Process Mapping as a Scaling Solution (part 1)

I love a good process map in all it’s permutations. It is important to remember that the various process mapping tools are on a scale on order of detail and complexity.

Tool NameDescription
Process Landscape DiagramA Process Landscape Diagram is a visual representation that outlines the structure and interdependencies of processes within an organization, providing insight into how these processes work together to achieve strategic goals. This tool helps in understanding process flows and managing business operations more effectively by illustrating connections and hierarchies among various processes.
SIPOCSIPOC is a visual representation tool for documenting a business process from beginning to end. It provides a high-level overview by summarizing the key components of Suppliers, Inputs, Processes, Outputs, and Customers.
Scope Diagram (IGOE Diagram)
The Scope Diagram, also known as the IGOE Diagram, is used to define and agree on the boundaries of a process, enhancing communication among stakeholders. This diagram illustrates the scope of a project at a high abstraction level and helps identify candidate processes for change. It focuses on the Inputs, Guides, Outputs, and Enablers of a business process, facilitating better understanding and management of the scope by clarifying process boundaries without detailing internal system features.
Process MapA Process Map is a visual tool used to represent the flow of work and the steps involved in a business process. This tool helps teams understand, analyze, and improve workflows by detailing the processes involved, making it easier to identify inefficiencies and areas for improvement. Process maps are often utilized in project management and continuous improvement efforts to enhance productivity and streamline operations.
Process Flow DiagramA Process Flow Diagram (PFD) is a diagram commonly used to indicate the general flow of plant processes and equipment. It visualizes the sequential steps and relationships between components in a process, aiming to improve project planning and identify inefficiencies.
Swim-lane Flow ChartA Swim-lane Flow Chart, also known as a cross-functional diagram, is a type of flowchart that shows the workflow and responsibilities in a process. It visually segments tasks into lanes that clarify who is responsible for each step, making it easier to understand complex processes and identify inefficiencies or redundancies.
Process Flow with RACI matrixThe RACI matrix is a project management tool that clarifies roles and responsibilities of team members by categorizing them into four groups: Responsible, Accountable, Consulted, and Informed. This structure aids in ensuring effective communication and workflow management across various stages of a project, helping teams stay aligned and avoiding confusion.
Process Mapping Tools

Process Landscape Diagram

A process landscape diagram is a high-level visual representation of an organization’s business processes and their relationships. Process landscape diagrams provide a comprehensive overview of an organization’s processes at a macro level and define the scope and relationships between an organization’s business processes. This serves as a simple way to handle process-related communication and serves as a starting point for detailed process discovery.

The process landscape diagram represents processes as ‘black-boxes’, focusing on interrelationships rather than internal details. Thus it shows the structure, grouping, modularity, functionality, and technology of chain processes, business processes, and working processes. Ideally this should include connections to external participants or stakeholders.

Components and Structure

A typical process landscape diagram may include:

  • Core processes (value chain or end-to-end processes)
  • Management processes
  • Support processes
  • Relationships and dependencies between processes
  • Connections to external participants or stakeholders

When to do

The process landscape diagram is design to enable organizations to maintain an overview of processes which makes this an excellent centerpiece to your Quality Manual.

ICH Q10 actually has a nice process landscape in it.

SIPOC

I’ve written about SIPOC’s in the past.

SIPOC diagrams are powerful tools in process improvement and management, offering numerous advantages that make them invaluable in various scenarios. These diagrams provide a high-level overview of a process, enabling teams to grasp the big picture quickly and efficiently. By facilitating clear communication and collaboration among team members and stakeholders, SIPOC diagrams help break down silos and foster a shared understanding of complex processes. This clarity often leads to the identification of improvement opportunities and potential problem areas that might otherwise go unnoticed.

One of the key strengths of SIPOC diagrams lies in their versatility. They serve as excellent tools for defining and scoping complex projects, helping teams to set clear boundaries and objectives from the outset. Additionally, these diagrams aid in understanding customer requirements and managing supplier relationships, two critical aspects of any business process. SIPOC diagrams also prove invaluable as training tools for new employees, offering a concise yet comprehensive overview of how a process functions within the larger organizational context.

