When Does Change Control Get Invited to the Investigation Discussion?

Somewhere between “What is the solution? (#4)” and “The best way to implement the solution (#5)” but definitely before “Implement CAPA Solution” is another necessary quality system called Change Control. Where in your Deviation – CAPA process is the linkage or hand-off to Change Control? When does the Change Control request get initiated? Is it part of the Deviations SOP, built into the CAPA process or is it a separate stand-alone system? For novice investigators, this additional requirement is very easy to overlook by assuming that it falls within the boundaries of CAPA.

When CA’s require more than SOP revisions

Let’s examine typical corrective actions (CAs) more closely.  By far, rewriting SOPs to correct a procedural step or clarify the wording is the most common corrective action for a CAPA.  Initiating a document control request as per the SOP on SOPs is a pretty routine task and I generally don’t see deviations relating to “failure to open a doc control request for SOP revisions”.  But what about changes to batch records?  This gets a little bit trickier when rewriting a batch record step is a change to the process and most likely will require some kind of validation activity.  Some CAs involve changes to methods, materials or even vendors.  Again requiring change controls to be initiated.  Even changes to tech-enabled “GMP Systems” needs to be evaluated for a performance qualification under a change control protocol.

Change Control during a CAPA Investigation is not an afterthought

How is this managed where you work?  Is there any evidence in the Deviation –Investigation CAPA file that points to or includes the change control request, protocol, a/o final report?  How does the Lead Investigator ensure that this “big step” is being managed? Is it the responsibility of the CAPA team, the Lead Investigator or the Change Control Manager who happens to hear about it at a morning huddle discussion?

So instead of treating Change Control as an afterthought like an unwanted guest to a party, why not add one more tool to the problem-solving toolbox?  It’s called a Process Change Analysis.  The purpose of this tool is to explore identified process steps being considered for change.  (Available to Mailing List subscribers).

Add one more tool to the problem-solving toolbox

As part of steps 4 and 5 of the Problem Solving Model Approach, the investigation team examines the effect of the proposed change might have on the individual performer, other processes and systems.  Using the Process Change Analysis worksheet not only captures the implications of the proposed change but also provides the proper documentation for both the CAPA Investigation File and the Change Control Request.  Asking team members to consider what else might have to change allows for a more comprehensive change control project that gets coordinated alongside CAPA implementations.

Quality systems were never intended to stand alone and function as siloed departments.  A sign of a good functioning Quality Management System is how well the linkages (handoffs) are integrated and understood by employees and not duplicated by mistake or as a result of not knowing enough about other site quality systems procedures.

Summary of the HPISC Deviation – CAPA Blog Series

Alas, I have come to the end of the Deviation –CAPA blog series.  Thank you for allowing me to share my thoughts, air my frustrations and suggest ideas for expanding the problem-solving tool kit while staying within the boundaries of Quality Systems expectations.

1st in the series – The Big Why for Deviations – where I proposed that deviations and investigations provide rich learning opportunities to find out what’s going with our Quality Systems.

2nd in the series – Why Do CAPAs Fail Their ECs? – where I introduced the HPISC CAPA Performance Chain and suggested that the Effectiveness Check must map back to the CAPA that maps back to the root cause.

3rd in the series – The Investigation Hand Off: Is it a Handshake or a Missed Step? – where I urged QA personnel to clearly define the roles of the Initiator and the Investigator.

4th in the series – Investigations 101: Welcome Newbies – where I highly recommended a dedicated program to qualify Deviation Investigators.

5th in the series – Conducting Root Cause Meetings vs. Facilitating Problem Solving Discussions – where I suggested a broader problem- solving approach to get better at fixing our repeat problems.

6th in the series – Please Tell Me There Are More Tools Than 5 Whys and Fish Bone Diagrams – where I advised investigators to consider which tool to use to help make the right choice to maximize the tool results based on the investigation stage.

7th in the series – When Does Change Control Get Invited to the Discussion.

The next blog series is currently being mapped out.  Stay tuned for more updates by subscribing to the Theory vs. Blog.  Reach out to me if you wish to see a QA or Training subject be developed into a future blog series.

Until then visit the HPISC library for published articles, eBooks, white papers and impact stories.  I will not add your name to the mailing list without your permission. 

© HPIS Consulting, Inc.

Who is Vivian Bringslimark?

