A systematic and functionally independent examination to determine whether activities and related results comply with a conforming standard, whereby all the elements MUST BE covered.

Is done According to ISO 19011:2002 and this Standard describes in details:

The Audit Standards.Managing the Audit.Audit Activities.Auditors Competency.

The Internal audits are conducted by the organization itself, or on its behalf, for management review and other internal purposes (e.g. to confirm the effectiveness of the management system or to obtain information for the improvement of the management system.

Internal audits can form the basis for an organization’s self declaration of conformity. In many cases, particularly in small organizations, independence can be demonstrated by the freedom from responsibility for the activity being audited or freedom from bias and conflict of interest.

Audit Criteria

Set of policies, procedures or requirements used as a reference against which audit evidence is compared.

Examples; HACCP, ISO22000, Statuary Regulations, … etc.

Audit Evidence;

Records, statements of fact or other information which are relevant to the audit criteria and verifiable.

Audit evidence can be:

Qualitative. Quantitative.

Audit findings

Results of the evaluation of the collected audit evidence against audit criteria.;Audit Findings: Indicate conformity or nonconformity. Can lead to the identification of opportunities for improvement or recording good practices. If the audit criteria are selected from legal or other requirements, the audit finding is termed compliance or non-compliance.

Audit conclusion

Outcome of an audit after consideration of the audit objectives and all audit findings.

Auditee,Organization being Audited.

Auditor,Person who conduct the Audit.

Audit teamone or more auditors conducting an audit , supported if needed by technical experts .

One auditor of the audit team is appointed as the audit team leader.The audit team may include auditors-in-training.

Technical expert,

person who provides specific knowledge or expertise to the audit team. Specific knowledge or expertise is that which relates to the organization, the process or activity to be audited, or language or culture.

Observer,

Person who accompanies the audit team (3.9) but does not audit.

An observer is not a part of the audit team and does not influence or interfere with the conduct of the audit . An observer can be from the auditee , a regulator or other interested party who witnesses the audit.

Guide,

Person appointed by the auditee to assist the audit team.

Audit Programme,

arrangements for a set of one or more audits (3.1) planned for a specific time frame and directed towards a specific purpose.

Audit Scope,

Extent and boundaries of an audit.

The audit scope generally includes a description of the physical locations, organizational units, activities and processes, as well as the time period covered.

Audit Plan,description of the activities and arrangements for an audit.

Risk,effect of uncertainty on objectives.

Competence,

Ability to apply knowledge and skills to achieve intended results Ability implies the appropriate application of personal behavior during the audit process.

Conformity,

fulfillment of a requirement.

Nonconformity,

Non-fulfillment of a requirement.

Integrity,

the foundation of professionalismAuditors and the person managing an audit programme should:

•— Perform their work with honesty, diligence, and responsibility;•— Observe and comply with any applicable legal requirements;•— Demonstrate their competence while performing their work;•— Perform their work in an impartial manner, i.e. remain fair and unbiased in all their dealings;

Fair presentation;

The obligation to report truthfully and accurately•Audit findings, audit conclusions and audit reports should reflect truthfully and accurately the audit activities. •Significant obstacles encountered during the audit and unresolved diverging opinions between the audit team and the auditee should be reported. •The communication should be truthful, accurate, objective, timely, clear and complete.

Due professional care;

The application of diligence and judgment in auditing.

•Auditors should exercise due care in accordance with the importance of the task they perform and the confidence placed in them by the audit client and other interested parties.

• An important factor in carrying out their work with due professional care is having the ability to make reasoned judgments in all audit situations.

Independence;

The basis for the impartiality of the audit and objectivity of the audit conclusions.

•Auditors should be independent of the activity being audited wherever practicable, and should in all cases act in a manner that is free from bias and conflict of interest. •Auditors should be independent from the operating managers of the function being audited. •Auditors should maintain objectivity throughout the audit process to ensure that the audit findings and conclusions are based only on the audit evidence.

Evidence-based approach;

The rational method for reaching reliable and reproducible audit conclusions in a systematic audit process.

Audit evidence should be verifiable

Internal audits play a critical role in :

•Basically Maintaining and Improving a Management System.

•Determine if the system is meeting requirements.

• Identify non-conformances.

• Drive continuous improvement.

• Measure compliance with the documented system.

