Daily Management System (DMS) PDF

Daily Management System (DMS) Root Cause Problem Solving Version- PPS/OE/DMS/RCPS/001  Operational Excellence 2 Objective & Imperatives Guided by our...

Daily Management System (DMS) Root Cause Problem Solving Version- PPS/OE/DMS/RCPS/001  Operational Excellence 2 Objective & Imperatives Guided by our Values Aspiring to achieve the Objective of P S C While addressing the imperatives of D Q Safety Quality Productivity Delivery Cost Morale Version- PPS/OE/DMS/RCPS/001  OE Framework > Driving Lean Mindset & Behaviours 3 Version- PPS/OE/DMS/RCPS/001  OE Framework > Driving Lean Mindset & Behaviours through DMS Version- PPS/OE/DMS/RCPS/001  Driving Lean Mindset & Behaviours through DMS Daily Management System (DMS) is our approach to engage ourselves on the continuous improvement framework to achieve the Piramal Pharma Operations objective of achieving Zero Deterrents, Zero Defects, Zero Harm and Zero Waste.  A proven approach to establish the Lean Thinking and aligned Mindset & Behaviors towards continuous improvement.  An effective method for Strategy Deployment. It enables the daily (routine) evaluation of operational performance with respect to the process standards and KPI objectives.  It creates a culture of analytical response to the business problems & strengthens accountability of the people at floor.  Engages people on Continuous improvement, fosters discipline & consistency and supports in building the Capability of the workforce Version- PPS/OE/DMS/RCPS/001  Driving Lean Mindset & Behaviours through DMS Our approach to defining, applying, following and Strengthening the foundation through the principles of 6S, with improving the “Standard Work” e.g. Operator standard a clear focus on eliminating the waste and foster discipline Work to follow the hourly/batch standards Standard Work Workplace Engages leaders to “Do the Right things”. processes Organisation Routing from strategy deployment, the A disciplined approach to follow a translation of the metrics across the various standard daily work routine. Reduce Tiers. This element makes process performance, NVAs in the work content and aligns Leader work to continuous improvement Visual metrics and associated problems visible to all in Standard a way that facilitates rapid sustainable Controls improvement. Work Daily Management System Leaders following a routine of “Go & Capability at Std. & Our approach to ensuring management See” at Gemba. Leaders following an approach to coach the team on the Gemba Rapid and functional support is available to value adding processes whenever there are continuous improvement framework Response problems, exactly as and when needed Root Cause Tiered Problem Accountability A systematic approach to eliminate/reduce the Solving Process The timings, content and structure of problems by counteracting on the Root cause. Aimed our daily and weekly meetings concerning planned execution to bring performance back to “normal” and to and improvement improve to the next level. Standard Work Performance Management System Problem Solving Version- PPS/OE/DMS/RCPS/001  Driving Lean Mindset & Behaviours thorugh DMS Standard Work Workplace processes Organisation Leader Visual Standard Controls Work Daily Management System Capability at Std. & Gemba Rapid Response Root Cause Tiered Problem Accountability Solving Process Version- PPS/OE/DMS/RCPS/001 Standard Work Performance Management System Problem Solving  How DMS facilitates Continuous Improvement! Continuous improvement is achieved Strategy Guided by LRP though effective Strategy deployment, Achieve objective of Zero Deterrents, Defects, Harm and Waste Deployment performance management and leadership engagement All KPIs performance review Business & Site KPIs Corporate- ExCom, SLC, MBR Site- Balanced Scorecard (Digital Cockpit) KPIs on Burning platform Incl. all thematic initiatives PMS 3 Tiered + Hourly PMS at sites Visual Control, Std & Rapid Response, Lag>Lead KPI translation following Y=f(X1,X2…Xn) function equation Tiered Accountability Capability @ Gemba Leader Overarching DMS standard to engage Standard Work leaders in Gemba to Process Confirm the standards Facilitates firming up routines of leaders Coaching routine to solve on Process, Performance & People problems on a continuous Standards Root Cause improvement framework Enhancement Solve the Problems Problem Solving Countermeasures based on Implement the Initiatives Focus on systematic Root Cause Problem Solving Hierarchy of Controls i.e. Enhancement through engagement