Interviewing

One of the great tools of root cause analysis, planning, process improvement and knowledge management is the interview. Properly used the interview allows one to gather a great deal of information and perspective and ferret out hidden information.

For interviews to be truly effective, we have to understand how the function and apply a process. Cognitive Interviewing, originally created for law enforcement and later adopted during accident investigations by the National Transportation Safety Board (NTSB), provides an effective framework. I was first introduced to this at my previous company, where it has become a real linchpin, so I share it here.

The two principles here are:

  • Witnesses need time and encouragement to recall information
  • Retrieval cues enhance memory recall

Based on these two principles there are four components:

ComponentWhat It Consists of
Mental ReinstatementEncourage the interviewee to mentally recreate the environment and people involved.
In-Depth ReportingEncourage the reporting of all the details, even if it is minor or not directly related to the purpose of the interview. This is intended to improve the detail and accuracy of memory.

For example, if investigation a computer error, you would encourage the interviewee to discuss everything they were doing around the event. You would hold the interview at the station the error happened, ideally using the computeras much as possible.
Multiple PerspectivesAsk the interviewee to recall the event from others’ points of view. For example, the person upstream or downstream, or a partner or observer.
Several OrdersAsk the interviewee to recount the timeline in different ways. Beginning to end, end to beginning.
Four Components of Cognitive Interviewing

A key part of this is that retrieval cues access memory. This is why doing the interview on the scene (or Gemba) is so effective.

The basic behaviors you want to bring to bear are:

  • Recreate the original context; have them outline and walk you through process to explain how they work.
  • Tell the the witness to actively generate information and not wait passively for the interviewer to ask questions.
  • Adopt the witness’s perspective; ask eyewitness-compatible questions.
  • Perform the interview at the Gemba, the place where the work happens.
  • Listen actively, do not interrupt, and pause after the witness’s response.
  • Ask open-ended questions, utilize short phrases when possible.
  • Encourage the witness to use imagery. Explicitly request detailed descriptions.
  • Follow the sequence of the cognitive interview major components.
  • Bring support materials such as attachments, procedures, and copies of relevant documents.
  • Establish a connection with the witness; demeanor has a big impact.
  • Remember, active listening.
  • Do not tell the interviewee how they made the mistake, blame, or assume.

Active listening is key here.

Active Listening funnel

At the mouth of the funnel we begin with an ‘open’ question. This question is intended to give the interviewee the widest possible scope for responding. Sometimes it may be necessary to repeat or rephrase this question to give the interviewee more thinking time and further opportunities to raise information. Working down the narrowing body of the funnel we use a series of probing questions to draw out further specific information and help complete the picture. Closed questions then have their place to draw out, check or confirm specific pieces of information, or to get the interviewee to commit on a point more precisely. This then brings us to the bottom of the funnel where we clarify, using a short summary, what we have got out of the discussion, aiming to check our understanding of the main points. The question sequence might go something like this:

  • ‘Tell me how you went about…?’ (open)
  • ‘How did you prepare?’ (open – secondary)
  • ‘What was your starting point?’ (probe)
  • ‘So, what happened next?’ (probe)
  • ‘Who else was involved?’ (probe)
  • ‘And how did they respond?’ (probe)
  • ‘What were your thoughts at that stage?’ (probe)
  • ‘What were the main outcomes?’ (probe)
  • ‘So, that took a total of 30 minutes?’ (closed – clarifying)
  • ‘And the task was completed?’ (closed – clarifying)
  • ‘So, let me see if I’ve followed you…’ (checking – summary)

A good interview requires preparation. Have opening questions ready, ensure you have all the right props and the right people involved. That extra hour or two will pay dividends.

Here is a helpful worksheet.

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.

SIPOC diagrams

I am a huge fan of a SIPOC which stands for suppliers-inputs-process-outputs-customers. A SIPOC diagram is a quick broad overview of all the elements of a process and serves as a great visual scope.

Blank SIPOC

Start with the process

Provide the key steps of the process in the middle column and briefly describe its key steps.  A SIPOC diagram is a high-level process map and is designed to get a birds-eye overview of the process. Do not include decision points or feedback loops.

Identify the outputs of the process

Focus on the key outputs of the process. In this step, write down the three or more main outputs. Use nouns for the most part and avoid categorizing your outputs into good or bad ones – that’s not the point of the diagram.

Identify the customers

List the people who benefit from the process. These don’t have to be the literal “customers.” E.g., if you are working on a diagram for an internal process, the “customers” are your coworkers. Think of who benefits from this process. Who would be upset if the process is not complete?

List the inputs for the process

List the inputs required for the process to function properly. Just like with every previous step, focus on the most important ones. Three to six main inputs should do.

Identify the suppliers of the inputs

List the suppliers based on what inputs the process uses. Be sure to mention any specific suppliers whose input has a direct influence on the output.

The template I use is here.

Examples of SIPOCs:

Personal Audits as part of team building for Projects

The personal audit is a tool used in change and project management (and such) to help team members and sponsors judge their strengths and weaknesses with respect to change leadership. It illustrates some skills from the full range necessary to introduce change into an organization.

This exercise is great to do at the beginning of the project, where it can help team members begin to understand some of the human issues applicable to all projects. As one mentor once told me – If this exercise strikes team members as inapplicable, then they really need to do it.

Domain What I do Well What I Need to Work On
Manage Attention: To what extent do I manage my time, energy, passion, focus and agenda?    
Adopt change roles? How much attention do I pay to matters like: Creating a need, Shaping a vision, Mobilizing commitment,  Monitoring progress, Finishing the job,  Anchoring the change)    
Technical competence: To what extent to I demonstrate competence in technical abilities?    
Interpersonal competence: how skilled am I at interacting with others?    
Vision: How well can I articulate the desired outcome of the project and the benefits to others?    
Teamwork: How often do I recognize good work done by teammates?    
Diplomacy: How closely am I working with all the groups affected by this project?    
Conflict management: Can I deal with disagreement without avoiding it or blowing up?    
Summary: Overall strengths and weaknesses    

Environment, Health and Safety and the compliance domain

Benefits of Written Rules:
Capture important learnings and assumptions
Establish a standardized, organized and reproducible, method of conducting work safely
Ensure effective transfer of knowledge to new members of the group
Require disciplined thinking to formally document thus reducing errors in processes
Create a framework for delegation of decision-making
Demonstrate the organizations commitment to safety

Chet Brandon “Tried and True: Written Procedures are a Foundation of EHS Success

I don’t think there is a quality person who would read that list and not nod knowingly. Reading the excellent article quoted above reminded me that we all probably do EHS, Quality and compliance in general all wrong.

Yes, Health & Safety is about the employee; Quality is about the product (and legal is about following the law and finance does something about money) but what when you look at the tools we pretty much have a common tool-box. Root cause analysis, procedures, risk management, system thinking.

What is truly different is the question we ask:

  • Quality asks about the customer
  • Health and Safety asks about the employee
  • Environment asks about, well, the environment

I find it fascinating that it became environment, health and safety and most companies, as again, the question asked is rather different. In companies where care of the environment is separate (such as the energy industry) you will definitely see it as a separate entity.

I have only been at one company that was on the path of looking at quality, environment, health and safety were all similar disciplines and united them under a chief compliance officer (who was also head of legal). My current company is still struggling along the path of uniting standards and tools.

There is definitely a lot of different domain knowledge between the three, the same way quality is different between industries. However the commonalities that unite us are many and ones we should spend more time exploring.