Real Lean in Quality Assurance. Gary Ryan, PhD. Agenda. ISPE Annual Meeting 29 October 1 November 2017 San Diego, CA

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1 Real Lean in Quality Assurance Gary Ryan, PhD Agenda Introduction / Common Practices Reengineering the Process Batch Record Review Disposition Deviations/Investigations Management Reengineering the Batch Record 1

Before we start. The first rule of any technology used in a business is that automation applied to an efficient operation will magnify the efficiency.

2 Before we start. The first rule of any technology used in a business is that automation applied to an efficient operation will magnify the efficiency. The second is that automation applied to an inefficient operation will magnify the inefficiency. Bill Gates Common Practices in QA Environments Backlogs of Batch Records at several review stages No Flow Lack of standardization in approach to review Resources dedicated by workstreams, or by product, or by production areas Poor visibility on day to day individual workload, or on overall workload Poor understanding of true capacity Poor batch record layout generic vs specific Poor Right First Time (RFT) Pressure on lower priority workstreams, e.g. change controls No visibility on performance or performance goals 2

3 Transforming QA Performance To improve RFT %, you must reengineer the batch record To cut lead times, you must tackle the review, disposition and investigation processes To improve productivity, you must address workload volatility Reengineering the Process 6 3

4 Sample Batch Review Process Map Batch Record Review Process Production fill the batch record Operator reviews Contact Team Leader Between 4 and 6 separate reviews 2nd Team Operator Leader Corrections 6 official delay points No File to QA Required? reviews reviews 10% Even after 3 production reviews 85% of yes 90% batch records are sent back for correction 23.6 w days 4.8 w days Resp. Chem. Reviews and releases Batch QA 1st Review Corrections yes An average 23.6 WD from production to QA Required? 85% delivery A total of 42.3 WD from end of production to File release to Production QA Review File to QA Production Correct Corrections An average of 19.7 WD from receipt in QA 9.6 w days to release 6.6 w days 1.7 days No 15% Update LIMS Deviations and QC results must be closed Key Solution Principles Real Time Review Level the load Combine different work streams / break siloes Flow Once you start keep going and don t stop Call priorities, but always finish what you start Standard work Fixed time periods for review/other activities 4

5 Real Time Review (RTR) Move some of the review effort closer to the point of data creation/recording The aim of RTR is to attempt to address as many potential issues as possible in real time, and therefore streamline the final review process and timelines, as well as start investigations sooner Defining what is in scope for RTR is critical Once the RTR is established the sections of documents receiving real time review will no longer have a final review because they have been reviewed already Real Time Review Scope (example) Review of all comments Review all annotations for completeness and accuracy Entries are legible No blank sections present Calculations Review associated attachments/printouts as applicable Provide support for documenting complex comments Labels are attached, where required Hold times are adhered to In process testing occurred on day as required Area Clearance performed on day as required EM settle plate exposure as per SOP Pre challenge set run as per SOP End of batch clearance as per PBR Applicable attachments present Confirmation that all additional pages requested as per SOP SAP transactions complete 5

6 Advantages of Real Time Review Reviewer workload is levelled mixed work stream levelling RTR with Stage review/other review workload Review is always FIFO This will give a consistent, much reduced lead time. There will be no need to expend effort moving or tracking the batch record Corrections will be completed closer to source less effort will be expended chasing operators...asking them if they remember what they did last Tuesday Better communication between Reviewer and operators will result in improvements in the quality of the batch record and right first time Deviations will be found and addressed earlier in the process Standardize Reviews & Corrections Common that different reviewers within in the same group will review to different standards Variation in the interpretation of requirements Source of frustration for reviewers and operators xxx wouldn t have sent that correction back. Last time xxx wanted me to do it that way last time Get reviewers to agree on standard comments and corrections Can generate work aids to help 6

Remove Review Duplications Define roles between In line review and off line review to avoid review duplications and any situation found could be manner in

7 Remove Review Duplications Define roles between In line review and off line review to avoid review duplications and any situation found could be manner in a timely manner prior to manufacturing close out. Variable workload and dedicated resources Run Late Work Load Excess Cost /Capacity Poor Productivity Time 7

8 Leveling Combine Workstreams to reduce Volatility Charlene Gary Doug Vickie Nathan Kristi Batches Batches Batches Received Batches Batches Batches Received Batches Batches Batches Received Batches Batches Batches Received Batches Batches Batches Received Batches Batches Batches Received Received Reviewed By HOTS Received Reviewed By HOTS Received Reviewed By HOTS Received Reviewed By HOTS Received Reviewed By HOTS Received Reviewed By HOTS Mean St Dev CoV Total Batches Batches Batches Received Received Reviewed By HOTS Visual Queue for BRR ~ 16 hours ~ 16 hours Product A Overdue Product B Product C Product D Product A Product A Product C Product C Review Today Product B Product B Product B Product A Product C Product C Review Tomorrow Product B Product B Product B Product A Product A Due Date Oldest Newest Levelled Demand in terms of hours of review is determined (16 hrs / day in this example) Visual Queue allows everyone (managers / supervisors / reviewers etc) to see if we (group) are on track against our daily target Individual reviewer assignments and progress can be monitored on a simple visual management board while monitoring overall performance versus our weekly group target 8

9 Capacity model to understand resourcing need when incoming HOTS volume changes Repeating Cycles and Standard Work 9

10 Physical Disposition Queue and VM Board New Process including physical queue and Daily Huddle Working according to Supply Chain Priorities Removal of dedication Deviations / Investigations 10

Triage Meetings Ideally Held Daily at a fixed time in the morning attendees include relevant stakeholders from QC, Production, and QA anyone who is an Owner or an Approver.

