Quality Planning at a Medical Device Processing Site

  • Published on: Oct 27, 2017

Purpose:

The purpose of this document is to identify and document the processes within a medical device manufacturer and distributor sites Quality Management System where the requirement for Quality Planning has been considered and implemented. The document explains how planning and correctly controlling the key business processes enables the site to meet our Legal, Regulatory and Customer requirements, whilst effectively achieving planned Business Objectives.

Scope:

The scope of this document covers the quality planning considerations and mechanisms which are applied to:

PLAN: Planning Processes

Setting Site Objectives

Planning Site Resources

Determining Customer Requirements

Meeting Legal and Regulatory Requirements

Risk Management & Business Continuity Planning

DO: Processing Phase

Sales & Marketing

Calibration & Maintenance

Service & Repair

Storage & Despatch

Purchasing

Documentation Control

Product Registration

Control of Nonconforming Material

Order Processing

CHECK: Monitoring Processes

Customer Satisfaction

Product and Process KPIs

Quality Audits

Product & Part Inspection and Test

ACT: Improvement of Processes

Management Review

Training, Recruitment and Staff Development

Corrective Action

Continual Improvement

Applicability:

This document is applicable to the processes forming the working practices and procedures incorporated into the Quality Management System of a medical device processing site.

Quality Planning Activities:

The following paragraphs indicate the areas where a medical device processing site particularly apply controlled mechanisms to ensure that planning for quality is achieved.

The site recognizes that Quality Planning is important to achieve both efficiency within the Quality Management System and safety, quality and reliability of the products supplied. Efficient Quality Planning will ensure the customers requirements are met and leads to the ongoing success and growth of the site.

Note that this procedure only serves as an indicator that these areas have been identified as vital to the sites quality planning activities. Full details of the actual mechanisms and responsibilities in regard to each activity can be found in the relevant quality procedure referenced in each section.

The Quality Management System documentation incorporates the Quality Manual and all referenced procedures and documents, which incorporate the overall operations of the Site. These are supplemented by working documents such as generic or product specific Work Instructions, Inspection & Test Instructions and departmental forms etc. The quality procedures and related documents reflect the requirement of the ISO 9001 and ISO 13485 standard and the adopted methods and processes by which the sites Mission Statement, principles and objectives are to be addressed and maintained.

Site Structure:

The Site Structure has been planned and developed to ensure that effective quality management to the requirements of ISO 9001 and ISO 13485 is achieved and also to ensure that the sites quality policy and objectives and also the requirements of our customers are fully met.

Specific responsibilities and levels of authority have been defined for all inpiduals within the site structure, including reporting, communication lines and inter-relation of activities.

Planning Processes:

Site recognizes the importance of planning for both the business objectives and the continual improvement of the business and services. Accurate control of these planning activities is vital, to support the subsequent activities within the Quality Management System.

Setting Site Objectives:

Site recognizes that a key factor in ensuring continual business success lies in efficient site planning. The site has mechanisms in place to ensure that the setting and implementing of corporate and quality objectives are identified, agreed by all stakeholders and implemented in a controlled manner.

These objectives are communicated throughout the organization and departmental and inpidual staff member objectives are then structured so as to support the overall site objectives.

By measuring the timeliness of effective implementation of these objectives, valuable information is gathered which assists in generating future objective and improvement plans.

Planning Site Resources:

The site has determined the necessary level of skill and competency for each position within the site structure in order to maintain the effectiveness of the Quality Management System.

The recruitment and assignment of personnel is undertaken with due consideration given to the level of education, skills, experience and knowledge required in order to achieve the desired level of competency for each position.

Ongoing competency and suitability assessments are maintained to identify applicable training needs.

Determining Customer Requirements:

Assessing and understanding the customers requirements is critical to achieving customer satisfaction.

Sales & Marketing Processes:

The site applies specific mechanisms to ensure that customer requirements, product and quality requirements, are fully assessed and documented, prior to providing a quotation for contract.

Customer Service Processes:

Upon receipt of a customer order, mechanisms are in place to check the information and to confirm that the customers requirements can be met. Customers are contacted in cases where there specific requirements, e.g. product type, quantity, delivery timeframe cannot be met and the issues are discussed and a course of action agreed by both parties. The customers are also contacted on cases where their order requirements are not clear or may contain information anomalies.

Meeting Legal and Regulatory Requirement:

The site is committed to meeting all its obligations relating to Regulatory and Legal requirements, whether concerning the ongoing business operations of the site or the Safety and Efficacy compliance of the products being distributed.

