Training

Training is another important part of medical device’s quality system. Ideally all personnel must be trained well to perform their daily works. Therefore, a procedure to handle training is warranted.

The purpose of this training procedure is to provide a system, assign responsibilities, identify training needs, provide the required training and  maintain training record.

The objective of a robust training program is to ensure all employees acquire the knowledge and skills when performing their jobs. They should be conversant with the relevant requirements of the quality system pertaining to their job functions.

The training blog is subdivided into 1) Company-wide Training and Awareness Programs 2) Departmental Training and 3) Training Effectiveness and Evaluation and 4) Training Record and Documentation.

1)    Company-wide Training and Awareness Programs

Company-wide training and awareness programs are discussed sub-categorically into the following sections.

1.1  General Orientation and Quality System Training

Normally, the human resource department provides for the general orientation while training department provides the quality system training. This training make the employees familiar with administrative rules, employee program and benefits, 401K plan, vacation policy, sexual harassment etc. The training also explains the medical device products, product requirements and the quality system. The product and quality system should comprises of the following:

 ·       Discussion of the Quality Policy. Normally, even the employee badge has the quality policy printed.

·       Overview of the company’s company system. For example, 21 CFR 820 quality system for medical device plus perhaps ISO 13485.

·       Training on each product the company make. Each employee shall be trained on each product on critical quality characteristics and ramification of a failure or malfunction of the device. How the product is made etc?

·       An explanation of how individual employee contributes to the well-being of the company quality system.

1.2  Safety Training

Safety training is also important in the organization. Many of the medical devices manufacturing processes and tool, for examples can cause serious harm to the employees during production. You do not want to start a fire to burn down the facility.

Therefore, all employees are trained in safe work practices, first aid, use of personal protective equipment, emergency procedures, fire extinguisher handling, as applicable. Safety training is provided by the individual responsible for Human Resources or directly by departments. Human Resources maintain these records.

1.3  Company-Wide System

Examples of company-wide system are Trackwise system. Trackwise system is used to record CAPA, Laboratory Investigation and Deviations. Other systems are Windchill, SAP, material-coding and bar-code system.

1.4  External Training

Many medical device sponsors have educational reimbursement policy for employees to participate in seminars, conferences or even getting another advance degree or certification pertaining to the industry. For example, project manager might take the Professional Management Professional (PMP) certification to efficiently handle a project. Or an employee who is getting a M.Sc in Regulatory Affairs to know more of the regulatory affairs.

1.5  Quality and Regulatory Certification

Company encourages personnel to be certified as Regulatory Affairs Certification (RAC) especially if you are in or planning to move to the Regulatory Affairs department. Certified Quality Auditor (CQA) and Certified Quality Engineer (CQE) are also useful as a quality professional like in auditing. There are also other certification like Clinical Research Associate and the list go on and on.

2)    Departmental Training

Each department is responsible to provide the necessary training to ensure employees are skilled, capable, and competent to perform their functions in the department in question. For example, if you are in the manufacturing, may be, more training on production process validation, process capability, out of specification training, verification and validation related activities training.

On-the-job training (OJT) is another important and efficient way to train less experienced employees. There are simply not easy to learn from a procedure and protocol. OJT must be used more often. Experience in the industry tells me that OJT is important, there may be things which are difficult to be captured in the procedure.

3)    Training Effectiveness and Evaluation

Training effectiveness is often not being paid more attention. After each employee is trained and it does not mean he or she is effectively trained. Often times, employees do not think it is important. They attend the training and sign the document and considered trained. Therefore, to gauge the effectiveness of the training regiment, the approaches are shown below.

This evaluation assesses whether a particular training has achieved its objectives and if the employee is competent and skilled to perform the new job function. The evaluation is taking test and performing several productions to gauge how many products have defects. Results of all the evaluation are recorded and is kept with the original training record.

4)    Training Record and Documentation

All training records can be kept virtually and in a cabinet. In this day and age, there are many training software to be deployed so that to keep all training records like Master Control. This is particularly important for sponsor which employs thousands of employees.

