The Corrective Action Handbook, Second Edition

Editorial Reviews. About the Author. Denise Robitaille is the author of numerous books on The Corrective Action Handbook, Second Edition Kindle Edition.
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She is a regular columnist for The Auditor newsletter and is the author of numerous articles. Would you like to tell us about a lower price? If you are a seller for this product, would you like to suggest updates through seller support? Learn more about Amazon Prime. Completely Revised and Expanded Many people are confused about corrective action.

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They know it s a requirement for compliance to standards such as ISO , but they don t always realize the benefits of a well-designed and well-implemented corrective action process. This newly revised edition of The Corrective Action Handbook will help make your corrective action process more organized, more efficient, and more productive.

Denise Robitaille s book is a terrific guide to corrective action for anyone involved in the corrective action process. The book s basic precepts hold true for any size organization, and they can be used by quality managers, ISO management representatives, production supervisors, production group leaders, customer service managers, quality technicians, or anyone else involved in the corrective action process.

Plus, the book includes sample forms that guide you through the corrective action process in a logical and straightforward manner. Corrective action request form Root cause analysis form Action plan form Follow-up form The Corrective Action Handbook has been completely revised for this second edition. Updates include newly revised forms, expanded chapters, and a new chapter on when to implement corrective action and when not to.

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About the Author Denise Robitaille is the author of numerous books on various quality topics. Paton Professional; Second edition November 17, Language: Further considerations on the storage and disposal of biomedical waste can be found in Section Waste resulting from normal animal husbandry e.

Human anatomical waste consists of all human tissues, organs, and body parts, excluding hair, nails, and teeth. Even after disinfection or decontamination, human anatomical waste is still considered biomedical waste and may require special means of disposal depending on applicable provincial, territorial, and local legislation. Animal waste consists of all animal anatomical waste carcasses, tissues, organs, body parts , bedding contaminated with infectious organisms, blood and blood products, items highly contaminated with blood, and body fluids removed for diagnosis or removed during surgery, treatment, or autopsy.

Hair, nails, teeth, hooves, and feathers are not considered animal waste. Even after disinfection or decontamination, animal waste is still considered biomedical waste and may require special means of disposal depending on applicable provincial, territorial, and local legislation.

Microbiology laboratory waste consists of cultures , stocks, microorganism specimens, prions , toxins, live or attenuated vaccines, human and animal cell cultures, and any material that has come in contact with one of these. Inactivation of pathogens and toxins prior to disposal is a critical step in preventing release of harmful material into the environment. Microbiology laboratory waste is no longer considered biomedical waste once it has been effectively decontaminated.

Human blood and body fluid waste consist of all human blood or blood products, all items saturated with blood, any body fluid contaminated with blood, and body fluids removed for diagnosis during surgery, treatment, or autopsy. This does not include urine or feces, as per the CCME guideline. Human blood and body fluid waste is no longer considered biomedical waste once it has been effectively decontaminated. Sharps waste consists of needles, syringes, blades, or glass contaminated with infectious material and capable of causing puncture wounds or cuts.

This can include pipettes and pipette tips that have come into contact with infectious material or toxins, unless they have been decontaminated prior to disposal. Using puncture-resistant containers located close to the point of use minimizes the risk of injury during handling. Sharps waste may be reduced by product substitution for some applications.

Sharps waste is no longer considered biomedical waste once it has been effectively decontaminated.

Chapter - Canadian Biosafety Handbook, Second Edition - leondumoulin.nl

Decontamination of all biomedical waste prior to disposal in the regular waste stream is essential to the protection of public health, animal health, and the environment. It is important to segregate and dispose of biomedical waste near the point that the waste is generated. For example, it is recommended that unbreakable discard containers e. Some types of pathogens, such as prions, are not inactivated by decontamination processes that would be effective against most microorganisms; therefore, prion-contaminated waste should be segregated from other types of infectious waste.

In facilities where multiple types of biomedical waste are generated, colour-coded waste holding bags or containers can be used to differentiate between types of waste. It is important that the waste container used is suitable for the type of infectious waste generated. Plastic bags, single-use containers e. Human anatomical waste, blood and body fluids, and animal waste should be placed in impervious, leak- and tear-resistant waste bags. Removing sharp objects e. Waste bags should be sealed, placed in leak-proof containers, and stored in a freezer, refrigerator, or cold room to await decontamination.

Reusable containers may be used, provided that they are decontaminated and cleaned after every use. Footnote 5 Broken glassware should never be handled with gloved or bare hands. Forceps, tongs or a dustpan should be used to pick up broken glassware and a wet paper towel held in tongs should be used to pick up tiny glass particles.

