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(9109-QE) Standard Work: A LEAN Tool for

Consistency and Efficiency in the Workplace

October 12, 2013 10:30 AM - 12:00 PM

Event Faculty List

Event Title:

9109-QE: Standard Work: A LEAN Tool for Consistency and Efficiency in the Workplace

Event Date:

Saturday, October 12, 2013

Event Time:

10:30 AM to 12:00 PM

Director Dennis Harpool, MT(ASCP)SBB Vice President Manufacturing Systems Blood Systems, Inc. dharpool@bloodsystems.org Disclosures: No

Speaker Laurel Anderson, MT(ASCP) Process Design Specialist Blood Systems landerson@Bloodsystems.org Disclosures: No

Speaker Michelle Nelson, MT(ASCP)SBBcm Regional Director of Technical Services Blood Systems/United Blood Services mnelson@bloodsystems.org Disclosures: No

Speaker Jacquelyn Vannoy, MT(ASCP), CQA, CMQ/OE(ASQ) JVannoy@bloodsystems.org Disclosures: No

9109-QE

Standard Work: A Lean Tool for Consistency and Efficiency in the Workplace

Laurel Anderson, MT ASCPProcess Design Specialist – Donor ServicesBlood SystemsAABB 2013

2

Standard Work - Course Objectives

• Differentiate between SOPs and standard work (aka Workflow Standards)

• Explain the benefits associated with implementation of Workflow Standards.

• Describe the role Workflow Standards play in external and internal audits.

3

Standard Work - Background

• Use of standard work in Lean Manufacturing

• Development of a standard work process at Blood Systems

• Template, forms, document control

4

Standard Work – Why have Standard Work?

– Standard Work helps to Standardize and Sustain,

part of the 6 Ss of Lean.

• Incorporates technical, business and service standards.

• Part of continuous process improvement.

• Getting the work team to the same level before the next change.

– Becomes new baseline.

(Sort Straighten Sweep Standardize Sustain & Safety)

5

Standard Work – How is it different from SOPs?

• If SOPs tell the what or how, and

Policies tell why & in which circumstances,

then standard work tells who/where/when.

• Focus on teamwork, layout, timing.

• Standard work does NOT

– Stand alone

– Supersede or conflict with SOPs

– Create regulatory compliance issues

6

Standard Work: Project Method – What did we do?

• What? – develop process for implementing Standard Work at BSI.

• Why? – because past Lean initiatives didn’t “stick”.– How can you minimize performance variation while still allowing flexibility?

• What is more than a suggestion and less than a rule?

• Who? – representatives from Training, Quality, Regulatory, Document Control, Manufacturing Systems, Process Improvement.

• How? - Identified obstacles to success and designed to overcome them. – FMEA (Failure Modes and Effects Analysis)

– Our Answer? Workflow Standards

7

Workflow Standards Process Design

1. Workflow Standards content development is typically led by Process Improvement/Design staff as part of a PI project.

2. WS is field-tested and training is developed.

– QMRA Local/Center quality staff participate in this process

3. WS materials and training are approved by corporate office (Quality and Technical staff)

4. Implementation plan (date, audience, monitoring, value/benefit, etc.) is developed.

8

Workflow Standards Process Design (continued)

5. WS Implementation Plan AND all materials

are released to field for feedback

– Modeled after FDA Draft Guidance comment period

– Typically 2 weeks, depending on scope

– Responses from each region submitted on a Workflow Standards Feedback form (via email to a steering committee)

3 categories of obstacles:

• Error/correction to material or training (affects all centers)

• Center-specific issue (requires counter proposal)

• Time related issue (requires new proposed timeline)

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10

Workflow Standards Process Design (continued)

6. Comments reviewed and changes made as needed

– Center variation must be approved at corporate office level by Workflow Standards Steering Committee

7. Final WS released for use

– Release document includes summary of feedback and conclusions.

– Quality writes a pre/post assessment plan.

8. Implementation and performance is monitored at self, supervisor/center, and PI levels.

– Feedback provided to center and WS Steering Committee.

– NOT part of Deviation Management.

