Presentation is loading. Please wait.

Presentation is loading. Please wait.

Abdulsalam A. OZIGIS Assistant Director (FCT ) NAFDAC Abuja

Similar presentations

Presentation on theme: "Abdulsalam A. OZIGIS Assistant Director (FCT ) NAFDAC Abuja"— Presentation transcript:


2   To identify the key issues in Consumers Complaint and recall handling  To understand the specific requirements for organisation, procedures and resources  To understand and develop actions to resolve current issues applicable to you objectives

3  “ All complaints and other information concerning potentially defective foods must be carefully reviewed according to written procedures.” (S.O.P) Product Complaint Principle

4   Handled positively and carefully reviewed  Must be seen as important work  Managed by a senior staff member  Thorough investigation of the cause is essential  A major source of information and learning  Enable possible production defects to be remedied before they lead to a recall.  Necessary actions taken – even a recall decision Complaints Handling Principle

5   Designated responsible person - May be authorized person - If not, must advise authorised person of results - Sufficient support staff - Access to records  Written procedure describing action to be taken  Acknowledge and respond to complainant within a reasonable period  Record written and verbal comments Complaints Procedure - I

6   Name of product  Name of ingredient if necessary  Packaging form and storage equipment  Batch number  Name of complaint and nature of complaint  Records, retention sample investigated, other batches reviewed and staff reviewed  Result of investigation: “Justified” or “Not justified”  If “justified, actions taken to prevent reoccurrence  Sign- off upon completion Records of Complaint Investigation

7   Complaint justified - Actions to prevent reoccurrence - On going observation of process - recall product may be required  Complaint “Not justified” - Advise customer of findings - Appropriate marketing response Decision from a complaint investigation

8   Regular review of trends required - Reoccurring problems - Potential recall or withdrawal of product  Inform competent authority (NAFDAC) of serious quality problems that relates to Public Health Other Issues

9   If complaint is justified then there has been a failure of the quality system  Once defect has been identified, company should be dealing with it in an appropriate way,  Even recall.  The definition of defects is useful.  The following system has been found in some countries - Critical defects -Major defects - Minor defects |Classification of Defects

10   Those defects which can be life threatening and require the company to take immediate action by all reasonable means, whether in or out of business hours Examples - Product labelled with incorrect name or incorrect content - counterfeit or deliberately tampered with product - Microbiological contamination of a product leading to spoilage/infestation & toxicity / off odour, off taste/ off colour Critical Defects

11   Those defects which may put the patient at some risk but are not life threatening and will require the batch recall or product withdrawal within a few days Examples - any labelling/ leaflet misinformation (lack of information) which represents a significant hazard to the patient - Microbial contamination of products with some risks for patients -Non- compliance to specifications (e.g. ingredient list) Major Defects

12   Those defects which present only a minor risk to the patient - batch recall or product withdrawal would normally be initiated within a few days Examples - Readily visible isolated packaging/closure faults - contamination which may cause spoilage dirt and where there is minimal risk to the patient Other Defects

13   Customer complaint  Detection of GHP failure and Non compliance to HACCP plan during preparation/ production  Result from on going stability testing  Request by the national authorities  Result of an inspection  Known counterfeiting or tampering  Adverse event reporting Reasons for Recall

14  “There should be system to recall from the market promptly and effectively, products known or suspected to be defective.” Product Recall Principle

15   Recall - Removal from the market of specified batches of a product - may refer to one batch or all batches of product Definition

16   May be authorized person  If not, must advise authorized person opf results  Sufficient support staff urgency of recall  Independent of sales and marketing  Access to records Designated Responsible Recall person

17   Established, authorized  Actions to be taken  Regularly checked and updated  Capable of rapid operation to hospital and pharmacy level  Communication concept to national authorities and internationally SOP for Recall

18   Available to designated persons for recall purposes  Accurate  Include information on - Outlet supplied by the CPKU (Central Processing Kitchen Unit) - Direct customers - Batch numbers - Quantities Distribution records

19   Written progress report and reconciliation - Record progress as a procedure followed - Reconcile delivered with recovered products - issue final report  Effectiveness of procedures checked - Test effectiveness from time to time  Secure segregated storage of returned goods - Essential to keep returned goods away from other goods

20   Collect 3 examples of complaints or recalls from your experience  Describe the actions to be taken by the company or authority and the implications for all interested parties  Suggest a classification of the complaint or recall into critical (life threatening ), major or other Group Session

21   No response to justified complaints  Response to unjustified complaints  Failure to recall  Failure to correct frequent complaints  No resources to investigate  No senior management support  Senior management interference Possible Issues - I

22   No distribution information/ batch records  No access to record  In ability to contact government during holidays/weekends  Disagreement on severity of defect Possible Issues -II

23   Department : Quality Management Document no QMS- 000  Prepared by : Date: supersedes:  Checked by : Date: Date issued :  Approved by :Date : Review Date:  Document Owner : Quality Assurance Manager  Affected Parties: All Manufacturing employees Standard operating procedure Title: Product complain Procedure

24   Purpose: This procedure descries the process to ensure that product manufacture by Stomarch care are documented, evaluated, monitored, reported, and trended in accordance with regulatory and corporate requirements.  Scope: The scope of this procedure covers receipt, logging, evaluation, investigation and reporting of all complaints received by stomach care customer complaint and quality assurance departments. Standard operating procedure Title: Product complain Procedure…….

