# Extracted primary-source evidence ## ICH_Q9_R1__Guideline_Step4_2022_1219.pdf URL: - i ICH HARMONISED GUIDELINE QUALITY RISK MANAGEMENT Q9(R1) ICH Consensus Guideline - SCOPE .................................................................................................................................... 2 3. PRINCIPLES OF QUALITY RISK MANAGEMENT ...................................................... 2 4. GENERAL QUALITY RISK MANAGEMENT PROCESS ............................................. 3 4.1. Responsibilities ........................................................................................................................ 3 - PRINCIPLES OF QUALITY RISK MANAGEMENT ...................................................... 2 4. GENERAL QUALITY RISK MANAGEMENT PROCESS ............................................. 3 4.1. Responsibilities ........................................................................................................................ 3 4.2. Initiating a Quality Risk Management Process ........................................................................ 4 4.3. Risk Assessment ....................................................................................................................... 4 - GENERAL QUALITY RISK MANAGEMENT PROCESS ............................................. 3 4.1. Responsibilities ........................................................................................................................ 3 4.2. Initiating a Quality Risk Management Process ........................................................................ 4 4.3. Risk Assessment ....................................................................................................................... 4 4.4. Risk Control ............................................................................................................................. 5 4.5. Risk Communication ............................................................................................................... 5 - 4.6. Risk Review ............................................................................................................................. 6 5. RISK MANAGEMENT METHODOLOGY ....................................................................... 6 5.1 Formality in Quality Risk Management ................................................................................... 7 5.2 Risk-Based Decision-Making .................................................................................................. 8 5.3 Managing and Minimizing Subjectivity .................................................................................. 9 - 5. RISK MANAGEMENT METHODOLOGY ....................................................................... 6 5.1 Formality in Quality Risk Management ................................................................................... 7 5.2 Risk-Based Decision-Making .................................................................................................. 8 5.3 Managing and Minimizing Subjectivity .................................................................................. 9 6. - 5.3 Managing and Minimizing Subjectivity .................................................................................. 9 6. INTEGRATION OF QUALITY RISK MANAGEMENT INTO INDUSTRY AND REGULATORY OPERATIONS ..................................................................................................... 9 6.1 The role of Quality Risk Management in Addressing Product Availability Risks Arising from Quality/Manufacturing Issues ........................................................................................................... 10 - INTEGRATION OF QUALITY RISK MANAGEMENT INTO INDUSTRY AND REGULATORY OPERATIONS ..................................................................................................... 9 6.1 The role of Quality Risk Management in Addressing Product Availability Risks Arising from Quality/Manufacturing Issues ........................................................................................................... 10 7. DEFINITIONS ...................................................................................................................... 11 - 8. REFERENCES ..................................................................................................................... 13 ANNEX I: QUALITY RISK MANAGEMENT METHODS AND TOOLS .............................. 15 I.1 Basic Risk Management Facilitation Methods...................................................................... 15 I.2 - ANNEX I: QUALITY RISK MANAGEMENT METHODS AND TOOLS .............................. 15 I.1 Basic Risk Management Facilitation Methods...................................................................... 15 I.2 Failure Mode Effects Analysis (FMEA) ............................................................................... 15 I.3 - I.9 Supporting Statistical Tools .................................................................................................. 18 ANNEX II: POTENTIAL APPLICATIONS FOR QUALITY RISK MANAGEMENT ......... 19 II.1 Quality Risk Management as Part of Integrated Quality Management ................................ 19 II.2 - ANNEX II: POTENTIAL APPLICATIONS FOR QUALITY RISK MANAGEMENT ......... 19 II.1 Quality Risk Management as Part of Integrated Quality Management ................................ 19 II.2 Quality Risk Management as Part of Regulatory Operations ............................................... 20 II.3 - Quality Risk Management as Part of Integrated Quality Management ................................ 19 II.2 Quality Risk Management as Part of Regulatory Operations ............................................... 20 II.3 Quality Risk Management as Part of Development .............................................................. 