21 CFR QSR (Subpart B), 60	Does the training procedures includes the identification of the training need?
21 CFR 820.20 (b)(2)	Has the company provided adequate resources, including the assignment of trained personnel, for management, performance of work, and assessment activities, including internal quality audits, to meet the requirements of this part?
21 CFR 820.25 (a)	Does the company have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required for the quality system are correctly performed?
21 CFR 820.25 (b)	Have procedures been established for identifying training needs, and ensure that all personnel are trained to adequately perform their assigned responsibilities?
21 CFR 820.25 (b)(1)	As part of their training, are personnel made aware of device defects that may occur from the improper performance of their specific jobs?
21 CFR 820.25 (b)(2)	Are the personnel who perform verification and validation activities made aware of defects and errors that may be encountered as part of their job functions?
21 CFR 820.25 (b)	Does the quality system ensure that all personnel are trained to adequately perform their assigned responsibilities?
21 CFR 820.70 (d)	Has the company established and maintained requirements for the health, cleanliness, personal practices, and clothing of personnel for situations where contact could be reasonably expected to have an adverse effect on product quality?
21 CFR 820.70 (d)	Has the company ensured that temporary personnel are appropriately trained or supervised by a trained individual?

Disclaimer: Although the author had exhaustively researched all sources to ensure the accuracy and completeness of the information contained in this blog, but no warranty and fitness is implied. I assumed no responsibility and implied warranty of any kind for errors, inaccuracies, omission, or any inconsistency herein. No liability is assumed for incidental or consequential damages in connection with the use of the information contained herein. Readers should always use their own judgment and review all related regulatory guidelines. Guidelines can change over time.

Management Review

Management review is another requirement of quality system for medical device manufacturer. A procedure for management review should be written to handle management review. This procedure is to provide a system and instruction, to assign responsibilities for scheduling, conducting and recording management reviews for the company’s quality management review. The blog for management review shall talk about 1. Frequency and scheduling 2. Attendance 3. Agenda 4. Review Input 5. Quality Policy and Quality Objectives 6. Review Output and 7. Record of management review.

1.     Frequency and Scheduling

Executive management should review the quality performance and quality management of the whole organization at least once a year. Specific dates like June and December should be stated if the management review decided to review twice a year. Executive management when responding to changing and special conditions and events like consent decree and warning letter can call for any unscheduled and extraordinary reviews. Nothing is carved in stone.

 2.     Attendance

Management reviews should be chaired by top executive like CEO and attended by managers representing Quality Assurance, Marketing and Sales, Design Engineering, Regulatory Affairs, Manufacturing, Quality Control, Purchasing and Human Resources. Managers who cannot be present can send representative and he or she after receiving the meeting minutes, may submit their input and comments to the CEO and/or quality assurance.

 3.     Agenda

QA should setup the agenda for management review a week or more prior to the meeting and distributed to all participating managers. This will give respective managers some time to prepare for the meeting and raise some quality issue during the management review.

 4.     Management Review Input

The following are some of the quality issues which can be discussed in the quality review: action Items from last meeting, process performance and product conformity, internal quality audits, external quality audits, corrective and preventive action (CAPA), post-production feedback, customer complaints, product recall, customer recall, training, continual improvement, new or revised regulatory requirements and its ramification, medical device reporting (MDR), safety and effectiveness, application status and any changes that could affect the company’s quality system.

 5.     Quality Policy and Quality Objectives

Quality policy and quality objectives are two keys issues to be discussed during management review. During management review, the progress of quality policy and quality objectives must be discussed.  Quality objectives must be systematically evaluated to access the progress during management review. If the quality objective of certain issue is closed, the resource can be moved to deal with another quality objective.

 If any quality objective is not achieved on time, the review can investigate and determine the causes of the failure to achieve the deadline. Management can decide what to do with the failed quality objective. They can drop the objective, reduce the scope, reassign responsibility, allocate additional resources or extend the deadline.

 During the management review, new objectives are established when necessary to improve quality performance during the management review. These new objectives should be documented in the Quality Objective Record.

 The quality policy of the organization shall be discussed to access its suitability to the whole organization in the middle of new regulatory, addition of new product, product changes and the like. For example, if a medical device company begins to manufacture Class III device, its quality policy and quality system may need to be updated.

 6.     Management Review Output

Resources needed for the implementations of the improvements are identified as review output. This includes the assignment of responsibility, time-frame, and allocation of human like more personnel and the employment of consultants, equipment and know-how. Management review output is documented in review meeting’s minutes. Action items are highlighted.

 7.     Record

Management review output during the meeting should be prepared by Quality Assurance and distributed to the attending managers and absent managers as well. All the management review record shall be stored in a known location both virtually and hard-copy. These record can only be disposed according to the time-frame stated in control of record’s policy.

21 CFR 820.20(c)	Does management with executive responsibility review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the company’s established quality policy and objectives?
21 CFR 820.20(c)	Are the dates and results of quality system reviews documented?

Disclaimer: Although the author had exhaustively researched all sources to ensure the accuracy and completeness of the information contained in this blog, but no warranty and fitness is implied. I assumed no responsibility and implied warranty of any kind for errors, inaccuracies, omission, or any inconsistency herein. No liability is assumed for incidental or consequential damages in connection with the use of the information contained herein. Readers should always use their own judgment and review all related regulatory guidelines. Guidelines can change over time.