Moving from Lecture to Delivering an EFFECTIVE Lecture

While lecture has its merits, today’s learners want engaging content that is timely, relevant and meaningful. Yet, most SMEs tend to suffer from the “curse of too much knowledge” and find it difficult to separate the need-to- know from the nice-to-know content.

Presenting for them takes on a lecture style format. The thought of facilitating an activity gives most SME a case of jitters and anxiety.  So, in the HPISC. “SME as Facilitator” workshop, attendees are encouraged to step away from the podium and use their eyes, hands and voice to engage with their audience. Easier said than done, yes. That’s why the course is designed to allow them to take small steps within the safety of a workshop environment.

But rather than trying to pull off a fully immersive session, SMEs as Facilitators are introduced to techniques that “liven up” the lecture. They are shown how to move back and forth from passive (sit, hear, see) to active involvement (write, construct, discuss, move, speak). This requires the ability to:

  • follow a well organized design plan
  • capture and hold attention of learners
  • use relevant examples and deviations if possible
  • show authentic enthusiasm
  • involve audience both directly and indirectly
  • respond to questions with patience and respect.

Great presentations are like great movies. They open with an attention-seeking scene, have drama and conflict in the middle so you stick around long enough to see the hero survive and they close on a memorable note. Using the movie analogy, a SME as Facilitator can open the session with something more than his/her bio. They can pick a notable career achievement that most folks aren’t aware of.  Keeping the interest alive, the SME can then draw the connection of content to the audience and address the WIIFM question on everyone’s mind. (WIIFM = What’s in it for me?)

While we don’t need to add to anyone’s stress load, overcoming conflict makes for great story telling. Case studies, major CAPAs, deviations and audit observations make it real life. Use of visuals especially diagrams is visually appealing to learners and keeps them engaged. (CAPA= Corrective Actions Preventive Action Investigations)

Thoroughness in the preparation reflects care and thoughtfulness. Learners appreciate the personal desire to deliver a more lively lecture. Therefore, I like to use the concept of a lecturette; 10 minute blocks of time to chunk up complex topics. Interspersing a 10—15 minute lecture segment with an activity whether self, small group or stand up at the flipchart, gives learners the opportunity to engage with new and/or more complex content in smaller doses.

Stepping away from the podium forces the SME to take action and allow the learners to “get up close” with the SME as Facilitator. This in turn is reflected in the learners desire to respond to questions and dialogue during a facilitated discussion. The rule of thumb for lecturing is approximately 20 minutes max. But with today’s technology buzzing away at your fingertips or on the tabletop, I’d say more like 10 or 15 minutes max if you are an engaging facilitator.

difference between a novice and wise teacher

Remember, the goal of a session is to maximize retention of the audience, not just tell them the content. Attendees learn more if the SME as Facilitator can focus their attention on the topic and deliver content that is relevant to their work situation. Involving the learners in a variety of ways is the key to effective lectures and great presentations. – VB

You might also want to get up to speed with current trend for SMEs – check out the blog post – Are your SMEs becoming duo purposed? Comments welcomed.

Moving from Presenter Controlled Training to Learner Focused Facilitation

The more trainer/instructor driven the course is, the less participation is required from the learner. For example, the instructor makes all the decisions about the course objectives and content, develops the course, delivers the course and conducts the assessment.

As you move along the Learner Participation Continuum, the
learner is required to participate more and the trainer does less “talking”. The learner acquires knowledge and skills through activities that s/he experiences with the assistance of a “facilitator”.  The facilitator is focused on helping the learners meet their needs and interests. It is through these first hand experiences and facilitated dialogue with other learners that thoughtful analysis and interpretation can become the focus of the instruction. The end result is that learners take full responsibility for decisions, actions and consequences.

Moving to a more Learner Controlled approach shifts the focus of the design from “deliver this content” to facilitate learning transfer for performance back on the job; which is after all the end goal for a training event. The new program includes opportunities for group participation, utilization of participants’ expertise and real life problem solving.

Learners are prompted to openly discuss issues and problems within the “learning lab”. Trainers become empathetic listeners as they create a climate of trust and safety. They become a Facilitator.

Of course, this shift also requires that site leadership and local management not only support the facilitated learning lab concept, but follow through on issues and concerns that surface. Failure to do so undermines not only the facilitator’s credibility but the entire training program. Wow, won’t this take longer to design, you ask?  Yes, in the sense that the design is now from the learner’s point of view. This means that the designer will need to research examples, collect data, and develop a story from an incident, a deviation or significant CAPA, etc.