20 II.4 - Quality Risk Management as Part of Regulatory Operations ............................................... 20 II.3 Quality Risk Management as Part of Development .............................................................. 20 II.4 Quality Risk Management for Facilities, Equipment and Utilities ....................................... 21 II.5 - Quality Risk Management as Part of Development .............................................................. 20 II.4 Quality Risk Management for Facilities, Equipment and Utilities ....................................... 21 II.5 Quality Risk Management as Part of Materials Management............................................... 22 II.6 - Quality Risk Management for Facilities, Equipment and Utilities ....................................... 21 II.5 Quality Risk Management as Part of Materials Management............................................... 22 II.6 Quality Risk Management as Part of Production .................................................................. 23 II.7 - Quality Risk Management as Part of Materials Management............................................... 22 II.6 Quality Risk Management as Part of Production .................................................................. 23 II.7 Quality Risk Management as Part of Laboratory Control and Stability Studies................... 23 II.8 - Quality Risk Management as Part of Production .................................................................. 23 II.7 Quality Risk Management as Part of Laboratory Control and Stability Studies................... 23 II.8 Quality Risk Management as Part of Packaging and Labeling ............................................. 24 II.9 - Quality Risk Management as Part of Laboratory Control and Stability Studies................... 23 II.8 Quality Risk Management as Part of Packaging and Labeling ............................................. 24 II.9 Quality Risk Management as Part of Supply Chain Control ................................................ 24 - Quality Risk Management as Part of Packaging and Labeling ............................................. 24 II.9 Quality Risk Management as Part of Supply Chain Control ................................................ 24 - 1 1. INTRODUCTION Risk management principles are effectively utilized in many areas of business and government including finance, insurance, occupational safety, public health, pharmacovigilance, and by agencies regulating these industries. In the pharmaceutical sector, the principles and framework of ICH Q9, coupled with the official ICH training material that supports this guideline, are - including finance, insurance, occupational safety, public health, pharmacovigilance, and by agencies regulating these industries. In the pharmaceutical sector, the principles and framework of ICH Q9, coupled with the official ICH training material that supports this guideline, are instrumental in enhancing the application of effective quality risk management by industry and regulators. The importance of quality systems has been recognized in the pharmaceutical industry and it is evident that quality risk management is a valuable component of an effective - agencies regulating these industries. In the pharmaceutical sector, the principles and framework of ICH Q9, coupled with the official ICH training material that supports this guideline, are instrumental in enhancing the application of effective quality risk management by industry and regulators. The importance of quality systems has been recognized in the pharmaceutical industry and it is evident that quality risk management is a valuable component of an effective quality system. - instrumental in enhancing the application of effective quality risk management by industry and regulators. The importance of quality systems has been recognized in the pharmaceutical industry and it is evident that quality risk management is a valuable component of an effective quality system. It is commonly understood that risk is defined as the combination of the probability of - It is commonly understood that risk is defined as the combination of the probability of occurrence of harm and the severity of that harm. However, achieving a shared understanding of the application of risk management among diverse stakeholders is difficult because each stakeholder might perceive different potential harms, place a different probability on each harm occurring and attribute different severities to each harm. In addition, subjectivity can directly impact the effectiveness of risk management activities and the decisions made. Therefore, it is ## Q10_20Guideline.pdf URL: - 1.5.3 Facilitate Continual Improvement ............................................................... 3 1.6 Enablers: Knowledge Management and Quality Risk Management ..................... 3 1.6.1 Knowledge Management .............................................................................. 3 1.6.2 Quality Risk Management ........................................................................... 3 1.7 - Enablers: Knowledge Management and Quality Risk Management ..................... 3 1.6.1 Knowledge Management .............................................................................. 3 1.6.2 Quality Risk Management ........................................................................... 3 1.7 Design and Content Considerations ....................................................................... 3 1.8 - Management Review ............................................................................................... 6 2.7 Management of Outsourced Activities and Purchased Materials .......................... 6 2.8 Management of Change in Product Ownership ...................................................... 6 - 3.2 Pharmaceutical Quality System Elements ............................................................. 7 3.2.1 Process Performance and Product Quality Monitoring System .................. 