Documentation standards training record

Once satisfied that the instrument is operating in accordance with its own specification, the end user should ensure that it is fit for purpose for the applications intended. This step is called Operational Qualification, OQ. This process would include writing the Standard Operating Procedure (SOP) and training staff in its use. Further testing may be required to ensure that the instrument performance is in accordance with National and Corporate standards if not carried out in IQ. Frequently, instruments are used with accessories or sub-systems, e.g. sipper systems or other sample presentation devices. Challenge the analytical system with known standards and record what you did. It is necessary to ensure that they work in the way intended and that documented evidence is available to support their use. 

This paper is concerned with the definition and documentation of primary raw data, or in other words, raw data directly associated with a study. Items such as standard operating procedures, methods, personnel qualifications and training records can be considered secondary raw data. Thus, even though these items are also archived, they are not considered explicitly here. But since they are just other examples of paper and/or electronic records, the same archival methods can be used. 

Validation test environment including hardware, software System security including passwords, network rights, functional security, physical security, modem access and virus protection Validation test environment including related documents, along with standard operating procedures, user manuals, and system development/ maintenance and documentation Validation assumptions, exclusions, and limitations Responsibilities matrix Validation data sets Acceptance criteria Expected results Execution of the validation plan Resolution of errors Documentation Training records... 

For all quality standards, staff working in a laboratory must be suitably trained. For laboratory workers a training record is a document used to record each analyst s training and the date when the analyst is deemed competent to... 

This section contains forms for documenting that all training requirements have been met, sample preparation instructions as necessary to the execution of the validation experiments, and data recording forms. Places for signatru es for performance and review should be included on each form as appropriate to company quality and documentation standards. For examples, see Tables 2 and 3.]... 

Add a section for comments, as well as a place for signatures for the personnel who reviewed the training records and conducted the validation training in accordance with company quahty standards for training documentation. 

The ACCE (2012), Document 103, defines the standards and criteria for accreditation of construction education programs. According to ACCE (2012), the curriculum of baccalaureate degree programs should address health and safety in the constraction courses related to project execution. ACCE (2012) requires that at least one semester credit (1.5 quarter credits) must be devoted to safety. This credit can be covered either in a single course or in multiple courses. Safety content must include safe practices mandatory procedures, training, records, and maintenance and compliance, inspection, and penalties. 

The standards for QA systems all emphasize the importance of well-trained staff and in order to be able to demonstrate the laboratory s commitment to training to assessors, for the purposes of accreditation, adequate training records must be maintained. The standards also emphasize the importance of using documentation to avoid ambiguities and com-mimication problems, and to ensure that all staff are trained and working to the same procedures. 

Medical recordkeeping, covered by 29 CFR 1910.1020(h), requires employers to keep medical and training records for each employee. OSHA permits employers not to retain medical records of employees working for less than a year need if given to the employee upon termination of employment. Keep medical records confidential except for disclosures permitted by the standard or by other federal, state, or local laws. Make all medical records required by the standard available to OSHA. The compliance officer must protect the confidentiality of these records. If copied for the case file, follow the provisions of 29 CFR 1913.10. Consider records about employee exposure to bloodborne pathogens and documenting their HIV/HBV status as medical records. 

As a part of quality systems, standard procedures can be implemented for functional assessment of employees. Job description of employees and their training records are efficient documents for that purpose. Procedures for the training of a new professimial, the continuous education and the yearly examinadmi of qualification can all be part of the quality system of the preparation unit. Such qualification is... 

It is usually a good idea for the employer to keep a record of all safety and health training. Records can provide evidence of the employer s good faith and compliance with OSHA standards. Documentation can also supply an answer to one of the first questions an accident investigator will ask Was the injured employee trained to do the job ... 

New employees and current employees who are transferred from another facility or jobsite must attend a facility or jobsite-specific new-hire safety orientation. This program provides each employee the basic information about the facility/jobsite-specific safety and health plan, federal and state OSHA standards, and other applicable safety rules and regulations. Attendance is mandatory before working for all company employees. The facility/jobsite supervisor is to document attendance using the company training form (see example. Figure 15.4) and all training records will be maintained by the company and placed in each worker s personnel file. 

Documentation that each contract employee has received and understood the training is also required under the OSHA standard. The records must contain the identity of the contract employee, the date of training, and the means used to verify that the employee understood the training. 

Training and documentation. Responsibilities associated with PV and QA depend on the training of manufacturing personnel and the documentation of their activities. Such activities help to form the recognized quality standard that a pharmaceutical company builds for its products. These personnel are trained to carry out the standard procedures required by GMP documentation includes the write-up/revision of these procedures. Other records document how a batch of product is manufactured, whether unusual incidents or deviations occurred, the existence of reject notices, product complaints, and the investigation and analysis (as needed) of the above abnormalities. 

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