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If you want to speed up your work when designing complex assemblies use the Master Modeling technique to avoid aligning all of the components individually.

Learn more about Square-1's CAD Services HERE.

[This article is also featured on episode 72 of the Business Wingmen Podcast Show]
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Successful performance is everything!  Our ability to execute at work is something we as professionals need to strive towards every day, yet many of our colleagues seem to have forgotten this time-tested reality of business.  As Rory Vaden, bestselling business author and leadership speaker, accurately shares, “success is not owned, it is rented - and that rent is due everyday.”

Vaden hits on a key piece which would serve all of us well to keep in mind as we come to work - our ability to successfully perform our job is what keeps us gainfully employed.  I’ll take it a step further, what got us the job was our credentials, the things we’ve done in the past.  What keeps us in the job thereafter is 100% our ability to get things done – the things that matter to the company and our respective performance. 

The same is certainly true in the consulting world, frankly I would argue it’s even more focused on performance and execution than a normal 8-5 full-time job is.  The world of consulting can be summed up in 3 words: execute, execute, execute!  Anything less and you’ve missed the mark.
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Consultants, like many of our fully employed brethren, has a tendency to forget the reason they are there, the reason they have a job – it’s to fix, solve and solution other peoples’ problems.  Our inability to do this will inevitably lead to a consultant, or consulting firm, finding themselves unemployed or not getting asked back to continue supporting their customers. It’s for these reasons we need to employ the below five ‘best practices’ in our daily work.  Your ability to do so will do two things – help keep you focused on what matters (successful execution of your task or job) while separating yourself from the competition and or your colleagues.  

​Best Practice #1 – Proactive Communication
If you’ve ever had some one say to you, especially someone in management, “can you give me an update on where you’re at with X”, you’ve just failed the first lesson of communication.  Professionals who operate at a high level understand the importance of fluid and consistent communication.  They know it’s important to communicate proactively, ahead of time.  They don’t wait until the last minute to spring an urgent matter on the team or their boss, they don’t procrastinate, and they certainly don’t wait to inform those around them they are going to miss a deadline the day the deadline is due.  Proactive communication is all about respecting the process and those around you. 

​Best Practice #2 – Positive Mindset
The beautiful thing about the way our minds work is we have an incredible amount of power over most of what happens in our heads.  In particular, our outlook on things, our attitude, is 100% within our control.  If we show up to work with a bad attitude, closed to others ideas, not welcoming feedback and or unwilling to collaborate with others we quickly will build a reputation as a person on the fringes.  There’s no quicker way to alienate oneself from a team or your boss than by having a poor attitude.  Yes, we all have our bad days – it happens even to the best of us.  What’s important is to have your moment and then move on.  Focus on what you can control and be open to ideas, different approaches and perspectives.  An open and positive mindset is contagious causing your colleagues to feel invigorated working with those of us who can come to the table and leave the sourness at the door.  Positive thinking also boosts our health by reducing stress!

Best Practice #3 – Ownership
We don’t need to be in management or the owner of a company to operate in a capacity of owning our work.  Those of us who employ ‘ownership’ in our work don’t make excuses for shortcomings, we don’t worry about excuses because we’re busy finding solutions.  When we own our work we don’t wait to be told what to do, we seek work proactively and or ways to improve things around us.  People who operate with an ownership mentality have a tendency of being able to make decisions quicker while experiencing success more often.  If you’ve ever said “that isn’t a part of my job description” you just failed the ownership best practice.  People who own their work get promoted more, are typically paid higher wages and increasingly get called back to help with projects.  They take responsibility for how they show up and encourage others around them to do the same.
Of all the best practices listed in this article it is my humble opinion the practice of owning ones work and being accountable for it carries with it the biggest positive impact on our jobs.

Best Practice #4 – Accessibility
In the dawn of everyone working from home these days, or remotely, being able to get a hold of someone during normal working hours is critical.  Simply put – if your boss has to track you down every time they need to reach you it probably isn’t going to end well for you in that job.  Same is true if your company uses communication tools like Slack or Microsoft Teams.  These tools are used to improve communication amongst the team, if you aren’t logged into the tool and or are unresponsive, you’re setting yourself up for a quick career death in your job.  This doesn’t mean you need to be chained to your desk or phone eagerly awaiting the next hopeful call by a colleague or boss.  What it does mean is that you need to be mindful of the various ways in which your company communicates and be attentive to those processes.  If people feel like its easy to get in touch with you and or you respond quickly, they will invariably feel you are on top of things and are a reliable person to work with.

