Compliance Zen

Featured Reading: Writing to Learn

 

For every business executive, there comes a moment when you realize that your polices, your procedures—even your memos and reports—have a fundamental flaw; a deep-rooted problem that invariably ends in:

·         Audit findings

·         Poor compliance and adherence

·         Personnel and training troubles

·         Constant rework

·         Endless meetings

·         Loss of time, effort and money.

The crux of the issue?  Poor writing.  Not the poor writing you’d find in an amateur’s first novel or a teenager’s angst-ridden love poem, but writing that lacks three specific characteristics:

1.       Clarity

2.       Accuracy

3.       Brevity

In Writing To Learn —a collection of essays covering different writing types (technical writing, corporate reports, scientific methods, etc.)—William Zinsser advises:  “the reader should be given only as much information as he needs and not one word more” (p. 34).

Think about the polices, the procedures, the reports you’ve seen.  Was every word, every sentence really necessary?  Was accuracy counterbalanced with brevity?

Suggest Zinsser’s Writing To Learn to your staff.

June SmarterCompliance Newsletter Available

The June issue of my SmarterCompliance^tm newsletter is now available.  Topics include:

• Analysis of the FDA's five year PDUFA IV plan
• Step-by-step guide to creating an FDA records discovery strategy
• FDA enforcement review of warning letters on supplier audits
• How to comply with the biosample retention requirements
• Boosting employee buy-in of policies and SOPs
• and more....

Subscriber downloads include:

• FDA's PDUFA IV Five-Year Plan
• EMEA Guidance:  ICH Q8, Q9, Q10 Frequently Asked Questions
• EMEA Guidance:  GCP Inspection Coordination
• Sedona Principles on E-Discovery
• Sedona Commentary on Records Litigation Holds

You can get my monthly newsletter by subscribing here:   http://www.ceruleanllc.com/Newsletter/Subscribe.htm

And if you're not sure if you want to subscribe, I do offer free 6-month trial subscriptions with my executive quick-start pack.  Alternatively, if you sign up for my mailing list at Cerulean, I'll be happy to send one issue free so you can decide if you want the trial or want to jump right in and start getting smarter about compliance.

Details on the executive quick-start kit are here:  http://www.ceruleanllc.com/Toolkit/QuickStartKit.htm

And you can join my Cerulean mailing list here:  http://www.ceruleanllc.com/ContactReq.aspx 

As always, give me a shout with questions....

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.

Featured Reading: Mind Set!

“Six Sigma...is beginning to run out of gas, as it is now being seen by many as a hindrance to creativity.”

A provocative statement from the individual who predicted in 1982 that television viewers would switch from the big three networks to cable in droves; 25 years ago, he was booed off the stage and labeled a “whacko” by the New York Times.

Today, John Naisbitt is internationally renowned for his forecasting abilities—and his accuracy.  For senior decision-makers who must balance corporate growth, marketplace product profitability, and regulatory compliance, Mind Set! is essential reading.

The first half of the book is devoted to the  eleven techniques Naisbitt has pioneered to analyze current trends and information.  The second section walks the reader through these techniques as applied to the global landscape today.

Even if you cannot devote yourself to the constant analysis and big picture summations necessary to successfully predict market evolutions, we suggest you and your executive team review the book and take note of its analytical techniques.  I personally make use of his techniques in my compliance newsletter of FDA forecasts and quality systems intelligence, especially when I craft the year-end planning issue.

You may not agree with Naisbitt’s conclusions (especially if you are in love with Six Sigma), but his eleven techniques are sure to enhance your decision-making abilities.

Mind Set! is one book that deserves to be a well-worn device in your executive toolkit.

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.”

Featured Reading: IT Governance

In the 21st century, reliance upon information technology (IT/ICT) is necessary to perform nearly any function in business today.  Sadly, most organizations do not get near the return on their investment in IT/ICT as they do in other capital-intensive projects.

And, given the reluctance of many regulatory affairs and quality systems executives in the life sciences, firms do not use computer technologies to effectively streamline their compliance.

The frameworks in this book can be drawn upon to both improve your use of IT/ICT and your return on investment.  However, you can also adopt the frameworks to help you strengthen your overall IT compliance and FDA quality systems strategies.

Key points:

1.       There are three types of governance mechanisms:  clear decision-making structures, business alignment processes to ensure compliance input into business decisions, and communication tools (including training).