The reward is that the Classroom SME stops talking and gives employees more engaging learning sessions. So learners become more accountable for participating and guess what – the SME’s session is no longer a boring podium speech. — VB

Silberman, M. (1990). Active Training: A Handbook of Techniques, Designs, Case Examples, and Tips.  Lexington Books, New York.

From training logs to OJT checklists and beyond

I can still picture my employee “blue card” that listed my department training events when I think of training records. Long before the days of LMSes, we logged events like the monthly Safety and GMP Meetings and an occasional deviation awareness session. But logging every SOP? That was unheard of until I was asked about it during an interview. After I accepted the position, I soon found out why that was such a watershed moment for the industry and me.

So we’ve evolved with our training practices to keep up with regulators expectations regarding GMP training. But have we changed the training culture yet? Are we just pushing attendance forms for e-data entry or are we delivering meaningful training? Can we confidently say, “Yes, our employees are qualified prior to release to task”?

What can “Qualified Employee” mean for a company?

For starters, it satisfies the CFR ξ 211.25 (c ) regulation … shall have the adequate number of qualified employees to perform. Successful qualification events also validate the OJT Program and confirm that the OJT methodology is working. And that Qualified OJT Trainers are consistently delivering on the job SOP training sessions. Meeting FDA expectations for qualified employees is paramount. The bonus is a renewed level of confidence in the ability of its people to deliver on performance outcomes for an organization. Qualified Employee status is not only a compliance imperative but a business driver as well.  See also – Moving beyond R & U SOP Training.

What then does the Qualification process look like?

The end goal is for an employee to perform independent of his/her QT coach. In order to be “released to task”, a final performance demonstration observed and documented by a qualified OJT trainer needs to take place. But don’t be fooled into taking the performance demo short cut! The last step in the training portion of the methodology is a performance demonstration to show the OJT-QT that the employee can mimic the steps of the QT. Can they perform at the same level of proficiency as their peer group? Probably not.

They may need more encouragement to build up confidence, correct paperwork documentation and time to become proficient with his/her speed while maintaining accuracy. That’s what practice sessions are for; time to master confidence with the steps and increase speed. When his/her performance is on par with “business as usual” performance levels, then the employee is ready to perform the final demonstration.

Performance Demos happen at least twice

During the final performance demonstration, the QT observes the performance. The feedback is evaluative and the result is formally documented on the OJT checklist. Granted, when someone is watching us, we tend to follow the rules. With enough repeated practice sessions, employees follow the procedure as “business as usual” regardless of who is watching them. It’s how they learn the ebb and flow from their peers. This is the optimum moment to determine if s/he is truly ready to perform without coaching or supervision from his QT. If a QT has to interrupt to correct a misstep or remind the employee that he is out of sequence, the event is terminated and documented as requires more review. More training practice is then scheduled.

Not all SOPs require a qualification event.

SOPs generally fall into two categories: FYI-type and Needs-OJT. The more complex an SOP is, the more likely errors will occur. Observing critical to quality (CTQ) steps is a key focus during the final performance demonstration. However, a 1-1 documentation path for every OJT related SOP may not be needed. Instead, batch SOPs a/o multiple SOPs of similar processes can be grouped into a “module” with documentation supporting similarity. In addition, there are minimal operator error related deviations tagged to the SOPs listed in the module packet. Where there are differences, the qualification event will document the observation of these CTQ elements.


Effective OJT enables a high quality workforce

Qualification events are not intended to be a rushed get ‘er done / one and done paperwork exercise. This distinction is critical to ensuring a successful qualification event and the increasing the confidence of repeating performance of task tomorrow, next week, etc. Whatever you call your last step in the OJT model (assess, qualify, evaluate, etc.) be sure to separate the training and coaching sessions with sufficient time in between to ensure knowledge has been retained and skill can be accurately reproduced.

Getting the paperwork right is important, don’t get me wrong. Inspections run much smoother when all the t’s are crossed and i’s have been dotted, no doubt. Yet, the effectiveness of an OJT program lies beyond the LMS printouts for QT Trainers and Qualified Employees. A qualified workforce means a team of well-trained employees who know how to execute their tasks accurately and with compliance in mind, own and document their work properly. And management considers them as key performance enablers for meeting organizational goals. When this happens, we have changed the training culture.