The use of SIPOC diagrams is particularly beneficial when embarking on new process improvement projects or redesigning existing processes by providing a structured approach to understanding the current state and envisioning future improvements. They’re also extremely useful in situations where the scope of a project is unclear or poorly defined, helping to bring clarity and focus to the team’s efforts.

SIPOC diagrams excel in fostering cross-functional collaboration. By providing a common language and visual representation of a process, they facilitate discussions and decision-making among different departments or stakeholders. This makes them particularly valuable in problem-solving initiatives and when ensuring compliance with regulations and standards. SIPOC diagrams also serve as effective tools for supplier evaluation and performance assessment, helping organizations maintain strong relationships with their supply chain partners.

SIPOC diagrams are most effective when there’s a need to quickly visualize and understand a process without delving into excessive detail. They help teams focus on the essential elements of a process and provide a solid foundation for more in-depth analysis and improvement efforts. Whether used in the early stages of a project, for ongoing process management, or as part of continuous improvement initiatives, SIPOC diagrams offer a simple yet powerful way to enhance understanding, communication, and efficiency across an organization.

I love a SIPOC in a program level document.

Scope Diagram (IGOE Diagram)

IGOE stands for Inputs-Guides-Outputs-Enablers, the basic components of any business process. This model is used to define the scope of a process with an initial, high-level overview of the process in-scope and the problems associated with that process and the relationships between the process-in-scope, upstream or downstream processes, relevant documents, stakeholders etc.

Scope Diagram- IGOE
  • Input is defined as something that is transformed or consumed, input can be information, materials, people
  • Guide is defined as anything that describes the when, why, or how a process or activity occurs, guides can be policies, strategies, regulations, law
  • Outputs are the product or result of the change that occurs to the Inputs or the result of the creation of something based on the Guides, outputs can be results, deliverables, products, information, people
  • Enablers are the resources or assets required to transform an Input into an Output or to create Outputs, enablers can be systems, equipment, tools, assets, facilities, human resources

These diagrams are particularly useful at the outset of a process improvement project, serving as a powerful means to define and agree upon the boundaries of a process. By clearly illustrating the process scope and interactions, IGOE diagrams play a crucial role in setting the right expectations among project stakeholders and establishing a solid foundation for the improvement effort.

One of the key strengths of IGOE diagrams lies in their ability to measure the reach of a process. By explicitly showing how the business interacts with external entities, these diagrams provide a systematic way to assess impact. This can really help identify stakeholders in a project.

Process owners and subject matter experts often turn to IGOE diagrams for high-level root cause analysis. This application allows them to conduct a relatively accurate assessment to determine the focus and scope of an improvement project.

Scope diagrams excel in enhancing communication with various stakeholders. Their intuitive nature and lack of technical jargon make them accessible to a wide audience, facilitating better understanding and alignment among team members and stakeholders. This clarity in communication is particularly beneficial when defining vision and building consensus.

Another significant advantage of scope diagrams is their ability to illustrate process dependencies. By providing a clear picture of the factors that shape processes, these diagrams create a better understanding of potential future process iterations. This insight is invaluable during task prioritization, as the additional information about importance and impact can guide strategic decision-making in the project.

Scope diagrams are most effective in communicating a comprehensive understanding of a process’s scope, boundaries, and interactions with its environment. Whether used at the beginning of an improvement initiative, for aligning stakeholders on process scope and impact, or as a precursor to more detailed process analysis, IGOE diagrams offer a structured and insightful approach to process understanding and improvement planning.

This is a tool we don’t use enough.

Process Map

Process maps are powerful visual tools that provide a clear and comprehensive representation of workflows or processes within an organization. These diagrams illustrate the sequence of steps, activities, and decisions involved in completing a task or achieving a specific outcome. By offering a visual overview of how a process works from start to finish, process maps serve multiple purposes, including identifying inefficiencies and bottlenecks, facilitating communication among team members and stakeholders, and serving as valuable training resources for new employees.

