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Abdulsalam. A. OZIGIS. Assistant Director. (FCT ). NAFDAC Abuja. abdulsalamozigi@yahoo.com. , . ozigis.a@nafdac.gov.ng. 08037024035. At. ONE-DAY NAFDAC / NIFST WORKSHOP ON CURRENT HYGIENE AND SANITARY PRACTICES FOR FOOD HANDLERS .

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Presentation on theme: "HANDLING OF CONSUMER/PRODUCT COMPLAINT"— Presentation transcript:





Assistant Director

(FCT )












To identify the key issues in Consumers Complaint and recall handlingTo understand the specific requirements for organisation, procedures and resources

To understand and develop actions to resolve current issues applicable to you


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

Product Complaint



Handled positively and carefully reviewedMust 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



andling PrincipleSlide5

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 periodRecord written and verbal comments

Complaints Procedure - ISlide6

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 InvestigationSlide7

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 investigationSlide8

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 IssuesSlide9

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 DefectsSlide10

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


- 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 Slide11

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


- 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 DefectsSlide12

Those defects which present only a minor risk to the patient

- batch recall or product withdrawal would normally be initiated within a few days


- Readily visible isolated packaging/closure faults

- contamination which may cause spoilage dirt and where there is minimal risk to the patient

Other Defects Slide13

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 RecallSlide14

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







- Removal from the market of specified batches of a product

- may refer to one batch or all batches of product

Definition Slide16

May be authorized personIf not, must advise authorized person


results Sufficient support staff urgency of recall

Independent of sales and marketing

Access to records

Designated Responsible Recall personSlide17

Established, authorizedActions 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 RecallSlide18

Available to designated persons for recall purposes Accurate

Include information on

- Outlet supplied by the CPKU (Central



Kitchen Unit)

- Direct customers - Batch numbers

- Quantities

Distribution recordsSlide19

Written progress report and reconciliation

- Record progress as a procedure followed

- Reconcile delivered with recovered products

- issue final reportEffectiveness of procedures checked

- Test effectiveness from time to timeSecure segregated storage of returned goods - Essential to keep returned goods away from other goodsSlide20

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 SessionSlide21

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 - ISlide22

No distribution information/ batch recordsNo access to record

In ability to contact government during holidays/weekends

Disagreement on severity of defect

Possible Issues -IISlide23

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


Purpose: This procedure descries the process to ensure that product manufacture by


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


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 Slide26

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


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 DocumentsSlide28

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 Slide29

After getting the Complaint D

etails 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 (


Finished Product specification or control method) and to


within the specified time.

They have to ensure any corrective action is taken to rectify problems identified.

QA Initial Evaluation Slide30

QA staff has to read all information available in the complaint


etails 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


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 GoodsSlide32

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 ……Slide33

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




(the appropriate year for sample disposal). Details and allocation of box numbers are recorded in the table QA complaint spread sheet

Storage of SamplesSlide34

The quality assurance staff reviews the data entered into an Excel


sheet for Customer complaint, periodically to determine if there are any unfavourable trends in the complaints Data. The data is


based on the following criteria:

Process Line (for

nin-house manufactured goods)

Product code

Date of manufactureThe 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 Slide35

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 diversionsSlide36

Na go deOsheooo



Thank you