8 3.2.2 Corrective Action and Preventive Action (CAPA) System ............................ 9 3.2.3 Change Management System ..................................................................... 10 3.2.4 Management Review of Process Performance and Product Quality ......... 11 - Management Review of the Pharmaceutical Quality System .............................. 11 4.2 Monitoring of Internal and External Factors Impacting the Pharmaceutical Quality System ...................................................................................................... 12 4.3 Outcomes of Management Review and Monitoring .............................................. 12 - Quality System ...................................................................................................... 12 4.3 Outcomes of Management Review and Monitoring .............................................. 12 5. GLOSSARY .......................................................................................................... 13 Annex 1:Potential Opportunities to Enhance Science and Risk Based Regulatory - system that is based on International Standards Organisation (ISO) quality concepts, includes applicable Good Manufacturing Practice (GMP) regulations and complements ICH Q8 “Pharmaceutical Development” and ICH Q9 “Quality Risk Management”. ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle. Much of the content of ICH Q10 applicable to manufacturing sites is currently specified by regional GMP -  Commercial Manufacturing: o Acquisition and control of materials; o Provision of facilities, utilities, and equipment; o Production (including packaging and labelling); o Quality control and assurance; - Regulatory approaches for a specific product or manufacturing facility should be commensurate with the level of product and process understanding, the results of quality risk management, and the effectiveness of the pharmaceutical quality system. When implemented, the effectiveness of the pharmaceutical quality system can normally be evaluated during a regulatory inspection at the manufacturing site. Potential opportunities to enhance science and risk based regulatory approaches are - 3 1.5.2 Establish and Maintain a State of Control To develop and use effective monitoring and control systems for process performance and product quality, thereby providing assurance of continued suitability and capability of processes. Quality risk management can be useful in identifying the monitoring and control systems. - To develop and use effective monitoring and control systems for process performance and product quality, thereby providing assurance of continued suitability and capability of processes. Quality risk management can be useful in identifying the monitoring and control systems. 1.5.3 Facilitate Continual Improvement To identify and implement appropriate product quality improvements, process - and product quality, thereby providing assurance of continued suitability and capability of processes. Quality risk management can be useful in identifying the monitoring and control systems. 1.5.3 Facilitate Continual Improvement To identify and implement appropriate product quality improvements, process improvements, variability reduction, innovations and pharmaceutical quality system - improvements, variability reduction, innovations and pharmaceutical quality system enhancements, thereby increasing the ability to fulfil quality needs consistently. Quality risk management can be useful for identifying and prioritising areas for continual improvement. 1.6 Enablers: Knowledge Management and Quality Risk Management - continual improvement. 1.6 Enablers: Knowledge Management and Quality Risk Management Use of knowledge management and quality risk management will enable a company to implement ICH Q10 effectively and successfully. These enablers will facilitate achievement of the objectives described in Section 1.5 above by providing the means - 1.6 Enablers: Knowledge Management and Quality Risk Management Use of knowledge management and quality risk management will enable a company to implement ICH Q10 effectively and successfully. These enablers will facilitate achievement of the objectives described in Section 1.5 above by providing the means for science and risk based decisions related to product quality. - manufacturing processes and components. Sources of knowledge include, but are not limited to prior knowledge (public domain or internally documented); pharmaceutical development studies; technology transfer activities; process validation studies over the product lifecycle; manufacturing experience; innovation; continual improvement; and change management activities. 1.6.2 Quality Risk Management - the product lifecycle; manufacturing experience; innovation; continual improvement; and change management activities. 1.6.2 Quality Risk Management Quality risk management is integral to an effective pharmaceutical quality system. It can provide a proactive approach to identifying, scientifically evaluating and controlling potential risks to quality. It facilitates continual improvement of process - and change management activities. 1.6.2 Quality Risk Management Quality risk management is integral to an effective pharmaceutical quality system. It can provide a proactive approach to identifying, scientifically evaluating and controlling potential risks to quality. It facilitates continual improvement of process performance and product quality throughout the product lifecycle. ICH Q9 provides - controlling potential risks to quality. It facilitates continual improvement of process performance and product quality throughout the product lifecycle. ICH Q9 provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality. 