6 Tips for a Fiscally Fit and Successful Freelance Business in 2013 | SBA.gov

6 Tips for a Fiscally Fit and Successful Freelance Business in 2013 | SBA.gov

Lean 101: 5S Workplace Organization (Part 2 of 2)

In last week’s blog, we learned that 5S is the foundation for a disciplined approach to the workplace. 5S provides many benefits including improved quality, employee empowerment and morale, safety and efficiency improvements.

How to implement 5S at your facility?

First step is to Sort the items that are needed from those that are not needed in the workspace. Create a space for items to be disposed (quarantine or scrap area). Common method is red-tagging items for disposal to make them easy to identify. Typical criteria used to sort items include:

• Frequency of Use
• Is item used hourly or daily? Store item at the workspace.
• Used weekly? Store near the workspace.
• Used Monthly or less than once per month? Store a more distant location.
• Used once a year or less? Dispose of item.
• Condition
• Is item broken or damaged? If so, dispose
• Is it worth fixing?
• Applicability
• Is item at all useful?
• Is it really needed to perform my job function?
• Can other team member use the item? Use a cross-functional team to evaluate keep/dispose status of items.

Straightening the workspace is the second step. The goal is to create “a place for everything and everything in its place”, everything has a clearly designated name and place to eliminate need to look for items. The goal is to design a quick retrieval and storage system.  The key to Straightening is visual management Common tools used in Straightening include:

• Shadow board
• Organized floor space, defined areas outlined with tape and labeled
• Labeled shelves / racks
• Signs / Flags labeling aisles, for example in a warehouse or supermarket

Once the work area has been sorted and straightened, the area is Shined (cleaned) to create a bright productive work environment. The two keys to Shine are assigned individual cleaning responsibilities and frequency of cleaning activities. This ensures cleaning takes place as required by specified individuals – there is not confusion around who should do it and when. Time may be set aside at the beginning or end of shift to sweep around the work area. Wipe down of work station between product batches may be required to prevent cross-contamination. Shine not only positively impacts employee morale, but also improves product quality!

Standardization refers to visual management and 5-S standardization. It is often referred to as the “5S Job Cycle” because it establishes periodic revisit to the 5S activities for each area. The manner in which 5S activities are carried is also standardized. For example, red tag is used the same way across the company, use of a common checklist for 5S audits, common cleaning practices. Standardization is critical to the last 5S step – Sustain.

Sustain is the individual discipline in maintaining an organized workplace, and the culture in the company to facilitate and encourage the discipline. How can 5S be sustained? Build regular 5S audits into your standard operating procedures. Integrate 5S maintenance into annual performance assessments. Create a rewards system or contests to encourage participation in 5S activities and maintenance.

Safety in the workplace for the employee must be considered and evaluated each step of the way in 5S. In the Sort stage, consider using a different color tag to highlight environmental, health and/or safety (EHS) concerns. Through straightening and shine, resolve the highlighted EHS issues from Sort. Incorporate EHS into the standard 5S audits to ensure continuous review and improvement of safety in the workplace. Include safety metrics in communications, into annual performance assessments and in rewards systems in the company. Creating a culture of safety is an integral part of the Lean and 5S culture.

What will you do today to start a culture of safety and organization?
What does your company do to maintain a lean culture?

FDA's Unique Device Identification Proposed Rule

The FDA's proposed rule on Unique Device Identification for medical devices was released on July 3, 2012. Congress directed the FDA to establish a unique identification system for medical devices.

What exactly is meant by UDI?

Unique Device Identification (UDI) will contain the device model and lot / production batch number. Other  details about the device, such as expiration date, may also be included. The UDI will be a numeric or alphanumeric code, and will also be in format that can be read by automatic identification and direct capture technology (for example, a bar code scanner). Below is a graphic depicting a sample UDI from the FDA's webpage on UDI. 

The goal of the rule is to facilitate identification of medical devices in the United States. Medical device manufacturers will provide a standard set of identifying elements to the FDA, to be populated into a database (Global Unique Device Identification Database - GUDID) that will be accessible by the public and health care community. No patient specific or personal privacy information will be listed in the database or connected to the UDI.

Consumer safety will be enhanced with this system. Unique identification of each device will facilitate 

• Accurate and targeted product recalls by manufacturers 
• Reduce errors by health professionals through a standard method of device identification
• Improve the data in post-market surveillance which can be used to in determining market-readiness of new devices or new uses of the same device

What medical devices will be impacted?

The FDA will implement the rule based on risk, starting with highest-risk medical devices. Some low-risk medical devices may not be required to carry a UDI. Devices sold over-the-counter may be excluded from the requirement since they generally have a UPC code in place.

Certain devices may also be required to have the UDI marked directly on the device. This will allow device identification even when it is separated from its labeling and packaging. 