AUDITOR COMPTENCY:

• Auditor needs to understand the principles of HACCP• Auditor needs to understand the process and the product which is produced.

• Internal auditors must complete an internal auditor training course.

Internal auditors are responsible for verifying the effective implementation of the food safety management system. Auditors have to: Find objective evidence that the system is implemented and effective.Identify non-conformances.Where the system is not implemented or operating as planned.Where the system does not meet requirements of the standard.

There are three main types of audit:

a) First Party

b) Second Partyc) Third Party

Also known as internal audit is being conducted systematically and periodically to evaluate the organization’s own process, procedures, and products.

“” “” Parties Involved = 1 (the Organization OnlyParties Involved = 1 (the Organization Only) “”) “”

“” “” The organization gets the report The organization gets the report ””””

Also known as external audits, customer audits or supplier audits which is a very Flexible and commonly based on customer requirements or what he wants.

“” “” Parties Involved = 2 (the Organization and the customer Parties Involved = 2 (the Organization and the customer Supplier) “”Supplier) “”

“” “” The reports goes to the customer””The reports goes to the customer””

Also known as registration audit and is Carried out by an independent organization which characterized by flexibility it must follow the audit process completely. �

“” “” Parties Involved = 3 (Parties Involved = 3 (Organization, customer and the certification body) “”) “”

“” Report goes to the organization and the certification � �Body “”

Focus on compliance to the organization as documented food safety system.

• Auditors will compare what is being done to the documented policies, procedures and other FSS – documentation.

• Is the process done according to the plan?

• Are employees aware of, trained on and following ?

the FSMS documentation and requirements?

Many companies have GMP inspections or regularly scheduled inspections of Prerequisite Programs but this completely differ from audits because inspection is typically based on a standard checklist that designed to look at each point individually and determine if a requirement is being followed, BUT Internal audits look at the system at all of it’s sides and include the interaction of processes.

Firstly an audit program must be planned and implemented.

And the program is designate responsibility for an audit coordinator that will:

• Maintain the audit schedule

• Assign auditors

• Initiate audits

The audit programme should include information and resources necessary to organize and conduct its audits.•— objectives for the audit programme and individual audits;•— extent/number/types/duration/locations/schedule of the audits;•— audit programme procedures;•— audit criteria;•— audit methods;•— selection of audit teams;•— necessary resources, including travel and accommodation;•— processes for handling confidentiality, information security, health and safety, and other similar matters.

When Preparing an audit schedule; Each area must be audited at least one a year, but for an effective program plan on auditing each area at least twice.

Organization Name

FST-L: ………… Date: ………….. Approved By: …………….. Date: …………….

Dept. / Audit #

123456

Management

15.0121.06

Sales & Marketing10.02

Quality Assurance31.03

Production10.04

Stores and Purchasing

20.0115.0309.05

HR and Training01.0220.0420.06

….

….

Identify what processes or procedures must be audited in each area or Department. And These will be included in the audit plan for the area.Example, Procedure

Code/No.

Management&

Administration

Q.ASalesProduction

Purchasing

HR

Document Control

DC-01

XXXXXX

Q.C RecordsQC-02

XXXXXX

Mngt. Responsibilities

MR-03

X

Training & HRHR-04

XXXXXX

Corrective Actions

CA-05

XXXXX

….

….

When an internal audit is coming up on the schedule, the audit coordinator will determine how much time and how many auditors are required Based on the status and importance, as well as the number of procedures that apply to the area and must be included in the audit.

The amount of time allotted has a direct effect on the scope and depth of the audit.

The auditor/s assigned must be independent of the area being audited.

Once the schedule is complete; after, it is time to get ready for your first audit ; Prepare your audit plan based on the processes and procedures that has been identified.

Example, Cont.,,,,

AUDIT NUMBEROpening Meeting Place, Time & Attendees: DATE:

Areas to be auditedClosing Meeting Place, Time & Attendees:

Scope of the Audit and Objectives:

Standard:-HACCP- ISO9001:2008

Auditors:

Proposed schedule

TimeProcess or Procedure

Team 1Team 2Notes

….

….

Corrective Actions to be achieved: ………………….

Additional Information: ………………………………

Lead Auditor Signature

Date

The continued auditing and verification of a HACCP system demands more attention than the initial development of a IIACCP plan.