If a meeting was held 2 times per week the report might look like this... A daily meeting should never see ages of 3/4/5 days!

11 Triage Meetings Ideally Held Daily at a fixed time in the morning attendees include relevant stakeholders from QC, Production, and QA anyone who is an Owner or an Approver. If the meeting is daily, no deviations should have a Triage Age > 1 day! The Triage Report is central to the meeting the agenda focuses only on deviations that need to be triaged/classified (e.g. Event, Minor, Major, Critical) so they can move quickly to the next stage of resolution. If a meeting was held 2 times per week the report might look like this... A daily meeting should never see ages of 3/4/5 days! Deviations: Visual Management of Milestones Logical process Milestones are identified. Target Lead times are expressed in + days from the completion of the previous milestone and are agreed, practical but ambitious targets Discrepancy No. Open Date Batch Due Date Initiation Owner Status (lab) Description Initiation (+1 Day) QA Initial Assessment Milestones Retest / Further QC Summary QA Review Further Actions QA Closure Analysis (+1 Day) (+4 Days) (+3 Days) (+ 2 Days) (+4 days) Trackwise Due Date The completion dates for the various milestones are manually updated in pen as the Deviation progresses, Trackwise Due Date is noted 11

recorded on a white peel able label This mock up could accommodate up to 21 new DR s per week (in 3 standard 32 slot T card holders)

12 DR Visual Management High Volume: T cards DR s move down the columns as they progress through the milestone phases If an individual DR s does not require a particular phase, it simply jumps down to the next relevant phase For Longer Phases, (>2 days) the due date is recorded on a white peel able label This mock up could accommodate up to 21 new DR s per week (in 3 standard 32 slot T card holders) Further Reading & Contact Information Foxit Reader PDF Document Gary Ryan Director of North American Operations, BSM gary.ryan@efeso.com 12

13 Appendix Batch Record Reengineering 13

14 Common Batch Record Observations Poor Layout, entries all over the page Poor ordering, requiring operators to turn back pages Large volume of transcribed data Obsolete entries and NVA entries Duplicate entries Entries and sections requiring N/A Large Volume of entries Layout does not support Real Time Review (in line sign off of sections) The result: errors and correction loops 14

Batch Record Reengineering Standardise batch record formats so that similar data is on similar pages (and in similar sequence) for all products Errors of

Transcription Eliminate Transcription wherever possible Use of Validated System Print outs Eliminate Duplicated entries Other reduction in Data Entry

15 Batch Record Reengineering Standardise batch record formats so that similar data is on similar pages (and in similar sequence) for all products Errors of Omission Use of Shading / Data Masks / Sequence of Steps Reduce the volume of manual entries Wherever possible prompt operator with the correct value Transcription Eliminate Transcription wherever possible Use of Validated System Print outs Eliminate Duplicated entries Other reduction in Data Entry Consolidating sign offs / checks (for successive activities) Elimination of NVA data Avoid having to use NA Generic BRs vs product specific BRs Challenge each entry in the batch record! 15

C/NC used everywhere Batch Record Simplification Example Instructions on Left side of page Parameters Named in centre Data Entry on

16 Batch Record Simplification: Example Data Entry all over the page Lots of white space: not obvious if everything is entered No data masking (where should we expect, e.g. decimal places, hours, minutes, months, etc. C/NC used everywhere Batch Record Simplification Example Instructions on Left side of page Parameters Named in centre Data Entry on Right side Highlight (in white) where data entry is required. Highlight in bold/colour critical parameters, or second checks. Use (C)onform box for fixed parameters Use masking for other data 16

17 Definition : Levelling A defined process that addresses the inherent volatility in short interval incoming QA workloads Objective(s) To release a level amount of work into the QA function / processes in each short interval (i.e. each day / each week) To give individuals a balanced productive workload each day / week Benefit(s) Enables the flow of work Supports short interval control & visualisation of workloads Improves productivity 10 15% Supports Improved lead times and Lead time consistency Detail The most common QA Levelling Strategies are Queue Based Levelling Mixed Workstream Levelling Real Time Review (for Batch Record review processes) In QA functions, the levelling process also normally includes a triage step (in order to size the task effort required) and a visual queue from which tasks are prioritised according to must start date and distributed to individuals Flow Definition : Flow means completing tasks in a timely fashion and at the earliest possible opportunity (once the task had been released into the function or process as part of a levelled short interval workload). Objective(s) To Reduce the through put time for QA tasks To standardise how specific tasks are processed by QA Benefit(s) Enables the levelling of work Supports short interval control & visualisation of workloads Significantly Reduces throughput times and work in progress Improves the predictability and reliability of task completion Detail Many QA processes involve interaction with other functions and / or have other inherent delays or decoupling points. Flow in these processes is achieved by dividing the process into logical milestones and flowing from milestone to milestone. Flow across milestones is normally achieved via (cross functional) visual management boards and direct person to person interaction with the other process stakeholders. This avoids long trails and enables decisions to be made quickly (e.g. Investigations processes) 17

