This Document provides the process for management of Adverse Incidents & Recalls.
This document covers the process for handling Adverse Incidents & Recalls in compliance of ISO 13485 (8.2.3. / 8.5.2.).
(Version history at end of page)
Signed V13 RB 05.07.2024
The process covers all documents and processes and products as define in the Standard of Procedure.
Approval: Author of the document, Marelize Robertson
Changes: Author of the document, Rachel Belcher
SOP: Standard Operating Procedure
PSO: Post Market Surveillance Officer
MD: Managing Director
NCR: Non-Conformance Report
Alert: Means the removal of specific batch/batches of a medicinal product from the market for reasons relating to deficiencies in the quality, safety or efficacy.
Adverse event: Means the removal of specific batch/batches of a medicinal product from the market for reasons relating to deficiencies in the quality, safety or efficacy.
Recall: Means the removal of specific batch/batches of a product from the market for reasons relating to deficiencies in the quality, safety or efficacy
SOP – Standard Operating Procedure
DoC – Declaration of Conformity
COA – Certificate of Analysis
SAHPRA - South African Health Products Regulatory Authority
7.1. ISO 13485 Clause 8.2.3. & 8.3.
7.2. SOP Non-Conformance Corrective Action
7.3. SOP Post Market Surveillance
7.4. SAHPRA Medical Devices Guidelines
7.5. Recalls Vigilance Medical Devices IVD's
Any Adverse event must be recorded and follow the SOP Non-Conformance Corrective Action
The Authorised Representative, independent of the sales and marketing organisation, is designated as responsible for execution and co-ordination of recalls and is supported by the Responsible Person to handle all the aspects of the recalls with the appropriate degree of urgency.
This Responsible Person must always be made aware of any recall operation, who will investigate and determine the class and type of Recall.
The Recall process must be initiated promptly and at any time and therefore there is the 24-hour contact number for the Managing Director as per SAHPRA timelines
Reporting to regulatory authorities; If applicable regulatory requirements require notification of complaints that meet specified reporting criteria of adverse events or issuance of advisory notices, the companies follow notification to the appropriate regulatory authorities as per point 6
The Regulatory Authority maybe informed promptly by e-mail or telephone call if products are intended to be recalled because they are, or are suspected of, being defective. Refer http://www.sahpra.org.za/acts-and-regulations/
GENERAL TIMELINES ref GHTF/SG2/N6R3:2002 New MDR EU refer Article 73 & 80
refer website http://www.imdrf.org/documents/documents.asph and CE requirements located http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards_en
The organisation issues advisory notices in accordance with applicable regulatory requirements and the attached letter format.
Letterhead: (Copy & Paste into a document)
Date
Regulator / Customer
Address etc
Re: Advisory Notice : Product : batch
Description of the medical device / product and model designation,
The serial numbers or other identification (for instance batch or lot numbers) of the medical device or product concerned,
The reason for the issue of the notice,
Any advice regarding possible hazards, and any consequent actions to be taken.
Yours Sincerely
PSO
The advisory notices must be reported to regulatory authorities if applicable and as identified by the appointed PSO refer PharmacoVigilance and Post market surveillance SOP.
The notice includes medical devices that need to be corrected in order to be safe and perform as intended, as well as nonconforming devices that cannot be corrected and have to be removed from the market.
Any specific regulatory procedures for processing advisory notices and recall must be followed as required by the regulatory authority.
The nature and seriousness of the hazard or nonconformity, the intended use of the medical device, and the potential for patient injury or failure to meet regulatory requirements, will determine whether it will be necessary to issue an advisory notice and to report to national or regional regulatory authorities.
These factors also determine the urgency and extent of the action.
The procedure for generating, authorizing and issuing an advisory notice is that the PSO will activate the process and in the event of the absence of the PSO then the MD will initiate with consultation to the PSO and regulatory authorities.
A team is co-coordinated to determine the affected products, the disposition of returned product (e.g. rework, repackage, scrap), and the communication system (which includes the necessity to report to local or national authorities), the points of contact and the methods of communication between the organisation and national or regional regulatory authorities.
If a medical device is returned to the organisation, the progress of agreed corrective actions is monitored by the team and, if appropriate, the quantities of product physically returned to the organisation or scrapped locally or corrected locally is reconciled.
The Consumer Protection Act - a recall may be notified refer; https://www.gov.za/documents/consumer-protection-act
1.1. The National Consumer Commission (NCC) re http://www.thedti.gov.za/agencies/ncc.jsp
1.2. The National Consumer Commission (NCC) is established in terms of section 85 of the Consumer Protection Act No. 68 of 2008, as an organ of state within the Public administration, and as an institution outside public service with jurisdiction throughout the Republic of South Africa. The NCC is charged with the responsibility to enforce and carry out the functions assigned to it in terms of the Act, which aims to:
Promote a fair, accessible and sustainable marketplace for consumer products and services, and for that purpose;
Establish national norms and standards relating to consumer protection;
Provide for improved standards of consumer information;
Prohibit certain unfair marketing and business practices;
Promote responsible consumer behaviour; and
7. Promote a consistent legislation and enforcement framework relating to consumer transactions. Commissioner (Acting) :
The distribution records are requested from the Authorised Representative, from the different departments who is to make them readily available to the Authorised Representative / Responsible Person, and should contain sufficient information on wholesalers and directly supplied customers (with addresses, phone and/or fax numbers inside and outside working hours, batches and amounts delivered), including those for exported products and medical samples.