1.7 Design and Content Considerations - 4 modifying an existing one. The design of the pharmaceutical quality system should incorporate appropriate risk management principles. While some aspects of the pharmaceutical quality system can be company-wide and others site-specific, the effectiveness of the pharmaceutical quality system is normally demonstrated at the site level. - (d) The pharmaceutical quality system should include appropriate processes, resources and responsibilities to provide assurance of the quality of outsourced activities and purchased materials as described in Section 2.7. (e) Management responsibilities, as described in Section 2, should be identified within the pharmaceutical quality system. (f) The pharmaceutical quality system should include the following elements, as - within the pharmaceutical quality system. (f) The pharmaceutical quality system should include the following elements, as described in Section 3: process performance and product quality monitoring, corrective and preventive action, change management and management review. (g) Performance indicators, as described in Section 4, should be identified and used to monitor the effectiveness of processes within the pharmaceutical - implemented throughout the company. (b) Management should: (1) Participate in the design, implementation, monitoring and maintenance of an effective pharmaceutical quality system; (2) Demonstrate strong and visible support for the pharmaceutical quality - Resource Management (a) Management should determine and provide adequate and appropriate resources (human, financial, materials, facilities and equipment) to implement and maintain the pharmaceutical quality system and continually improve its effectiveness. (b) Management should ensure that resources are appropriately applied to a - described in Sections 3 and 4. 2.7 Management of Outsourced Activities and Purchased Materials The pharmaceutical quality system, including the management responsibilities described in this section, extends to the control and review of any outsourced activities and quality of purchased materials. The pharmaceutical company is ultimately ## Q12_Guideline_Step4_2019_1119.pdf URL: - ICH Q12 Regulatory Tools and Enablers ............................................................ 7 2 CATEGORISATION OF POST-APPROVAL CMC CHANGES .................................. 9 3 ESTABLISHED CONDITIONS (ECS) ......................................................................... 10 3.1 - Roles and Responsibilities ................................................................................. 14 4 POST-APPROVAL CHANGE MANAGEMENT PROTOCOL (PACMP) ................. 15 4.1 Definition of a PACMP ..................................................................................... 15 4.2 - PQS General Considerations ............................................................................. 19 6.2 Change Management Across the Supply Chain and Product Lifecycle ............ 20 7 RELATIONSHIP BETWEEN REGULATORY ASSESSMENT AND INSPECTION 20 8 - RELATIONSHIP BETWEEN REGULATORY ASSESSMENT AND INSPECTION 20 8 STRUCTURED APPROACHES FOR FREQUENT CMC POST-APPROVAL CHANGES ..................................................................................................................... 21 - 1.1 Objectives This guideline provides a framework to facilitate the management of post-approval CMC changes in a more predictable and efficient manner. A harmonised approach regarding technical and regulatory considerations for lifecycle management will benefit patients, industry, and regulatory authorities by promoting innovation and continual - lifecycle (i.e., product development, registration and launch). This guideline addresses the commercial phase of the product lifecycle (as described in ICH Q10); and it both complements and adds to the flexible regulatory approaches to post-approval CMC changes described in ICH Q8(R2) and Q10 Annex 1. This guideline is also intended to demonstrate how increased product and process knowledge can contribute to a more precise and accurate understanding of which post- - less need for extensive regulatory oversight prior to implementation. This approach can incentivize continual improvement by providing an opportunity for greater flexibility in making post-approval changes. It could also result in fewer associated post-approval submissions to the Marketing Authorisation Application (MAA), and less associated regulatory burden. The extent of this operational and regulatory flexibility and its adequate implementation is subject to the regulatory framework in - can incentivize continual improvement by providing an opportunity for greater flexibility in making post-approval changes. It could also result in fewer associated post-approval submissions to the Marketing Authorisation Application (MAA), and less associated regulatory burden. The extent of this operational and regulatory flexibility and its adequate implementation is subject to the regulatory framework in place, as well as product and process understanding (ICH Q8(R2) and Q11), application - flexibility and its adequate implementation is subject to the regulatory framework in place, as well as product and process understanding (ICH Q8(R2) and Q11), application of quality risk management principles (ICH Q9), and an effective pharmaceutical quality system (ICH Q10). Regulatory Members of ICH are encouraged to provide publicly available information, preferably on their website, about the implementation of ICH Q12 in their region, - ICH Q12 Regulatory Tools and Enablers Use of the following harmonised regulatory tools and enablers with associated guiding principles, as described in this guideline, will enhance the management of post-approval changes, and transparency between industry and regulatory authorities, supporting innovation and continual improvement. • Categorisation of Post-Approval CMC Changes (Chapter 2) - changes, and transparency between industry and regulatory authorities, supporting innovation and continual improvement. • Categorisation of