ASQ Audit Conference – Day 2 Morning

Jay Arthur “The Future of Quality”

Starts with our “Heroes are gone” and “it is time to stand on our  two feet.”

Focuses on the time and effort to train people on lean and six sigma, and how many people do not actually do projects. Basic point is that we use the tools in old ways which are not nimble and aligned to today’s needs. The tools we use versus the tools we are taught.

Hacking lean six sigma is along a similar line to Art Smalley’s four problems.

Applying the spirit of hacking to quality.

Covers valuestream mapping and spaghetti diagrams with a focus on “they delays in between.” Talks about how control charts are not more standard. Basic point is people don’t spend enough time with the tools of quality. A point I have opinions on that will end up in another post.

Overcooked data versus raw data – summarized data has little or no nutritional value.

Brings this back to the issue of lack of problem diagnosis and not problem solving. Comes back to a need for a few easy tools and not the long-tail of six sigma.

This talk is very focused on LSS and the use of very specific tools, which seems like an odd choice at an Audit conference.

“Objectives and Process Measures: ISO 13485:2016 and ISO 9001:2015” by Nancy Pasquan

I appreciate it when the session manager (person who introduces the speaker and manages time) does a safety moment. Way to practice what we preach. Seriously, it should be a norm at all conferences.

Connects with the audience with a confession that the speaker is here to share her pain.

Objective – where we are going. Provide a flow chart of mission/vision (scope) ->establish process -> right direction? -> monitor and measure

Objectives should challenge the organization. Should not be too easy. References SMART. Covers objectives in very standard way. “Remember the purpose is to focus the effort of the entire organization toward these goals.” Links process objectives to the overall company objectives.

Process measures are harder. Uses training for an example. Which tells me adult learning practice is not as much as the QBOK way of thinking as I would like. Kilpatrick is a pretty well-known model.

Process measures will not tell us if we have the right process is a pretty loaded concept. Being careful of what you measure is good advice.

“Auditing Current Trends in Cleaning Validation” by Cathelene Compton

One of the trends in 2019 FDA Warning letters has been cleaning. While not one of the four big ones, cleaning validation always seems relevant and I’m looking forward to this presentation.

Starting with the fact that 15% if all observations on 483 forms related to leaning validation and documentation.

Reviews the three stages from the 2011 FDA Process Validation Guidance and then delvers into a deeper validation lifecycle flowchart.

Some highlights:

Stage 1 – choosing the right cleaning agent; different manufacturers of cleaning agents; long-term damage to equipment parts and cleaning agent compatibility. Vendor study for cleaning agent; concentration levels; challenge the cleaning process with different concentrations.

Delves more into cleaning acceptance limits and the importance of calculating in multiple ways. Stresses the importance of an involvement of a toxicologist. Stresses the use of Permitted Daily Exposure and how it can be difficult to get the F-factors.

Ensure that analytical methods meet ICHQ2(R1). Recovery studies on materials of construction. For cleaning agent look for target marker, check if other components in the laboratory also use this marker. Pitfall is the glassware washer not validated.

Trends around recovery factors, for example recoveries for stainless tell should be 90%.

Discusses matrix rationales from the Mylan 483 stressing the need to ensure all toxicity levels are determined and pharmaceological potency is there.

Stage 2 all studies should include visual inspection, micro and analytical. Materials of construction and surface area calculations and swabs on hard to clean or water hold up locations. Chromatography must be assessed for extraneous peaks.

Verification vs verification – validation always preferred.

Training – qualify the individuals who swab. Qualify visual inspectors.

Should see campaign studies, clean hold studies and dirty equipment hold studies.

Stage 3 – continuous is so critical, where folks fall flat. Do every 6 months, no more than a year or manual. CIP should be under a periodic review of mechanical aspects which means requal can be 2-3 years out.

Goals, Objectives and Transparency

Organizations, projects and teams have goals and objectives, and often these terms are used interchangeably. When I’m trying to be good on nomenclature, I use the following standard definitions:

Goal is generally described as an effort directed towards an end. In project management, for example, the term goal is to three different target values of performance, time and resources. To be more specific, the project goal specifies the desired outcome (performance), the specific end date (time) and the assigned amount of resources (resources). A goal answers to “What” is the main aim of the project. 

An Objective defines the tangible and measurable results of the team to support the agreed goal and meet the planned end time and other resource restrictions. It answers to “How” something is to be done.

I think many of us are familiar with the concept of SMART goals. Lately I’ve been using FAST objectives.

From “With Goals, FAST Beats SMART” by Donald Sull and Charles Sull

Transparency provides the connective tissue, and must be a primary aspect of any quality culture. Transparency is creating a free flow within an organization and between the organization and its many stakeholders. This flow of information is the central nervous system of an organization and it’s effectiveness depends on it. Transparency influences the capacity to solve problems, innovate, meet challenges and as shown above, meet goals.

This information flow is simply that critical information gets to the right person at the right time and for the right reason. By making our goals transparent we can start that process and make a difference in our organizations.

Conducting an ACORN test on my mission statement

Here is my first draft at a mission statement developed after reviewing my SWOT and doing a quick brainstorming exercise asking myself some what, why and how questions:

The mission of my blog is to encourage a thoughtful life as a quality professional. I want to ask and explore questions related to building a quality culture and utilizing system thinking to spark a dialogue with my peers. I am to become a leader in quality both internal to my own company and externally to the wider profession.

An acorn

The ACORN test is a check on a mission or project charter goal to determine if it well defined. I am drawing from The Quality Toolbox, but this is a tool you can find all over the internet.

QuestionThoughts
AAccomplishment. Does the goal describe results rather than behaviors? The goal here is to write. Secondary to that I want to spark a dialogue and also be invited to conferences and other speaking opportunities.

The mission statement as is could use some tightening here.
CControl. Does the team’s actions determine whether not the goal is accomplished? If the way the mission is articulated primarily depends on others outside the team, consider rewriting it.
I am a team of one. Everything within my mission statement is in my own power. I can write, and publish and share. Publicizing my posts is within my control.
OOnly Objective. If this and only this was accomplished would it be enough?

O is sometimes also phrased as “Overall Objective” — Make sure that the mission truly captures the organization’s reason for being. Avoid writing a mission that is simply a subgoal of that overall purpose.
My only goal is thinking aloud. I am not trying to sell anything, nor am I concerned about finding a job (I work in pharmaceutical quality in Boston, getting a new job involves going to Kendall square and waving a resume around)
RReconciliation. Will accomplishing this goal prevent another group within the organization from accomplishing its goal? Does anyone else have this goal?
Various units should be working in harmony to achieve the overall organization mission.
As an individual, I do not need to worry about other groups. However it is important for my mission statement for this blog not to interfere or conflict with any of my other goals.

This mission statement is aligned to my personal and professional goals. In fact it helps further several of them.
NNumbers. Can this goal be measured?Blogging has several measurements built in – views, visitors, likes, shares and comments.

I can also measure other things like invitations to speaking opportunities, questions directed to me, and others.

An overall mission statement must pass all give parts of the ACORN test in order to be well defined. In my case I pass but need some tightening in accomplishment.