VV_8.0_8. MEASUREMENTS, ANALYSIS AND IMPROVEMENT

8.1.  General

Supply Direct is committed, using factual data, to planning and implementing of the measurements, analysis, monitoring, and improvement processes needed for the following:

• To demonstrate conformity of the products,
• To ensure conformity of the QMS, and
• To maintain the effectiveness of the QMS.

8.2.  Measurements and Monitoring

8.2.1.     Feedback

The organization has established a documented procedure for a feedback and complaint system to provide early warning of quality problems and for input into the corrective and preventive action processes. The information on customer satisfaction is used as one of the measurements of the performance of the QMS.
 

Applicable Procedures/Instructions:
Instruction-Customer Feedback
Instruction-Complaints Handling
Instruction-PMS

8.2.2.     Complaint handling

Procedures for complaint handling has been established to secure timely complaint handling in accordance with regulatory requirements. The organization secures that;
§  Relevant information concerning the complaint is recorded
§  Evaluates if the information may be justified as a complaint
§  Complaints are investigated, in conjunction with the relevant supplier, if applicable
§  Reporting to relevant authorities are conducted – where appropriate
§  Products affected by the complaint are handled
§  The need for issue of a CAPA is determined.
 

Applicable Procedures/Instructions:
Instruction-Complaints Handling
Procedure-Corrective and Preventive Actions (CAPAs)
Instruction-Vigilance reporting and recall
Instruction-Field Safety Corrective Action (FSCA) and Field Safety Notice
Instruction-PMS

8.2.3.     Reporting to regulatory authorities

Procedures for reporting to authorities has been established and implemented in case an adverse event is reported to The organization.
The procedures distinguish between EU Vigilance reporting and US MDR reporting of events.
 

Applicable Procedures/Instructions:
Procedure-Managing Non-Conformances
Instruction-Complaints Handling
Instruction-Vigilance reporting and recall
Instruction-Field Safety Corrective Action (FSCA) and Field Safety Notice

8.2.4.     Audit

The organization conducts internal audits at planned intervals to determine whether the QMS;
 
§  Conforms to the planned arrangements, to the relevant regulations and to the QMS requirements established by the organization, and
§  Is effectively implemented and maintained.
 
Personnel independent of those that have direct responsibility for the activity being audited performs audits, in some cases, outside resources will be used for audit.
 
Internal audits, planned audits of departments in the organization and supplier audits are scheduled on the basis and importance of the activity to be audited. Personnel responsible for the audited activity must take timely corrective action on deficiencies found during the audit.
 
The implementation and effectiveness of the corrective action taken is recorded and subsequently verified during follow-up audit activities.
 
Internal Audit Reports, follow-up Audit Reports and Corrective Action Reports, are retained as quality records.
 
External Audits can be planned and unannounced. The audit findings from external audits are handled the same as for internal audits.
 

Applicable Procedures/Instructions:
Procedure-Corrective and Preventive Actions (CAPAs)
Procedure-Quality Audits

8.2.5.     Monitoring and Measurement of Processes

Processes used for the Product Realization are monitored and measured through inspections, testing and verifications activities according to the applicable Work instructions.
The relevant processes for the QMS are measured and monitored against quality objectives.
 

Applicable Procedures/Instructions:
Instruction-Management Review
Instruction-Product Release
Procedure-Managing Non-Conformances

8.2.6.     Monitoring and Measurement of Product

Monitoring and Measurement of products performance are established and maintained to ensure that specified requirements for the products are met. This measurement is defined in quality objectives and evaluated at management review meetings.
 
Product is held with the manufacturing until required measurement and tests have been performed and completed, or until necessary reports have been received or generated. Product release is conducted by The organization only and product is held in quarantine with the supplier until released by The organization.
 
No product is dispatched from the supplier until all activities specified for measurement and monitoring have been completed and accepted, and the associated data and documentation is available, validated and approved.
 

Applicable Procedures/Instructions:
Instruction-Management Review
Instruction-Product Release
Instruction-Complaints Handling

8.3.  Control of Nonconforming Product

8.3.1.     General

The organization ensures that product which does not conform to requirements are identified, segregated and controlled to prevent unintended use or delivery.
 
Non-conforming products disposition may involve the following;
 
§  100% inspection to identify conforming from non-conforming product
§  Returning components and parts to supplier
§  Destruction
§  Re-manufacture 
§  Assigning the non-conforming products to another application
§  Granting a concession if regulatory requirements for the product are met

Corrected or reprocessed products are re-verified in accordance with existing procedures.
 