Post-Approval CMC Changes (Chapter 2) Categorisation of Post-Approval CMC Changes describes a framework that encompasses a risk-based categorisation for the type of communication expected of the Marketing Authorisation Holder (MAH) with the regulatory - innovation and continual improvement. • Categorisation of Post-Approval CMC Changes (Chapter 2) Categorisation of Post-Approval CMC Changes describes a framework that encompasses a risk-based categorisation for the type of communication expected of the Marketing Authorisation Holder (MAH) with the regulatory authority regarding CMC changes. - information that would not involve a regulatory communication, if changed. In addition, guidance is included for managing revisions of the ECs. • Post-Approval Change Management Protocol (PACMP) (Chapter 4) The PACMP is a regulatory tool that provides predictability regarding the information required to support a CMC change and the type of regulatory - associated reporting category for changes made to ECs. The document also captures how a product will be managed during the commercial phase of the lifecycle including relevant post-approval CMC commitments and PACMPs. 1 For drug substance information incorporated by reference (e.g., a Master File) in an MAA, the holder of the referenced information may use Q12 tools where applicable. Use of Q12 tools is not intended - An effective PQS as described in ICH Q10 and compliance with regional GMPs are necessary to gain full benefit from this guideline. In particular, management of manufacturing changes across the supply chain is an essential part of an effective change management - • Relationship Between Regulatory Assessment and Inspection (Chapter 7) This guideline outlines the complementary roles of regulatory assessment and inspection in the oversight of post-approval changes; and how communication between assessors and inspectors facilitates the use of the tools included herein. • Structured Approaches for Frequent CMC Post-Approval Changes (Chapter 8) In addition to the other tools described above, this guideline describes a strategy - inspection in the oversight of post-approval changes; and how communication between assessors and inspectors facilitates the use of the tools included herein. • Structured Approaches for Frequent CMC Post-Approval Changes (Chapter 8) In addition to the other tools described above, this guideline describes a strategy for a structured approach applicable to frequent CMC changes, and a discussion of data expectations, to enable the use of immediate or other post- - company’s Pharmaceutical Quality System; changes to ECs must also be reported to the regulatory authority. Where the regulatory system provides for Categorisation of Post-approval CMC Changes for reporting according to risk, the MAH may propose reporting categories for changes to ECs based on risk and knowledge gained through enhanced pharmaceutical development. A system with risk-based reporting categories also facilitates the use of Post-Approval Change Management Protocols, which - reporting categories for changes to ECs based on risk and knowledge gained through enhanced pharmaceutical development. A system with risk-based reporting categories also facilitates the use of Post-Approval Change Management Protocols, which provide predictability regarding planning for future changes to ECs. The Product Lifecycle Management Document is a summary that transparently conveys to the regulatory authority how the MAH plans to manage post-approval CMC changes. The - provide predictability regarding planning for future changes to ECs. The Product Lifecycle Management Document is a summary that transparently conveys to the regulatory authority how the MAH plans to manage post-approval CMC changes. The tools and enablers in this guideline do not change the Relationship Between Regulatory Assessment and Inspection; however, collaboration and communication between assessors and inspectors are necessary for the implementation of this guideline - between assessors and inspectors are necessary for the implementation of this guideline by regulators. This guideline provides Structured Approaches for Frequent CMC Post-Approval Changes to enable the implementation of certain CMC changes for authorised products without the need for prior regulatory review and approval. Finally, this guideline provides Stability Data Approaches to Support the Evaluation of CMC Changes; i.e., where the stability study is undertaken to confirm previously - 2 CATEGORISATION OF POST-APPROVAL CMC CHANGES Regulatory mechanisms that allow the timely and efficient introduction of CMC changes are important for drug quality, safety, and availability. There is a range of potential CMC changes for which communication between a company and the - This guideline establishes a harmonised approach to defining which elements in an application are considered necessary to assure product quality and therefore would require a regulatory submission if changed post-approval. These elements are being defined in this guideline as “Established Conditions for Manufacturing and Control” (referred to as ECs throughout this guideline). 