with the LSS Elimination> Substitution> Poka Yoke> Admin YB,GB & BB program controls (6S, SWP,WI, SOP, Checklist etc) Version- PPS/OE/DMS/RCPS/001  Daily Management System (DMS) Root Cause Problem Solving Version- PPS/OE/DMS/RCPS/001  Root Cause Problem Solving The problem solving standard provides a standardised, disciplined approach to identify root cause and apply robust solutions in a timely manner to prevent recurrence The intention is to ensure rapid intervention to contain issues and return to standard whilst investigating the cause with a sense of urgency The purpose of this standard is to ensure we Understand the problem, its impact and determine the need for investigation Involve the right people or seek help, if required Determine the true root cause and robust solutions by using the 7 step standard thinking Use problem solving to drive continuous improvement Capture and use lessons learned from problem solving Recognize the Learn the Root Implement To Achieve Problem Cause Countermeasure Version- PPS/OE/DMS/RCPS/001  Approach on the Issues We need to address all issues that impact SQCDP performance systematically i.e Issues detected in real time Recurring issues exposed through trended performance & the attribute sheet Real Time Performance Trended Performance Log Issues The routine capturing of issues will help to identify recurrent or systemic problems Immediate single issue Recurring/systemic issues Usually detected (but not restricted to) in Usually captured in the PMS boards KPIs, process and captured in the attribute sheets & issue logs. The issues hourly/milestone PMS boards. Any reflects from trended data and are repeating abnormality observed during the production in nature operation, whether related to SQCDP The CFTs across the PMS tiers identify the Top 3 problems associated with SQCDP Rapid response to immediate, real-time performance and engage in conducting Root problems –using defined standard response Cause Problem Solving to identify & (as described in performance management implement countermeasure. LSS YB, GB & standard). BB trained personnel engages in the process. Version- PPS/OE/DMS/RCPS/001  Categorisation of Problems Issues/Problems are recognized and registered across the value chain systematically in; Attribute sheets- A standard feature of the Hourly/milestone and Tier 1 PMS boards Issue Logs- Placed in the zones alongside the PMS boards The issue should be categorized basis the “Severity” and “Occurrence”, which should help in determining Which problem-solving approach to be applied Whether issue escalation is required to the above Tier The basic approaches based on the Severity & Occurrence Simple problem statement, 5W1H, and 5 whys approach only used when high-level cause is very obvious, the issue is not a repeat, there are no change control requirements and the solution(s) will not compromise EHS or quality 7 step root cause analysis approach is used when the cause is not obvious, the problem is complex, recurring or systemic and there are change control requirements Version- PPS/OE/DMS/RCPS/001  Categorisation of Problems Hourly/ Milestone Tier 1, 2 & 3 PMS PMS Boards Boards Real-time issue & Issues from the issue log & attribute sheet attribute sheet Problem High High Severity? Occurrence? registered Low Low Yes Obvious High Occurrence? Cause? Take correction and Once or Low No Corrective action Problem statement, 5W1H and Why- 7 step RCA DMAIC Yes Why RCA Hierarchy of controls Hierarchy of controls Hierarchy of controls required? No Check sustainability through the countermeasure tracker & temporary/lead KPIs in PMS End Share the lessons learned Version- PPS/OE/DMS/RCPS/001  Categorisation of Problem Solving approach Obvious cause? Use 5W1H and High Why- Why DMAIC Not Obvious Cause? Use 7 Step RCA Severity Low Correction and 7 Step RCA Corrective Action Low High Version- PPS/OE/DMS/RCPS/001 Occurrence  Logical Problem Solving Approach To ensure problems are rapidly and permanently solved, a logical, standardised problem solving process will be used. Standard tools are available to support problem-solving. These include: 5W1H+Why Why Analysis - Used only when the high-level cause is very obvious, the issue is not a repeat, and there are no change control requirements. 5W1H is used to capture initial information about the problem by capturing the initial problem statement, who, what, when, where, which, and how. 7 Step problem solving –use 7 steps problem-solving template for complex problems associated with Immediate single issues and recurring/systemic issues.  