Corrective And Preventive Action In Quality Management Information Technology Essay

Corrective And Preventive Action In Quality Management Information Technology Essay CAPA is an important Quality tool in the pharmaceutical industry. CAPA is defined as the corrective action and the preventive action. A corrective action is a change implemented to address a weakness identified in a management system whereas the preventive action is The action to eliminate the cause of a potential nonconformity or other undesirable potential situation. Management plays a key role in the successful implementation of the CAPA system for achieving the high quality pharmaceutical products. It helps the management to identify the problem that arises in the system and helps the administration to come up with the innovative ideas to improve the quality of the product.This Document discusses the Obstacles for achieving the integrated CAPA compliance, quality system CAPA procedure, Flow chart for implementing the CAPA system, phases of the CAPA system, benefits of the CAPA system .. In this stage of the CAPA process there must be the problem that has been identified, defined and documented. The documentation should completely explain about how the information has been gathered and it also should have the proof for the existing problem. In the appraisal stage the quality personnel member of the CAPA case will need to determine the impact of the quality on the companys overall quality management system which include cost, function, safety, quality etc.. The determination regarding impact should include the risk to the customers as well as risk to the employers. Once the impact and the risks are identified then the seriousness is determined. Based upon the companies long term experience the companies will associate the varying degree of the seriousness based upon which the necessary corrective and preventive actions will be taken. DISCOVERY:- Phase-3 discovery phase commences only when the remedial action does not solve the problem during phase-2 or when a long term action is required then the phase-3 action commences. Discovery phase is also called as the investigation phase and before the investigation commences specific goals are set in a manner such that these goals are accomplished before the phase-6.For accomplishing these goals specific strategy is developed which includes specific strategy for determining the contributing and root cause of the problem. It also include all specific circumstances related to the problem which include training, software, external factors, procedures, personnel, materials and equipment. EXAMINATION:- During the examination phase rooting out of the problem takes place after determining the possible and probable causes of the problem and data has been collected to refute these problems. The data that has been collected during this stage has been organized and documented .The sources for the examination phase can be from the testing results and review of the records, processes, service information, design control, operations which helps in determining the root cause of the problem. All the information is collected, organized and documented in readable form. ACTION AND IMPELMENTATION:- During this phase the REAL LIFE of the CAPA takes place. In this stage the investigator has to determine the root cause of the problem and he or she has to develop the methodology that prevents the problem to occur further. All the incidents in this stage are documented and for the successful implementation of this stage a successful CAPA SOFTWARE has been introduced which not only save the time and money but also keeps the records for the long term usage for tracking how the problem has been resolved. OBSTACLES FOR ACHEVING INTEGRATED CAPA COMPLIANCE:- CAPA management is an important part of the regulatory requirement which helps in reducing the liability, increases the customer satisfaction, helps in the reduction of the financial losses and strengthens the companys reputation. To achieve the maximum benefits from the CAPA, it must be an integral part of the enterprise compliance and quality management system(ECQM) which helps in the collection of the data on the existing problem, investigators will analyze the potential data, digs out the root cause of the problem, addresses the issues and follows the procedures to avoid the similar problem in the future and documents the entire process. CAPA can be effective only when it is an integral part of the companys culture. However they were many obstacles which prevents for achieving a truly integrated quality management system. Among those are the 1-DISPARATE SYSTEMS:- CAPA compliance is included in companys standard operating procedures however it is difficult to achieve the process with systems that most companies have. They are different programs that dont interface with each other, homegrown systems that dont have universal recognition, delaying the resolution of the quality issues and clouding the compliance picture. 