3.2 - current product and process understanding, that assures process performance and product quality. The controls can include parameters and attributes related to drug substance and drug product materials and components, facility and equipment operating conditions, in-process controls, finished product specifications, and the associated methods and frequency of monitoring and control (ICH Q10). - substance and drug product materials and components, facility and equipment operating conditions, in-process controls, finished product specifications, and the associated methods and frequency of monitoring and control (ICH Q10). The ECs for a manufacturing process should be defined, based on product and process understanding, taking into account all the relevant elements of the control strategy. In ## part-211 URL: ## when-your-lean-supply-chains-feel-out-control-focus-what-you-can URL: - When Your Lean Supply Chains Feel Out of Control, Focus on What You Can Control | NIST - https://www.nist.gov/blogs/manufacturing-innovation-blog/when-your-lean-supply-chains-feel-out-control-focus-what-you-can - Many manufacturers who adopted lean principles by applying a “just-in-time” (JIT) mindset to inventory of materials and parts have been burned, sometimes badly, by cascading supply chain disruptions. Broken links in the supply chain have created havoc, especially for smaller manufacturers. Some have scrambled to build “safety stock” of hard-to-find supplies. Others have sought out redundant sourcing. The reality is that everything is connected in your supply chain, and those connections can be fragile when they are not well supported. - Some have scrambled to build “safety stock” of hard-to-find supplies. Others have sought out redundant sourcing. The reality is that everything is connected in your supply chain, and those connections can be fragile when they are not well supported. No, lean supply chain is not dead. It’s quite the opposite. When your supply chain breaks down, lean systems for the rest of your value stream system will help you deal with the issue. Solutions revolve around agility and controls, not masking inefficiencies. - No, lean supply chain is not dead. It’s quite the opposite. When your supply chain breaks down, lean systems for the rest of your value stream system will help you deal with the issue. Solutions revolve around agility and controls, not masking inefficiencies. Busting the Myth of Lean Supply: It’s Not Just About Size of Inventory - Busting the Myth of Lean Supply: It’s Not Just About Size of Inventory Being lean does not mean having little inventory; that has always been a higher-risk strategy. “Lean supply” means having a defined value of what your inventory levels should be and what risk you are willing to take on. JIT is a lean methodology that includes developing standard inventory buffers in your value stream. It requires strong relationships with suppliers so you can work with them through shortages and price increases. - Being lean does not mean having little inventory; that has always been a higher-risk strategy. “Lean supply” means having a defined value of what your inventory levels should be and what risk you are willing to take on. JIT is a lean methodology that includes developing standard inventory buffers in your value stream. It requires strong relationships with suppliers so you can work with them through shortages and price increases. Smaller manufacturing operations often have had an element of JIT for their hard-to-find inventory. One example is with the price of copper, which has fluctuated in the past 15 years. It is a business decision whether you can absorb the financial impact of storing more copper when the price is low. The size of your copper inventory has to make sense for process flow, cash flow and margin, storage space, and more. - Smaller manufacturing operations often have had an element of JIT for their hard-to-find inventory. One example is with the price of copper, which has fluctuated in the past 15 years. It is a business decision whether you can absorb the financial impact of storing more copper when the price is low. The size of your copper inventory has to make sense for process flow, cash flow and margin, storage space, and more. Companies with more agile operations routinely outperform those that carry more inventory. However you adjust to a disruption, the alternative should not create more waste overall or mask inefficiencies. - Companies with more agile operations routinely outperform those that carry more inventory. However you adjust to a disruption, the alternative should not create more waste overall or mask inefficiencies. Disruptions Can Have Vast Impacts Throughout the Company - Disruptions Can Have Vast Impacts Throughout the Company A supply chain disruption can have a significant trickle-down impact through your operation, not just in sourcing but also in how you use newly sourced materials. New components or materials often result in an operational process change, which can be a challenge to manage, whether it is short or long term. Some changes in inventory and processes can even be a challenge with your existing plant layout. Potential impacts are vast. - A supply chain disruption can have a significant trickle-down impact through your operation, not just in sourcing but also in how you use newly sourced materials. New components or materials often result in an operational process change, which can be a challenge to manage, whether it is short or long term. Some changes in inventory and processes can even be a challenge with your existing plant layout. Potential impacts are vast. For example, electronics manufacturers have struggled with supplies of semiconductors and components. A replacement chip or transistor may have different tolerances and variation in performance. Some engineering development work may be necessary for that component to work effectively in a product. - Uncertainty and temporary solutions can lead to failure to adhere to lean principles, especially if you are using multiple alternative materials or changing more than one dynamic. Food Manufacturer Sees Impact of Changing One Ingredient - A recent case at a food manufacturer illustrates the direct and indirect impacts of disruptions. It also speaks to the power of documenting standard work and the need for strong lean systems. One of the products that the company makes uses a white chocolate coating, and it was forced to use an alternative supplier for this coating. The compound of the new white chocolate supply was different, and not as reliable, which resulted in a series of changes. The first change was to the recipe, and then to the operational