"The types of devices that would be subject to the direct marking require are implantable devices; devices intended to be used more than once, and which are intended to be sterilized before each use; and stand-alone software. These types of devices have physical characteristics, or characteristics of use, that significantly increases the probability that the device will become separated from its label, particularly when used over an extended period of time." (Federal Register Docket No. FDA–2011–N–0090, Vol. 77 No. 132, July 10, 2012.)

How is your company preparing to implement the UDI ruling?

Graphic credit: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm

Lean 101: 5S Workplace Organization (Part 1 of 2)

The foundation to creating a lean culture of continuous improvement is an organized workplace. To clearly identify any form of waste in business processes, the clutter must be removed from the workspace. 5S is the foundation for a disciplined approach to the workplace. The term “5S” comes from the Japanese method for workspace organization and housekeeping. Each step in the system starts with the letter S. Safety is the sixth “S” which has been added to ensure a safe workplace is created. The term “6S” or “5S+Safety” are often used to include Safety in the original Japanese system. Steps are outlined below with the English translation:

5S Cycle

1. Sort: Remove what is not needed
2. Straighten: “A place for everything and everything in its place”
3. Shine: Cleaning
4. Standardize: Visual management and standardization
5. Sustain: Discipline to maintain and build upon improvements through 5S process
6. Safety: Identify and eliminate safety hazards

Why perform 5S? What are the benefits?

o  Business Efficiency! It takes MUCH LESS time to find items you use regularly. For example, the “catch-all” drawer in the kitchen cabinets where all phone numbers and small tools get lost for months and years. How long does it take to find anything in there? With a clean, organized drawer that contains only the necessities, any item can be found in a snap! Same goes for business processes - first step to lean operations are organized work spaces.

o  Empowerment! By having team members take ownership for their own workspaces, they feel empowered to make decisions and take action to improve the quality of their work.

o  Safety! By removing clutter and broken or damaged items, the workspace becomes safer to work in. Eliminate opportunities for slips, trips and injuries

o  Morale! Employees take pride in the quality of their work and the appearance of their workspaces. Get your teams on the right track by providing these tools.

o  Quality! Reduced opportunity to damage product because clear space is delineated to place product, no stray tools to fall on product, and product status is clearly identified as accepted / in-process / rejected / quarantined.

Stay tuned for the second installment of this blog to learn how to implement 5S at your workplace!

Ready for an audit? Prepare for Success!

All companies may be audited at one point or another – no escaping the Tax Man if your number comes up! ISO-certified companies require periodic inspection by a registrar to maintain their certification status. If food, drug, cosmetic or life-saving devices are manufactured or repaired, then a visit from the country-specific government health agencies (e.g., FDA for USA) can be expected.

Are you and your company ready to be audited? Do you know what steps you should take to make the audit as smooth as possible?

Audit preparedness is everyone’s responsibility!

• Create a culture of awareness Does your team understand what an audit is? Do they understand their role in the audit, and why your company is being audited?
• Do what you say you do Do you understand your job responsibilities? Are job descriptions updated? Is your resume / CV up-to-date? Did you ensure your documentation is filled out completely, accurately and is free of good documentation practices (GDP) errors? Are organization charts up-to-date?
• Quality is Job One Ford had it right in the 1980s with this marketing campaign! Quality is the responsibility of each and every employee. Do you know your company’s Quality Policy? Can you explain it in your own words? Can you identify defects or non-conformances in your job function? Do you understand the impact of defects or non-conformances on consumer safety and product quality? Is non-conforming product clearly identified and segregated from in-process or conforming product?
• Training: “What I do, I understand." – Confucius Training is a key element for any employee to do his/her job properly. Auditors will be looking for verification of this in the form of your training records. Are your training records up-to-date and available for review? Have you been trained and certified to all procedures required on your job's training matrix? Are you performing any work that you are NOT trained/certified to?
• First Impressions are Lasting Impressions Is your work area is neat and orderly? Do you have controlled or uncontrolled documents on your desk? Are you using the latest revision of your procedure(s)? Did you verify the revision? Are post-its or scraps of paper being used to document activities? Are your work areas clearly identified?
• Practice, Practice, Practice!! Best way to get ready for an audit is to perform practice or mock audits. Running through a simulated audit can identify any deficiencies that need fixing, help ease those auditor interview jitters, and get everyone in an audit-readiness state of mind!

Back to Basics: GDPs & Reducing Regulatory Risk (2 of 2)

Welcome back!

In Part 1 of "Back to Basicss: GDPs & Reducing Regulatory Risk", we reviewed the real regulatory impacts of not following Good Documentation Practices. We also learned an easy way to remember the basic tenets of GDPs: ALCOA!

• Attributable
• Legible
• Contemporaneous
• Original
• Accurate

To help you apply these principles when documenting data or reviewing data, I have assembled this checklist of the most common GDP issues encountered. Please feel free to use and distribute!

