This article explains why remote audit duration should not exceed 90 minutes and the unique opportunities created by a series of short remote audits.
Parkinson’s Law and the subject of audit duration
On November 19, 1995, Cyril Northcote Parkinson published an essay in the Economist. The title of the article was “Parkinson’s Law.” In the first sentence of the essay, Parkinson says, “It is a commonplace observation that work expands to fill the time available for its completion.” This essay refers to the observation that work is elastic concerning the demands on time when completing paperwork. When I first trained as an auditor, trainers emphasized that the most significant challenge faced by auditors is to complete an audit within the time available. An auditor’s task is to achieve the audit objectives within the time specified by the audit program manager. Time is precious, and you cannot easily extend the audit duration after scheduling the audit.
How much time is needed for a full quality system audit?
This question is a silly question to ask a consultant that works on an hourly basis. A consultant working on an hourly basis will make more money if they work more hours. Therefore, there is little incentive to underestimate the time required to complete the objectives of an audit. However, after completing hundreds of audits, I can honestly state that eight hours is not enough time to perform a full quality system audit of a medical device company’s quality system. However, I completed a full quality system audit of a small company in less than two days. I also had difficulty completing an audit of a larger company in four days. An FDA inspector typically requires four days to complete a routine inspection, even at foreign manufacturers where English is a second language, and they only need to return on the fifth day to prepare their FDA 483 observations to give to the company. Therefore, three days is typically the absolute minimum time required to complete a full quality system audit.
Does Parkinson’s Law apply to audit duration?
Parkinson’s Law certainly applies to the audit duration. If the lead auditor assigns a team member to review the CAPA process, the task is unlikely to be completed in 30 minutes, and most auditors would struggle to appear busy for more than three hours. You need enough notes to provide objective evidence of conformity for your audit report, but if you finish too quickly, then others may perceive that you were not thorough. Therefore, most auditors will begin any process audit by asking for a copy of the procedure and a log of the records available. The auditor will quickly review the procedure’s revision history to determine when the last revision was made and if there have been any significant revisions since the last audit. Next, the auditor will review the log to estimate how many records should be sampled. The auditor will then estimate how much time is needed to review the sampled records. Finally, a quick mental calculation is made to determine how much time remains for procedure review before the auditor must move on to interview the next subject matter expert.
Why are auditors always behind schedule?
An auditor begins with small, close-ended questions that are designed to put the auditee at ease. The auditor may even comment on unrelated subjects to build rapport first. Records may not be readily available, but auditors almost always have to wait for record retrieval. The request is recorded, copies are made, and the subject matter expert may need a little time to review before handing the auditor the requested record. Auditors will ask clarifying questions, and auditees will need a few moments to check their facts. Any one of these delays is insignificant by itself, but collectively there may be two-and-half minutes of delay cumulatively for each record requested if you sample five records, which represents a combined delay 12.5 minutes. If you average only seven minutes to review each record, then a sampling of five records will require 47.5 minutes. This will leave you only 12.5 minutes for introductions, review of the procedure, and conclusions. If you want to interview any of the people that investigated root-cause, then you will need more than an hour to complete your audit, and you will not finish in the one hour scheduled.
Why is it so hard to complete a full quality system audit in three days?
Most of your process audits require a few more minutes than you expected, but you will also need time to walk to the next subject matter expert, or you will be waiting for the next subject matter expert to enter the conference room. If the quality system consists of only the minimum twenty-eight required procedures, your full quality system audit will require more than 28 hours to complete. If there are additional regulatory requirements for CE Marking or ISO 13485 certification, you will need even more time to audit every process. You should also expect certain processes to require more time to properly sample records, such as technical documentation and design controls. Even the most experienced auditors struggle to review a technical file and/or design history file in less than two hours.
What happens to an auditor after auditing all day?