Simple- One page 7 Steps RCPS  Detailed- 7 Steps RCPS Version- PPS/OE/DMS/RCPS/001  Logical Problem Solving Approach A structured approach helps to resolve the root causes of the right issues The 7 Step thinking is a structured approach to problem solving Step 1 Initial Problem Statement Understand the Problem 5W1H & Is-Is not Step2 Should have happened Understand deviation from standard What did happened? Step 3 Gap analysis Refined Problem Understand what changed Refined problem statement Statement Step 4 Fish bone analysis Determine potential causes Perform Cause validation & filter out the vital causes Step5 Determine root cause Perform Why-Why analysis on vital causes to identify root cause Step 6 Implement Countermeasure Follow hierarchy of controls Step7 Introduce lead/temporary KPI in PMS Evaluate the outcome & Sustain the improvement Check impact on the lag KPI Version- PPS/OE/DMS/RCPS/001  Logical Problem Solving Approach Step 1: Understand the Problem Step 4: Cause and Effect Analysis Step 6: Implement the Countermeasures Problem statement Root Counterme Sr. no Responsible Timeline Status Cause asure 5W1H Is Is Not What? 1 Where? Who? When? Which? 2 How? Step 2 & 3: Understand Deviation from Std. 3 process Process Flow Potential Data/Info Observation Is this cause Step 7: Check Sustainability Cause required valid? Temporary/Lead KPI 1 Temporary /Lead KPI 2 Owner: Owner: Should Happen Did Happen Gap Analysis Gap(s) identified Step 5: Why Why Analysis WHY 1 WHY 2 Redefined Problem Statement WHY 3 WHY 4 Version- PPS/OE/DMS/RCPS/001 WHY 5  7 Step Problem Solving- Step 1 Understand the Problem Problem statement “5W and 1H” is used to help structure the problem A clear, short statement, developed by the right Who team, that clearly describes the problem, its Who discovered it? Which team? extent, and its impact What Creates a sense of ownership for the team What product? What materials? The extent of problem? Focuses the team on an agreed problem When Describes the symptoms in measurable terms When did it happen? Day/time? When did the issue begin? When has it happened before? Frequency? Where Physical location? Process step? Has it happened elsewhere? Which Which characteristics changed over time? Is there a turning point? How How was it detected? What changes occurred? Important: Not to cover “Why” at this stage Version- PPS/OE/DMS/RCPS/001  7 Step Problem Solving- Step 1 Example Step 1 Understand the Problem Problem Yield of product ABC, Batch M123 is 95%, against the YTD average yield of 98% statement 5W1H Is Is Not Yield of product ABC is below the average yield i.e. 95% against 98%, due to high What? rejection during the compression stage Rest of the stages, bx yield variation In the O block compression stage, the bx yield of 95.5% was observed against YTD Where? compared to the YTD average yield, is stage average of 99% not significant The operator "name 1" observed the frequent cosmetic defects in the tablets i.e. Who? rough surface and pitting, during the in-process checks. This phenomenon was No other operator or supervisor shared with the shift supervisor "name 2" Bx compression happened in B shift on During Batch M123 execution in the B shift on 01/01/23, at around 1600 hrs the When? 01/01/23 only, as the std bx cycle time is operator started observing frequent stoppage of the compression machine 5 hrs. Thus, no other shift Which? The tablets had cosmetic defects i.e. rough surface, pitting No other issues During the In-process checks, after the machine settings. The operator cleaned the How? punches and restarted the operation, however, the phenomenon kept repeating. Step 1 helps in clarifying and zoom in to the scope to conduct further analysis Version- PPS/OE/DMS/RCPS/001  7 Step Problem Solving- Step 2 Understand deviation from Standard A systematic assessment of “What actually happened” vs “What should have happened” i.e. Actual to the Standard process. A step-by-step assessment while comparing the standard to actual helps in learning the deviations, which actually are problems and/or may be contributing to the problem. What should have happened? What should happen? G (Standard, target) The process should have worked as per the standards mentioned in; a Performance p What actually happened! SOP/ WI Operator Standard Work Batch Records….. What did happen? Understand the actual against the standard by systematically mapping through; Observation/ process confirmation in Gemba Interviewing the doer Data collection Photo/video