11

Workflow Standards Templates

Three Workflow Standards templates were developed:

1. Step Action template – most similar to SOPs

2. Layout Template – allows for diagrams, drawings, flow charts

3. Time Graph Template – modeled after standard work tools

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Workflow Standard – Step Action Template

13

Workflow Standard – Layout Template

14

Workflow Standard – Time Graph Template

15

Thank you

Blood Center

Workflow

Standards

Workflow Standards in the Blood Center: The Center’s Perspective

Michelle Nelson, MT(ASCP)SBBcm

United Blood Service – Rocky Mountain RegionBillings, MT

Share and discuss an example of workflow standards implemented at the blood center

Discuss the challenges and impact of the implementation to blood center departments

Discuss how a customer is positively impacted by blood center implementation

Workflow Standard for Pre-Positioning Antigen Negative RBCs: Improves TAT

Identify and sequester rare antigen negative units

Pre-confirm units of more commonly ordered phenotypes

Manage in-house sequestered inventory for prepositioning for release to customers

System Antigen Inventory Database (SAID)

4Pre-Positioning Antigen Negative RBCs Workflow Standard

5Pre-Positioning Antigen Negative RBCs Workflow Standard

“Sequestered Phenotyped Units” Binder with Colored Tabs

+

Descriptions of Sequestration for Lab and HS Staff

Category Rh/Kell O + O ‐ A + A ‐ Total Hold period

Confirmed Common D+C‐E‐K‐ 5 0 3 0 8 NA

Confirmed Common D‐C‐E‐K‐ 0 1 0 1 2 NA

Confirmed Common c‐E‐K‐ 4 0 2 0 7 NA

Confirmed Common Total 9 1 5 1 16 NA

Hist/Conf Uncommon D+C‐E‐K‐ 5 0 3 0 8 NA

Hist/Conf Uncommon D‐C‐E‐K‐ 0 1 0 1 2 NA

Hist/Conf Uncommon c‐E‐K‐ 4 0 2 0 6 NA

Hist/Conf Uncommon C‐e‐K‐ 2 0 1 0 2 NA

Hist/Conf Uncommon None 0 0 0 0 0 NA

Hist/Conf Uncommon Total 11 1 6 1 18 NA

Hist/Conf Rare D+C‐E‐K‐ 4 0 2 0 6 21Hist/Conf Rare D‐C‐E‐K‐ 0 1 0 1 2 21

Hist/Conf Rare c‐E‐K‐ 1 0 3 0 4 21Hist/Conf Rare C‐e‐K‐ 0 0 0 0 0 21

Hist/Conf Rare None 0 0 2 0 2 21Hist/Conf Rare Total 5 1 7 1 14 21Hist/Conf Very Rare D+C‐E‐K‐ All All All All All 21

Hist/Conf Very Rare D‐C‐E‐K‐ All All All All All 21Hist/Conf Very Rare c‐E‐K‐ All All All All All 21

Hist/Conf Very Rare C‐e‐K‐ All All All All All 21Hist/Conf Very Rare Total All All All All All 21

Guidelines for Phenotype Categories

Common Phenotype: c‐ E‐; C‐ e‐; or C‐ E‐; and K‐Uncommon Phenotype: c‐ E‐; C‐ e‐; or C‐ E‐; and K‐ and 1‐2 extended typing

antigen negatives (S, Kidd, Duffy)Rare Phenotype: c‐ E‐; C‐ e‐; or C‐ E‐; and K‐ and 3 or more extended typingantigen negatives (S, Kidd, Duffy)

Very Rare Phenotype: S‐s‐, U‐, Jk (a‐b‐), or negative for High IncidenceAntigens [e.g., Co(a‐), Js(b‐), Jo(a‐), Lu(b‐), Yt(a‐), Ge‐, Di(b‐), k‐]

System Antigen Inventory Database (SAID)

SAID

Improve Visibility

Import

Historical Information

Manage Inventory

11

12

Documentation of Sequestration Work Flow

Example of Sequestered Rare Units

15 Searching for a rare component in SAID

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Challenges and Impacts Identified by Implementation of the Work Flow Standard

Unnecessary Workload

Amount of time needed for entry and removal

Cross Department Functions and Monitoring

Training and Retraining Training of Staff

Benefits for the Hospital Antigen Negative Workflow Standard Implementation

Improve local and system stock levels

Pre-confirmed more common antigen

negative units

Availability of testing staff to do other patient testing

Delivery of components is timely

Improve fill rate and fill time

Customer Service Improvement

Desiree and Erin Make the Workflow Happen

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Do the workflow standards really work for an organization?

