ASQ BOSCON

The Boston Section of the ASQ is hosting the 39th annual BOSCON March 30-31, 2020 at the Airport Hilton hotel & conference center here in Boston.

ASQ BOSCON is proably the biggest and best run regional quality conference. I’ve been going for years and I highly recommend it to everyone.

The BOSCON 2020 theme is Performance Excellence—Your Competitive Edge. “To succeed in today’s digital economy, Quality must lead the way. Quality principles and practices are essential, but practitioners must innovate, learn and lead in how they are adapted to the digital age.”

The Team and Workplace Excellence Forum is proud to be a silver level sponsor. We firmly believe in quality’s role to build a culture of excellence, and that the challenges of the digital age are exciting ones to overcome.

A strongly recommended conference and I hope folks will be able to attend. Registration information can be found here.

There are also some good classes for certification preparation being offered after the conference for the Supplier Quality, Biomedical Auditor and Reliability Engineer certifications.

Conference Speaking -2020 Lean and Six Sigma

In February I will be presenting at the 2020 ASQ Lean and Six Sigma Conference in Phoenix on Sustaining Change – Executing a Sustainability Plan.

Here’s the presentation summary:

For Lean and Six Sigma projects a central question should always be “how do we sustain this change?” Sustainability is a major part of all the major change models but is often the easiest to neglect. This session will engage the participant in building a Sustainability Plan, a key tool to ensure the change is anchored and embedded in the organization. Through three case study examples of changes at the three major change levels -transactional, organizational and transformational – the participant will gain the knowledge to create and execute an effective change plan.

During this session examples will be given for each component of a sustainability plan:

  • Communication: Mechanisms for persuasive communication and ongoing socialization of the change, rites of parting (saying goodbye to the old ways of doing things), and rites of enhancement (acknowledgment of quick wins and continued adoption)
  • Metrics Tracking: How to identify and execute consistent and effective ongoing measurement and results reporting to track progress and ensure sustained results • Performance Management: Process for observing and objectively measuring desired behaviors and attitudes, including performance appraisal process, promoting, demoting and transferring, and training and development
  • Rewards and Recognition: Program of intrinsic and extrinsic incentives to reinforce desired behaviors and attitudes
  • Sustaining Ownership: Consistent process for ensuring sustained ownership of the change through the ongoing transfer of experience and knowledge
  • Continuous Improvement: Mechanisms for responding to changing requirements and implementing improvements based on feedback, observations, and metrics

The following questions will be explored, and tools for finding answers will be provided:

  • How should organizational achievements reinforcing the change be commemorated
  • What behaviors should be observed and measured on a regular basis?
  • What results should be observed and measured on a regular basis?
  • What metrics should be used for measuring behaviors and results?
  • What mechanisms should be used for reporting results? • What criteria should be used to allocate rewards and promotion?
  • What mechanisms should be used for training, coaching, and role modeling?
  • What processes and procedures should be put in place to ensure sustained ownership of the change?
  • What continuous improvement mechanisms will address low adoption rates and ensure the change becomes part of the organization’s normal functioning?

At the end of the session the user will have a template for creating a sustainability plan and will have been provided tools to successfully execute the sustainability phase of a change.

Learning Objectives 1. Assess the role of sustainability in the major change management methodologies and apply to lean and six sigma projects. 2. Facilitate the sustainability phase of change management. 3. Compose a sustainability plan.

2019 State of the Blog

I started this blog as an exercise in deliberate practice, as well as reflective. In order to grow it is important to engage in critical reflection, which requires a process of mutual learning, a consciously organised process of deliberative and distributed reflection. Which is what I strive to do in my blog posts.

At the end of last year, I evaluated my blog goals through an ACORN exercise, as well as updating a SWOT. These stand up pretty well, even in a year of changes where I took on member leader responsibilities as the chair of the ASQ’s Team and Workplace Excellence Forum and took a new job.

I met my posting goal, which was 1.5 posts a week, with 81 posts and 33.5k words.

The top 5 posts of 2019 are:

  1. FDA signals – no such thing as a planned deviation: Written in 2018 this post directs a lot of traffic to the blog from search engines, and has the largest geographic spread. Key message here continues to be all temporary changes, all planned departures, need to go through a change control system of appropriate rigor based on the risk involved.
  2. Risk Based Data Integrity Assessment: Data Integrity and Risk Management are two of my favorite topics and in this post I combine the two and provide a fairly usable tool. I wrote this post while at the ASQ’s Audit Conference, where I presented on data integrity.
  3. Lessons Learned as a Developing Leader: I am very gratified that this piece of introspection was viewed as many times as it was. Three months into my current job and this post, and the followup, are a good roadmap.
  4. Decision Quality: How we make decisions, deal with subjectivity and uncertainty and problem-solve are all big concerns for our organizations. This post serves as a good anchor for my thought and practice, as well as the direction of future endeavors.
  5. Driving for Mature Quality Organizations – FDA recent perspective: Building a quality culture, driving maturity in our organizations are critical. The FDA is spot-on, and companies really need to be coming to grips and dealing with this systematically.

Looking ahead to 2020 for the blog, I am going to take a bit of direction from Luigi Sille who set the following goals for himself:

  1. Build up my expertise
  2. Grow my network
  3. Continuously improve every single day

For building expertise, I want to continue to focus on building tools and methods to: deal with subjectivity and uncertainty around decision making and risk management; proactively build a culture of quality and excellence, especially dealing with aspects of data integrity; and, find connections between the larger organizational/leadership/operational bodies of work and adapt them to the quality profession.