2-LAX DOCUMENTATION:- Companies should require the centralized control without which the documentation chain required by the regulatory agencies is frequently broken. Companies should document their CAPA procedures without which the FDA will not know the CAPA requirements have been fulfilled. 3-COMMUNICATION BARRIERS BETWEEN CULTURES AND SPECILATIES:- Employees working in the company dont speak the same language, literally. In addition the terms that an engineer uses to describe a quality system may be different from that marketing manager or the compliance officer. 4-LACK OF TRAINING:- Majority of the employees that are working in the compliance issues are not well trained.so the Employees who are working in the quality management do not know, understand and take the responsibility as their role as the quality management. 5-DISCONNECT AMONG BUSINESS UNITS:- CAPA management is frequently seen as a job for the quality management but not as a concern in which production, RD, marketing or other departments which should be involved. 6-NON COLLECTION OF TRENDING DATA OR DATA NOT READILY AVAILABLE TO APPROPRIATE PERSONNEL:- Without the integrated ECQM, most departments keep the records on their own systems without which the company management cannot see the Companies compliance picture. Without this vision, the management cannot predict and prevent possible deficiency to meet the CAPA regulations. 7-SEEKING A QUICK FIX VERSUS SEEKING TO CORRECT THE ROOT CAUSE:- Companies generally focus on the product and the material issues rather than reaching below the surface to identify and address quality concerns. It results on focusing on product problems rather than on the systemic issues which prevents them to correct a root problem. However getting to the root cause is main aim of the CAPA. TRUE CAPA implementation is to identify and correct the problem by putting practices to prevent the future issues which require the integration and flow of information freely among companies various departments and locations. Five steps for success of CAPA system:- 1. Companies should implement an effective quality management system for tracking and logging the events utilizing centralized software system which helps in determining the root cause and implement an effective CAPA system. Moreover it also helps in the reduction on the boundaries between various departments. 2. Companies should implement an effective comprehensive investigation and root cause analysis which helps in developing the effective corrective and preventive action. 3. Accountability is maintained through notification and escalation procedures by utilizing the automated and the on the demand reporting. Communication helps in the resolution of the events in the timely manner whereas notification helps the management know where exactly the record is in and who is working on it. Notifications are approved to key personnel via record origination, record assignment, task completion and record approval. An escalation procedure helps in ensuring the key personnel about the dates approach and priority management responsible tool to the particular parties. 4. Easy accessibility of the Records, Notification and reports helps all the key personnel in the immediate response of the resolution process. Web based system also helps in to log in into QUALITY MANAGEMENT SYSTEM from any location which helps in quick response. 5. Effective checks are conducted to measure how well the CAPA plan worked Post implementation. A well-defined planning is essential for the elimination of the recurring events. This system helps in creating and assigning the effectiveness of the check records for each CAPA plan. If the issue is resolved, a review is conducted in the final stage. Phases of CAPA system:- CAPA system plays an important role in the quality management system. CAPA consists of the four important phases.. Phase-1: Planning Planning for the Measurement, Analysis and Improvement Process Establish the Data Sources and the Criteria Phase2: Measurement and Analysis Customer survey Service Report Process Control Complaints Supplier performance Return Product Supplier Performance Quality Audit Measurement and Analysis Phase-3 Improvement Identify the Action Identify the Root Cause Investigate Verification Of identified Action Implement Action Determine Effectiveness of Implemented Action Reporting to Management Management Review Phase 4 Input Management Sample CAPA Process Flow Factory Distributor Customer Data Corrective Action Request CRA Remediation Action RMA CAPA Completed No Action Needed CAPA Needed Root cause analysis and Corrective Action TASK Effective No YES CLOSE Requirements of Corrective and Preventive action (21 CFR 820, Subpart J) (1) For the corrective and preventive action, manufacturer should create and maintain the procedure and this procedure include some requirements for:- a) Service record complaints, Audit report of quality, records of quality, and operations of work, quality data sources to justify the obtainable and possible cause of original product. For