For example, our company practices the ‘1/24 rule’ during standard business hours.  We expect our teammates to acknowledge a communication with a response within an hour and provide an answer, or what to expect next within 24 hours.  We aren’t perfect at this down to the minute (as that would be unrealistic) but I’ll be the first to say this practice makes our teammates highly proficient and therefore their jobs easier.

Best Practice #5 – Systems & Tools
Whether you’re a consultant, an employee or just new to your job, in today’s world there’s no excuse for not learning a company’s procedures, systems and tools.  Those of us who choose not to work within these parameters typically find ourselves making careless mistakes, coming up short on our projects and irritating the heck out of our colleagues and management.  Why is this?  Well, when we don’t use a tool right, or don’t follow a certain SOP accurately it inevitably makes more work for someone else down the road.  Trust me when I say every one hates having to fix other people’s inaccuracies, especially when it’s documentation related.  If you’re new to a company do everything you can to quickly spool up by learning the tools, systems, workflows and documentation processes.  The quicker you learn it the better your work product and output will be.  People may just like working with you better as a result.
 
Conclusion
While there are many things which lead to someone being successful in their line of work, I firmly believe these five best practices are things all professionals can do, regardless of their experience, education level, etc.  We have a choice to make every day when we show up to work – be the best at what we do or simply be average.  As the job market continues to tighten up those of us who are average will find themselves unemployed far more frequently than those of us who choose to operate at a high frequency.  It’s a choice – do you have what it takes? 

EU MDR got you down? Is the mountain of compliance work you have in front of you taking away from other projects?

It's time you got some help! Learn more HERE

#compliance #consulting #qualityengineering #regulatoryaffairs

Being a consultant can feel like you're on an island by yourself, especially when you're on project with a client.  Having a community you can collaborate with can give you the tools to not just survive your next project but finish it with a masters grace.  

This is the reason Square-1 started the Consulting n' Coffee networking group - to build community for those of you who need it most.  Learn more about the free meet-up networking group at Consulting n' Coffee HERE.

This full length video showcases the importance of using the sweep and loft functions within Solidworks to create complex shapes.  After the console and or enclosure is complete, split the model up into multiple parts to aide in proper DFM and ease of assembly.

Learn more about Square-1's CAD Services at by clicking HERE

Today's Solidworks quick tips highlights the importance of working smarter, not harder, using the Hole Wizard tool to efficiently design holes within a chassis.

For more information visit: www.sqr1services.com/cad-services.html

We’ve heard it a thousand times - the labor market is tight and only getting worse.  Unemployment for professionals is close to an all-time low while demand continues to skyrocket.  Frankly, this is nothing new, nor should this be news to most of us.
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What is rather striking are the number of companies who seem to have little plan in place for how they’re going to continue to hire new employees amidst one of the most competitive and challenging employment times in our nations’ history.  Where plans lack, so do results.  Long gone are the days where we can post a job online and get a slew of great applicants, especially in the technology sector.  Why?  Because everyone is working, which means those who aren’t, well there might be a reason for that. 

What this also tells us is in large part the people we all want to hire are gainfully employed elsewhere, to get their attention to come work for you you’ll need to have a plan in place to do so.  Before we can build a hiring plan we first need to understand what we’re up against.

Local Marketplace Dynamics – Orange County, CA:
·       Wages in OC are on average 17.3% higher than the national average and 21% higher than neighboring counties

• OC unemployment in September 2021 was 5%, for professional workers it’s estimated to be under 2% (meaning more than 98% of professionals are gainfully employed right now)
• Many industries are experiencing record growth including IOT, app developers, banking, services and healthcare
• Supply vs. Demand - there are more than 3x the number of job opportunities available as there are people in professional roles to fill them; the supply and demand disparity is even worse in the technical sectors
• Hiring for light industrial/ manufacturing personnel is incredibly challenging due to sheer demand coupled with the supply of personnel still artificially minimized due to geopolitical reasons

 
If your organization is hiring now or in the near future, especially for technologists, I strongly recommend you consider the following hiring and company operational best practices as these will set up both your organization to attract and retain the best people.

Remember, the ‘art of hiring’ isn’t a guessing game or round of blindfolded pin the tail on the doneky.  People work where they feel appreciated, respected, and compensated appropriately so your organization needs to be able to demonstrate that and then operate accordingly.
 
