ipswebsite

Balancing Project Management Standards with Real-Life

hello@flowwright.com (Harold Engstrom) — Tue, 10 Sep 2024 15:28:42 GMT

Balancing Project Management

Standards with Real-Life

by Innovative Process Solutions

Have you ever read project management standards or taken a project management course? On paper and in a classroom, projects make a great deal of sense. There are phases and paths and deliverables and roles and responsibilities – and they all fit together snugly in diagrams and charts. Then, you look at the pieces of your own project and think, “OK, we can do this!” Then, you find that those pieces – people, challenges, resources, business drivers – don’t fit perfectly Sometimes when you change your plans and pieces not only does your project no longer closely resemble the ideal you were shooting for…but it all starts to feel out of control.

The ideals include standards such as the stage (or phase) gate process, engineering and testing standards such as ASTM E2500-07, quality standards such as ICH Q9 and Q10, automation standards such as S88.01, and others. These standards do have real value and are filled with real substance. Still, they are not rigid rules and require some interpretation. As Father Guido Sarducci says about commandments 11 through 20, they are really more like guidelines.

Each project is different from the start. For example, let’s take a typical conceptual design �� basic design �� detailed design engineering flow and think about how it might be applied differently to different projects. First, consider a project that entails building a manufacturing plant for a product that is in high demand with demand projected to grow for ten years and your company has a lock on the market because it owns the intellectual property (a cure for cancer or a chocolate bar that causes the eater to become healthier.) In this case, the capital is approved for the entire project, the land is purchased immediately, permits are pulled, and your project places orders for long lead time equipment before the conceptual design phase is even complete. In this first case, you have hired engineers who are already working on each process unit’s deliverables – P&IDs, instrument specifications, electrical one-line drawings, etc. – even though some deliverables properly belong in the basic and detailed design stages of your project. In short, while you understand your stage-gate process well, you have largely abandoned the distinctions between stages. Instead, you are focused on generating the deliverables you need to construct and test as quickly as possible. And that is OK. You are doing the right thing.

On the other hand, let’s say your company has a different project in mind that involves a product that seems promising…but there is still considerable commercial risk involved. For example, a refinery using a process that is profitable only when the price of oil is greater that $60 per barrel or a manufacturing facility for a drug that showed good results in early testing but not good enough that there is not still some concern that it will fail late-stage trials. It is possible that oil prices will drop and building the facility will not make sense. Or it is possible that the phase 3 trials for your drug will exceed expectations and you will need a plan in place to build quickly (or that the trials will fail…) In either of these cases, your company is only committing to conceptual design: it wants to understand costs and schedule and de-risk budget and cost issues. In these cases, your project plan will hew very closely to what the textbook prescribes for methodically executing the conceptual engineering stage of a project: you will be just at the brink of basic design but commit nothing more until the business agrees it is important to do so.

So, two projects, two different approaches to stage gate. The first lesson is: everything is driven by business needs. A typical stage-gate project process, for example, that described by the ISPE Project Management Best Practices Guide, is all about spending small amounts of money in order to de-risk the efforts that will be funded by a larger amount of money first. The degree of risk that a business is willing to tolerate and the urgency that a business feels around a given project fundamentally changes how closely a company follows the stage-gate process or a variant thereof.

The more certain a company is that a project is required, and the more urgent the requiring, the more a plan becomes driven by a “bottom-up” strategy than by theoretical standards. “Bottom-up” means that you emphasize starting at the end and working backward. For example, if you know you have a winning industrial enzyme that has a massive market and you are definitely committed to building a new purification facility, then you focus entirely on what construction needs to successfully build from day one without regard for stage-gate (stage-gate shown in brackets):

Process Flow Diagrams (Conceptual)
Equipment specifications (Basic)
A sequence of operations (Basic)
Civil/structural supports (Detailed)
Piping isometrics (Detailed)
Instrument specifications (Detailed)
Electrical one-lines (Basic)
Drive panels and layouts (Detailed)
Wiring drawings (Detailed)
Instrument index (Detailed)
P&IDs (Basic)
Unit boundary definitions (Basic)
Network architecture (Detailed)
Fieldbus diagrams (Detailed)
Loop diagrams (Detailed)
Piping schedule (Detailed)
Etc. etc.