Version- PPS/OE/DMS/RCPS/001  7 Step Problem Solving- Step 3 Understand what changed While the assessor may find multiple deviations during the Should happen-Did happen exercise in step 2, only the relevant “changes” needs to be picked up, that may have lead to the subjected problem. What should have happened? (Standard, target) G a Performance p What actually happened! What lead to this gap? Many things may have changed but The relevant gaps feed into the Fish need to focus on changes relevant bone in step 4 to the problem Refine the Problem statement as per the reflections from the Step 2 and step 3 Note: The “non-relevant” deviations should also be tapped and counteracted, to prevent any potential problem to occur. These should be captured in the issue log and addressed systematically. Version- PPS/OE/DMS/RCPS/001  7 Step Problem Solving- Step 2 & 3 Example Step 2 & 3 Understand Deviation from Std. process Should Happen Did Happen Gap Analysis Inspection of the punch condition during the changeover Inspection conducted None. Verified from the log process None. Verified through BMR and discussion Batch Setting with Std. operating procedure Batch Setting with Std. Operating Procedure with Operator Compression force, hardness and weight setting to be Compression Force, Hardness and Weigh Setting done None. Verified through BMR done as per the BMR guideline as per BMR guideline Start the batch compression with all CPPS in place, as per Batch started with CPPs set as per mention in the BMR None. Verified through BMR the BMRas per setting of CPP Sampling and checking done by the operator as per the In-process sampling and checking after every 30 minutes None. Verified through BMR guidelines Report if any deviation observed w.r.t Hardness, Weight Operator "name 1" reported cosmetic defects observed Issue reported. Operator cleaned the Variation, any defects observed after 1 hr. of batch start. punches and restarted the operation. Inspection of machine parts, cleaning, maintenance and Inspection of machine parts, cleaning, maintenance and machine setting to be done machine setting done Version- PPS/OE/DMS/RCPS/001  7 Step Problem Solving- Step 2 & 3 Gap(s) identified After 1 hr of batch compression, the operator observed the cosmetic defects i.e. Rough tablet surface and pitting. As a result of this, the operator cleaned the punches as the material was found to be sticking to them. Post restart the problem was observed 5 more times during the shift (till the batch completion), leading to tablet rejection and delay in batch completion. Redefined Problem Statement The overall yield of Batch M123 of Product ABC was registered to be 95% against the YTD average of 98%, triggered by lower yield in the compression stage i.e. 95.5% against the YTD compression stage average of 99%. During compression operation in the B shift on 01/1/23, a sizeable rejection of the tablets was observed by the Operator "name 1" during the in-process checks, due to cosmetic defects i.e. rough surface and pitting, that he reported to the shift supervisor "name 2". As a result of this issue, the operator had to frequently stop the machine to clean the punches (5 times stoppage in the shift) Version- PPS/OE/DMS/RCPS/001  7 Step Problem Solving- Step 4 Determine Potential causes Fish Bone Analysis Purpose: Fishbone Analysis is carried out to identify multiple probable causes for a chronic problem. It provides an opportunity to brainstorm & identify the possible causes in different categories (6Ms) – Man, Machine, Material, Method, Measurement, Mother Nature. Do’s  Organize an appropriate team (CFT) to carryout the brainstorming session  Clarify the Problem statement & major cause categories  Brainstorm in each category, what are the probable causes of the Problem  Collect more details/data if required, identify sub causes from the major causes  Team members working closely in a process can be part of the CFT. Dont’s  Do not carry out the Fishbone Analysis in silos (without team involvement).  