Compliance Zen

Three Tips to Elevate Your Compliance Communications

Good communication is a hallmark of trust.  If people know they can count on you to communicate well, to articulate thoughts in ways that are understandable to any listener, then people will see you - and the programs you champion - as worth paying attention.  And when it comes to dealing with the FDA or the EMA or Health Canada or any other regulatory agency, communications speak volumes about the levels of trust and competence that regulatory authorities should assume about you.

Three tips to elevate your communications when it comes to regulatory compliance and quality systems:

1. Equate email with image.  Think of email as tiny bits of a virtual company image.  At a minimum, use spell check (but don't rely solely upon it), keep the number of recipients to a minimum, do not flag items as urgent or high priority if they really aren't, and understand that email is not private.  As a colleague once put it in a training session, "Don't put anything in your email that your mother would be ashamed of reading in tomorrow's New York Times."
2. Readability of memos and emails.  When it comes to memos, use your word processing program to check for the ease of comprehension (e.g., readability).  Microsoft Word, for instance, will allow you to check readability levels when you check spelling and grammar.  But when it comes to emails, you'll need to do the work, so some rules to keep in mind:  anything more than 3 paragraphs will encourage skimming so be cautious; when you can, number items rather than bullet point them; keep lists to under 5 items; and make sure to read through any email to a regulatory agency or your boss (at minimum) to ensure you've not inadvertently left out a word or two (something we're all guilty of occasionally).
3. Visit in person.  Know when to write, call, or visit.  If you're having trouble picking just the right words or phrases to use to avoid misunderstandings, that's the signal to step away from the computer and go talk to someone in person or on the phone.

The news is full of pharmaceutical and device firms who've gotten sued or otherwise involved in litigation, and have been forced to divulge their emails and internal business communications.  Don't join in.  Use these tips to help you think twice about recording comments and phrases that might later be taken out of context and used to portray you or your company in a negative, uncaring light.

For more advice you can use on controlling records and handling requests from FDA for records or emails, see my recorded seminar, FDA Quality Systems Records Requirements and Retention for Pharmaceutical, Biotech, and Device Firms - GLPs, GCPs, GMPs, QSRs.  You get a 9-page matrix detailing out various retention requirements under each regulation along with loads of tips and advice on how to build in retaining the right records to prove compliance and product safety, efficacy, and quality.

And if you need more advice, feel free to contact me directly.

Avoiding Groupthink in Compliance – Six Tips

Being compliant isn't just about reading and following the regs.  It's about balancing business and regulatory expectations with the needs of the people involved.  Good compliance is about leadership.  And the smart executive can turn good compliance into competitive advantage.  So what's stopping you?

One hurdle might be the need for constant consensus.  It's something we've all fallen prey to at times in our careers.  But eventually, the need for mutual support and approval can lead to doubt suppression, illusory assumption sharing, and premature consensus.

Ultimately, this results in disastrous decisions, especially when dealing with FDA compliance and quality systems.

Six tips can help:

1.  Encourage skepticism.

For any significant decision, ask your colleagues or staff to identify at least two reasonable conditions under which a particular choice your team faces might result in failure.  When I advise Quality Systems and Regulatory Affairs teams on lean compliance, I suggest they use the "2% rule" to define "reasonable."  In other words, for something to be reasonable, there has to be a 2% or greater chance of it working, occurring, etc.  It's a great rule-of-thumb for figuring out where to draw the line when it comes to how much risk assessment is enough.

2.  Allow freewheeling discussions.

Talking in a group under strict rules and protocols can inhibit the greater intelligence of group thinking; informality can encourage the expression of doubts and ideas.

In a regular staff meeting, you might want to stick to the agenda to keep things focused on action items.  However, for reviewing open items and trying to come to conclusions, this is the way.  Even in staff meetings, consider leaving some time at the end of the meeting to raise open issues.  15 minutes can more than suffice to simply raise the issue and get input.  Save the decision-making for later.

3.  Foster a “third way.”

Keep an eye on group dynamics—when polarization threatens, push the two “right” and “wrong” decisions off the table and force your team to identify at least three unorthodox options that might work.

This can be a painful moment for many quality and regulatory professionals who have that "black and white" mentality.  You may be surprised at how little they will contribute ... until they see that the unorthodox options actually work.

4.  Restate conclusions.

It may seem obvious, but this is so often forgotten in the heat of the moment.  Summarize any  discussions along with any “to-do’s” for various individuals.  It’s one thing to agree with something in a meeting; it’s another if you end up tasked with it.

For leaders, this is a good way to closeout any meeting.  Years ago, I worked for a boss whom I'll call Brent.  He and I did not see eye to eye most of the time.  However, he did observe something about my meeting style that, while I didn't like it at the time, I've since realized was extremely accurate and helpful.  I rarely ever ended a meeting by summarizing what each person was supposed to "go do" and get done before the next meeting.  As a result, I spent a lot of time chasing down my staff to clarify deliverables; my staff started to get resentful, thinking they'd left the meeting with 3 things to do only to find out they actually 4 ... or 2.  When I changed that, and ended every meeting with a summary list of all the things each participant was going to go do, productivity and morale went up almost immediately.  Thank you to Brent for this advice.

5.  Sleep on it.

For particularly challenging decisions, break off discussion before consensus and have everyone “sleep on it” for a day.  Pushing against an artificial deadline can create unintended resistance, miss midnight inspirations, or erode trust.

Unless you’re an emergency room physician, you always have the option of delaying for a day.  This includes responding to FDA 483s.  Your response isn't due now - it's due 15 working days from now.  And make sure to get that response done at least a day early so you and your team can sleep on it.