The versatility of process maps makes them indispensable in various business scenarios. At the outset of process improvement projects, these visual aids help teams gain a thorough understanding of the current state of a process before embarking on optimization or redesign efforts. They are particularly useful when defining project scope, as they assist in setting clear boundaries and expectations for process improvement initiatives. For complex processes, maps break down intricate workflows into more manageable, understandable steps, making them easier to analyze and improve.

Process maps excel as communication tools, proving invaluable during team brainstorming sessions by providing a visual aid for discussing and analyzing processes. They also serve as effective training resources for new hires, offering a clear, step-by-step guide to understanding roles and responsibilities within the organization. When documenting standard operating procedures, process maps complement written instructions, enhancing clarity and comprehension.

In problem-solving scenarios, process maps are instrumental in identifying the root causes of issues within a workflow. They allow teams to examine each step of a process for efficiency and effectiveness during process analysis, leading to more targeted improvements. Furthermore, process maps provide a concise way to explain processes to stakeholders who may not be directly involved in day-to-day operations, fostering better understanding and alignment across the organization.

When implementing new systems or technologies, process maps help identify how these tools will impact existing workflows, facilitating smoother transitions and integration. This makes them particularly valuable in organizations focused on continuous improvement, quality management, and operational efficiency.

Process maps are versatile tools that can be employed whenever there’s a need to understand, analyze, improve, or communicate about a process. Their visual nature makes complex information more accessible, promoting better decision-making and more effective process management. Whether used in small-scale departmental improvements or large-scale organizational transformations, process maps remain a fundamental tool in the arsenal of business process management and continuous improvement methodologies.

In my next post in this series I will start with Business Process Notation as a methodology for process mapping.

FDA Inspections – GAO Report

The GAO has published a report on FDA’s Inspections that found a 36% decrease compared to fiscal year 2019 in the number of inspections, partly due to reduced investigator capacity. A piece of information that should surprise noone.

The report highlights a concerning trend in the FDA’s drug inspection workforce. From November 2021 to June 2024, the vacancy rate among investigators who inspect foreign and domestic manufacturers increased from 9% to 16%.

I think we’ve all seen the impact of this. It’s worth spending a little time reading the report.

ISO 8061 Adoption in Pharma

How widespread is adoption of ISO 8601, the standard for date and time formats? Is your company aligned?

I see ISO 8601 widely used in scientific fields, software development, and more and more international correspondence. Yet, I think its fair to say the adoption in pharma has been lacking. So I am really curious, has your organization fully or partially adopted it? If so, how did it go?

Date Format

The basic principle of ISO 8601 for dates is to represent them in a descending order of significance:

  • Complete date: YYYY-MM-DD (extended format) or YYYYMMDD (basic format)
    Example: 2022-09-27 or 20220927
  • Year and month: YYYY-MM
    Example: 2022-09
  • Year only: YYYY
    Example: 2022

Time Format

ISO 8601 defines the following time format:

  • Basic format: Thhmmss
  • Extended format: Thh:mm:ss

Where:

  • T is the time designator
  • hh represents hours (00-24)
  • mm represents minutes (00-59)
  • ss represents seconds (00-60, where 60 is used for leap seconds)

Example: T134730 or T13:47:30 represents 1:47:30 PM

Combined Date and Time

ISO 8601 allows combining date and time representations:

  • YYYY-MM-DDThh:mm:ss or YYYYMMDDThhmmss

Example: 2022-09-26T07:58:30 represents September 26, 2022, at 7:58:30 AM

Time Zone Designators

The standard also specifies how to represent time zones:

  • Z: Represents UTC (Coordinated Universal Time)
  • ±hh:mm or ±hhmm: Represents the offset from UTC

Example: 2022-09-07T15:50+00:00 or 2022-09-07T15:50Z represents 3:50 PM UTC on September 7, 2022.