On-Site with Human interactions:On-Site with Human interactions:-Conducting interviews-Completing Audit checklist and questionnaires with auditee participation- conducting document review with auditee participation.-Sampling

On-Site with No Human Interactions:On-Site with No Human Interactions:-Conducting Document Review (e.g. Records and Data analysis).-Observation of work performed.-Sampling.

Steps to Audit

Audit the entire HACCP plan– Include prerequisite programs.– Review the entire 12 step HACCP process.however address each component separately–Compare to Codex Alimentarius.• Communicate to all parties to be audited• Use the process audit approach

Review the documentation,Review the documentation,

The auditors should consider if:•— the information in the documents provided is:•— complete (all expected content is contained in the document);•— correct (the content conforms to other reliable sources such as standards and regulations);•— consistent (the document is consistent in itself and with related documents);•— current (the content is up to date);•— the documents being reviewed cover the audit scope and provide sufficient information to support the•audit objectives;

�

• — the use of information and communication technologies, depending on the audit methods, promotes efficient conduct of the audit: specific care is needed for information security due to applicable regulations on protection of data (in particular for information which lies outside the audit scope, but which is also contained in the document).

Document review can give an indication of the effectiveness of document control within the auditee’s management system.

Facility inspection,

• Verify documentation to what is really occurring.• Condition of facility

Monitoring - Observe employee performing task.

• Compare to written procedures.• Use of calibrated instruments.• Interview the employee.–Ask open ended questions?–What are their authority?–Do they understand what and why they are doing their task?• Review their training records

Corrective Actions,

• Review past deviations.• Look for trends.• Were actions complete?• Was suspect product contained?• Review records

Verification

• Observe and compare

• Review records.

• Who is verifying?

• How were deviations handled?

Recordkeeping,

• If it is not recorded, assume it is not being done!• Review records for completeness–Signature of person monitoring–Time and date–Critical limit recorded–Correcting mistakes on paperwork • Electronic data–Assurance of integrity

Validation

• Biggest challenge for small and very small plants• Review documentation • Supporting documents sufficient and credibleReassessment�

• Review records.• Frequency.• Ask about changes in process.

Common HACCP Failures:Common HACCP Failures:

CCP IdentificationCCP Identification

• Too many CCPs identified

Ineffective monitoring� Ineffective monitoring�

• CCP not monitored frequently enough to control • Personnel unsure of task • Not performed as described in HACCP Plan

Missing HACCP PlanMissing HACCP Plan

• Each product or product group has to have their own plan.

Lack of trainingLack of training

• General staff• Quality Assurance/HACCP Monitors• Do not understand the “whys”• Lack of documentation to support training• Proper monitoring procedures

Instruments used in monitoringInstruments used in monitoring

• Not calibrated .• Not calibrated correctly.• Calibrated inconsistently.• Record of calibration missing.• No procedure or action for handling an instrument.•found to be. out of calibration

Documentation missingDocumentation missing

• CCP decision tree• Hazard analysis• Identification of food safety team

Corrective Action not completed�Corrective Action not completed�

• Root cause not identified• Observe reoccurrence of problem• Four criteria of corrective action not met

Methods not validatedMethods not validated

• Is there scientific proof to support control measures and critical limits?• Is supporting documents from a credible source?

Lack of HACCP Plan review�Lack of HACCP Plan review�

• Minimum requirement is annually• Required to review whenever there is a change in the system

Level 1

Level 2

Level 3

• المراجعة في األنشطة من Oجًانبًا يأخذ .أنيفقد • أو عليه المراجع من يقًاد أن.القيًادة• همته تثبط .أن• يراجع مًاذا يختًار عليه المراجع .يتركافتراضًات • أو مسبق انطبًاع يأخذ أن.مسبقة

• للمراجعة ويستعد يعد .أن• بًالتوقيتًات يلتزم .أنالموجه • الشخص يجيب أن على اإلصرار

بنفسه األسئلة .اليه• أمكن مًا Oقليًال .التحدث• الخًاطئ الفهم .تجنب• ومختصرة واضحة دائمة أسئلة .إلقًاء

• والسًالم التحية إلقًاء

• المراجعة أثنًاء عدوانيين أشخًاص .مقًابلة• خجولين عليهم .مراجع• عليهم المراجع .افتقًاد• وثًائق وجود .عدم• ) بنفسك ) تختًار Oدائمًا Oمسبقًا المعدة .العينًات• الخًاصة .الحًاالت• المحلية والتقًاليد .العًادات• العًاطفية .الحًاالت