As part of the setting of new business objectives, including the launch of new products into the market, or the restructuring of the Quality Management System, the site undertakes a detailed review of all Legal and Regulatory requirements and ensures that any activities are undertaken in a manner that ensures all our obligations are fully met.

Risk Management:

ISO 13485 standard provides the basis for the sites approach to risk management and staff awareness presentations are undertaken to educate all personnel as to the benefits of applying these principles to every daily process.

The site applies a culture of Risk Management when determining processes and considers these principles when structuring the sequence of activities involved in support of each process. Checkpoints are placed at strategic points in the sites processes, to ensure that any errors or anomalies do not pass down the process chain undetected, which could then negatively impact other internal or external stakeholders. The quantity, location and effectiveness of such process check points is constantly reviewed for suitability, with checkpoints being moved, added or removed to ensure the process runs at optimum efficiency.

Business Continuity Planning:

The site has undertaken an extensive review of the key business processes, and determined the minimum amount of resource required to maintain these processes, at a reduced level, in the event of a major adverse event causing a disruption to our operations.

Each department has developed their own Business Continuity Plan, identifying the potential impacts, the resource required, the timeframe involved and the specific activities to be undertaken in the event of an adverse incident. The departmental plans have been generated to address varying types of adverse events, and contain differing continuity and recovery actions as required.

Processing Phase:

The inpidual activities which make up this section are usually driven by the prior Planning activities. Once the initial assessment and planning phases have been undertaken, the Processing activities take over and the services being provided are activated.

Checking to ensure that the product or service meets the customers requirements, also forms part of these activities.

Sales & Marketing Processes:

As this aspect of the sites business usually involves meeting face to face with the customer, these process have been planned so as to identify and then act on the customers requirements as a priority concern.

Having secured the sale of products, the Sales & Marketing procedures have then been structured so as to provide an accurate means of reporting sales figures back into the business. This information is critical in assessing how well the sites sales are progressing compared to the budget.

Technical Services Processes:

Calibration and Maintenance

The acquisition and control of tools, jigs, and test and inspection equipment is strictly controlled to ensure that equipment suitability, functionality and stability results in fully conforming products being provided to customers after repair and servicing has taken place.

The identification of the appropriate equipment, including the requirement for periodic maintenance or calibration activities to be performed, is assessed and documented during the initial planning of the repair and service processes.

Service and Repair

Planning for equipment service and repair activities is undertaken in conjunction with the original equipment manufacturer, i.e. the applicable Sites Medical manufacturing site nominated as the Design Authority for the particular device.

The site ensures that it has on-line access to the latest versions of the work instructions, test instructions, and operators manuals for all equipment being serviced or repaired, and where applicable test equipment and software programs will be validated in accordance with the manufacturers validation protocols prior to use, and periodically when required.

Where a particular environment is required, e.g. precautions against the effects of Electrostatic Discharge (ESD) damage to components, suitable protection mechanisms are identified and utilised.

IT System

The site has planned to control the majority of our product forecasting, ordering, receipt, dispatch and financial accounting processes via the Exact system located on the site network. The network used on site is administered via the IT authorities.

This flexibility allows for instant viewing of data and considerably improves our process efficiency across many departments.

The IT systems within the site share the same security and back up features, and we have local disaster recovery procedures in place, to allow for system recovery in the shortest possible time in the event of a major system crash.

Logistics Processes:

Storage and Despatch

The handling, storage and despatch of goods is carefully controlled, ensuring that full product traceability is maintained, both prior to and after despatch to customers. Handling and storage conditions are employed which provide the optimum protection and preservation of the products and ensures that any sterilisation is not compromised.

If applicable, specific requirements, such as environmental control, are identified during the planning stages, and the appropriate mechanisms are introduced to provide the correct storage conditions.

Purchasing

The selection of suppliers, the communication of the sites requirements, and the verification of the procured material, all form part of the sites purchasing activities. Each of the above phases are tightly controlled, to ensure the needs of the site are met, along with the needs of the customer. A structured supplier performance monitoring system provides data to indicate where improvement actions may be required.

Regulatory Affairs & QA Processes:

Document Control

The correct identification, availability, and content of documents within the site is of vital importance. Systems are in place to assess the requirement for documents, their generation, approval, and subsequent distribution. The system ensures that only current documents are available at the point of use, with obsolete documents being removed. The site also has procedures for the retention and retrieval of superseded documents and all Quality Records.

Product Registration

Communication channels have been established with Regulatory Affairs departments at each of the affiliate manufacturing sites. This ensures that when new product registrations are to be submitted to the regulatory authorities, all the information required is promptly and accurately supplied by the manufacturer.