detection of returning quality problems, this type of statistical methodology should be employed b) For the product, processes, and the system of quality, consider the cause of non-fulfillment of requirement. c) For the reappearance of unusual product and problem related to quality, recognize the corrective and preventive action. d) To decide the recognized corrective and preventive action is successful and has no adverse effect on finished devices; validate that corrective and preventive action. e) For correct and prevent recognized problem of quality it is necessary to implementing and recording the changes in method and procedure. f) Decide that information which are related to the problem of quality which is circulated and directly responsible to give surety such product quality for avoid of such problem. g) For review of Management, submit the corrective and preventive action and information of recognized problem of quality. (2) All actions necessary under this section, and their results should be documented Benefits and futures of CAPA (Fig -1- Benefits and Future of CAPA) 1.COST EFFECTIVE:-Many organizations do not implement a robust CAPA process because of its high cost.so CAPA is tracked by simple spreadsheets and home grown database which do not require full CAPA requirements. Where as Ready CAPA provides an application to meet quality management at an affordable price. 2. COMPLETE VALIDATION PACKAGE:-It is the part of the READY CAPA which ensures that the application is ready to use in days versus weeks 3. WORK FLOW APPROACH:-READY-CAPA enables to know that issues are tracked completely to resolution. CAPA helps in deciding the issues related to the problem and helps in solving and easily documented. It also helps in deciding the progress of the CAPA. 4.REGULATORY COMPLIANCE:-The procedures and policies followed by the companies must meet the regulatory compliance which includes the identification of the interphase system, constructed and tested the documents and policies and procedures. 5.CLOSED LOOP CAPA PROCESS:-It is implemented by the Ready CAPA electronic work flow. This helps in identifying the issues ,investigating the cause, action planning for the corrective and preventive action, implementing the actions, verifying the quality assurance approval, monitoring the periodic challenge option and closing 6. Closed loop CAPA helps to reduce the loss of data. 7. Closed loop CAPA management helps in providing the controlled environment. 8. CAPA helps in increasing the product quality by reducing the product cost and cycle time. Conclusion:- Now a days Quality has become an important issue in the pharmaceutical Industry. CAPA plays an important role in achieving the high quality of the pharmaceutical products. Many pharmaceutical companies are implementing the CAPA system which helps in reduction of the cost as well as improve the quality of the product. For the successful implementation of the CAPA, there should be a well-trained knowledgeable operator. The main aim of the CAPA is to identify the Root Cause of the problem and provide a solution to the problem that does not occur repetitively. Manufacturers when implementing the corrective and preventive actions must comply with the ISO standards for achieving the high quality. Management plays a key role in the successful implementation of the CAPA in the company for achieving the high quality of the product. Thus this document provides the guidance for the successful implementation of the CAPA.

Barium Enema Essay -- essays research papers fc

Everyone should know that a lower GI is a very common and important exam used to diagnose many colon conditions. A lower GI examination, also know as a barium enema, is an x-ray examination of the large intestine. The large intestine, or large bowel, consists of the entire colon, including the appendix, rectum, and sigmoid colon. This commonly performed test is essentially the predecessor to the more familiar colonoscopy. A lower GI is used worldwide to help diagnose fatal diseases and many other problems that affect the large intestine. Some of the reasons that your doctor might order this exam are if you are experiencing diarrhea, constipation, blood in your stool, unexplained weight loss, anemia, to screen for colon polyps or colorectal cancer. Because this test demonstrates the large bowel, it is imperative to clean out the bowel completely. The smallest amount of stool left in the intestine can affect the accuracy of the test. To ensure the colon is cleaned the patient is instructed to be on a clear liquid diet for 24 hours prior to the exam. They are also instructed to take a strong laxative the day before. Most patients say that the preparation for the exam is the worst part. Before the test is started an x-ray of the abdomen is taken to check for residual stool and gas. If there is too much stool remaining in the bowel, the patient will have to be rescheduled, and take the laxative prep again. A barium enema test is done by a radiologist and one or two radiographe...