Recalled products are identified and stored separately in a secure area (Quarantine) while awaiting a decision on their fate; as per Rejected Materials
Customers are notified by the customer service manager with the letter from the Person Responsible
The progress of the recall process is recorded and a final report issued, including a reconciliation between the delivered and recovered quantities of the products.
The effectiveness of the arrangements for recalls should be evaluated from time to time through Self inspection / Internal auditing or a mock recall is initiated and recorded.
Recalls are classified into both the class according to the level of health hazard involved (risk to the patient) and type which denotes the depth or extent to which the product should be recalled from the distribution chain, e.g. Class I, Type C recall, etc.
Class I
Class I is for defective/dangerous/potentially life-threatening MEDICAL DEVICE / IVDs that predictably or probably could result into serious health risk/adverse events or even death.
Examples:
Wrong Product ( The label and contents are different products)
Correct product but wrong strength, with serious medical consequences
Microbial contamination of a sterile injectable or ophthalmic product
Chemical contamination with serios medical consequences
Mix-up of some products with more than one container involved
Class II
Class II is for MEDICAL DEVICE / IVDs that possibly could cause temporary or medically reversible adverse health problem or mistreatment.
Examples:
Mislabeling e.g. wrong or missing text or figures
Missing or incorrect information (Leaflets or inserts)
Microbial contamination of non-injectable, non-ophthalmic sterile product with medical consequences
Chemical/physical contamination (significant impurities, cross-contamination, particles)
Mx up of products in containers
Non compliance with specification (stability, weight)
Insecure closure with serious medical consequences (e.g. cytotoxins, potent products)
Class III
Class III is for MEDICAL DEVICE / IVDs that are defective and are unlikely to cause any adverse health reaction or which do not comply with the requirements of Act 101 of 1965 in terms of the requirements of printed packaging material, product specification, labeling, etc.
Examples:
Faulty packaging e.g. wrong or missing batch number or expiry date
Requirements of printed packaging material, product specification, labelling etc..
Faulty closure
Contamination e.g. particulate matter
Type A
A type A recall is designed to reach all suppliers of MEDICAL DEVICE / IVDs (all distribution points) i.e. wholesalers throughout the country, directors of hospital services (private as well as state hospitals), retail outlets, doctors, nurses, pharmacists, authorised prescribers and dispensers and individual customers or patients through media release (radio, television, regional and national press).
Action: Recall letter to all distribution points plus media release.
Type B
A type B recall is designed to reach wholesalers throughout the country, directors of hospital services (private as well as state hospitals), retail outlets, doctors, nurses, pharmacists, authorised prescribers and dispensers.
Action: Recall letter to all distribution points.
Type C
A type C recall is designed to reach wholesale level and other distribution points (e.g. pharmacies, doctors, hospitals) this can be achieved by means of a representatives calling on wholesalers and/or retail outlets. If it is known where the product in question had been distributed to, specific telephone calls or recalls letters to arrange for the return of the product could be made.
Action: Specific telephone calls, recall letters to representatives calling at distribution points if known where the MEDICAL DEVICE / IVDs have been distributed.
NOTE: Decisions on the class and type of a recall to be initiated are a matter of the MEDICAL DEVICE / IVDs Control Council and MEDICAL DEVICE / IVDs Regulatory Affairs in consultation with a holder of the registration certificate and shall be based on the evidence and/or expert opinion of the REGULATORY AUTHORITY and HCR. In the event of greater urgency e.g. after hours or over weekends, the decision to recall can be initiated by the HCR.
8.4.2.1.1 Recall communication from holder of the registration certificate to the distribution chain should be written in accordance with the following directive (Recall Letter Template)
8.4.2.2. The letter should be typed and sent to the SAHPRA Inspectorate Regulatory Compliance for approval before being dispatched to customers:
Email for approval (Sent the letter to all of the emails listed below and request approval to prevent any delays):
dimakatso.mathibe@sahpra.org.za; eyvett.mogane@sahpra.org.za; mokgadi.fafudi@sahpra.org.za; dimakatso.mathibe@sahpra.org.za; khanyisile.nkuku@sahpra.org.za; Ofentse.Ramokgopa@sahpra.org.za
8.4.3.3. In case of an international distribution of the recalled product Envision Africa shall inform the applicant / manufacturer immediately and or endeavor to make information available to the regulatory authority in that country.
8.4.3.4. Where recalled stock has been distributed to a limited number of hospitals and the recall letter is not to be sent to all hospitals in the province, the letter should include the following: "If any of the recalled stock could have been transferred from your hospital to another, please let that hospital know or alternatively inform our company so that we can make contact with the hospital supplied from your hospital".