Key Features

  1. The standard uses the Gregorian calendar.
  2. It employs a 24-hour clock system.
  3. All elements are represented by a fixed number of digits, zero-padded if necessary.
  4. The standard allows for reduced precision by omitting certain elements.
  5. It can represent dates, times, time intervals, and recurring time intervals

Government and Official Use

Many countries have officially adopted ISO 8601 as their recommended or mandated date format for government and official use. For example:

  • The UK government has mandated the use of ISO 8601 for IT systems, APIs, and machine-to-machine communication.
  • Canada’s government and Standards Council officially recommend ISO 8601 for all-numeric dates.
  • Australia recommends ISO 8601 as the short date format for government publications.

The European Union has adopted ISO 8601 as the European Standard EN 28601, making it valid in all EU countries.

Has anyone seen Health Canada or an EMA (and/or national competent authority) push back at a time/date not in ISO 8061 format? I think there has been a lot of push back in health care around adoption, for example the NHS in the UK uses 01-JAN-2017 for medicine labels even though the UK has adopted ISO 8061.

I find it fascinating that the eCTD specification does not mandate a specific date format for metadata or content within submissions, allowing flexibility for regional requirements. Yet we have seen many health authorities that have implemented eCTD do recommend or require the use of ISO 8601 date formats in certain contexts:

  • The US FDA guidance on eCTD recommends using ISO 8601 format (YYYY-MM-DD) for dates in the submission.
  • The EU guidance on eCTD also recommends ISO 8601 format for dates in certain metadata fields.

The eCTD XML backbone uses the W3C XML Schema date and dateTime datatypes, which are based on ISO 8601 formats. While not explicitly requiring ISO 8601, the eCTD specification does emphasize the importance of consistent and unambiguous date representations, which aligns with the goals of ISO 8601. It really makes me wonder when this decision will start rippling through other parts of the industry.

I’d love your thoughts.

Preparing your BCP for Trump’s Attacks on Immigration

Time (maybe past-time) to evaluate your organization’s business continuity plan and anticipate the potential actions against immigrants, in particular the potential impact of Trump’s proposed immigration policies on the facility cleaning industry, particularly cleanrooms, which could be significant.

Labor Shortage

The cleaning industry, including cleanroom maintenance, heavily relies on immigrant labor. A mass deportation policy could lead to:

  • Significant workforce reduction: Many cleaning companies employ immigrant workers, both documented and undocumented. A large-scale deportation could severely reduce the available workforce.
  • Increased labor costs: With fewer workers available, companies may need to offer higher wages to attract and retain employees, potentially increasing operational costs.

Industry Disruption

The cleanroom industry, which requires specialized skills and training, could face particular challenges:

  • Loss of experienced workers: Cleanroom maintenance requires specific knowledge and expertise. Deporting experienced workers could lead to a skills gap in the industry.
  • Reduced productivity: As companies struggle to replace deported workers, there might be a temporary decrease in productivity and quality.
  • Increased costs for clients: Higher labor costs in the cleaning industry could be passed on to clients, potentially affecting industries that rely on cleanroom facilities, such as pharmaceuticals and electronics manufacturing.

Actions to Evaluate

Time to evaluate internal training programs to quickly upskill current and new workers, particularly for specialized cleanroom maintenance. Be prepared for the need to have your staff step in and clean, on the moment’s notice. This is a key action to have in the business continuity plan, and frankly should already be there.

Compliance and Legal Challenges

Beyond that, companies should be evaluating their other plans with broad stakeholders like HR and legal for when law enforcement comes calling as a result of heightened enforcement and audits of cleaning companies to ensure compliance with immigration laws. Remember these cleaners work side-by-side with your staff and quite frankly, are really hard to tell the difference. Are you prepared to side with law enforcement, or delay law enforcement? What is your risk tolerance for navigating the complex legal situations, particularly if long-term employees are suddenly subject to deportation?

While the full extent of the impact remains uncertain, Trump’s proposed immigration policies could significantly disrupt the facility cleaning industry, which will greatly impact every manufacturing site I know. The industry may need to adapt quickly to potential labor shortages, increased costs, and changing regulatory landscapes, while navigating the thorny ethical considerations.

No time like the present to start.

What is Ahead for US Pharma?

It has been a wild ride this past week. I know my family and I have been on an emotional rollercoaster, and I bet many of you are feeling the same way. One question that keeps popping up in our household (and probably yours too) is: “What does this mean for my job, and should I be freaking out?”