By unit, you would focus on the whole list of deliverables for each unit from the start and probably treat the building (or buildings) as a separate unit, including HVAC. That means that from day one you have a list of all the design deliverables, regardless of stage-gate, listed on the task list in your “war room”. It is much more efficient to do related activities together with a dedicated team that knows they have a 12-18 month mission than it is to consciously pause at stage-gate boundaries while waiting for the business decision regarding whether or how fast to proceed.

On the other hand, inefficiency is preferable to spending money that may never provide a return. If the business requires more discipline and deliberation, then being methodical is important. It is the responsibility of a company and their project steering committee to decide whether commercial risk requires caution and adherence to practices designed to mitigate financial and technical risk or to proceed with technical rigor but a greater focus on schedule and budget efficiencies.

Similarly, ASTM E2500-07, ICH standards, and S88 and S95 require context in order to choose how best to implement them. Other blog posts will cover these specific choices and how to make them in the next future!

Risk Assessment and ASTM E2500-07: Using Risk Assessment to Provide Real Value

hello@flowwright.com (Harold Engstrom) — Sat, 29 Jun 2024 15:51:18 GMT

Risk Assessment and ASTM E2500-07:

Using Risk Assessment to Provide Real Value

by Innovative Process Solutions

In the life sciences world, the profession of validation is all about risk reduction. Validation professionals have a mission to identify areas of risk associated with making and managing therapies from the supply chain through delivery to patients. Naturally, validation professionals need several key categories of information to be successful with this mission:

Understand what aspects of ingredients, intermediates, and final product must be controlled to ensure safety to the patient and efficacy to the product
Determine what processes need to be in place to demonstrate their company is operating in a demonstrably controlled manner
Set up a structured program of risk assessment and testing to verify that risk is identified and either engineered or tested down to an acceptable level

Number 1 above is identified by a life science company’s regulatory and quality personnel. These are the critical-to-quality attributes (CQAs) that are explicitly called out in the Chemistry, Manufacturing, and Control section of electronic Common Technical Documents (eCTDs.) The eCTD format is the format required by the United States and European Union for regulatory filings. CQAs are attributes such as product strength or microbial contamination that must fall within specified parameters to ensure product integrity for patients. Here are examples from our risk management application of some CQAs associated with a solid dosage product:

Were there a CQA associated with this step, then it would be cited. Perhaps there is not CQA at risk…perhaps safety, control, efficiency, cost, or some other risk is identified. Some people might choose Failure Mode Effects and Criticality Analysis (FMECA) to assess equipment, with the same purpose:

Both forms shown above have important fields to be filled out and modified over time. Yes, the obvious assessment itself, but note that the level of risk that come out of the assessment dictates (per your company’s policy) whether commissioning or validation is required to test out that risk. Or, possibly, the risk level may be so high that your company may mandate that systems and/or processes be re-engineered so as to reduce risk. And, also note that risk assessments themselves have status (per ICH) as shown in next image.

Identified
Evaluated
Analyzed
Accepted

At the end of this risk assessment process is the use of ASTM E2500-07 (Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment) to capture specifications and testing in an organized manner but also to ensure commissioning and validation is managed efficiently. This ASTM standard boils down to, essentially:

Test specifications once (if possible)
Test specifications only as rigorously as needed

In practice, if what a specification describes is assessed at low risk and will not impact safety or a CQA then it may be testing once in commissioning. For example, clean stainless pipe may be checked once for clean welds and legitimate material certifications during an FAT. However, if a specification impacts a CQA or safety, or even is assessed at a high risk or perhaps is changeable, then it will need to be validated (and probably re-validated on some schedule.)

Traditionally, companies have commissioned AND validated everything – often several times. ASTM E2500-07, informed by the rigorous risk assessments done above, helps companies not only reduce the cost of testing – but makes testing more effective and enables companies to demonstrate to regulatory agencies that it can show exactly where the CQAs referenced in their eCTDs are potentially impacted by their processes and systems.

ipswebsite

Balancing Project Management Standards with Real-Life

Balancing Project Management

Standards with Real-Life

by Innovative Process Solutions

Risk Assessment and ASTM E2500-07: Using Risk Assessment to Provide Real Value

Risk Assessment and ASTM E2500-07:

Using Risk Assessment to Provide Real Value

by Innovative Process Solutions

﻿