Oaklahoma Tornado

On Monday may 20th, 2013 a devastating tornado ripped through the small town of Moore, Oklahoma. This tornado was part of an outbreak of tornados that began in the plains on the 19th. Many towns were affected by Monday’s tornado however Moore got the brute of it. Moore is just 20 minutes south of Oklahoma City. The final death toll is 24 people; this was considered a miracle considering the amount of damage. Many rescue crews worked day and night to try to save as many people as they could. Everyone had to work together for it to be organized. Moore, Oklahoma is a town of 55,000 people. The first tornado warning was issued at exactly 2:40pm. This was 16 minutes before touch down of the massive twister. An average warning only goes out 8-10 minutes before a tornado. During this massive tornado outbreak, 28 tornados were reported touching down in the states of Oklahoma, Kansas, Illinois and Iowa. Tornados are rated on how severe they are on a scale called the Enhanced Fujita Scale, which is named after the man who invented it, Dr. Theodore Fujita. The Enhanced Fujita Scale goes from EF-0 (light damage) to EF-5 (incredible damage). EF-0 tornados are 65-85mph (105-137km/h) winds. EF-5 tornados are greater than 200mph (322km/h) winds. The national weather service originally classified the tornado that tore through Moore as an EF-4, but later changed it to an EF-5. This tornado was 2 miles wide at its widest point and traveled a 17 mile long path. Authorities said this was the deadliest tornado in the United States since 161 people died in Missouri 2 years ago. Over 13,000 homes were damaged or destroyed by this life shattering tornado. Originally 51 people were reported dead directly from the tornado and injuries sustained from it. That number later dropped to 24 people. It was said that bodies were counted multiple times in the field and reported but the official number came from the coroner’s office. Out of those 24 dead, 9 of them were children. 7 of those 9 children came were at the Plaza Tower Elementary school when it was turned to rubble. The Plaza Tower Elementary was smashed by the tornado sending many to the hospital. Hospital staff worked around the clock and called many extra workers in to help the overwhelming amount of people coming in. 299 were reported to be seen at any area hospitals. Moore Medical Center was evacuated after it was damaged from the storm. All patients were sent to either Norman Regional Hospital or Healthplex Hospital. Between those two 80 patients were seen for various traumatic injuries. Oklahoma University Medical Center treated 93 patients, 59 children and 34 adults. They treated injuries from minor cuts and lacerations to impalements and open fractures. St. Anthony Hospital treated 36 patients, 14 of them being children. They also transferred 3 patients to another hospital because of their injuries. 0 patients were reported to be seen at Integris Southwest Medical Center for trauma related injuries. On Tuesday 60 patients remained hospitalized following Monday’s tornado. Hospital staff worked nonstop to get done what needed to be done and to get people healed. Countless amounts of people came from all over to help. Some of the first to arrive were the first responders. Firefighters, EMS crews, police officers, the military and many more had to work together in a race against the clock looking for survivors and getting the injured help. Oklahoma army and air guard troops were activated to help search. Fire crews from all over Oklahoma came to help including the fire crew from Tinker Air Force base, which is the closest base to the affected area. 80 National Guard members were deployed for search and rescue. Because of the mass amounts of people coming to help the roads were packed. State Highway Patrol asked people not involved in search and rescue to stay off the roads so emergency responders can do their job. Firefighters used thermal imaging cameras (TIC) to find victims trapped in the rubble. Because crews worked all night the cameras helped see when it was too dark. The National Guard had other specialized equipment to also help. One of the first places searched was the Plaza Tower elementary. Rescuers pulled many children unharmed from the school and took them to a triage center set up in the parking lot. Cadaver dogs were used to sniff for survivors trapped in the rubble. At dawn new search and rescue teams moved switching out with 200 or so emergency responders who worked timelessly all night. Moore fire Chief, Gary Bird said they were going to search every building â€Å"at least 3 times†. After 24 hours he said he was confident there were no more suriviors or bodies. After a place or car was searched they were parked with a red X. An incident command system is needed in place of every disaster. In the case of a tornado everything needs to be smooth. The command post has to be located in the right spot. It must have good communication abilities and enough space for everyone to work. The command post should set up a place to receive 911 calls directly so they can quickly assign recon teams to where they are needed. It is also a good idea to have a TV at the post so they can watch what the news helicopters are covering and where needs the most attention. The Fire Department had an important role in the entire process. They have the tools and equiptment to extract vitims and 4Ãâ€"4 vehicals to access areas that others can not. EMS of course is very important. They were limited emergency treatment and transport so they did not become engaged in long rescues and so more patients can be seen in the hospital. EMT’s were limited to triage so the more advanced paramedics can do more treating en-route to the hospital. The police played a major role which was perimeter control. Many people wanted to see the damage which was getting in the way of workers. They also had to keep people back because of the hazards from downed power lines and natural gas leaks. Everyone that came to help played a role that was beneficial to everyone. This tornado was a terrible disaster. Mother Nature is a powerful thing and should never be under estimated. Everyone affected by this tornado is never going to forget this, but they all will get past it. The town of Moore will be rebuilt and stronger than before. All hospital staff will remember this day as one of the busiest days of their career. Incident command systems are always needed to be set up ASAP to get everything handled correctly and fluidly.