If waste is not decontaminated and disposed of immediately, it may be stored temporarily provided that it is in a designated area that is separate from other storage areas and clearly marked with a biohazard symbol. Some types of waste e. Once materials have been decontaminated on-site, the biohazard symbol on the receptacle is removed or defaced to indicate that the infectious material has been inactivated.

Decontaminated material may be disposed of as regular waste in areas of heavy traffic or public areas, provided that the facility has specific labelling procedures in place. In other cases, it may be necessary to transport waste off-site for decontamination and disposal. Whether the waste will be decontaminated on-site or off-site, placing waste in appropriate disposal containers promptly and labelling the containers accordingly will keep all infectious waste segregated from regular waste until decontamination and disposal.

Limiting the movement of waste disposal containers to the point of use in the work area, storage e. More information on the movement and transport of biological material can be found in Chapter It is critical that all containment zones address situations where biosafety or biosecurity issues may arise as a result of an emergency.

Emergency situations may include incidents or accidents , medical emergencies, fire, spills e. The emergency response plan ERP , based on an overarching risk assessment , describes the procedures relevant to any emergency situation and is essential to protect lives, property, and the environment.

The ERP will identify foreseeable emergency scenarios and describe response measures that are proportional to the scale and nature of the emergency. The plan should take into account the hazards in the geographical area e.

The ERP may also include contingency plans to continue operations in a safe and secure manner. The minimum requirements for an ERP in regulated containment zones are specified in Matrix 4. Footnote 1 There are many additional resources widely available to assist in the development of an ERP. Footnote 2 Footnote 3 Footnote 4 Footnote 5. When developing the ERP for containment zones, collaboration with experienced facility staff will ensure that the final plan is comprehensive and integrated with facility-wide plans, where appropriate.

Personnel involved in ERP development may include facility administrators, scientific directors, principal investigators, laboratory personnel, maintenance and engineering support staff, biological safety officers BSOs , and facility security officials.

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Coordination with local first responder organizations, including police, fire department, and paramedics, is recommended. The ERP should be specifically tailored to the organization, facility, and containment level and will address the safety of emergency personnel who may enter the containment zone, particularly at high containment levels.

It may also be advisable to inform emergency personnel of the type of infectious material in use within the containment zone. Mitigation strategies to address the biosecurity issues that arise from emergency personnel who may have access to restricted infectious material, toxins, or sensitive information while responding to an emergency should be considered. Once developed, the ERP or a summary of the plan can be included in a facility's Biosafety Manual and communicated to all facility personnel appropriately.

Training of personnel on the emergency procedures is essential to make certain that personnel, particularly new personnel, are aware of and familiar with the procedures to follow prior to an actual emergency event. This is to be incorporated into the facility's training program CBS Matrix 4. Annual refresher training for existing personnel is considered appropriate to maintain knowledge of emergency procedures, although more frequent training may be indicated by a risk assessment or training needs assessment. Structured and realistic exercises are useful tools to verify that personnel demonstrate knowledge of the ERP, understand its importance, can provide assurance of its effectiveness, and identify any deficiencies or areas for improvement.

Biosecurity-specific procedures and scenarios can be included e. In addition, all aspects of the ERP e. It is always important to revise the ERP and keep it up to date with respect to any changes within the containment zone or the surrounding environment e. It is the responsibility of the facility to determine the frequency of ERP reviews, assessments, and updates. Following an emergency in which the ERP was activated, it is recommended that the ERP be reviewed to address any newly identified deficiencies. Spills are the most common incidents with the potential for exposure of personnel to pathogens or toxins, or their release from containment.

Spills can contaminate surfaces, equipment, samples, and workers. The decontamination protocol used depends on where the spill occurred and its size volume. When a spill occurs outside a BSC, the potential exists for all those present in the work area to be exposed to infectious aerosols or aerosolized toxins. Personal safety is the top priority, but it is also important to prevent the spread of contamination outside the immediate area and the containment zone.

Having a pre-assembled biological spill kit on hand that contains all items needed to contain and clean up a spill e. It is important that personnel are adequately trained to follow spill response procedures. After the risk of injury has been controlled, the following steps are recommended to contain a spill of infectious material and decontaminate the area affected by a spill: The size of the spill is determined by how far it spreads, and less by its volume. When a small spill occurs inside a BSC, the worker is not considered contaminated unless a splash or spillage has escaped the BSC; however, the gloves and sleeves may be contaminated.

Chapter 16-20 - Canadian Biosafety Handbook, Second Edition

The following general procedure is recommended for spills inside a BSC:. If a breakage occurs or is suspected while a centrifuge is running, the motor should be switched off and the centrifuge left closed e. Should a breakage be discovered only after the centrifuge has been opened, the lid should be replaced immediately and left closed e. Though the terms " incident " and " accident " are often used interchangeably when referring to reporting procedures, a distinction should be made between the two words.