This blog is a large part of growing my network and I want to get to 2 blog posts a week consistently. I’ll continue to work with the ASQ as chair of the Team and Workplace Excellence Forum, including holding at least 2 events (including an unconference!). I am also trying to pull together a group of speakers to bring data integrity and quality culture as a stream to ASQ BosCon. I’ll speak at least 2 ASQ Conferences. I’ll also deepen some ties with the PDA, including speaking at one conference.

As I continuously work to improve, I will bring the topics I’m learning and implementing back to this blog.

ASQ TWEF UnConference

I’m organizing a mini UnConference for the ASQ Team and Workplace Excellence Forum.

A survey for logistics and attendance is here.

An UnConference, otherwise known as a OpenSpace or BarCamp, is a tool I’m a huge fan of. They can really serve to generate action and build energy, commitment, and shared leadership with a group by unleashing self-organization. The idea is to make sure that ALL of the issues that are most important to the participants are raised, included in the agenda, and addressed, making it possible for participants to take responsibility for tackling the issues that they care about and for what does or doesn’t happen

Which makes it a great tool for the Team and Workplace Excellence Forum to really generate some activity. If you are interested please respond to the survey above.

Leverage the CPGP for Quality Maturity

The ASQ’s Certified Pharmaceutical GMP Professional Certification is under-valued. The ASQ really needs to step up and place itself in the forefront of quality culture and maturity, utilizing this certification, as a center-piece. I don’t think there is really a comparable certification on the market and I am continually puzzled why there has not been more adoption.

Let’s break down the ten-points in the St Gallen’s FDA Quality Metrics project and how they link to the body of knowledge behind the CPGP.

Optimized set-up and cleaning procedures are documented as best practice process and rolled out throughout the whole plant.

Cleaning is pretty strong within section IV, Infrastructure: Facilities, Utilities, Equipment, starting with C. Equipment which includes:

  • Equipment layout. Determine the layout of equipment to minimize the risk of errors, to facilitate effective cleaning and maintenance, and to avoid contamination or any other undesired effect on product quality. (Apply)
  • Equipment cleaning and maintenance. Review procedures and schedules for equipment cleaning, maintenance, and, where necessary, sanitization to ensure that they meet requirements. (Apply)
  • Equipment cleaning validation or verification. Evaluate the need and methodology for product-contact cleaning validation and/or verification. (Evaluate)
  • Equipment change control. Verify that change control has maintained the qualified state of equipment. (Apply)

And section F, General Cleaning, Sanitization, and Sterilization Systems

  • Cleaning procedures. Review cleaning procedures in accordance with cleaning validation, whenever validation is required and performed. (Apply)
  • Sanitization procedures. Review sanitization procedures for facilities and equipment, and ensure all are in accordance with any required validation studies, including details on cleaning schedules, methods, equipment, materials, sanitizers, disinfectants, sporicides, and sterilants. (Apply)
  • Pest control. Review and verify that a pest control program is in place and that it uses authorized rodenticides, insecticides, fungicides, fumigating agents, and appropriate traps for pest elimination. (Apply

A large percentage of equipment on the shop floor is currently under statistical process control.

Section VIII. Product Development and Technology Transfer, is strong here, though I recommend that section IV, Infrastructure: Facilities, Utilities, Equipment have material added here.

For root cause analysis, the firm has standardized tools to get a deeper understanding of the influencing factors for problems.

Section II, Quality Systems. The ASQ is strong in root cause analysis, and this is one of those areas where thinking of the CPGP as a industry specific to add to a problem solving certification pathway. Subsection F. “Investigations and Corrective and Preventive Action (CAPA)” covers this well with:

  • Trigger events. Identify events that require: investigation, root cause analysis, and impact assessment both directly and indirectly related to the event. (Evaluate)
  • Response actions. Define immediate action, corrective action, preventive action, management responsibility, and methods of implementing them. (Evaluate)
  • CAPA feedback and trending. Describe how CAPA trending is used to modify appropriate quality system elements. (Create)

Goals and objectives of the manufacturing unit are closely linked and consistent with corporate objectives and the site has a clear focus.

Operational controls and monitoring is throughout the CPGP. This is also a great tie-in with the CMQ/OE.

Manufacturers have joint improvement programs with suppliers to increase performance.

Section 2, K Supplier and Contractor Quality Management breaks this nicely down into Supplier Quality Systems, Supplier Controls and Supplier Evaluation.

All potential bottleneck machines are identified and supplied with additional spare parts.

Section 4, C 1 Equipment planning which covers “Equipment planning Review equipment location, design, construction, installation, and maintenance based on the operations to be conducted. (Apply)” and 3 Equipment cleaning and planning “Review procedures and schedules for equipment cleaning, maintenance, and, where necessary, sanitization to ensure that they meet requirements. (Apply) “

For product and process transfers between different units or sites,standardized procedures exist that ensure a fast, stable and compliant knowledge transfer.

Section VII Product Development and Technology Transfer covers this very thoroughly.

Charts showing the current performance status such as current scrap rates and current up times are posted on the shop floor and visible for everyone.

Discussed throughout the body of knowledge is operational controls and failure rates.

The firm regularly surveys customers’ requirements.

Not explicit in the body of knowledge. Much stronger in other certifications, such as CMQ/OE. Probably a good area to get added.

The firm ranks its suppliers and conducts supplier qualifications and audits.

Section 2, K Supplier and Contractor Quality Management breaks this nicely down into Supplier Quality Systems, Supplier Controls and Supplier Evaluation.