable state why. (same criteria for Kappa attribute studies) – see Slide #13.

15 | Covidien | June 13, 2012 | Confidential

MEASURE

全球500强某美国医疗器材公司内部最专业,最具条理性,最系统的6sigma报告模版

Measure Current Process Performance – Baseline Process Capability and MetricsProcess Capability of Overall_RdmUSLP rocess Data LS L * Target * USL 300 S ample M ean 1132.03 S ample N 30 S tDev (Within) 81.1742 S tDev (O v erall) 99.8615

P r ocess Capability of sampledur ationUSL

Within OverallP otential (Within) C apability Cp * C PL * C P U -3.42 C pk -3.42 O v erall C apability Pp PPL PPU P pk

C pm * * -2.78 -2.78 *

P roce ss D a ta LS L T a rge t USL S a m ple M e a n S a m ple N S tD e v (W ithin) S tD e v (O v e ra ll) * * 5 24.5 30 15.8352 15.9952

W ith in O v erallP ote ntia l (W ithin) C a pa bility Cp C PL C PU C pk * * -0.41 -0.41

O v e ra ll C a pa bility Pp PPL PPU P pk C pm * * -0.41 -0.41 *

300O bserv ed P erformance P P M < LS L * P P M > U S L 1000000.00 P P M Total 1000000.00

450

600

750

900E xp. PPM PPM PPM

1050 1200 1350O bse rv e d P e rform a nce P P M < LS L PPM > USL P P M T ota l * 1000000.00 1000000.00

0P P M < LS L PPM > USL P P M T ota l

20* 890920.14 890920.14

40P P M < LS L PPM > USL P P M T ota l

60* 888600.59 888600.59

80

E xp. Within P erformance P P M < LS L * P P M > U S L 1000000.00 P P M Total 1000000.00

O v erall P erformance < LS L * > U S L 1000000.00 Total 1000000.00

E xp. W ithin P e rform a nce

E xp. O v e ra ll P e rform a nce

Show relevant Cpk s and Minitab graphs for continuous data. If discrete data, use Minitab to transform the percentage into a Z-value then to a Cpk value. Cut and paste this output What are you measuring? DPMO etc This is only required for at least one project before certification. What do you do if the data are not normal?

16 | Covidien | June 13, 2012 | Confidential

MEASURE