An accident is an unplanned event that results in injury, harm, or damage. An incident is an event with the potential to cause injury, harm, or damage.

Incidents include accidents, as well as near misses and other dangerous occurrences. Footnote 1 All incidents, even those seemingly minor, should set in motion the facility 's internal incident reporting procedures as described in the Biosafety Manual and other appropriate protocols e. The minimum requirements for incident investigation and reporting in regulated containment zones are specified in Matrix 4. Protocols for incident reporting and investigation are an integral component of a facility's emergency response plan ERP. Incidents need to be properly reported, documented, and investigated in order to learn from these events and to correct or address any problems or issues that may have caused the incident and prevent a recurrence, and to notify external authorities i.

Exposures in a containment zone can occur via inhalation e. Incidents may be indicative of failures in containment systems , biosafety -related standard operational procedures SOPs , training programs, or biosecurity systems; subsequent investigation enables containment zone personnel to identify these failures and take corrective action.

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Reporting and investigation procedures should be developed to complement or integrate with existing facility-wide programs e. The ERP is discussed in more detail in Chapter Several standards are currently available to assist facilities in the development of incident reporting and investigation procedures. Footnote 2 Footnote 3 Footnote 4 The minimum requirements for incident reporting and investigation in regulated containment zones are specified in Matrix 4. Record retention requirements for incidents are specified in Matrix 4.

All incidents involving infectious material, infected animals, or toxins, such as a containment systems failure, an exposure to a human pathogen or toxin, or release of an animal pathogen , must be reported immediately to the appropriate facility personnel e. Moreover, all persons working under the authority of a licence are legally obligated to notify the appropriate facility personnel if they have reason to believe that an incident has occurred involving inadvertent release, inadvertent production, disease i.

It is important to promptly report incidents internally, within the facility, so that management including the licence holder in licensed facilities is made aware of the events, can implement immediate hazard reduction and mitigation strategies, and initiate a preliminary assessment to determine if an exposure has likely occurred Figure illustrates a decision chart to assist in the exposure assessment. As well, internal reporting initiates the facility's process to investigate the incident, determine the root cause s , plan corrective actions, document outcomes i.

In the event of certain types of incidents involving pathogens, infectious material, and toxins, personnel in facilities that are regulated by the PHAC and the CFIA are likewise obligated to notify or report to the appropriate regulatory authority.

The Certified Quality Technician Handbook, Second Edition (e-book)

Regulated facilities are also required to develop and maintain documented procedures to define, record, and report incidents involving infectious material or toxins CBS Matrix 4. These procedures should also comply with any additional applicable federal, provincial or territorial, and municipal regulations, as well as the organization's internal incident reporting and investigation requirements. Infections that result from an exposure to pathogens or infectious material being handled in the containment zone are referred to as LAIs; this term also includes a disease caused by exposure to a toxin i.

Exposure incidents are more encompassing, and include any incident involving a pathogen or toxin where infection or intoxication is likely to have occurred, and thereby a potential for disease whether or not overt disease actually does develop. This initial notification of the exposure incident captures brief information to describe the incident, the name of the pathogen or toxin involved, and other preliminary information relating to the incident, such as immediate mitigation measures and current status of the affected individual s , if known.

Personal identification of the affected individual s is not normally required, but may be requested in exceptional circumstances e. An exposure follow-up report documenting the outcomes of the incident investigation is to be submitted to the PHAC within 15 or 30 days of the exposure notification report, depending on whether or not SSBAs were involved in the incident.

Figure illustrates a decision chart to assist in the assessment of an incident to determine if an exposure is to be notified in accordance with HPTA Section There are two scenarios: I a recognized incident where assessment is required to determine or rule out possible exposure s to human pathogens or toxins among one or more individuals involved in the incident; and, II a recognized disease in one or more facility personnel or other individuals e. Reporting to the PHAC is not necessary in the case of an incident in a licensed containment zone wherein the incident investigation and local assessment of facts has determined that exposure i.

Reporting to the PHAC is also not necessary in the case of a recognized disease that is determined not likely to have been caused by an exposure incident in the containment zone. In this latter case, the incident investigation and local assessment of facts has ruled out exposure in the laboratory setting and determined that a community , travel-related, or other exposure setting is the most likely source of the disease.

Please contact the PHAC directly for more information on voluntary reporting of incidents.

