This article lists my top 10 ideas for time management to help prevent work overload–including suggestions for apps and other resources.

I am a workaholic and I don’t recommend it–unless overweight, out of shape, friendless and divorce sounds like a great life plan. I work with regulatory affairs and quality assurance managers at every client, and 100% of them have insufficient resources. Expectations internally and externally never decrease. The saying used to be, “Do more with less.” Now it feels like we have one egg, one basket and we are expected to save the world.

Stop feeling sorry for yourself. Every department manager feels this pressure. If you don’t believe me, look around you. Everyone is popping 400mg of ibuprofen and stressed to their limit.

So what can you do to make things better?

That question is critical. It shows that internally you acknowledge that you can do something to make things better. I obviously don’t have all the answers, but I have found some tools in the past year that really made a magnificent difference in helping me with time management. 100% of these ideas were suggested by others that appear to be more at peace and happier than I was last year.

#1 Get some sleep

Two years ago I woke up after 3-4 hours of sleep every night. Last year I was almost up to 6 hours of sleep on a good night. Now I am consistently getting 6-8 hours of sleep, and once I slept for 9 hours. There are lots of suggestions for how to get more sleep, and I’ve tried them all. What works for me is: 1) no alcohol or coffee within 4 hours of bedtime, 2) melatonin just before bed, 3) exercise every day, 4) eating well, and 5) a habit of reading each night to calm myself and relax. I also use a white noise app on my phone.

#2 Budget your time management

You will never get everything done. It’s a fact. Just like money, you can always spend more. Instead, decide how much of your life you want to spend doing things. Don’t micromanage your time. Think of the big picture. There are 168 hours in a week, and >42 hours should be spent sleeping. 40-50 hours a week will be spent working. 5-10 hours per week will be spent getting to work. More than two-thirds of your life is spent sleeping and work-related–if you’re not a workaholic. Be very selfish of how you budget the remaining third of your life. I like to re-read habit #3 from Steven Covey’s book “7-Habits of Highly Effective People.” It will help you remember what’s important. Your priorities should be physical health, mental health and your family. If you devote an hour a day to each of those, you might have time left for eating, grooming and reading a book. Yes, you need vacations too!

#3 Minimize multitasking

Some people believe time management is managing multiple tasks at once, but it is actually less efficient to multitask. Picking something up, putting it down, picking it up again…didn’t you learn from your lean manufacturing training that motion, waiting and queue are all muda (i.e., waste). You need to start a task, finish that task and then start the next task. If you want more advice on this topic, try reading “Getting things done” by David Allen. This one was recommended to me by an uber-productive orthopaedic surgeon.

#4 Don’t forget to “sharpen the saw”

This is the seventh habit from Covey’s book. You should never stop improving. For example, entrepreneurs need to learn marketing. I don’t have time for an executive MBA to learn marketing. Instead, I teach myself every day while I’m working out. I have a bicycle on a trainer set-up in front of my TV. The TV is only connected to the internet. If I need a break, I watch Netflix while cycling. However, usually I’m listening to podcasts, watching YouTube videos about marketing and software tools or I’m reading books on my Kindle. I also purchase a lot of audiobooks that I listen to in the car while driving my children to rock climbing, soccer, plays and during my two-hour ride to and from the nearest airport. This is the only kind of multitasking I’m good at.

#5 Just say no.

You need to put first things first (i.e., habit #3). On a scale of 0-10, how important is it. Is it important to you, your boss, your spouse, your children or your best friend. If not, why are you wasting your precious time on it. Say no. If it’s a 9 or 10 to your spouse, say yes–even if it’s a 2 on your scale. If you have a time conflict with two items that are high on the scale, then you need to find a win-win (i.e., habit #4). This is why communication skills and empathic listening (i.e., habit #5) are the most important skills you will ever learn.

#6 Don’t read your emails “real-time”

You should have a plan for what you are going to do each day. Reading your emails throughout the day will result in reactive behavior that will always result in time management failure. Be proactive (i.e., habit #1). Read your emails just before lunch in a batch and just before you go home in a batch. You should also read “Getting things done” by David Allen. He has fantastic advice for how to process emails. This is an area I’m still working on, but I get 400+ emails a day and that doesn’t include spam, social media or promotions. You should also tell people you work with, “Call me or text me if it’s important.” Good advice for any client of mine. For example, you should probably text me if the FDA is coming on Monday and you need my help.