Do not eliminate any cause without cause validation. Version- PPS/OE/DMS/RCPS/001  7 Step Problem Solving- Step 4 Determine Potential cause Fish Bone Analysis- Example Measurement Machine Man Scratches on the head of punches Improper cosmetic Operator not adequately defects checking by skilled to run the the operator Coating on the punch surface compression operation worn out Tablets rejection due to cosmetic defects i.e. rough surface and pitting Deficiency in the amount of Moisture Level lubricant within the formulation Problem Statement of Granules Higher than the limit, Improper Tablet Inadequate The MOC of the punch humidity level inside Design compaction the compression parameters suite Environment Method Material Version- PPS/OE/DMS/RCPS/001  7 Step Problem Solving- Step 4 Determine potential cause Cause and Effect- Validation A systematic data based approach to validate and filter the potential causes from the list. The validated causes are taken for further Root cause analysis in step 5. Potential Cause Data/Info required Observation Is this cause valid? Version- PPS/OE/DMS/RCPS/001  7 Step Problem Solving- Step 4 Determine potential cause Cause and Effect- Validation - Example Is this cause Potential Cause Observation valid? Higher than the limit, the humidity level inside Humidity levels where as per std. as seen in data logger report No the compression suite Improper cosmetic defects checking by the IPQA Testing was done as per std. procedure operator No Operator not adequately skilled to run the Operators and Supervisors where trained on the machine No compression operation and product manufacturing. Verified through training records. Inadequate Compaction Parameters Sticking to punch surfaces occurs if the cohesive bonding Yes within the tablet is not as strong as adhesion to the punch surface Scratches in punches Scratches on the punches where observed during cleaning and inspection Yes Deficiency in the amount of lubricant Lubricant was applied as per BOM during Granulation No Improper Tablet Design Tablet design and embossing is not complex and is establish at R&D No Moisture and fines Level of Granules Granules bulk density and LOD were within limits No Punch MOC don't offer superior anti-sticking This Product has sticking characteristics with certain material, Yes properties hence this reason can be significant Version- PPS/OE/DMS/RCPS/001  7 Step Problem Solving- Step 5 Identify the root cause Why-Why Analysis Purpose: Why-Why or 5 Why Analysis is carried out to identify the root cause by asking Why 5 times until the root cause is found. It helps to identify how to really prevent the issue from happening again. Do’s  Involve the right people. They should be familiar with the problem and process. They should be from different Why-Why analysis departments if possible. Date :  Clarify the Problem statement.  Ask "Why does the... take place?" That's a first why. Problem :  For each of the answers ask again "Why does the... take place?“ until you arrive at the root cause.  Collect more details/data if required. Why 1? Don'ts Why 2?  Avoid blaming for problems Why 3?  Do not carry out the Why-Why Analysis in silos (without Why 4? team involvement).  Don’t jump to conclusions, rather perform a step-by- Why 5? step analysis  Fix the root cause, not just the problem - Do distinguish Root Cause between an incident, problem and root cause. Don't stop at fixing only the problem  Do not only look at 5th Why as the root cause, Root cause may be in a Why above it also. Version- PPS/OE/DMS/RCPS/001  7 Step Problem Solving- Step 5 Identify Root Cause Step 5 Why-Why Analysis Scratches in the head of the Punch MOC don't offer superior WHY 1 WHY 1 Inadequate Compaction Parameters WHY 1 punches anti-sticking properties Polish worn out with time and the tool room operator Adhesive force more WHY 2 couldn't notice the wear and WHY 2 WHY 2 Design limit* than Cohesive Force tear to decide the re- polishing The magnifying glass couldn't WHY 3 be found during the WHY 3 Lesser Dwell time during compaction inspection process The magnifying glass was taken by another operator Operating Speed of Tablet Compression WHY 4 for a purpose, and wasn't WHY 4 machine is on higher side of specs intimated to the tool room operator Operator missed to follow the defined Negligence in informing the operating limits of machine RPM- WHY 5 WHY 5 tool room operator* Actual at 37 RPM and operating limit is 30-35 RPM Operator read this in the BMR, however WHY 6 missed to remember while enhancing the machine speed * *Root Cause statements Version- PPS/OE/DMS/RCPS/001  7 Step Problem Solving- Step 6 Implement the Countermeasure Develop solutions to address the root cause(s) which lead to permanent fixes and that do not compromise Safety, Quality or efficiency Follow the hierarchy of controls while defining the countermeasures Undertake a deeper effort with the team to move below the ladder of hierarchy of controls. High Elimination Substitution Effectiveness Poka Yoke Admin controls Low (6S, SWP,WI, SOP, Checklist etc) A detailed implementation