Here we are again, another year older, wiser and all that stuff, nearing the holidays and probably in a mad scramble to get everything done - and that’s just at home! What about everything that needs to get done to ensure you’ve wrapped up all the loose ends in your safety and quality programs at work? While Mary is jet-setting the globe, how about you and I take a  look at the items in both programs that need to be done at least once a year to ensure you reduce your risk of regulatory trouble.

Safety
1. Employee Safety Training – Employees must be trained on a variety of safety topics every year and this training documented. Topics included are bloodborne pathogen exposure prevention, review of respiratory protection measures, emergency action procedures, fire prevention, and control of hazardous energy (Lockout/Tagout).
2. Documented review of bloodborne pathogen exposure prevention methods employed by the lab including prevention of injury due to exposure to contaminated sharps. Here is an excerpt of the OSHA requirement:
1910.1030(c)(1)(iv) The Exposure Control Plan shall be reviewed and updated at least annually and whenever necessary to reflect new or modified tasks and procedures which affect occupational exposure and to reflect new or revised employee positions with occupational exposure. The review and update of such plans shall also:
1910.1030(c)(1)(iv)(A) Reflect changes in technology that eliminate or reduce exposure to bloodborne pathogens; and
1910.1030(c)(1)(iv)(B) Document annually consideration and implementation of appropriate commercially available and effective safer medical devices designed to eliminate or minimize occupational exposure.
3. Formal Evaluation of Personal Protective Equipment - You must re-certify your PPE program every year.  This re-certification includes if the PPE you’re providing is effective and if employees are using it properly. This covers PPE in your receiving departments, voluntary use of respirators and dust masks, etc.  SafeLink Consulting clients have a chart that they can update every year listing all of the areas where PPE is provided, what it is being provided for, and a place to sign and date showing that it is effective for another year.  The OSHA standard is very specific about this and if you don’t currently have an assessment program in place, you may want to check out the following OSHA link: http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&...
4. Respirator Fit Testing – If you have employees that are REQUIRED to wear an N95 or N100 respirator due to dust exposure, they must be re-fit tested every year to ensure they are still being protected by the equipment you provide. (OSHA standard 29CFR1910.134)
5. Annual inspection of emergency equipment including your eyewash stations, fire extinguishers (this is done by an outside agency to ensure container integrity), first aid kits, chemical spill kits, fire blankets, CO detectors, and smoke and fire alarms. As is always the case, you should document that each piece of equipment received an annual inspection.
6. Conduct an annual evaluation and summary of your health and safety program including the effectiveness and actions taken during the year by your Safety Committee (if you have one) and an annual safety inspection.  You should be conducting self-assessments throughout the year, but annually, at a minimum, is strongly recommended.
7. If you are located in the states of Washington, Hawaii, Nevada or Minnesota, you must track all recordable workplace injuries and illnesses on the OSHA 300 forms. Annually, these must be tabulated and posted on the Summary form in a place where all employees can view from February 1 - April 30.

Quality System
1. Audit, audit, audit! How do you know if you are doing what your quality manual says you do except by auditing your system?  Also, if you have authority or own a particular process covered in your quality system then you know you can’t audit yourself, so you will need to cross train others in the laboratory to help you. This is an annual requirement and must be documented.  Any concerns or action items generated from this process, must be followed up on and documented until closure.
2. As you go through the year, you should be conducting regular quality meetings for the purpose of evaluating client and vendor complaints, remakes, etc. to help identify trends to take corrective actions and preventive actions (CAPA). Annually, you should look at the entire year, summarize your findings and note this in your management review meeting minutes.
3. Your management review meeting, affectionately known as the MRM, is held once a year and is a meeting of your quality system’s management representative and executive management. The purpose of the meeting is to review the suitability and effectiveness of the quality system.  At a minimum, the following topics are discussed:
Results of quality audits
Supplier/Subcontractor performance
Customer Complaints and CAPA
Effectiveness of the QS to meet the quality objectives
Continuous improvement actions taken over the past year.
Any changes made during the year and future changes due to new technology and/or processes.

Minutes of the management review meetings are taken. The minutes are maintained by the management representative and filed as a quality record. Copies are distributed to executive management.

Well, that about wraps it up with a nice little bow! Hopefully, you have done or have made preparations to perform all of the above and can enjoy the upcoming season and ringing in of the New Year.  We sure hope so and let me speak for the team at SafeLink Consulting in wishing all of you a bountiful, safe and healthy 2010!