Lieutenant General A.P. Hill in the Civil War

Born November 29, 1825, at his family plantation near Culpeper, VA, Ambrose Powell Hill was the son of Thomas and Frances Hill. The seventh and final of the couples children, he was named for his uncle Ambrose Powell   Hill (1785-1858) and Indian fighter Captain Ambrose Powell.   Referred to as Powell by his family, he was educated locally during his early years. At age 17, Hill elected to pursue a military career and received an appointment to West Point in 1842.   West Point Arriving at the academy, Hill became close friends with his roommate, George B. McClellan. A middling student, Hill was known for his preference for having a good time rather than academic pursuits. In 1844, his studies were interrupted after a night of youthful indiscretions in New York City. Contracting gonorrhea, he was admitted to the academy hospital, but failed to improve dramatically. Sent home to recover, he would be plagued by the effects of the disease for the remainder of his life, usually in the form of prostatitis. As a result of his health issues, Hill was held back a year at West Point and did not graduate with his classmates in 1846, which included notables such as Thomas Jackson, George Pickett, John Gibbon, and Jesse Reno. Dropping into the Class of 1847, he soon befriended Ambrose Burnside and Henry Heth. Graduating on June 19, 1847, Hill ranked 15th in a class of 38. Commissioned a second lieutenant, he received orders to join the 1st US Artillery which was engaged in the Mexican-American War. Mexico Antebellum Years Arriving in Mexico, Hill saw little action as the bulk of the fighting had finished. During his time there he suffered from a bout of typhoid fever. Returning north, he received a posting to Fort McHenry in 1848. The following year saw him assigned to Florida to aid in fighting the Seminoles. Hill spent the majority of the next six years in Florida with a brief interlude in Texas. During this time, he was promoted to first lieutenant in September 1851. Serving in an unhealthy climate, Hill contracted yellow fever in 1855. Surviving, he received a transfer to Washington, DC to work with the US Coast Survey. While there, he married Kitty Morgan McClung in 1859. This marriage made him brother-in-law to John Hunt Morgan. The marriage came after a failed pursuit of Ellen B. Marcy, daughter of Captain Randolph B. Marcy. She would later marry Hills former roommate McClellan. This would later lead to rumors that Hill fought harder if he thought McClellan was on the opposing side. The Civil War Begins On March 1, with the Civil War looming, Hill resigned his commission in the US Army. When Virginia left the Union the following month, Hill received command of the 13th Virginia Infantry with the rank of colonel. Assigned to Brigadier General Joseph Johnstons Army of the Shenandoah, the regiment arrived  at the First Battle of Bull Run that July but did not see action as it was assigned to guard Manassas Junction on the Confederate right flank. After service in the Romney Campaign, Hill received a promotion to brigadier general on February 26, 1862, and was given command of the brigade formerly belonging to Major General James Longstreet. The Light Division Serving gallantly during the Battle of Williamsburg and the Peninsula Campaign in the spring of 1862, he was promoted to major general on May 26. Taking command of the Light Division in Longstreets wing of General Robert E. Lees army, Hill saw substantial action against his friend McClellans army during the Seven Days Battles in June/July. Falling out with Longstreet, Hill and his division were transferred to serve under his former classmate Jackson. Hill quickly became one of Jacksons most reliable commanders and fought well at Cedar Mountain (August 9) and played a key role at Second Manassas (August 