#7 Use productivity apps for time management

Microsoft seems to have a strangle hold on corporate America, but Outlook is a horrible tool for managing your tasks and time. You need something for personal time and personal tasks, because you have less time available for the things that are more important in your life (i.e., health, family and friends). If I empty the milk carton, I grab my phone and add milk to my “Out of Milk” app. I also use this app for planning what I need for trips, meetings and Christmas present ideas for the kids. Evernote is an uber-app. It organizes everything. Website links, blog ideas, business cards, photos, an address, directions, photos of the person I’m meeting and I use it for lists too (if I already have it open instead of Out of Milk). If you want to know how the most productive people in the world use apps like Evernote, John Lee Dumas includes apps like Evernote in every entrepreneur interview he does–1,303 podcasts and counting.

#8 Block off time to get work done

Some people believe that time management only involves scheduling meetings. You schedule weekly meetings with your boss. You schedule lunch meetings. You should also block off some time for getting work done–without interruptions. You might try blocking off every day from 11:30-Noon for emails, Noon-1pm for a lunch and a walk and 4:30-5pm for emails. If you need to review complaints each day for the need to report as an adverse event, block off some time for that each day. My advice would be to devote time to reviewing CAPAs, complaints and MDRs every day. These are the most critical areas for FDA inspections and you can’t afford to let these tasks fall behind. If you have these tasks assigned to you, then you work on the most urgent task and get it done. Then you schedule the next step for that CAPA, complaint or MDR and go onto the next task you scheduled. If you manage these processes, then you should block off time for reviewing metrics and investigate the exceptions. If it seems like you never have enough time in your schedule for all the tasks, maybe you need to delegate some of those tasks to other departments or people in your department.

#9 Schedule shorter meetings

Not all meetings deserve 1 hour. Some things can be done in 15 minutes, 30 minutes or 45 minutes. Learn about good meeting etiquette, make an agenda and manage the meeting so it’s done on-time or early. Make sure you show up on-time and get it done on-time or early. If people leading meetings are poor at time management, do not let them lead the meeting.

#10 Schedule breaks too

Outlook will allow you to schedule back-to-back meetings from 7am to 7pm (or longer). That doesn’t mean that you should, and that is definitely not good time management. Time management needs to create windows of time where you can rest too. I drive a lot. In order to survive 50,000 miles of driving a year with a congenital spine defect (i.e., L5 fused to pelvis one one side), I need to take breaks and stretch. When I don’t do this I pay dearly. The same thing happens to me when I try to work 12 hours straight without a break. You will be more focused and productive if you take a break once and while.

This article explains how to write a quality system plan template to revise and update your quality system for compliance with ISO 13485:2016. If you want to download our free template, there is a form to complete at the end of this article.

Templates are the key to writing a quality system plan

Plan, do check, and act (PDCA) is the mantra of the Deming disciples, but does anyone know what should be in your quality system plan template. Everyone focuses on the steps–the “What’s.” Unfortunately, people forget to include the other important pieces of an all-inclusive quality system plan. Why? When? Who? And How much?

The table in the template is an example of “What?” steps to perform, but it is specific to my procedures. You will need to revise the table to reference your procedures, and the changes you make will be specific to your quality system plan. The other sections of the template tell you what needs to be included in that section, but I did not provide examples for those sections.

Why should you create a quality system plan template?

The purpose section of the quality system plan answers the question of “Why?” You need to specify if the purpose of your quality system plan is compliance with new and revised regulatory requirements, preventing recurrence of quality issues, or maybe a faster development cycle. The purpose section of the plan also provides guidance with regard to the monitoring and measurement section of your quality system plan template.

When should you create a plan for quality system changes?

Most changes have deadlines. In the case of ISO 13485:2016, there will be a 3-year transition period. Still, most companies establish internal goals for early implementation by the end of the fiscal year or the end of a financial quarter. Some of the changes can be made in parallel, while other changes need to be sequential. Therefore, there may be specific milestones within your quality system plan that must be completed by specific dates. These dates define “When?” the steps in the quality system plan must be implemented.

