Loss of Personnel - Root Cause Analysis

[QC Dave]

During our re-certification to ISO 9001:2008 audit, we have a couple minor NCs the root cause of which is basically that my predecessor, the former QC Manager, left the company and did not communicate that certain things needed to be done annually, every three years etc.

Our response was that the root cause was lack of communication. Our CAR said that we would go through our SOPs, listing everything that had to be done on an annual, etc. basis. We would then put this information into a system that enables us to track when everything needed to be done.

The external auditor's response was that it seems our root cause was the loss of personnel and that the Corrective Action needs to address this fact.

Question. How would you address this? You obviously can't keep people from leaving. To me, the root cause is still the lack of communication, and I feel that my plan would address this somewhat. I DO understand that Knowledge Management is something we will need to address as we move towards transitioning to ISO 9001:2015 next year. But for right now I need to address the current issue.

Any help would be greatly appreciated.

 

[Sidney Vianna]

The external auditor's response was that it seems our root cause was the loss of personnel and that the Corrective Action needs to address this fact.

Based on the description of the situation, it seems to me that, the real issue is knowledge management as it relates to process ownership transfer. The previous person left the company, but, his absence could have been for other reasons, such as death or illness.

When someone is no longer available to manage a process, his/her replacement needs to become familiar with the responsibilities ASAP. Sometimes, the hand-over can be done while the individual is working at the organization, during normal succession, but, sometimes, in case of abrupt departures, the incoming responsible has to become aware quickly of the process requirements. Some companies address this via the figure of an alternate/deputy process owner, who is very familiar with the process and can take ownership, in an accelerated manner should the need arise.

Good luck.

 

[Randy]

It's very simply an ineffective management of change issue, I'm dealing with one right now where I'm auditing, the exact same problem.

We can manage change of production, infrastructure documents and everything else pretty well, but change of people or anything that involves people is universally weak across all organizations

 

[chasf]

Along the same line as the previous comments:
He might be looking for a list of responsibilities for all key personnel and a plan of action to bring a new employee up to speed in the event that there would be a sudden vacancy.

 

[Golfman25]

During our re-certification to ISO 9001:2008 audit, we have a couple minor NCs the root cause of which is basically that my predecessor, the former QC Manager, left the company and did not communicate that certain things needed to be done annually, every three years etc.

Our response was that the root cause was lack of communication. Our CAR said that we would go through our SOPs, listing everything that had to be done on an annual, etc. basis. We would then put this information into a system that enables us to track when everything needed to be done.

The external auditor's response was that it seems our root cause was the loss of personnel and that the Corrective Action needs to address this fact.

Question. How would you address this? You obviously can't keep people from leaving. To me, the root cause is still the lack of communication, and I feel that my plan would address this somewhat. I DO understand that Knowledge Management is something we will need to address as we move towards transitioning to ISO 9001:2015 next year. But for right now I need to address the current issue.

Any help would be greatly appreciated.

I agree with you in this case. Your talking about deadlines and communication or recordkeeping of those deadlines. It seems you had no way of knowing what was due, when -- so when the guy left, things got missed. Even if you addressed "loss of personnel" and onboarding the new guy (you), if your systems aren't setup to flag a due date, you still might miss it.

We all do it in calibration, no. Everything has a "due date" and we can print the list of what is due each month and get it done. Setting up a similar systems for all your quality dates might be helpful. Good luck.

 

[Ian_Morris]

Hi QC Dave,

From the information provided, I hope that the auditor was referring to not identifying, planning for or managing the risk of loss of key personnel and consequently key organisational knowledge.

There will undoubtedly be more instances where processes in organisations, possibly still within your own, that rely heavily on the work of one person, without the controls in place to ensure continuing service in the event of that person leaving their position (especially if it is done suddenly).

Identifying the key people within your organisation and having those plans for contingency are critical to meeting your day to day client obligations, let alone the requirements of the standards.

Hope you find this useful.

 

[locutus]

Interesting situation. In my own thoughts, this is exactly for all of the text in ISO 9001:2015 now, e.g. risk and opportunity, planning, PDCA, and more importantly knowledge of the organisation. Just in another thread someone was asking about how to create and audit to knowledge of the organisation (that thread is long and has many good helpful advice). This is exactly why organisations need to examine this aspect, whether you call it knowledge, business continuity, risk, etc. it all boils down to the same thing - what happens when a key individual leaves a company and all their knowledge and information goes with them?!?

I can tell you from my own perspective being hired on as the "new" QA Manager, that I never had anyone explain the job to me, what needed to be done, or how things were done. I always had to figure things out on my own. This was always a challenge because being the new person, some things did fall through the cracks.

My own opinion is this is where quality planning is key. Whether you create a document, structure, or process, there needs to be methods for capturing when activities need to be done or things upcoming. In your specific example about things being done annually or every three years, I always created a "Company Annual Quality Plan" where I outlined all those routine things that needed to be done. This annual quality plan pointed to my external certification audits, routine regulatory inspections, pointed to our internal audit programme, management reviews, business reviews, customer feedback reviews, documentation reviews, etc. etc. The "list" or document as such is just populated to keep track of all those routine and on-routine tasks that companies do.

 

[Golfman25]

I don't see this as a knowledge issue as much as a processing issue. It's really no different than a shipping schedule. We all use some type of Erp system to know what to ship and when. Anything not in that system has the potential to get missed. Similarly, law firms usually have a master schedule for all of their attorneys. All important dates are logged in that schedule. That way a person can review the list and make sure everything is covered, regardless if the assigned attorney is there.

 

[Cari Spears]

I agree with you in this case. Your talking about deadlines and communication or recordkeeping of those deadlines. It seems you had no way of knowing what was due, when -- so when the guy left, things got missed. Even if you addressed "loss of personnel" and onboarding the new guy (you), if your systems aren't setup to flag a due date, you still might miss it.

We all do it in calibration, no. Everything has a "due date" and we can print the list of what is due each month and get it done. Setting up a similar systems for all your quality dates might be helpful. Good luck.

I agree. I recently answered a number of NCRs from our Nadcap audit with [lack of succession planning / organizational knowledge] as the root cause. The Quality Director here retired, and a number of things did not happen between then and when I started.

I designated back ups for various things and added stuff to the internal audit schedule, the record retention matrix, our management review schedule, etc.