Applicable Procedures/Instructions:
Instruction-Non-conformance

8.3.2.     Actions in response to non-conforming products detected before delivery

In case a medical device is found to not be in compliance to specifications, The organization does not distribute the device until proven to function as intended and specified.
 

Applicable Procedures/Instructions:
Procedure-Managing Non-Conformances

8.3.3.     Actions to products detected after delivery

In case a medical device fails to conform to specifications or in the event of a reportable event, The organization initiates appropriate action by recommending stop of usage and/or initiate service and/or repair on-site.
 
 

Applicable Procedures/Instructions:
Procedure-Managing Non-Conformances
Instruction-Complaints Handling
Instruction-Vigilance reporting and recall
Instruction-Field Safety Corrective Action (FSCA) and Field Safety Notice

8.3.4.     Rework

In case products needs rework or concession, the procedure for non-conforming products outlines the process to ensure that the activity does not adversely affect the product and that the product prior to release undergoes the same review and approval as the original procedure.
 
Rework and concessions are only conducted if regulatory requirements are met.
 

Applicable Procedures/Instructions:
Procedure-Managing Non-Conformances

8.4.  Analysis of data

Data are analysed based on quality records and compared to defined quality objectives. These data are analysed and used as input to Management reviews and control of processes related – but not limited – to;
§  Complaints and customer feedback (complaint forms and complaint statistics)
§  Products ability to meet specifications and customer expectations (NCR and Complaint data)
§  Production and quality system processes (NCR and CAPA reports)
§  Supplier´s ability to provide products on time and according to specifications (supplier evaluations).
 
Data are analysed using recognized statistical methods.
 
Data are used to evaluate if the QMS remains effective or if improvements should be defined and implemented.
 

Applicable Procedures/Instructions:
Procedure-Purchasing
Procedure-Managing Non-Conformances
Procedure-Quality Audits
Instruction-Complaints Handling
Procedure-Risk Management
Procedure-Corrective and Preventive Actions (CAPAs)
Instruction-Field Safety Corrective Action (FSCA) and Field Safety Notice
Instruction-PMS

8.5.  Improvement

8.5.1.     General

Improvement activities are those which identify and implement any changes necessary to ensure and maintain the continued suitability and effectiveness of the quality system to meet the requirements.
 
If a need for corrective or preventive action is identified, this indicates that the quality system has not been suitable or fully effective in an area.
Correcting the problem or potential problem by implementing corrective or preventive action to bring the quality system back to a fully suitable and effective state is an improvement.
In case of reporting of an Incident, systems for Advisory notice to authorities and customers are implemented.
 
The quality policy, analysis of data, corrective and preventive actions and post market surveillance contribute to the continual improvements. The function responsible persons may recommend improvement activities, but the management review has the overall responsibility for executing the activity.
 

Applicable Procedures/Instructions:
Instruction-Complaints Handling
Procedure-Managing Non-Conformances
Procedure-Corrective and Preventive Actions (CAPAs)
Instruction-Vigilance reporting and recall
Instruction-Field Safety Corrective Action (FSCA) and Field Safety Notice
Instruction-PMS
Procedure-Quality Audits

8.5.2.     Corrective Action

The organization takes action to eliminate the root-cause of non-conformities in order to prevent recurrence. Corrective actions are appropriate to the effects of the nonconformities encountered. A CAPA procedure is established to define requirements for;
 
§  Reviewing non-conformities (including customer complaints), determining the root-causes of nonconformities,
§  Evaluating the need for action to ensure that nonconformities do not recur,
§  Determining and implementing action needed, if appropriate, updating documentation,
§  Recording of the results of any investigation and of action taken and reviewing of corrective action taken and its effectiveness.
 

Applicable Procedures/Instructions:
Procedure-Corrective and Preventive Actions (CAPAs)

8.5.3.     Preventive Action

The organization determines action to eliminate the root-causes of potential non-conformities to prevent their occurrence. Preventive actions taken are appropriate to the effects of the potential problems or to implement identified improvements to processes or products.
 
The same CAPA-procedure is used to define requirements for;
 
§  Determining potential nonconformities and their root-causes,
§  Evaluating the need for action to prevent occurrence of nonconformities,
§  Determining and implementing action needed,
§  Recording of the results of any investigations and of action taken,
§  Reviewing preventive action taken and its effectiveness.
 

Applicable Procedures/Instructions:
Procedure-Corrective and Preventive Actions (CAPAs)