Who should write your quality plan?

As my quality system plan template indicates, I recommend defining both individual process owners and teams of process owners where processes can be grouped together. For example, I typically group the following four processes together as part of “Good Documentation Practices (GDPs)”: 1) control of documents (SYS-001), 2) control of records (SYS-002), 3) training (SYS-004), and 4) change control (SYS-006). I cover all four processes in a webinar called “GDP 101.”

It is important to have one person that is accountable and has the authority to implement changes for each process, but only one person should be in control of each process. If you have four related procedures, then the team of four people will need to coordinate their efforts so that changes are implemented swiftly and accurately. For the overall quality system plan template, I recommend assigning a team leader for the team of four process owners described above. One of those people should be responsible for team leadership and writing the quality system plan template.

Monitoring implementation of your quality plan?

Monitoring the progress of your plan ensures the successful implementation of the plan. Sometimes things don’t work as planned, and corrections need to be made. Additional resources might be needed. The plan may have been too optimistic with regard to the implementation time required. I recommend assigning one person the task of retrieving team status reports from each of the teams and consolidating the team reports into an overall progress report.

Free download of ISO 13485:2016 quality system plan template

The sign-up form below will allow you to receive an email with the ISO 13485:2016 quality system plan template attached. This is a two-step process that will require you to confirm the sign-up.

If you have a suggestion for a different type of quality plan, please let us know.

This article is a case study that explains how to implement a new ISO 13485 quality system plan at an accelerated schedule of just four months. The quality system will also be compliant with 21 CFR 820.

ISO 13485 quality system plan

Typically, I recommend implementing a new ISO 13485 quality system plan over a period of 6 months. The reason for this is that people can only read procedures and complete training at an individual pace. Since there are approximately 30 procedures required for a full-quality system, an implementation pace of one procedure per week allows a company to complete 90% of the reading and training in six months.

In October, a new client asked me for a proposal to implement a new ISO 13485 quality system plan. The proposed quality system plan indicated that the project would start in October and finish in March. The client accepted my proposal, but they asked me to help them implement the quality system plan in four months, as indicated in the table above. We just started the implementation of the quality system plan last week, and I have discovered some secrets that dramatically simplify the process.  This blog shares some of the lessons learned that help implement the quality system plan at this faster pace.

Outsourcing ISO 13485 quality system development

Not everyone has the skill and experience to write a quality system procedure. Still, if you have a good template, you understand quality systems–then you can write quality system procedures. Depending upon the length of the procedure, it may take four to eight hours of writing for each procedure. Therefore, an in-house quality manager needs to allocate one day per week if they plan to write all the procedures for their quality system in six months. For a four-month implementation of an ISO 13485 quality system plan, you need to allocate two days per week to writing.

Alternatively, you can outsource the writing of your quality system. However, someone must be responsible for “customizing” generic procedures to fit your company, or the procedures need to be written from scratch. A third and final option is to have a hybrid of in-house procedures and outsourced procedures. If your quality manager has limited time resources, then you can supplement the managers’ time with procedures that are purchased and customized to fit your template. If there are specific procedures that the quality manager needs help with, such as risk management, then you can also purchase just those procedures.

Continuous Improvement

One of the basic principles of quality management systems is “continuous improvement.” The continuous improvement cycle is also known as the “Deming Cycle.” There are four parts to the cycle:

1. Plan
2. Do
3. Check
4. Act

When you are developing an ISO 13485 quality system, the first step is to develop the quality system plan. I recommend the following guidelines for a quality system plan. First, plan to implement the quality system at a steady pace. Second, organize the implementation into small groups of related procedures.

In this case study, I have 29 procedures that we are implementing, and there are 11 recorded training webinars. During each of the four months, approximately the same number of procedures are implemented. Then I organized the small groups of procedures around the scheduled webinar training. For example, the month of November will have a total of 24 documents (i.e., eight procedures and 16 associated forms and lists) implemented, and there are four webinar trainings scheduled. Therefore, four procedures related to “Good Documentation Practices 101“ will be implemented as a group under document change notice (DCN) 15-001. Two procedures associated with “Are your Suppliers Qualified? Prove it!“ will be implemented as a group under DCN 15-002. The remaining two procedures, design controls, and risk management, will be implemented as a group under DCN 15-003 with two related webinars on design controls and ISO 14971.