Hiring & Company Operations Best Practices:

• Attraction – two of the best ways to get more eyeballs on your company organically is through your existing employees and social media.  If your existing employees like where they work they’ll tell others, simple as that.  Good people attract other good people.  Some companies offer referral bonuses to their employees for helping to fill key roles.  Secondarily, social media continues to reign supreme when it comes to getting the word out to a large audience.  The trick is to determine which platforms are the best then ensure your messaging is consistent and resonates with your audience.

 

• Sell Your Story – process by which companies build out their sales pitch to attract better talent by using a story to describe the company’s ‘WHY’; it’s a marketing strategy based around the company’s vision and mission – your reason for existing as a company.  This approach is especially powerful with younger generations.

 

• Fringe Benefits & Perks – this isn’t just for Silicon Valley companies any longer, if you aren’t offering some of these you’re automatically in 2nd or 3rd place as an employer:
  • Retirement plans with match
  • Additional compensation via bonuses
  • Work from home programs
  • Vacation for new employees starting at 3 weeks, a 2 week offering is becoming a thing of the past
  • Employee recognition programs
  • Sign on bonuses for new hires
  • Onsite barista/ drink and or snack stations
  • Medical/ dental/ vision plans 100% paid for by employer
  • Employee referral compensation programs
  • Free lunch for employees, or onsite cafeterias with subsidized meals
  • Company ownership incentives
  • Education reimbursement
  • Paid paternal leave for parents (including fathers) beyond FMLA offerings
  • Wellness programs
  • ‘Quiet Room’ spaces which allow employees to decompress
  • Commuter assistance
  • Childcare assistance
  • Car cleaning services

I’ll admit some of the above items seem a bit over the top yet in the same breath I must also admit many of these things are becoming common place.  It’s not to say you need to do them all, but to not offer any of these perks to current and or prospective employees means you may likely find yourself losing current employees to other companies who do have them, or not being able to hire at all.  SHRM estimates the cost to backfill an existing employee is 6-9 months of their annualized salary.  This offers a good moment of reflection – should you invest upfront (perks) or pay in the rears as you look to backfill and replace employees?

Additional Best Practices:

• Employee Onboarding Program - new employees who experienced a well-structured onboarding orientation program were 69% more likely to remain at a company three plus years.  Learn more about onboarding programs at http://www.sqr1services.com/white-papers/why-your-new-employee-wants-to-quit-part-3-finale

 

• Incentives to Stay - Hiring a new employee in today’s market is challenging, ensuring they’ll stay employed with you after the fact is another consideration altogether. Consider implementing or refreshing your programs in areas like on-the-job training, career growth development, mentoring and employee appreciation programs.  These programs showcase an employers’ desire to invest in their employees both for the present and future.

 

• Shorten Your Hiring Process – long gone are the days of half a dozen interviews, followed by panel discussions and presentations.  The employers today who are scooping up the best employees on the market are doing so largely because they’re acting quickly.  In some cases I’ve heard of offer letters presented to prospective hires after just one interview.  Every time a candidate takes another job while they were in the middle of your hiring process that’s time you’ve spent you can’t get back.  Act quick and be decisive.

 

• Use a Hiring Service – most of us are in the business to be good at our chosen professions, which for most doesn’t include acting in the role of HR/ recruiter.  If you can afford the extra cost it’s advisable to partner with someone who does candidate sourcing and hiring on a daily basis as their profession.  Recruiters and personnel in HR typically understand the market and hiring conditions for their local areas well and know how to target people who are gainfully employed – a tactic called ‘direct sourcing’.  In today’s employment market if your strategy is to post and coast (put a job up on an online job board and pray for good candidates) you’re already starting off at a deficit you’ll likely never climb out of.  All hiring strategies must include a direct sourcing component to be successful.

 

• Get Active – not everyone can afford the cost associated with working with recruiters, which for professional hiring, especially in the technology sector commonly comes with a fee of 25% the candidates annual salary.  If you can’t afford a recruiter you’ll need to get active yourself, start by jumping on LinkedIn and reaching out to candidates directly using the messaging service.  Another good practice is to attend industry or trade events with the hopes of meeting good people who could be prospective future employees.  Remember, these approaches typically don’t produce results quickly so you’ll need to invest time and remain consistent at it.

 
To attract the best of the best we need to constantly review and optimize our strategies to ensure they are both keeping up with the current marketplace while producing the results we need.  Remember, continuing to do the same thing over and over again yet expecting different results isn’t a good recipe for hiring success, it’s corporate insanity. 