Short-term outlook: Keep calm and carry on

First things first, take a deep breath. In the immediate future, it’s unlikely that we’ll see any massive shifts in pharma world. Most of us can probably continue our daily grind without too much disruption. So, for now, it’s business as usual, folks! Unfortunately that business has been pretty tough the last two years.

Long-term forecast: Cloudy with a chance of uncertainty

Now, here’s where things get a bit murky. The long-term outlook? Well, it’s like trying to predict the weather a year from now – pretty darn tricky. What we do know is that this situation has cranked up the uncertainty dial, and let’s face it, uncertainty in the pharmaceutical world is very unwelcome.

We already have a hefty dose of uncertainty due to the 2024 Supreme Court decisions, which are slowly starting to have impact but the boundaries are really unknown. Add to that an incoming administration with a noted dislike (and a set of vendettas) against the HHS and FDA, and government employees. And on top of that we have the wild card of Robert F. Kennedy Jr. being able to “go wild on health” – whatever that ends up meaning but my fear is nothing good.

But I also need to be pragmatic, and as a quality individual involved in risk management and managing uncertainty, I need to start evaluating impacts. Here are the things I am looking at.

On-Shoring

On-Shoring has been a growing conversation for years. We are an incredibly global industry and have been hard hit by a variety of supply disruptions:

  1. Global Pandemic: COVID-19 threw a massive wrench into our well-oiled supply chain machine.
  2. Geopolitical Tensions: The ongoing trade tiffs between major economies have kept us on our toes.
  3. Natural Disasters: Mother Nature hasn’t exactly been playing nice lately.
  4. Labor Shortages: Finding skilled workers has become a bit like searching for a needle in a haystack.

Add to this cocktail the ongoing GMP issues with sites in key manufacturing countries like India and China, and you’ve got a recipe for some serious supply chain headache,

Add to that we have a whole lot of talk of tariffs. The incoming Trump administration is practically drooling to raise tariffs which will have some serious implications:

  • Market Access Issues: Suddenly, selling your products in certain countries becomes a whole lot trickier.
  • Higher Costs: Tariffs often mean higher prices for imported goods.
  • Retaliation Risks: When one country imposes tariffs, others tend to follow suit.

The Critical Component Conundrum

Here’s where things get scary. We are seeing an increase in both price and availability issues for critical raw materials and components. And it is not just about overseas suppliers – even our domestic suppliers are feeling the heat. Remember the great plastics shortage that hit our Single-Use System (SUS) component suppliers? That is potentially just the tip of the iceberg.

The Ripple Effect

Now, let’s connect the dots:

  1. Supply Chain Vulnerability: Our global supply chains are showing their weak spots.
  2. Critical Item Shortages: There’s a growing concern about shortages of essential items.
  3. Price Hikes: As supplies tighten and tariffs kick in, prices are heading north.
  4. Market Access Challenges: A potential trade war could make it tough to serve international markets from the U.S. And remember, we are a very global industry.

Risk Management Approach

  1. Diversify Supply Sources: Don’t put all your eggs in one basket (or country).
  2. Build Resilience: Create buffer stocks of critical components.
  3. Explore On-Shoring Options: Look into bringing some production closer to home.
  4. Stay Flexible: Be ready to pivot your strategy as the global situation evolves.
  5. Plan for multi-country impact: Evaluate what happens when other countries start retaliating and it becomes difficult to get clinical or commercial supply into a country.

Regulatory Changes

Here are my fears where RFK Jr can really do damage. He may push for less stringent approval processes for certain drugs or treatments he favors, potentially allowing more alternative or “natural” products to enter the market. Conversely, he could impose stricter regulations on vaccines and other pharmaceutical products he views skeptically (which is all of them).

There may be efforts to roll back regulatory controls that currently protect public health, potentially allowing unproven treatments to reach consumers more easily. All of this uncertainty is going to be difficult and will impact company’s ability to raise funds. Which will impact the job market. And it has been a bad couple of years for layoffs.