Requirements Conformity Y / N

Details

Management Commitment

1. Senior Management Ensures that the responsibilities and authorities are defined and communicated within the company

Internal communication

1. There is a clear communication and reporting channel between senior management and personnel

Management Review

Includes:1.Audit results2.Customer feedback3.Process performance and product conformity4.Status of preventive and corrective action5.Follow-up action from previous management reviews6.Planned changes that could effect the quality system7.Recommendations for improvement

Quality Manual

1. A quality manual with appropriate procedures exists

Control of documents

1.Document control procedures are in place including approval for adequacy prior to use, updates and re-approval, identification of current version, availability, legibility 2.Records are controlled (identifies which records should be kept and how long)3.The following records are as appropriate to the product (e.g. GMP, production records, master record file)

Internal Audit

1.Internal audit are performed on scheduled intervals to assess the effectiveness of the QMS2.Personnel identified and trained to perform internal audit.3.Documentation the corrective and preventive action were performed as an outcome of the internal audit.

Site Standards

1.Procedures exists for the review and evaluation of food safety hazards in the event of new or changed quality.2.Buildings and grounds are adequately and routinely maintained.3.Buildings are maintained in reasonably clean and orderly manner.4.Buildings are of suitable construction to minimize access to rodents, birds, and other pets.5.Building provides adequate space and lightening.6.All equipment maintained in reasonably and orderly manner.7.All equipment are of suitable size, design, construction, precision, and accuracy for its intended needs.8.All equipments are maintained to prevent lubricants and coolants introduction as unsafe additive to food.

Site standard cont.,

9. All equipment are designed, constructed and maintained to facilitate inspection and use of cleanout procedure.10. work areas and equipment used to manufacture and storage of food are kept separate from chemicals.11. All equipments are properly cleaned to prevent unsafe contamination of food.12. There are procedures in place controlling calibration of equipments.13. There is a master sheet of all equipments.

Purchasing

1.Evidence that ingredients specifications are provided to supplier exists 2.Traceability procedures exists to facilitate product recall3.Established inspection procedures or other inspection activities to ensure that purchased material specification are in place, including contamination.

Control of production

1.Master record file is maintained for each product which include product specs, formulation, label, and special manufacturing instruction.2.Frequency and number of samples needed during production for each batch.3.Proper identification and date of production are provided.4.Production records are maintained that provide formulation, date of production, date of shipment to facilitate recall of products.5.Work instructions for proper manufacturing procedures are available to personnel.6.Production records are inspected for accuracy at scheduled intervals.7.Equipments is suitable for manufacturing of product to specification 8.Monitoring devices are available and used.

Validation of production process

1. Validation procedure are in place and conform to science based performance standards.

Identification and Treacibilty

1.Finished products are properly packaged and labeled for identification and should include name, product description, net weight (or bulk statement), lot number, shelf life date, and label regulatory requirements.2.Procedures for product traceability are documented 3.Retained samples are identified for traceability (shelf life).

Control of monitoring and measuring devices.

1.Monitoring and measuring devices use to manufacture product are properly maintained, calibrated and recorded.2.Instrumentation and devices used to calibrate monitoring and measuring devices are verified at specified intervals against

Monitoring and measurements of process

1.Monitoring procedures have been established to evaluate the manufacturing processes, where appropriate.2.Scheduled monitoring activities have been established.

Monitoring and measurement of product

1. Procedures are in place to ensure products conforms to requirements.

Storage of products

1. Products are properly identified, stored, handled, and controlled to maintain their identity and integrity

Customer satisfaction

1. Procedure for recording and evaluating complaints exists.

Control of non-conforming products

1.Procedures to control non-conforming products have been established and are in place.2.N0\on-conforming products are properly identified and stored in specified location 3.Documentation of final disposition of non-conforming products which may include rework or re-verification.4.Procedures have been established for product recall or customer notification if non-conforming product is detected after delivery.5.Procedures for handling returned goods are established.6.Documented procedures that established requirements for reviewing and preventing non-conformities including customer complaints, determine reason of non-conformity, recorded of results of action taken and reviewing corrective action taken.