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The exposure follow-up report form, available from the PHAC, is an extension of the exposure notification report, wherein the preliminary incident details provided upon notification can be updated, added to and submitted electronically through the Biosecurity Portal in the exposure follow-up report. The design and format of the electronic report is intended to capture the outcomes of the incident investigation process. Ultimately, it serves to document key details on the incident, assist with conducting a root cause analysis, and record the corrective action plan aimed at mitigating the event and reducing the likelihood of a recurrence.

An exposure follow-up report detailing the exposure incident investigation is to be submitted to the PHAC within 30 calendar days of submission of the initial exposure notification report for incidents, or within 15 calendar days if the incident involves an SSBA CBS Matrix 4. The PHAC reviews and analyzes information contained in exposure notification and follow-up reports to monitor for potential patterns, assess the potential significance for public health, and determine if any direct involvement by the PHAC is warranted.

This decision may be based on consideration of factors such as risk group s of the human pathogens or toxins involved in the incident, the communicability of the human pathogens, the number of affected individuals, and the likelihood of spread to the community. Where it is deemed appropriate, the PHAC will contact the licence holder promptly to follow up on actions taken.

Upon request, the PHAC can also assist with the assessment, investigation, and reporting process by providing guidance, subject matter expertise, or related support. As an additional condition of licence, licence holders authorized to work with SSBAs may be required to submit an annual report to the PHAC summarizing all incidents involving SSBAs that occurred during the previous 12 months or a report indicating that no incidents have occurred.

The annual report is to include: The annual report builds upon the regular incident reporting requirements by providing the PHAC with a better understanding of the frequency and potential causes of incidents involving SSBAs. Since detailed information on any exposure incident involving an SSBA will be reported via the required initial exposure notification report, and the exposure follow-up report submitted 15 calendar days later, this information does not need to be repeated in the SSBA annual report.

This allows the PHAC to monitor developing trends, and may prompt the issuance of biosafety advisories as well as contribute to updates of biosafety best practices and training. Under normal circumstances, the PHAC does not gather confidential business or personal information with respect to incidents involving the exposure of an individual to a human pathogen or toxin; however, should such information be required, it is protected in accordance with applicable federal laws.

Information collected from exposure notification and follow-up reports documenting exposures or LAIs involving human pathogens and toxins is analyzed by the PHAC to help shape current and future biocontainment and biosafety practices in Canada. The Health of Animals Act HAA sets out requirements for the notification of the CFIA in the event that an animal is discovered to be infected with pathogens causing, or showing signs of, a reportable disease or toxic substance.

Footnote 8 Footnote 9 This may be of concern in an animal containment zone where an experimental animal is discovered to inadvertently carry or develop clinical signs of one the indicated diseases. Please contact the CFIA directly for more information on reportable and notifiable diseases. Based on the conditions included on an animal pathogen import permit , any incident involving an animal pathogen, toxin, or other regulated infectious material in a facility to which that material was imported or transferred using an animal pathogen import permit or transfer authorization issued by the CFIA, or in a facility that has been certified by the CFIA, may require reporting to the CFIA.

The CFIA will review the information surrounding the incident to verify that a release has not occurred and to ensure continued compliance with the CBS. The animal pathogen import permit may include further conditions on reporting to the CFIA. Please refer to the conditions of permit for further information. Incident investigation is necessary to determine the root cause s of the incident, in other words, to identify the most basic or underlying reasons why the incident took place.

Equally important, results of a thorough incident investigation, serve to determine and direct appropriate corrective actions to mitigate the current problem s as well as prevent similar incidents from occurring in the future. As such, incident investigation provides a crucial feedback mechanism to assist in the improvement of existing incident mitigation and prevention strategies.

Incident investigation and reporting procedures to uncover and document these findings may include the following:. The extent and depth of the incident investigation may vary, depending on the severity of the incident or the level of concern associated with the pathogen or toxin involved e. Prior to commencing an investigation, the personnel responsible for this duty should be selected and identified. Depending on the nature and severity of the incident, one individual may be assigned to conduct the investigation or a team may be assembled for more complex scenarios.

The investigator s should conduct the investigation with an open mind taking care to exclude any pre-conceived notions and opinions regarding the nature and cause of the incident. Incident investigation procedures should be reviewed and updated regularly so that they are current and effective. The investigation process is systematic and generally includes the stages outlined in the subsections below. She is an internationally recognized speaker who brings years of experience in business and industry to her work in the quality profession.

Denise is an active member of U. As the principal of Robitaille Associates she has helped numerous companies in diverse fields to achieve ISO registration and to improve their quality management systems. She has conducted training courses for thousands of individuals on such topics as corrective action, management review, auditing, document control and implementing ISO She is a regular columnist for The Auditor newsletter and is the author of numerous articles.

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