2.       The more that management communicates (e-mail, meetings, etc.) about compliance and expectations, the more effective the effort.  This also includes personal meetings with those individuals having trouble.

3.       Prioritizing projects and spending by business objectives allows for the maximum return on investment.

The internet is littered with websites and vendors touting one type of governance (such as CoBIT or ITIL) over another.  IT Governance lays out the frameworks of good e-governance, leaving others to argue semantics.

Six Tips to Better Quality Systems Management Reviews

The International Conference on Harmonization (ICH) Q10 standard, Pharmaceutical Quality System, requires company executives to regularly review their quality and compliance systems.  With the US Food and Drug Administration (FDA) pushing for ICH compliance, how can you ease this new regulatory burden?

 

Tip #1:  Stay Out of the Weeds

For many companies, the management review is an all day marathon best slogged through with coffee and cookies.

Consider limiting your review to six hours or less.  Realistically, if you cannot get through a review of your compliance/quality systems in six hours, there are too many tangents or explorations in the weeds.

When I conduct mock FDA inspections or due diligence audits, the first set of documents I typically request is the company’s quality systems management review report.  A good summary report should only require 1-2 hours of review (including its supporting data); anything more and I’m inclined to assume some sort of smoke screen in going on.  Keep this in mind.  If I’m only allotting several hours to a review of your review, spending more than 3x that amount of time and effort on the actual review itself is not likely to be a fruitful use of your time.

Focus on the most important items.  The checklists I have in my seminar, Quality Systems Management Review Best Practices, will allow you to limit your scope appropriately.

 

Tip #2:  Segment the Review

Consider segmenting the review into two, possibly three, sections with 30 minute breaks between.  Two natural sections are the overall compliance and quality system review, and then the review of your product(s).  The third section can be a site-by-site review if you have multiple locations, or a personnel, project and budget review if you only have one site.

 

Tip #3:  Limit Prep Material

To help participants prepare for the annual review, limit the amount of meeting pre-reads.  I like to limit the pre-reads to 3-4 items only, all of which will preferably on a single sheet of paper (or one-page email):

·         The objectives of the review;

·         The agenda;

·         Specific logistics (include any ground rules on checking e-mail, crackberries, or phone messages);

·         And then a single question that clarifies an expectation about this year’s progress (e.g., “Have nonconformances been up or down this year?”)

Any other pre-read information is likely to be read and forgotten, ignored, or lost.

 

Tip #4:  Limit Improvements

One of the basic building blocks of success is recognizing reasonable limits for what can, and cannot, be accomplished.

Consider limiting your compliance and quality systems improvement areas to no more than ten (10).  Preferably, those areas will have one common theme (i.e., quality by design in preclinical, stronger computer security, better inventory controls, etc.).

Given marketplace realities, the inevitable day-to-day crises and the constant parade of new guidance documents and international regulatory harmonization efforts, limiting your improvement targets demonstrates a balance between an idealized intent to comply and your awareness of practicalities—this is the essence of executive leadership in compliance.

 

Tip #5:  Synchronize with the Budget

Make sure you have the resource and the monies aligned with the improvements you approve at the quality systems management review.  Clarify this with your CFO during the review.

If you have already completed your original budget for the year, then use a portion of the review to prepare for first or second revised budgets by obtaining agreement on necessary funding shifts.

Remember that there are always options in how to accomplish your goals.  Whenever I discuss projects with prospects, I provide them at least two options for achieving their desired end state (and usually one option is cheaper than the other).  When you look at your deliverables, make sure each of them has at least two options – you can sort out the details later after the management review.  Budget for the most expensive, but be ready to roll with the most frugal.

 

Tip #6:  Keep Two Ends in Mind

When closing and wrapping up the quality system management review, get firm commitments from the participants.

In my experience, the best way to get commitment is to bracket the request in terms of the two fundamental goals of the review:

1.       Continual improvement of your processes, controls and products; and

2.       Summary proof of such continual improvements to give to outside auditors and regulatory investigators.

As you might imagine, participants will have difficulty shying away from actively supporting those two objectives.  And ultimately, without participant commitment, your quality systems management review is just an exercise in paperwork.

For more detailed advice, best practices, and checklists for easy implementation, see my recorded seminar, Best Practices for Quality Systems Management Reviews.

 

Tell me about your own experiences – good or bad – with the quality system management review.  I'm always looking to improve.