Training

1.Records are available that demonstrate personnel competence and training.2.Job description are available that include the responsibility and skills required by the employees.3. personnel and are properly trained in personal hygiene where appropriate to avoid contamination.4.Training matrix is in place.5.Refreshing training procedure is in place.6.Training records are available for personnel dealing with the CCP’s.

HACCP1.The HACCP team has been trained and the training has been recorded: a- includes the names of HACCP team and training/ experience of HACCP application b- the individual developing the hazard analysis, including delineating control measures successfully completed training in the application of HACCP principles. c- the individuals developing a HACCP plan that is appropriate for specific site successfully completed training in the application of HACCP principles. d- the individual verifying and modifying the HACCP plan successfully completed training in the application of HACCP principles. e- the personnel preforming the record review successfully completed training in the application of HACCP principles.

2. The HACCP plan is specific to the location and site.

3. The HACCP plan is specific to the ingredients, food process.

4. If ingredients, food or processes are grouped together in single plan, evidence exists that share a common hazard.

5. The hazard analysis lists all hazard, a- the written hazard analysis identifies hazards, for each process step or includes the statement “ non identified at this time”. b- the written hazard evaluation is based in scientific evidence, considers hazard frequency and severity and has been performed for every identified hazard. c- the control measures for significant hazard have been identified. d- the pre-requisite program is exist for significant hazards and are correctly referenced to the HACCP plan. e- the hazard analysis procedure included an evaluation of SOP and modifications are performed when necessary. f- critical control points exist for significant hazard. g- the hazard analysis considered external and internal hazards.

h- evidence exists that the HACCP team considered, at minimum, biological, chemical and physical hazard listed in this section. i- the hazard analysis considered possible sources of adulteration including all process steps including packaging, storage, transportation, intended use, facility and equipment function and design, and plant sanitation including personnel hygiene.

6. All identified hazards are evaluated for their significance

7. CCPs are assigned for significant hazard.

8. If applicable to process flow and hazard evaluation, CCP’s are assigned for significant hazards outside the site.

9. Critical limits are identified for each CCP.

10. Procedures exist for monitoring each CCP.

11. Monitoring frequency ensures adherent to the critical limits.

12. The HACCP plan includes corrective action plans developed. a- the corrective action plan describes steps to be taken and assigns responsibility in response to deviations from critical limits and: - ensure adulterated product is not distributed or used after the deviation has been identified and before the corrective action has been taken - corrects the deviation. b- for deviation that occurs and the site does not have a corrective action plan product is segregated and held, tested for acceptability not used until product is bought into conformance with HACCP plan. c- for deviations that occurs and the site doesn't have a corrective action plan the cause of the deviation is corrected and verified by trained personnel to determine whether HACCP plan requires modification. d- Records provide evidence that the corrective action were performed as described in the HACCP plan

13. The HACCP plan lists validation and verification procedures and their frequency

a- evidence that the site reviews consumer complaints and their relationships to the HACCP plan’s performance or are a new hazard b- verification that key manufacturing equipment are calibrated according to the plan was performed. c- Verification of process monitoring calibration performed. d- verification that the site performs end-product testing if included in the HACCP plan. e- Verification within (7 days) that critical control points monitoring records were completed, signed, and documented values were within the critical limits. f- procedures outlined in section were followed whenever any verification establishes the need for corrective actions. g- verification within (7 days) that calibration records for equipments were performed in accordance to the HACCP plan

h- validation procedures were conducted at specific time intervals. i- whenever no significant hazard have been identified, a reassessment of the hazard analysis adequacy will be performed annually or after process modification by individual trained and recorded.

14. The HACCP plan includes a record keeping system for monitoring CCPs a- written hazard analysis in place that has identified all significant biological, chemical, and physical hazards. b- written HACCP plan for this location for each type of ingredient. c- monitoring of critical control points and their critical limits d- calibration of key manufacturing equipments. e- calibration of processing monitoring instruments f- corrective action including disposition. g- records documenting verification and validation of the HACCP plan. h- all records include the name and location. i- All records includes the date and time. j- all records includes signature or initial person performing the operation or creating the records. k- all records are signed and dated.

l- all records are included the identity of the product and if required the production code.

m- all records include the processing observations and other information entered at the time observed. n- records required are retained for 3 years after the date of production ( electronic records are acceptable) o- Records required are available for review and copying during certification audit.