8.4.3.5. Stock should either be returned to the manufacturer for credit or sent for destruction this will be will depend on the nature of the situation.
8.4.3.6. After the recall carried out successfully, provide SAHPRA with the post recall report refer to 8.4.3.
8.4.3.1. At two weeks after the implementation of the recall (or at other agreed times with SAHPRA) SAHPRA should be provided with an interim report on the effectiveness of the recall.
8.4.3.2. Within 30days of the recall having been instituted SAHPRA shall be provided with a final post recall report.
8.4.3.3. Make use of the Post Recall Letter Template (the report may include, but is not limited to the sections added in the drafted template) to complete the necessary information for SAHPRA.
Mock recall may be initiated to measure the effectiveness of a recall - record in the Google drive
8.4.1. The Authorised Representative sets out the plan and starts the process as per below – taking note of the date and times when each step is started and finalised.
8.4.2. The Authorised Representative selects a random product
8.4.3. The Mock Recall letter will be drafted and distributed via email with the heading "MOCK RECALL" with the relevant supporting documentation to the following:
Customer Service: monique@envisionafrica.co.za; orders@envisionafrica.co.za
Supply Chain: catherine@envisionafrica.co.za: lynn@envisionafrica.o.za; warehouse@envisionafrica.co.za
Production: anashya@envisionafrica.co.za; dean@envisionafrica.co.za
Top Management: james@envisionafrica.co.za; william@envisionafrica.co.za
8.4.3.1. It remains the departments line managers responsibility to ensure that employees are competent and knows the action required when they receive such notification (refer to Training SOP). The departments shall inform their superiors of the notification received. The person responsible received the following email addresses to notify:
8.4.3.2. Customer Service
Person Responsible: Customer Service Manager, Email: monique@envisionafrica.co.za, Contact number: 072 235 0031
Alternative contact details: Senior Customer Service Administrator, saaleha@envisionafrica.o.za, Contact number: 010 007 2431
8.4.3.3. Supply Chain
Person Responsible: Supply Chain Manager, Email: catherine@envisionafrica.co.za; Contact number: 082 893 8448
Alternative contact details: Inventory Supervisor,Email: lynn@envisionafrica.co.za; Contact number: 063 855 5911
8.4.3.4. Production and Quality
Person Responsible: QA and RA Officer, rachel@envisionafrica.co.za, Contact number: 068 657 5274
Alternative contact details (Production): Product Manager: dean@envisionafrica.co.za, Contact number: 082 562 2774
Alternative contact details (Quality): Chief Operating Officer: william@envisionafrica.co.za, Contact number: 079 500 3072
The QA and RA Officer will confirm that all the departments received the notification within 10minutes of sending the notification email.
8.4.4. The Customer Service Manager will gather the distribution records that contains the information required to locate the selected product (being addresses / phone contact details / batch numbers / serial numbers and quantity).
8.4.5. The Customer Service department should provide the Authorised Representative with the distribution records of the product
8.4.6. The Production Manager needs to check with Production in which BOM's the affected product has been used
8.4.7. The Warehouse Manager also then locates the product selected which is still stored in the warehouse and identifies the quantities and where they are stored.
8.4.8. The Stock will be Quarantined until their fate can be determined
8.4.9. The Authorised Representative now formulates a Mock post recall report
8.4.10. A mock recall should be done annually - Mock recall schedule
In the event of non-compliance follow SOP Non-Conformance Corrective Action.
The Risk Assessment to is found in SOP Preventative Action Risk Assessment refer Document.
The analytical reviews of non-conforming product and any other quality related matters, are reported to management and forms part of the input to management review refer Data Analysis
The Trend analysis may identify any potential and recurring incidents, where corrective action must be reported at the management review to facilitate continual improvement.
Revision 13; 15.07.2024 - RB - Change over to SharePoint Site
Revision 12;25.10.2022 - MR - DK 25.10.2022 - Added Reference 7.4. ; 6. SAHPRA added; 8.4.1. Added Examples; 8.4.2. Updated and reviewed and retyped - linked the Recall Letter Template; Added 8.4.3. Post recall report; 8.4. Updated CEO does not request documentation; 9.1. Removed analytical reviews of supplier performance - not applicable. 8.4.4. Reviewed and Updated the Mock Recall SOP and linked documentation templates
Revision 11; 14.10.2021 - MR - Updated Mock recall
Revision 10; 05.08.2021 - MR - Reviewed
Revision 9, 03.08.2021 - TNA - addition of procedure for mock recall 8.4.3
Revision 8, 23.06.2021 - TNA - Updating the SOP to the new format. Risk Based Approach / Approval / Scope / Records and Revision History / numbering.
Revision 7, Digitally signed on 29.06.2020 by WJW
Revision 1-6, unknown due to google site change to new google site
Name Retained in Retention period Hard copies Destroyed by
Mock Recall & documentation Google Drive 5 years Management Representative deletion
MOCK Recall SharePoint 5 years Management Representative