18 Standard Work Definition : Defined or Dynamic QA roles that that combine tasks and use people s time well. Discrete Processes : The process steps are separated into milestones and/or tranches of work that can be logically completed by one person in one continuous period Dynamic daily roles are assembled based on priorities and a triage of the effort required for each tranche of work Objective(s) Routine Processes : Defined, fixed and repeating QA roles that meet the levelled demand and use people s time well. Note: For both role types, the task methodology is standardised using documented guidelines or other supports (where possible). Discrete Processes (e.g. CAPA s, Change Controls, SOP updates etc.) To give individuals a productive days work each day Routine Processes (e.g. Batch Record Review) To develop balanced, productive, repeatable QA roles (Note: this is only possible if the short interval workload is being controlled via levelling. To define and standardise the methodology and develop task guidelines or supports (e.g. use of standard check sheets for batch record review) To design and document the optimum sequence of tasks in carrying out the process and to support individuals in following that method. Benefit(s) Improves the consistency and reliability of QA processes. Improved Productivity 10 15% Enables short interval control Reduces errors and failures (over time) Detail Some people are naturally good time and task managers and will organise and sequence their work in a logical and productive manner but some people are not. Standard work is a way to capture the best method and support people in following that method. Short Interval Control Definition : A defined, visually managed process for : Daily task management Visualization of task progress Interventions & recovery actions as required Objective(s) To monitor short interval progress of QA tasks and processes To prompt and facilitate pro active interventions to recover from issues or delays To foster ownership and accountability for individual and departmental performance Benefit(s) Improves the operation of the defined QA processes Supports more consistent & predictable performance Detail Discrete Processes (e.g. CAPA s, Change Controls, SOP updates etc.) The current workloads and the status of individual items versus defined process milestones are visualised on a visual management board e.g. tracking of open CAPA s. Work is assigned from these queues (based on priority and a triage of the effort required) to give individuals a day s work each day. These are known as dynamic roles Routine Processes (e.g. Batch Record review) Routine processes operate at calculated levelled demand rates with Defined standard work roles Short Interval control of Individual roles The daily roles for Individual persons (both Defined and Dynamic roles ) are also visualised and coloured magnets are used to update the current status The supervisor or group leader works with individuals to agree recovery actions as needed Role progress and performance are reviewed at a 5 10 minute daily huddle meeting held at the daily visual management board 18

19 Performance Management & Continuous Improvement Definition : Active, ongoing and timely management and control of measurable performance Routine measurement, review and analysis of QA performance Timely interventions to address negative trends and / or improve performance. Objective(s) To develop metrics & visual displays that are easy to see and interpret correctly To create a clear, shared understanding of the QA performance and trends To foster ownership of the metrics & performance objectives by the QA team To support continuous improvement activity focused on managing and improving measurable performance Benefit(s) More consistent & predictable performance Improved customer service levels A culture of pro active performance management and continuous improvement Greater empowerment of QA personnel Detail Appropriate Customer Performance and Leading process metrics (consistent with site goals) are agreed and defined for Quality / Timeliness /Productivity / others as required If necessary a process to collect the data and update weekly graphs is established The QA team reviews performance and trends at a structured weekly meeting and initiates corrective actions and/or mini projects as required Lean Investigations & CAPA Definition : A Defined Visually Manged process supported by Flow and Standard work. Objective(s) To reduce Investigation and CAPA processing and management effort To reduce delays and duplication of effort Benefit(s) Improved Change control lead time performance Improved ability to make accurate commit dates to initiators and to achieve them Improved productivity Improved understanding and planning of change control capacity Detail Investigations and CAPA s typically have 30 day and from 30 to 90 day lead times respectively. While not changing the official lead times, it is good practice to design a process based on shorter process lead times Shorter process lead times do not increase the effort required. In fact when individual Investigations or CAPA s are processed quicker there is less picking up and putting down, less re familarization and less duplication of effort. Faster processing lead times result in less open Investigations or CAPA s at any given time. This makes it easier to manage them In a Lean process we set practical but ambitious lead time targets for the completion of each key milestone in the process and use these in the visual management design To avoid delays and potential communication issues, the interactions & reviews with QA and the other stakeholders are carried out face to face in front of the visual management board. Flow: Individual investigations or CAPA s move quickly through the various process steps and reviews. Long e mail exchanges /delays are avoided by having short regular meetings between QA and the other process stakeholders in font of a visual management board that tracks the progress of individual change controls based on defined process milestones and interim lead time targets for each step Standard Work: Individual process steps are standardized and defined (where possible) with process supports being developed to improve RFT and reduce backflows (e.g. more prescribed Investigation reports often with leading sentences ) 19

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