temperature, which changed the way the equipment was run and how the company measured the quality of coating. This even changed how the company had to store the material, keeping it separate from other supplies, and how it had to clean the equipment to ensure compliance for traceability. - One of the products that the company makes uses a white chocolate coating, and it was forced to use an alternative supplier for this coating. The compound of the new white chocolate supply was different, and not as reliable, which resulted in a series of changes. The first change was to the recipe, and then to the operational temperature, which changed the way the equipment was run and how the company measured the quality of coating. This even changed how the company had to store the material, keeping it separate from other supplies, and how it had to clean the equipment to ensure compliance for traceability. The company faced the dilemma of whether these changes were a short-term solution or if it needed to update the standard work documentation and training modules — all for one ingredient. - Documenting standard work is a cornerstone for lean. Standard work procedures should be updated frequently, but it is a tedious, difficult task, so it is not unusual for small manufacturers to have documentation that is two or more years old. Changes in materials as a result of supply chain disruption often lead to subtle process changes. You may view this as a temporary situation, with the expectation that you will soon be going back to the original process. However, even a few months can have a big impact. Now you have a new process and new procurement. Danger creeps in when you don’t have standard controls in place. Manufacturers can lose sight of this when they are in reactive triage. - Changes in materials as a result of supply chain disruption often lead to subtle process changes. You may view this as a temporary situation, with the expectation that you will soon be going back to the original process. However, even a few months can have a big impact. Now you have a new process and new procurement. Danger creeps in when you don’t have standard controls in place. Manufacturers can lose sight of this when they are in reactive triage. It becomes imperative to establish benchmarks and key performance indicators, even as a supplemental standard of work. Stepping back to analyze a situation and re-establish a new standard is a proactive approach. You are in a stronger position to address issues if you are measuring and tracking performance. This is why lean methods apply now more than ever. - It becomes imperative to establish benchmarks and key performance indicators, even as a supplemental standard of work. Stepping back to analyze a situation and re-establish a new standard is a proactive approach. You are in a stronger position to address issues if you are measuring and tracking performance. This is why lean methods apply now more than ever. Don’t Overlook Training as a Tool for Mitigating Supply Chain Disruptions - Don’t Overlook Training as a Tool for Mitigating Supply Chain Disruptions Disruptions often result in the need for more frequent and varied training, which puts stress on your instructors. When process changes occur, you must update your training program. If you are shutting down one product line for several weeks due to a material shortage, you may need to cross-train some employees on a different machine or process. - Disruptions often result in the need for more frequent and varied training, which puts stress on your instructors. When process changes occur, you must update your training program. If you are shutting down one product line for several weeks due to a material shortage, you may need to cross-train some employees on a different machine or process. If you don’t update standard work and training, even temporarily, you open the door to other issues, especially with new employees. Lack of documentation with training can lead to process issues, which often cause more tension[MDE1]  and quality issues. Additionally, when employees get discouraged, retention issues increase. - Supply chain disruptions will have direct and indirect impacts on your operation. You may see a dip in overall equipment efficiency or increased waste. Your continuous improvement program will be less effective because you are in reactive, problem-solving mode. Whatever you do, avoid causing unintended consequences. Take a back-to-basics approach to track performance and keep more things within your control. Use daily management display boards and follow the plan-do-check-act (PDCA) methodology for any changes you implement. Here are four keys to help mitigate impacts: - Be proactive versus reactive: It becomes hard to close a gap if you are not closely monitoring performance. Pursue two levels of improvements: - Leverage relationships: Maintain or improve relationships with suppliers and customers to find what works best for both parties. Maintain a system of controls: - Local MEP Centers Can Help You With Your Lean Supply Chain A disciplined approach to lean supply chain helps keep you in control of as many variables as possible. When one critical aspect of lean manufacturing is being disrupted, the other elements are more important than ever. Experts at your - A disciplined approach to lean supply chain helps keep you in control of as many variables as possible. When one critical aspect of lean manufacturing is being disrupted, the other elements are more important than ever. Experts at your local MEP Center can help you manage supply chain disruptions. - Gene Kaschak is Director of Continuous Improvement and Lean Coaching for the Manufacturers Resource Center (MRC), an MEP Center in eastern Pennsylvania. He has a background in continuous improvement, product development, manufacturing engineering, maintenance leadership, information technology and change management.