28-30). Marching north as part of Lees invasion of Maryland, Hill began bickering with Jackson. Capturing the Union garrison at Harpers Ferry on September 15, Hill and his division were left to parole the prisoners while Jackson moved to rejoin Lee. Completing this task, Hill and his men departed and reached the army on September 17 in time to play a key role in saving the Confederate right flank at the Battle of Antietam. Retreating south, Jackson and Hills relationship continued to deteriorate. Third Corps A colorful character, Hill typically wore a red flannel shirt in combat which became known as his battle shirt. Taking part in the Battle of Fredericksburg on December 13, Hill performed poorly and his men required reinforcement to prevent a collapse. With the renewal of campaigning in May 1863, Hill took part in Jacksons brilliant flanking march and attack on May 2 at the Battle of Chancellorsville. When Jackson was wounded, Hill took over the corps before being wounded in the legs and being forced to cede commander to Major General J.E.B. Stuart. Gettysburg With Jacksons death on May 10, Lee began to reorganize the Army of Northern Virginia. In doing so, he promoted Hill to lieutenant general on May 24 and gave him command of the newly formed Third Corps. In the wake of the victory, Lee marched north into Pennsylvania. On July 1, Hills men opened the Battle of Gettysburg when they clashed with Brigadier General John Bufords Union cavalry. Successfully driving back Union forces in concert with Lieutenant General Richard Ewells corps, Hills men took heavy losses. Largely inactive on July 2, Hills corps contributed two-thirds of the troops involved in the ill-fated Picketts Charge the next day. Attacking under the leadership of Longstreet, Hills men advanced on the Confederate left and were bloodily repulsed. Retreating to Virginia, Hill endured perhaps his worst day in command on October 14 when he was badly defeated at the Battle of Bristoe Station.   Overland Campaign In May 1864, Lieutenant Ulysses S. Grant commenced his Overland Campaign against Lee. At the Battle of the Wilderness, Hill came under heavy Union assault on May 5. The next day, Union troops renewed their attack and nearly shattered Hills lines when Longstreet arrived with reinforcements. While fighting shifted south to Spotsylvania Court House, Hill was forced to cede command due to ill health. Though traveling with the army, he played no part in the battle. Returning to action, he performed poorly at North Anna (May 23-26) and at Cold Harbor (May 31-June 12). After the Confederate victory at Cold Harbor, Grant moved to cross the James River and capture Petersburg. Beaten there by Confederate forces, he began the Siege of Petersburg. Petersburg Settling into the siege lines at Petersburg, Hills command turned back Union troops at the Battle of the Crater and engaged Grants men several times as they worked to push troops south and west to cut the citys rail links. Though commanding at Globe Tavern (August 18-21), Second Reams Station (August 25), and Peebles Farm (September 30-October 2), his health began to deteriorate again and his missed actions such as Boydton Plank Road (October 27-28). As the armies settled into winter quarters in November, Hill continued to struggle with his health. On April 1, 1865, Union troops under Major General Philip Sheridan won the key Battle of Five Forks west of Petersburg. The next day, Grant ordered a massive offensive against Lees overstretched lines in front of the city. Surging forward, Major General Horatio Wrights VI Corps overwhelmed Hills troops. Riding to the front, Hill encountered Union troops and was shot in the chest by Corporal John W. Mauck of the 138th Pennsylvania Infantry. Initially buried in Chesterfield, VA, his body was exhumed in 1867 and moved to Richmonds Hollywood Cemetery.