6.  Just say "Why."

This is one that I admit I learned from my wife.  And over the years, it's worked wonderfully in work settings.  Consider laying down a “Just Saying ‘No’ Isn’t Allowed” ground rule.  Anyone voicing their resistance to an idea or choice must state their logic AND provide at least one reasonable alternative.  So if your question is, “Are we ready to submit this NDA?” and someone says No, that person needs to provide their reasoning along with reasonable steps to be taken (including in a reasonable timeframe) to get the NDA ready for submission.

Each of these tips will help you improve your ability to achieve compliance and business flexibility.  That's the role of a good leader and the path to success.

Are you ready?

Keep an Eye on Costs with These Easy Steps

Costs ignored are costs out of control.  Four steps to ensure control:

1.  Monthly check-ins.  Once a month, review your operational expenses.  This is not about the details, but rather large monthly “buckets” – telecom bills, transportation costs, total office supplies, and so forth.  Do your people see laptops and crackberries as perks, or do they really monitor operations in real-time 24x7 and travel consistently?

2.  Flag trends.  Look at the monthly expense for a particular category, such as phone bills, and over a 3-month to 2-year period, look for trends.   Are costs going up or down by more than 10-15%?  Why?

3.  Identify disparities before you dig.  If you are growing, your costs should be as well.  However, if you’ve grown by 5% and your costs have grown by 20%, then it’s time to look at the details of why.

4.  Heads-up notices.  Ensure your purchasing policies have an appropriate threshold ($5,000, $50,000, etc.) wherein a simple cover memo or email to you must be sent as a “heads-up” (not pre-approval) that explains where the money is going to go and what the rationale is behind it.  To keep this from being micro-managing, set it up so if you don't repond "WAIT" within 24 business hours, you're assumed to have no problems with the purchase.  This "heads-up" email or memo is just an opportunity for you to bring any additional information you might have (but haven't yet shared) to the table before the money is spent (for instance, one of your teams wants to bring in a temporary worker for a month to help with a work backlog but doesn’t realize you’re in the process of hiring a new staff member who’s first task will be to tackle that backlog).

 

For more ideas and tactics, download my e-booklet, Ten Ways to Control Compliance Costs, or see my article “Cost-Effective IT Outsourcing.”

Four Ways to Better Communicate Behind-the-Scenes Decisions

All the cultural transparency and emotional leadership advice aside, there are times when managers need to make decisions behind closed doors.  To minimize negative reaction, follow these four tips:

1.  Plan the announcement.  As you draft the announcement, put yourself in your employees’ shoes.  Write with an eye toward how personnel will respond.  Just stating the facts will not be enough.  Rather, compare the decision to other decisions in similar contexts (either in or out of your company).

2.  Provide actionable next steps.  Give your teams something to act upon—action will minimize the inevitable rumor mill, allowing teams to focus on implementation not speculation.

3.  Monitor and respond.  The goal is not to justify yourself or your decision.  Instead, try to eliminate misunderstandings and distortions of the facts and the context.  “Message sent” does not necessarily mean “message received.”  Give people time to digest the decision before responding  to misrepresentations; some degree of distortion is inevitable in any level of person to person communication.

4.  Be patient.  Give your folks time to act appropriately before you step in with further guidance.

 

For more leadership quick tips, consider subscribing to SmarterCompliance newsletter.  Every month I craft a section on tactics you can put to immediate use.

Four Tips to Ensure Compliance Effectiveness

Compliance programs, from SEC to FDA, require senior management review of policies and procedures to gauge and verify effectiveness.  The key is avoiding the minutiae.  Use these tips:

1.  Flowcharts.  Focus on process flowcharts rather than turning to details.  Look at a flowchart for each process;  ensure that checkpoints in the process are clear and match any automated approvals.  If you are not including a process flowchart in each of your SOPs, why?  People find it easier to follow along visually rather than plodding through page after page of detailed steps.

2.  Organizational charts.  Match accountabilities in each policy or procedure with your organizational chart; ensure that roles and responsibilities are clear to the individuals who currently hold those positions.

3.  Staff responsibilities.  Line workers generally have no real decision-making authority or ability to inform themselves of the risks and requirements involved in processes and controls.  Make sure your SOPs do not hold line workers accountable for an overall SOP – individual steps within the processes are fine.

5.  Find gaps.  Trace a flowchart to find gaps in overall business processes; identify each policy and/or procedure in play (for instance, from the need for a chemical through the chemical being ordered, then received, quality checked, inventoried, and so on).  Are there any process components not covered?  What about decision points?  Are there opportunities such as automated inventory management system that could speed things up and improve control?

 

For more practical management best practices when it comes to quality systems compliance, review my seminars and toolkits:  Effective Compliance and Quality Systems Oversight for Executives and Best Practices for your Quality System Management Review.

Control Compliance Costs – Four Tips

1.  Narrow your scope.  Ask your legal and records management groups to define your “regulated records.”

2.  Automate common controls.  Have your computer department map your business processes to find checkpoint similarities; these can be the bases for standardization or elimination of redundancy.

3.  Encourage work re-tasking.  Incorporate relevant financial controls and 3rd party audit results into your FDA compliance strategy...and vice versa.  Compliance is about control.  Make sure your segregation of duties isn’t leaving gaps.

4.  Hesitancy checks.  Institute controls that make people hesitate – even just for a moment – to think through an expenditure.

 

For more ideas and tactics, download my e-booklet, Ten Ways to Control Compliance Costs, or see my article “Cost-Effective IT Outsourcing.”