As a Notified Body auditor, I used to leave my home in Vermont on Sunday afternoon and drive two hours to the nearest major airport. Then I would be gone all week conducting audits. On Friday, I would drive home and arrive in the middle of the night. Each day audits would begin early in the morning, and I would complete the day after 8.5 to 9 hours of work. Jet lag, sleep deprivation, too little exercise, and constantly eating at restaurants took its toll. I would consult my Google calendar to learn what city I was in each morning, and to remember what company I was on my schedule for the day. I would purposely try to do as much walking around during the day just to keep my blood flowing and to help stay awake. I would read documents while pacing back-and-forth in conference rooms, and I would always make sure that we had to audit the most remote area of a facility after lunch to make sure that I didn’t fall asleep. I will tell stories and jokes to entertain my hosts, but it was necessary to break up the monotony of auditing quality systems seven days a week. I would make sure I drank at least six liters of water each day for health, but this also gave me an excuse to go to take frequent bathroom breaks. Somehow I managed to survive that lifestyle for more than three years. Each day my feet, legs, back, and neck were in severe pain. I had constant headaches, and I know the quality of my work gradually declined throughout each day. The most valuable lesson I learned was, you need to move frequently, or you will die.
What happens when you sit in front of a computer for eight hours?
I can sit in front of a computer longer than almost anyone I know. When I focus on work, four hours can elapse without me getting up from a chair even once. I might pick up my empty coffee mug four or five times to take a sip before I am conscious of the need to get another cup. On days where my schedule consists primarily of Zoom meetings, I may sit through as many as six consecutive meetings before I take the time to get up and go to the bathroom and get a drink of water. Clients may perceive that I have tremendous endurance, but there are negative consequences to this work pattern. My wrist becomes sore, and I need to switch my mouse pad and the style of the mouse I am using every day. I change computers, switch microphones, and take a short walk. My neck, back, and legs will hurt worse than any of the audits during my years as a Notified Body auditor. Sitting at a computer all day has resulted in mild symptoms of restless legs syndrome. Sitting at a computer continuously for the audit duration is physically exhausting and tedious. If you must complete a remote audit on a continuous eight-hour day, you can, but it is not healthy or productive. The negative health consequences and negative impact on productivity are equally applicable to auditees.
What can you do to reduce audit fatigue during a remote audit?
The most straightforward strategy for reducing fatigue is to take breaks. Instead of auditing for eight hours continuously, try auditing in two or three 90-minutes segments each day. If you are auditing someone in a different time zone, you may only be able to accommodate an audit duration of one 90-minute session per day without working through the night. Taking breaks will allow you to leave your computer, eat food, and even go to the bathroom. You can recharge your headset during a break too. You should consider taking a walk outside. It is incredible how much better you feel when you get some exercise, stretch, and experience a little natural light instead of the unnatural glow of your computer’s monitor. The person you are auditing will appreciate the breaks, but they will also enjoy the improvement in your overall demeanor. A simple smile after a 30-minute break has a tremendous positive impact.
How can we utilize breaks more effectively during remote audits?
Auditors need documents and records to review as objective evidence. The most obvious way to make use of breaks is for the auditor to give the auditee a list of documents and records to gather during the break. This will give the auditee an excuse to go and get the documents and records if they are stored in another location. The auditee might also scan records during a break. A break also gives subject matter experts time to re-familiarize themselves with the documents and records before resuming the audit. Auditees and auditors will need to recharge batteries, but the auditor might take time to convert their notes into a summary for the final audit report. The auditor might also review the audit criteria one more time before writing a nonconformity. The auditee might take advantage of the break to initiate a new CAPA and write a draft of the corrective action plan. Then when the audit resumes, the auditee can review the draft plan with the auditor to ensure that the plan is appropriate and nothing was accidentally omitted from the CAPA plan.
Why are 90 minutes a magical audit duration?
Auditing one process in a single 45-60 minute session is ok, but if you audit two processes in a single 90-minute session, you can reduce the time spend starting and stopping the audit session by half. Adding a third process to a single session will have a smaller impact, and the meeting will need to be so long that most participants will begin to lose concentration, and fatigue becomes a significant factor. Ninety minutes is not quite long enough to audit two processes effectively. Still, an auditor can request procedures in advance of the session or spend time after the session reviewing procedures. Therefore, by paying an additional 30 minutes reviewing two procedures “off-line,” the auditor can dedicate 100% of the “on-line” time to reviewing records and interviewing subject matter experts. The result is a fast-paced, 90-minute session where each subject matter expert typically is only needed for 45 minutes. Alternatively, if you are auditing more complex records like a design history file, you can spend all 90 minutes discussing that area.