Quality Objectives

A procedure for ‘quality objectives’ is to provide a system and instructions, and to assign responsibility for the initiation, implementation and monitoring to achieve quality objectives in the organization. The objective of this procedure is to improve the quality of the products, manufacturing and support processes and the entire quality management system.

1)    Establishment of Quality Objectives in the Organization:

The quality objectives are established to improve the performance and quality system in order to achieve the quality policy, organizational goals and objectives.

New quality objectives can be established and recorded at the management review.  Management review and the process is discussed in another blog.

For each quality objective, the QA Manager shall establish a quality objective record. The following information should be in the quality objective.

·       Quality objective to be achieved by the project.

·       The present level of the objective and the performance level to be achieved. (For example, at present, there are 30 CAPAs generated each month and in 12 months, the goal of the quality objective is to reduce by 50%, therefore only 15 CAPAs or less can be generated.

·       A target date or time-frame must be in the quality objective. Try as hard as possible to achieve within the target date. Should an extension be made, ensure to record the justification as to why the extension is warranted.

·       The assignment of personnel like project manager and human and financial resources must also be clearly stated in the quality objective. How many personnel required to complete the quality objective on time like the hiring of consultants, additions of full time employees and how much money be allocated in the project must be clearly stated and justified.

2)    Implementation of Project to achieve the Quality Objective  The next phase is the implementation which is the hardest portion. 

   Project manager must garner support from all related departments to ensure the
  seamless execution and implementation of the quality objective.  After the
   quality objective is bought in by all related departments, QA manager will
  have to initiate the following:

·       The identification of the major elements and phases of the project; areas where the project to be implemented; other departments’ involvement, managers; requirement for personnel, facilities, equipment and other resources must be clearly identified and stated in the quality objective.

·       Monitoring and measurement methods and means to be used to measure the progress toward the underlying objective. Interim progress, problems, issue and state of the project must be periodically assimilated to all involved with the project.

·       QA manager should prepare intermediate reviews and distributed to all related personnel. Should there be any adjustment like additional resources, more personnel required; these shall be discussed in the meeting and reported in the interim report.

·       The establishment of a special project file to organize associated documents and records like interim reports, data sheets and meeting minutes. A special folder in the computer should be established and collect all documents and organized them well in the folder. For hardcopy, a special cabinet shall be provided to collect them in a logical and chronological manner.

3)    Review and Close-out of Quality Objectives

After the quality objective is achieved, the result should be reported to the management review. The closing out of the project is recorded in the closeout of the management review and shall be documented in the Quality Objective Record. All documents either virtual or hardcopies shall be updated in the folder and specific cabinet.

Below is the exact wordings from FDA website.

21 CFR 820.20 (a)	Does management with executive responsibility establish its policy and objectives for, and commitment to, quality?
21 CFR 820.20 (a)	Does management with executive responsibility ensure that the quality policy is understood, implemented, and maintained at all levels of the company?
21 CFR 820.20 (b)	Does the company establish and maintain an adequate organizational structure to ensure that devices are designed and produced in accordance with the requirements of this part?
21 CFR 820.20 (b) (1)	Does the company establish the appropriate responsibility, authority, and interrelation of all personnel who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks?
21 CFR 820.20 (b) (3) (i)	Does management with executive responsibility appoint, and document such appointment of, a member of management who, irrespective of other responsibilities, shall have established authority over and responsibility for ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part?
21 CFR 820.20 (d)	Has a quality plan been established which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured?
21 CFR 820.20 (d)	Has management established how the requirements for quality will be met?
21 CFR 820.20(e)	Has the company established an outline of the structure of the documentation used in the quality system?
21 CFR 820.5	Does the company establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured, and that meets the requirements of this part?
21 CFR 820.5(d)	Does the company establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured?
21 CFR 820.5(d)	Does the company establish how the requirements for quality will be met?
21 CFR 820.5(e)	Does the company establish quality system procedures and instructions?
21 CFR 820.5(e)	Where appropriate, has the company established an outline of the structure of the documentation used in the quality system?

Courtesy of www.mnc.umd.edu 

Disclaimer: Although the author had exhaustively researched all sources to ensure the accuracy and completeness of the information contained in this blog, but no warranty and fitness is implied. I assumed no responsibility and implied warranty of any kind for errors, inaccuracies, omission, or any inconsistency herein. No liability is assumed for incidental or consequential damages in connection with the use of the information contained herein. Readers should always use their own judgment and review all related regulatory guidelines. Guidelines can change over time.