25   A complaint is any expression of dissatisfaction with a product or service marketed.  Complainant – A person or organisation making a complaint.  Customer – the person or institution making the complaint  Critical complaint – a complaint that strongly indicates the purity, identity, safety or efficacy of a product may have been compromised and has the potential to cause a life threatening or serious health situation.  Serious complaint – a complaint that indicates the purity, identity, safety, or efficacy of a product may have been compromised, but does not present as a life threatening or serious health risk. Definition

26   Standard complaint : a complaint that is neither critical nor serious.  Justified complaint - A complaint where the investigation has shown the complaint to be valid and it occurred under company control.  Non-justified complaint is complaint where the investigation has shown no valid reason for the complaint.  DR- Deviation report system  MI- Sheet manufacturing instruction sheet  BPN- Batch production Number Complaint…..

27   Form -000 Complaints Details form  Form -000 Laboratory testing form for customer complaint enquiry  Form -000 Complaint investigation Report  Form – 000 Process Data Collection Form  LAB-000 Retention Samples-Laboratory Related Documents

28   If the customer has returned multiple samples of the same batch number, but clearly indicates that there is more than one complaint, then these issues must be logged separately.  If the customer has returned multiple samples of the same batch number and clearly indicated that all are for the same issue then these are will be logged as one complaint.  The package containing the complaint form (Form-000) and sample is sent to the quality assurance where the details are checked and an evaluation of the product can be made. Procedure for handling product complaint

29  After getting the Complaint Details Form and the samples, the QA staff has to initiate the following things:  The initial evaluation of complaints  Create a QA complaints spread sheet and enter the details of the complaint in the file  Determine the investigation plan and send the complaints samples to either in  Production, laboratory or other contract manufacturers as appropriate.  Ensure the complaint investigation and documentation is completed within the time frames.  The Area Managers or Laboratory Manager should be responsible for giving the complaint sample to appropriate staff for investigation with necessary directions (i.e Finished Product specification or control method) and to finih within the specified time.  They have to ensure any corrective action is taken to rectify problems identified. QA Initial Evaluation

30   QA staff has to read all information available in the complaint Details Form.  Concerning the particular complaint. Ensure that all information entered in the form is correct and make necessary changes if its not.  Check batch number details for all parts of the product returned. The product and the outer packaging may have been interchanged if the batch numbers are different, then use the batch number of the actual unit or product. Enter details into QA complaint spread sheet like expiry date, product code and Box number for storage of sample after evaluation.  Enter information relating to the quantity and condition of product received, e.g. number of units, containers are whether full, empty, used, opened, sealed or damaged,(this is very important, especially if tampering with the product ids suspected.) QA Initial Evaluation ……..

31   label the returned product securely with the complaint reference number quoted from the complaint from (Form-000) and the storage box number on all sections of the complaint sample that are able to be separated e.g. outer packaging.  For suspect counterfeit or tampering complaints the chain of custody needs to be maintained. Refer to section 7 of this SOP.  Determine if the complaint is critical, serious or standard. If the complaint is critical in nature in form the QA manager, or delegate. Complaints should be worked on in order of severity, (i.e. critical complaints get highest priority).  Determine the site of manufacture. If the product has been in – house manufactured.  If the product has been imported or contract manufactured. Complaints for In-house Manufactured Goods

32   The process for imported or contract manufactured complaint is very similar to locally manufactured complaints. The difference is that the responsibility for investigation is for the contract manufacturer.  For investigation by contract Manufacturer, forward sample with covering letter detailing the complaint and results of initial evaluation to designated contact.  Keep track of complaints with the contract manufacturer so that they will be analysed and reported within the specified time frame Complaints for In-house Manufactured Goods ……

33  The QA staff is responsible for the storage of samples using the following process:  Disposal of samples takes places as set out in the SOP  Samples are to be preserved days past their expiry date. Boxes are kept in designated complaint storage are in the retention sample room.  The system in place allows for samples to be stored in numbered boxes that can be easily discarded at the end of the storage period.  The boxes are numbered and clearly labelled complaints, Box number --- to be discarded in December xxxx (the appropriate year for sample disposal). Details and allocation of box numbers are recorded in the table QA complaint spread sheet Storage of Samples

34   The quality assurance staff reviews the data entered into an Excel sprea sheet for  Customer complaint, periodically to determine if there are any unfavourable trends in the complaints Data. The data is analyzed based on the following criteria:  Process Line (for nin-house manufactured goods)  Product code  Date of manufacture  The data will be sent to management for review and copy of the data will be held in QA files under Quarterly complaints trend review.  Any unfavourable trends will be discussed in the quality Meeting with the view to generate  Continuous improvement plans and preventive action plans to reduce the level of complaints received for the issue identified. Trending of product complaints

35  A sample will be suspect if there is reason to believe that : A counterfeit product and or pack is when  Product that has been tampered with  Product that has been diverted from the normal supply chain.  A written and documented record (Chain of Custody) of the history and movements of the suspect sample to support any legal prosecutions has to be initiated and maintained with sample by the designated QA staff if a suspect sample is received and should include the relevant information. Handling of Suspect counterfeit samples and product diversions

36   Na go de  Osheooo  Dalu  Avo Thank you

Download ppt "Abdulsalam A. OZIGIS Assistant Director (FCT ) NAFDAC Abuja"

Similar presentations

Ads by Google