​Remediation in the medical device industry is often described as a matter of “it’s not if it will happen, it’s when it will happen”.
 
With so many companies over the years going through major remediation efforts one would think by now most people in the business would have a good appreciation for what success looks like to navigate through FDA remediation projects.  Yet, many people will tell you the remediation projects they’ve been a part of were messy, unorganized and a galactic waste of money.  Unfortunately, when we’re faced with remediation there is no choice other than to mend our broken wings before flying home for the summer.
 
This sparks an interesting question – if I have a remediation project ready to deploy what are the things I can do to ensure it succeeds?  Regardless of the project size implementing these six keys to success will drastically help increase your ability to successful execute on your next remediation project:
 
1.       Ensure Your Entire Company (Especially Executive Management) is Onboard
Everyone in the organization, bottom up, needs to understand why this project just went to the top of the work list.  Everyone needs to be bought in and rowing in the same direction, otherwise you’ll experience cumbersome internal issues as mentioned above, which waste time, money and energy.  One can accomplish by using a tactical scorecard as described in #4.
 
2.       Establish Clear, Consistent and Easy Communication Protocols for the Project
Once your entire management team and company is onboard its time to set expectations for communication.  This is one of the most overlooked parts of any large scale project.  It’s especially important when considering cross functional company divisions and the people accountable to working towards successful completion.  When people are misinformed or don’t know what’s going on you can be certain it will slow your project down and cause further product quality and procedural issues down the road.
 
3.       Get a Lobbyist 
You’ll need someone acting as the liaison between your company and the FDA.  Typically, this person comes from your QA/ RA group, but is that the right person?   Don’t assume your de facto executive in QA / RA is the best for the job.  Ensure your company aligns itself with a proven individual who has relationships within the FDA and knows how to play the game.  If necessary get a consultant to support this effort.  This will pay off huge dividends in the end as they’ll know how to navigate delicate situations, get continuances and or leniencies where able.
 
4.       Employ a Tactical Scorecard
Remediation projects can quickly run off the rails if leadership isn’t hyper focused on tangible execution.  When projects span an entire organization involving dozens of resources and a multitude of external suppliers its easy for things to get lost in the shuffle causing delays and confusion among the troops.  To overcome this challenge utilize a tactical scorecard which everyone in management has access too along with anyone who is in a lead role for the remediation project.  It’s a project charter and Gantt Chart combined into one, just simplified.  This scorecard should breakdown the project into four or five key areas as necessary, but no more than five.  Each of these project areas act as a cost center of sorts for accountability.  Within each area you’ll have the activities coming up in the next 30 days, deliverable dates and the people who own the work.  A process like this creates transparency while providing clear direction.  The key stakeholders should meet at least monthly, if not earlier, to review the status of the project in comparison to the scorecard.  SCRUM style meetings offer a good approach for transparency and accountability.
 
5.       Learn How to Manage Cost Early On
Often companies will use a consulting group to lead or help work through their remediation efforts.  All too often the selection process for that supplier comes down to a key relationship within the company which basically side tracks any formal vetting process of other possible suppliers.  Cost becomes a 2nd or 3rd consideration over a relationship.  This can be disastrous as selecting the wrong supplier to help you with a remediation project can end up costing you thousands, if not hundreds of thousands, of dollars extra down the road.  Case in point – when you use suppliers that fly in consultants you are literally paying more than double the cost for that service just because those resources weren’t local.  Flights, housing, food, per diems, auto, travel, etc. adds up incredibly fast.  I’ll admit, sometimes the best solution is an out-of-town supplier, however be sure to do your homework before you settle on the one supplier that’s going to get your company back on track. 
 
6.       Know the Difference Between Execution & Strategy
As mentioned above, companies use consultants because it’s a good way to get ahead of a remediation project with people who have been there an done it before.  It momentarily expands your bandwidth for as long as you need.  While that sounds lovely there is a downside to the consulting and client relationship – the difference between strategy and execution.  Some consulting companies bill themselves as experts and charge big prices to boot.  What many companies find out the hard way is that these overpriced consulting firms stay up in the stratosphere where strategy is best played and seldom come down to the ground level to get their hands dirty.  This means they can put a plan together but executing on it is another story all together.  If you’re going to use a consulting firm make sure your contract includes deliverables which focus on execution and completion of work. 
 
Key Take Away:
If you’re heading into an FDA remediation project it is paramount to set up a company wide communication protocol which provides direction and project updates in real time.
 