Document Change Notice (DCN)

The next step in the Deming Cycle is to “Do.” For the implementation of an ISO 13485 quality system plan, “doing” involves the creation of procedures, forms, and lists, but “doing” also involves the review and approval of these documents. The form we use to review and approve procedures is called a document change notice or DCN.

It’s been almost 20 years since I completed my first DCN. For anyone unfamiliar with the review and approval of new and revised documents, most quality systems document the review and approval of procedures and forms on a separate form. The reason for this is that when you make one change, it often affects several other documents and forms. Therefore, it is more efficient to list all the documents and forms that are affected by the change on one form. This results in fewer signatures for reviewers and approvers. Several of the companies that I have helped to implement an ISO 13485 quality system plan for failure to review and approve the documents and forms in a timely manner. I think there are two reasons for this:

1. they haven’t been responsible for document control before, and
2. they don’t want to have to create and maintain quality system records any sooner than required.

The first reason can be addressed quickly with training. The second reason, however, is flawed. It is essential to implement the procedures as soon as possible to begin creating quality system records that can be audited by an ISO 13485 certification auditor or by FDA inspectors for compliance with 21 CFR 820. I have struggled with this hesitation in the past, but for this project, I am completing DCNs for the initial release of all the procedures and forms. This ensures that all the procedures and forms will be reviewed and approved shortly after the webinar training is completed. Also, this gives my client multiple examples of DCNs to follow as they make revisions to the procedures and forms over time.

Quality Objectives & Data Analysis

The third step in the Deming Cycle is to “check.” I recommend using quantitative metrics to track progress toward your goal of completing the quality system implementation. For example, if you have 50 documents to review and approve, you can track the % complete by just multiplying each document that is approved by 2%. You can also track the implementation of documents separately by type. Every DCN you route for approval will take a certain number of days to complete. You might consider tracking the duration of DCN approval. As a benchmark, an efficient paper-based DCN process should average about four days from initiation to completion. I have seen average durations measured in months, but hopefully, your average duration of DCN approval will be measured in days. Another metric to consider is the % of required training that has been completed for the company, for each department, and for each employee. Regardless of which metrics you choose to evaluate your quality system implementation, you should pick some of these metrics as quality objectives (i.e., a requirement of ISO 13485, Clause 5.4.1). You should also analyze this data for positive and negative trends as required by ISO 13485, Clause 8.4.

Your first CAPAs

The fourth and final step in the Deming Cycle is to “act.” Acting involves taking corrective action(s) when your data analysis identifies processes that are not functioning as well as they should be. To achieve ISO 13485 certification, you will need some examples of corrective and preventive actions (CAPAs) that you have implemented. The steps you take in response to observed trends during data analysis are all potential CAPAs.

Download an ISO 13485 quality system plan

Later this week, I will be posting a follow-up blog that explains how to write an ISO 13485 quality system plan for establishing a new quality system. There will also be a link for downloading a free ISO 13485 quality system plan.

This article explains what a master validation plan is, when is it appropriate to have a master validation plan, and when you need one.

Master Validation Plan

In the United States, there are two applicable regulations for medical device manufacturing process validation: 1) 21 CFR 820.75, and 2) ISO 13485, Clause 7.5.2. Neither the QSR regulation nor the ISO 13485, include any mention of a master validation plan. There is a requirement for product realization planning, and a master validation plan could be an essential part of that planning. However, master validation plans are not mentioned anywhere.

MDD – Master Validation Plan?

For companies that manufacture CE Marked products, the term validation appears in the MDD (93/42/EEC as modified by 2007/47/EC) a total of two times. Only one of those references is specific to process validation, but there is no mention of a master validation plan. The single mention of validation appears in Annex VII, and the reference is specific to the requirement for including a copy of the sterilization validation report in a technical product file.

CMDR – Master Validation Plan?

For companies that hold one or more Canadian Medical Device Licenses, “validation” appears in the Canadian Medical Devices Regulations (CMDR) a total of eight times (four times as part of the French translation). The first four references are part of the definition of validation, where the CMDR is referring to design validation. The remaining four references specifically mention the requirement for the inclusion of process validation and software validation in a medical device license application for Class IV devices. None of those references say of a master validation plan.