Are these workflow standards really helpful to staff processes?

Do the staff understand the difference between a workflow standard and SOP?

Do these workflow standards really drive consistency productivity and efficiency?

How does an organization monitor a workflow standard at their facility?

Consistency

Productivity

Efficiency

Share and discuss an example of workflow standards implemented at the blood center

Discuss the challenges and impact of the implementation to blood center departments

Discuss how a customer is positively impacted by blood center implementation

21

• Travis Glanzer, Process Design Specialist and his workgroup team at United Blood Service in Fargo, ND.

Acknowledgements:

9109-QE

Standard Work: A Lean Tool for Consistency and Efficiency in the Workplace

Jackie Vannoy, MT (ASCP), CQA, CMQOECorporate Director, Compliance and Regulatory AffairsBlood SystemsAABB 2013

2

Standard Work - Course Objectives

• Describe the philosophy and talking points for Quality staff.

• Describe the document control aspects.

• Describe the role Quality staff plays.

3

Talking Points and Philosophy

Talking points document – Developed to help Quality staff explain this new philosophy and

associated standards to external investigators.

– Quick reference tool - NOT intended to hand to investigators

– Includes references to guiding SOPs and release documents

Philosophy– Provide direction for performing tasks to achieve an optimum

workflow or arrange work areas in a specified layout based on Lean production methods.

– Designed to eliminate process waste, minimize process variation, and increase efficiency and safety.

4

Philosophy (cont’d)

Workflow Standards are:

• Tools for standardizing processes

• Agreed-upon set of work rules to be consistently followed

• Part of a framework of systematic performance measurement

• Monitored and evaluated as part of continuous process improvement

• NOT intended to replace SOPs or training

• Designed to describe process flows and work area layouts

5

Document Management

Standard work documents are:

• Version controlled

• Written in standard template format with unique document identifiers

• Authored by individuals trained in Lean manufacturing principles

• Approved by Central Office staff

• Released through existing communication methods

• Updated as needed

6

Quality’s Role

• Development Activities

– Active team member

– Assist with implementation plan

– Assist with identification of monitoring data to be collected

– Work with field operations staff during field-testing and monitoring

7

Quality’s Role (cont’d)

• Pre-Comment Period Activities

– Review and approve materials and training

– Develop quality project documents as needed

– Collect necessary data

8

Quality’s Role (cont’d)

• Comment Period Activities– Provide set timeframe for review and consensus

– Coordinate meetings to discuss as needed

– Collate feedback and determine with operations if comments and/or center variation should be submitted

– Approve variations as members of steering committee

9

Comment Examples

Comment Resolution

Center had concerns with frequency of performing steps.

Frequencies suggested to ensure historically rare units are available to meet system demand. Centers that consistently achieve target levels may adjust frequencies as appropriate.

Center would like to combine some bins as space is limited.

Bin quantities determined by location. Key point is to label bins allowing quicker location of units.

Center had suggestions for sequester category definitions.

Category definitions removed to allow centers to utilize options appropriate for their location.

Center had concerns with requiring a minimum of 2 confirmed common even when no demand at center.

Reworded block and added comment in notes to remove requirement for centers to pre-confirm units when historical demand doesn’t indicate need.

Center had concerns with removing units from sequester with only 7 days shelf life.

Step written to allow centers to remove from sequester earlier if desired.

10

Quality’s Role (cont’d)

• Release and Implementation Activities– Incorporate use of new data collection field in

deviation management system

– Implement pre/post assessment plans

• Includes collection of monitoring data

– Assess and summarize implementation activities

11

Quality’s Role (cont’d)

• Post Implementation Activities– Provide feedback to center and Steering Committee

– Incorporate review into internal audits

– NOT handled as part of Deviation Management.

– Process Analysis process is utilized when Standard Work documents are not followed.

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Thank you so much for your attention!