Action Item:
Remember – it’s not ‘if’ but ‘when’ you’ll find yourself in a situation where you’re stuck going through remediation.  Therefore, you must be proactive.  Before you need the help, begin compiling data on suppliers that could help with a possible remediation project.  Compare their capabilities, learn how they would approach a potential project, how do they charge, etc.  Once you’ve done your homework you’ll then have all the necessary information upfront to make a strategic and informed decision when it comes time to dive into remediation.

You’ve got an idea!  Maybe it’s to optimize a process, save the company money or to develop a new product.  Many of us at one point or another in our careers will come across this situation where we have a brilliant idea but we don’t know how to implement it.   Once we have the idea what we do after the fact is what makes or breaks our ability to turn into reality.
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The steps below can help you organize your thoughts in a formal manner so you can further vet your idea while positioning yourself (and of course your idea) for the best possible chance to get approval from the powers that be.

Step #1 – Develop A Business Case

A business case captures the reasoning for initiating a project or task. It is often presented in a formatted written document outlining everything from the reason for the project, problem(s) it solves and the ROI.
 
Components of a business case document may include:

1. Identifying the business need (‘why’ should the company invest in your idea)
2. Expected Outcome & ROI
3. Justifying why the project is necessary
4. High level outline of project goals and objectives
5. What does successful completion look like
6. List of assumptions, things you believe to be true regarding your project
7. What challenges or constraints will you likely encounter?
8. Share what alternatives have you considered
9. Perform a cost benefit analysis to determine the strengths and weaknesses of alternatives in comparison to your idea or project
10. Close with a strong recommendation on why the company should invest in your idea (this needs to clearly articulate why it would be a dumb decision for the company not to move forward with approving your idea or project)

Once you’ve compiled your business case now it’s time to present it.  Set a meeting with your boss, or the appropriate party who would most likely approve your idea and or project.  Inform them ahead of time what the purpose of the meeting is and arrive prepared with multiple copies of your business case both to reference and present from.  Leave the approver with a copy of your business case and an action item to keep them engaged and thinking about your presentation.

Well look at that!  You did such a good job compiling your thoughts and presenting your idea that your boss granted you approval to move forward in the project.  Excelsior!

Now that you have approval, which is a fancy way of saying “we like your idea enough to put money behind it”, you will need to build out the project in detail using a ‘Project Charter’ to ensure it meets a successful conclusion.
Note: What’s the difference between a ‘Business Case’ and a ‘Project Charter’?  A business case comes first as it is an assessment or feasibility study of an idea or task; the sponsor (person who has the idea) pitches their case to the funding stakeholders (typically your boss or people in management). If approved, a project charter is completed outlining the project in detail. The information within the charter is the constraints for which success will be measured.

Step #2 – Develop a Project Charter

As mentioned above, the project charter is a document which clearly defines the project scope, objectives, and participants involved. Components of a project charter may include:

1. A clear statement, or project scope, describing deliverables and the problem or opportunities the project is meant to address along with phases throughout the project
   1. This also includes what’s out of scope for the project, meaning work which isn’t involved in this project
2. How are you evaluating performance via success criteria
3. Objectively and upfront identifying areas of risk, these are ways the project could fail if not addressed properly
4. Detailing out project requirements which are conditions or tasks that must be completed to ensure the success or completion
5. Outlining a schedule for events for the project, this is typically accomplished using a milestones approach or Gantt Chart
6. Describing the project budget, including funding sources and how those funds might be used from a time/ resources and materials perspective
7. Identify team members and project lead(s) as well as what other resources will be used to support the project (cross functional, suppliers, consultants, etc.)
8. Establish communication expectations so the team knows how and when project updates will be given; consider using the SCRUM or Agile methods

 
You’ll note that much of the work that was done initially for the business case can in turn be used in completing the project charter. If your project is big enough it may be worth looking into project management software, like Basecamp or JIRA, to electronically track your projects activities and deliverables.

Now that you’ve got your main documents guiding you through the project out of the way the next step will be to kick off the project and get underway.  I recommend doing the kickoff meeting in person if possible, or via video conference call, where the team can openly talk about the needs of the project and how tasks will be divided up.  All resources involved in the project should have a copy of the project charter along with clear expectations on what their role is and timeframe to deliver those tasks.
Now that you have a basic foundation for what is needed to get your projects approved and kicked off the next step is to look into resources like the Project Management Institute (PMI) and their primary resource guide called Project Management Body of Knowledge (PMBOK).  These resources will help you stay on track while providing vast amounts of information on how to move projects through to successful completion.