Sites RA/QA staff attends periodic regulatory seminars, to ensure they are conversant with all the current and proposed changes to the local regulatory requirements.

Control of Non Conforming Material

Where products, material, or processes are found to deviate from planned or documented criteria, strict identification and segregation controls are applied.

The actions to be taken and responsibilities involved are clearly documented, to ensure unintended use or delivery of nonconforming material does not occur.

Customer Service Processes:

Comprehensive process maps exist for the processes undertaken by the Customer Service Department, to ensure that the customers requirements are understood and acted upon promptly. The Customer Service Department interfaces with all other departments regularly, and these interface activities have been included into the relevant process maps for the department.

Monitoring Processes:

The availability of efficient monitoring and measurement mechanisms is critical to ensure that the sites Quality Objectives are being met. The following are the sites key monitoring activities:

Customer Satisfaction

The collection and analysis of information relating to the satisfaction of the customer is a key activity in improving the business.

Information and feedback is collected via means such as customer complaints, pro-active customer satisfaction questionnaires, and meetings between customers and Sites Medical representatives.

Analysis of this data identifies areas where corrective action can be introduced. The effectiveness of these actions is then subsequently measured by the initial monitoring mechanisms.

Product and Process Key Performance Indicators (KPIs):

The site has introduced measurement mechanisms for several key performance indicators across all the departmental activities. Each of these areas gives vital information relating to the level of business efficiency and the quality of service being provided to customers.

The data collected is periodically analysed, and forms a significant input for the Management Review activity.

Quality Audits

Performing internal quality audits monitors the ongoing suitability and effectiveness of the quality management system. These audits are performed against a planned schedule which takes into account every aspect of the quality management system and every departmental activity within the site.

Internal audit findings provide significant input for the sites Management Review activities and audit schedules are planned and amended to reflect increased surveillance of problem areas.

Product and Part Inspection and Test:

Prior to despatch, all new items of capital equipment are given an abridged functional test in accordance with the manufacturers instructions. The results of this test are documented.

Products having been repaired or service by the site are given a full functional test in accordance with the manufacturers instructions. Where applicable, all equipment test results and readings are documented and form part of the equipments service history records.

Improvement Processes:

The site recognises that it is very beneficial to pro-actively seek out opportunities where improvements can be made to the Quality System, the quality of the products, and the skills and resources we have available.

Management Review:

The Quality Management System suitability and effectiveness, and the progress of the site against the Business Objectives are formally reviewed at defined intervals by the sites senior management. These reviews analyse the results of the various performance monitoring mechanisms and identify improvement opportunities for products, processes and the Quality Management System itself.

Training, Recruitment and Staff Development:

The recruitment, training, qualification and awareness and personal development of the sites staff has been identified as central to achieving business objectives and meeting the customers requirements, whilst ensuring continual improvement of the sites skill base.

Specific recruitment criteria have been developed in order to secure staff with the appropriate skills, competency and experience relative to their position. The site monitors staff competency and identifies both training needs and training effectiveness by performing periodic performance appraisals.

Internal and external training programmes are employed for staff at all levels within the site, with comprehensive records being generated to record not only the occurrence of this training but also the level of competency achieved for certain activities.

Corrective Action:

Quality Management System :

Mechanisms are in place to ensure that Quality Management System improvement opportunities are identified and acted upon via the Internal Audit mechanisms.

Customer Product Complaints:

Customers dissatisfaction with a product is formally captured via the customer complaints system, with all relevant details and subsequent investigation and corrective action being recorded on a Corrective Action Report.

Customer Service Complaints:

Where a customer is dissatisfied with the quality of service they have received regarding stock despatched by the site and where they subsequently have goods which they wish to return, these actions are formally documented via the Returned Material Authorisation process within the ERP system.

The system records all the relevant details and also records what actions were undertaken to address the issue. All financial transactions e.g. credit, re-stocking fees that took place as a result of the complaint are recorded in the Oracle system.

Customer Satisfaction:

The site identifies and implements improvement opportunities based on information collated via the Customer Satisfaction Surveys

Continual Improvement:

The site Quality Management System has been structured to facilitate the continual improvement of all the sites business activities. The cycle of collecting the data, implementing the actions, then measuring the results, is applied across all quality system processes undertaken by the site. Staffs are trained to apply a continual improvement approach to their tasks, by continually assessing outcomes at all levels and suggesting improvement actions where possible.

Quality Records:

All documentation generated as a result of the Quality Planning activities are to be classed as Quality Records and processed and archived.

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