plan is developed with clear accountabilities for delivery. Progress is monitored – typically through the PMS tiered accountability process Note: Need to check if change control is required and that the selected solution does not cause a problem somewhere else Version- PPS/OE/DMS/RCPS/001  Sli 7 Step Problem Solving- Step 6 de 31 Implement the Countermeasure- Example Step 6 Implement Counter Measures Sr. no Root Cause Description Responsible Timeline Status Mistake proofing- The magnifying glass to be Negligence in informing the tool fixed in the wall panel (immovable). The 1 room operator for the magnifying ABC 15-Jan Completed punches to be inspected below the fixed glass magnifying glass Operator missed to remember the Mistake proofing- The operating limits to be fed 2 operating limits of RPM, while in Machine SCADA. Machine won't allow the XYZ 30-Jan Completed enhancing the machine speed RPM to be beyond the specified limits Punch MOC don't offer superior anti-sticking properties Use of XYZ brand surface engineered anti-stick 3 OPQ 15-Feb Completed coating. Procurement to be done Version- PPS/OE/DMS/RCPS/001  7 Step Problem Solving- Step 7 Evaluate the outcome & Sustain the improvement Solution implementation must be tracked and the effectiveness verified to ensure performance is returned to standard with no recurrence. Temporary/lead KPIs are introduced at the relevant PMS boards to monitor the sustainability. The relevance of the impact on the corresponding lag KPI is also monitored. Verification through Gemba process confirmation is also done to determine if the solution is in place and has been effective KPI Issue Impact Root Cause Responsible Timeline Counter action Status Name Problem Solving (Yes/No) Yield Lower Yield at 4% Yield loss of Yes ABC 10 Jan-23 Use of XYZ brand compression stage the product surface engineered anti-stick coating Cycle Delay in Dispensing 2 hrs. waiting for No XYZ 1 Jan-23 Pre-dispensing of Batch Time of batch processing the batch Problem defined Root cause identified Countermeasure implemented Performance Sustained In case the desirable movement in the corresponding lag KPI is not observed, further investigation is done to identify and act on other causes Version- PPS/OE/DMS/RCPS/001  7 Step Problem Solving- Step 7 Evaluate the outcome & Sustain the improvement Prevent recurrence through seeking and sharing lessons learned Seek lessons learned before solving problems and identify and share the lessons learned after problem-solving to ensure rapid and efficient resolution of similar problems A structured lessons learned card will be used to capture the initial problem, solutions, and learnings and will be made available across similar processes within the site as a minimum. This will ensure a more rapid and efficient resolution of similar problems. Initially, the collation and sharing will be manual and within a site. Over time the sharing process will extend across the network, with the help of automated solutions e.g. Smartsheet Version- PPS/OE/DMS/RCPS/001  7 Step Problem Solving- Vital features The operational issues detected in real-time and recurring/systemic issues exposed through trended or attribute sheets will be managed in a standard way. Standard response to issues must be defined at all levels to ensure quick reactions to protect the customer, employee, and environment. The standard response should be formalized through the PMS-tiered accountability process. The issue log should navigate the categorization of the problem and define the RCPS approach. At each management level, issues should be captured, made visible and used to identify the top 3 problems (recurring/systemic) for each of deterrents, defects, harm, and waste. To ensure problems are rapidly & permanently solved, logical, problem-solving will be used. Seek lessons learned before problem-solving. Systematically follow the hierarchy of controls to determine the most effective solution to address the root cause of the problem. Build the solution into standard work to ensure that benefits are sustained and to provide a platform for future improvement. Solution implementation must be tracked and the effectiveness verified to ensure performance is returned to standard with no recurrence. Verify -(through Gemba+ data) to determine if the solution is in place and has been effective. Identify and share the lessons learned to ensure the prevention of the problem elsewhere. Version- PPS/OE/DMS/RCPS/001  Let’s Counteract to Root Cause, Let’s Improve! Version- PPS/OE/DMS/RCPS/001