IQ/OQ/PQ Requirements?

Not only is there no mention of a requirement for master validation plans in any of the medical device regulations, but there is also no mention of installation qualification (IQ), operational qualification (OQ), or performance qualification (PQ). The only mention of validation protocol or report appears in 21 CFR 820.70 as it refers to using validation protocols for validation of software controlling automated equipment.

21 CFR 210 or 21 CFR 211 requirements?

The requirements for medical devices historically are derived from pharmaceutical regulations–which included the requirement for process validation. However, neither 21 CFR 210 nor 21 CFR 211 mention master validation plans (need to verify). They also don’t mention IQ/OQ/PQ requirements.

Where did the idea for Master Validation Plans Come From?

GHTF/SG3/N99-10:2004 is the guidance document that was created by the Global Harmonization Task Force’s Study Group 3 for guidance on process validation. The guidance even includes templates for a master validation plan, IQ, OQ, and PQ. The guidance indicates that the purpose of a master validation plan is to plan validation and revalidation activities. There are other planning documents that could be used instead. For example, design plans include process validation as part of the design transfer activities when a new product is being developed. Quality plans are used for facility expansions and construction of new facilities. Some companies even include validation and revalidation plans in their process validation procedure and/or sterilization validation procedure.

For companies that have equipment that requires validation, I like to use an equipment register that identifies calibration, preventive maintenance, validation, and revalidation requirements as part of the equipment register. This allows me to use one single document to manage all the planning of calibration, preventive maintenance, and validation. If there are no validation requirements, then the appropriate column of the equipment register will indicate “n/a.”

What is a Master Validation Plan?

A master validation plan (MVP) is simply a plan for your equipment and process validation activities. All the equipment, processes, and software requiring validation should be included in the MVP. The plan should reference the applicable protocol and report for each item in the plan. If there are revalidation requirements, the plan should indicate when the last validation was performed and what the frequency of revalidation should be. Ideally, similar equipment will use the same validation protocols that are controlled documents and pre-approved. Over time the number of reports referenced will increase, but the plan should only reference the most recent approved protocol(s).

Some companies include the rationale or triggers for revalidation in the plan–just as you would for a record retention table. However, other companies will include this detail in the validation protocol and/or in the process validation procedure. The rationale for revalidation only needs to be in one of three places, and duplication of the information just encourages errors and audit non-conformities.

Procedures & Templates

We also have a process validation procedure.

Medical Device Academy released a new webinar this week for training companies on good documentation practices.

Have you ever wondered where the FDA regulation is that says, “…shall not use white-out to correct quality system records.”

Don’t bother looking, because you won’t find it. You also won’t find any regulations against the use of red pens, highlighters, pencils, or markers. You can’t even find a guidance document that tells you not to put a single line through mistakes, initial and date it.

The applicable regulation is 21 CFR 820.180, but the regulation doesn’t specifically say these things. Instead, the regulation states: “Records shall be legible and shall be stored to minimize deterioration and to prevent loss.” The ISO 13485 Standard is not much different. It states that you must establish a procedure that will “Define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.”

Over time medical device companies have developed some standard approaches to meet the requirements for Document Control, Control of Records, and Training. These are the three core processes that I call “good documentation practices.” If you need training or you need tools for training employees, click on the link below to purchase our new webinar on good documentation practices.

http://robertpackard.wpengine.com/good-documentation-practices-webinar/

The webpage also includes an exam for training people on good documentation practices. The exam serves as a useful check for the training, but we recommend that process owners monitor these processes–especially if the process is manual. For example, QC inspectors will complete inspection records and file the record as a quality system record. The QC supervisor, or process owner, should periodically review these records for completeness and accuracy. If the supervisor notices an error, the supervisor should notify the inspector and have them correct the mistake. The supervisor should also track how many times each error is made and specifically where errors are occurring. The collection of this data gives the supervisor trend data to help them identify which forms need to be updated to prevent mistakes and which employees require retraining. This data also provides evidence of competency for each employee concerning good documentation practices.

After you have completed the training, you might also be interested in downloading our procedures for Document Control, Control of Records and Training:

http://robertpackard.wpengine.com/standard-operating-procedures-medical-device-academy/