Common GDP Watch-outs

• Do use indelible ink for handwritten entries.
• Don't use Pencils and Erasable pen inks for handwritten entries. Should not use fountain pens or other inks that smudge easily.  
• No correction fluids (e.g. Liquid Paper) allowed!
• Ensure all raw data is kept Keep all raw data - it cannot be destroyed!
• Don't use post its, scrap paper or other uncontrolled sheets to record data.
• Entries are initialed and dated at time they are made.
• Don't back-date or forward-date your entries!
• Ditto marks or continuation lines / arrows are not acceptable.
• Don't leave spaces blank designated for handwritten entries. Cross out or "N/A" and initial/date the blank spaces.
• Don't sign for another person or sign another person's name.
• If you need to correct an error:
• Put a single line through incorrect entry, write in new entry next to it, initial and date.
• Original entry must remain visible
• Reason for correction must be recorded
• Common abbreviations for entry error reasons that can be used are: EE – Entry Error, TE – Transcription Error, OW – overwrite.

Recommendations for Official Documents

• Each page of the document should have a unique identifying number - this way if a page gets detached, it is clear what document it belongs to
• Include revision/version number and effective dates
• Securely fasten all sheets document together
• Number each page of the document (x of y)
• Label each page of the attachment with document unique identifying number and attachment number
• Define abbreviations when first used in a document
• Always remember to write your documents such that any individual with no knowledge of your work or products can pick up the document and understand the premise.

Back to Basics: GDPs & Reducing Regulatory Risk (1 of 2)

What are GDPs? Why do they matter?

Good Documentation Practices are standards by which data quality and integrity are ensured. GDP can be summed up like this: If you didn’t record it, you didn’t do it! 
This is a basic element of current Good Manufacturing Practices (cGMPs). Even though it may not be written explicitly in the Quality System Regulations (FDA 21CFR820), GDPs are most definitely a part of FDA's audits! 


Here are a few FDA audit observations that refer to GDP deficiencies identified during audits:

• Audit observation due to changes to data not dated: US FDA Form FDA 483 Observation #9A
• Warning letter specifically referring to inaccurate, incomplete and altered laboratory data, including original data being obscured and use of pencil to record data  US FDA "Warning Letter" 320-01-02
• Warning letter addressing use of correction tape, erasures and write-overs of data  US FDA "Warning Letter" to Simmons Pet Food 23-Jul-08, Observation #13b.

As you can see, Adherence to GDPs is critical to reducing your regulatory risk! GDPs are straightforward and easy to follow. This is one of the easiest ways to limit your risk of observations during an audit!

The basic tenets of GDPs can be summed up in the acronym ALCOA:

• Attributable: 
• Data must be linked to its source (equipment name, study name, patient identifier, etc) and to the individual(s) who observed and recorded the activity. If one person observed and another recorded the data, then data must be attributed to both persons. 
• If any changes are made, the individual making the changes must be clearly identified as well.
• Per FDA regulation  21CFR58.130, "All data entries shall be dated on the date of entry and signed or initialed by the person entering the data...  In automated data collection systems, the individual responsible for direct data input shall be identified at the time of data input".
• Legible: 
• If data cannot be read, then it cannot be utilized! Entries must be written clearly, with permanent ink.
• Changes to data cannot obscure the original entry - legibility applies to errors as well!
• Per FDA regulation  21CFR58.130, "Any change in entries shall be made so as not to obscure the original entry, shall indicate the reason for such change, and shall be dated and signed or identified at the time of the change".
• Legibility requirements apply to electronic data as well. Per 21CFR11.10 (b), " The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency." Also in  21CFR11.10 (e), "Record changes shall not obscure previously recorded information."
• Contemporaneous:
• Data is to be recorded at time observation is made - contemporaneous with the observation.
• No back-dating! 
• Per FDA regulations 21CFR11.10 (e) "All data generated ...shall be recorded directly, promptly, and legibly in ink. All data entries shall be dated on the date of entry and signed or initialed by the person entering the data."
• Original:
• First record of observation is most accurate and reliable recording of data. 
• Also known as source data or raw data
• FDA regulations 21CFR11.10 and 21CFR58.130 apply as well
• Accurate:
• Free from errors
• Data recorded as is, no modifications or falsification
• FDA regulations  21CFR11.10 and 21CFR58.130 apply as well

Even though regulatory focus of this blog entry has been on the FDA, the EU also has a guidance document on GDPs with many similar requirements:

• EU Guidance Document guidance for the interpretation of the principles and guidelines of good manufacturing practice (GMP) for medicinal products as laid down in Directive 2003/94/EC for medicinal products for human use and Directive 91/412/EEC for veterinary use.

Stick around for part 2 of this blog entry on Friday June 22 to get a GDP checklist you can use today!