1. INTRODUCTION

1.1 In today's global market, quality and safety have become competitive edge for the enterprises producing goods and providing services. With the advent of ISO 9000 series of standards, the concept of quality has taken a tangible form . These standards have made a dramatic impact on business around the world. For the first time there is a broad consensus about quality system's minimum requirements. This is the reasons why ISO 9000 has unanimously received a world wide acceptance. This presents a good opportunity for the food industry for upgrading quality and bringing uniformity and consistency in their supplies to international market.

1.2 The food industry plays an important role in the national economy. It has a major share in India's exports. Since the international market has become demanding in terms of quality, safety and delivery, installation of quality systems and Hazard Analysis Critical Control Points(HACCP) in food industry would provide a competitive edge to food supplies in the international market.

1.3 The Quality System standards seek to accomplish the following three objectives with regard to quality:

a) The enterprise should achieve and sustain the quality of the product or service produced so as to meet contractually the purchaser's stated or implied needs.

b) The enterprise should provide confidence to its own management that the intended quality is being achieved and maintained.

c)The enterprise should provide confidence to the purchaser that the intended quality is being or will be achieved in the delivered product or service provided. When contractually required, this provision of confidence may involve agreed demonstration of requirements.

1.4 Similarly HACCP system, a well established concept in food safety, identifies specific hazards and provides preventative measures for their control to ensure the safety of food. The application of HACCP is compatible with the implementation of ISO 9000 and is the system of choice in the management of food safety. The pace of progress of HACCP has been accelerated dramatically mainly due to the following two reasons:

a) many hitherto unrecognized microbial food borne hazard have come to light since 1960's,

b) the rapidly increasing global sourcing of raw materials and distribution of finished products make it imperative that governments cooperate at the international level to provide assurance of food safety.

1.5 HACCP is a tool to assess hazards and establish control systems that focus on preventative measures rather than relying mainly on end-product testing. It is now widely embraced by the food industries and by the government regulatory agencies around the world as a most cost-effective means of minimizing the occurrence of identifiable food borne biological, chemical and physical hazards and maximizing product safety .It is a system which targets critical areas of processing, and in doing so reduces the risk of manufacturing and selling unsafe products.

1.6 HACCP can be applied throughout the food chain from the primary producer to final consumer. It enhances food safety and other, benefits include better use of resources and more timely response to problems. In addition, the application of HACCP systems can aid inspection by regulatory authorities and promote international trade by increasing confidence in food safety. The successful application of HACCP requires the full commitment and involvement of management and the work force as in case of ISO 9000.The HACCP approach adds value to ISO 9000 Quality Management System and a combined effect would be a safe and wholesome food to consumers.

2. PRINCIPLES of HAZARD ANALYSIS CRITICAL CONTROL POINTS(HACCP)

2.1 The HACCP system consists of seven principles.It is a system which identifies specific hazard(s) and preventative measures for their control. These principles outline how to establish, implement and maintain HACCP system.

PRINCIPLE 1

Identify the potential hazard(s) associated with food production at all stages, from growth, processing, manufacture and distribution, until the point of consumption. Assess the likelihood of occurrence of the hazard(s) and identify the preventive measures for their control.

PRINCIPLE 2

Determine the points/procedures/operational steps that can be controlled to eliminate the hazard(s) or minimize its likelihood of occurrence [Critical Control Point (CCP)]. A "step" means any stage in food production and/or manufacture including raw materials, their receipt , harvesting, transport, formulation, processing, storage, etc.

PRINCIPLE 3

Establish critical limit(s) which must be met to ensure the CCP is under control.

PRINCIPLE 4

Establish a system to monitor control of the CCP by scheduled testing or observations.

PRINCIPLE 5

Establish the corrective action to be taken when monitoring indicates that a particular CCP is under control.

PRINCIPLE 6

Establish procedures for verification which include supplementary tests and procedures to conform that the HACCP system is working effectively.

PRINCIPLE 7

Establish documentation concerning all procedures and records appropriate to these and their application.

2.2 These principles are closely related to the 20 elements of ISO 9000 (See Fig.1) . This shows how the two systems could be intertwined to be more effective.

3. APPLICATION OF THE PRINCIPLES OF HACCP

3.1 When conducting the hazard analysis, consideration must be given to the impact of raw materials, ingredients, manufacturing practices, role of manufacturing processes to control hazards, likely end-use of the product, consumer populations at risk and epidemological evidence relative to food safety. The intent of the HACCP system is to focus control at CCPs. HACCP should be applied to each specific operation separately. For identification of CCPs all aspects of food chain need to be examined. The HACCP application should be reviewed and necessary changes made when any modification is made in the product, process, or any step. It is important when applying HACCP to be flexible given the context of the application.

3.2 Steps Involved in Implementation of HACCP-The implementation of HACCP principles requires the following tasks as identified in Fig.2 Logic Sequence for Implementation of HACCP.

3.2.1 Constitute HACCP team

The HACCP is carried out by people. If the people are not properly trained and experienced then the HACCP system is likely to be ineffective. It should be a multidisciplinary team that has specific knowledge and expertise appropriate to the product for example agronomists or veterinarians, production personnel, microbiologists, medical experts, public health specialists, food technologists, chemists and engineers according to the particular study. Where such expertise is not available on site, expert advice should be obtained from other sources.

3.2.2 Describe the product and its intended use

It should be noted what the product actually is and how/by whom it will be used. A full description of the product should be drawn up, including information on composition and method of distribution. The intended use should be based on the expected uses of the product by the end user or consumer. In specific cases, vulnerable groups of the population, for example institutional feeding, may have to be considered.

3.2.3 Construct a process flow diagram

The process flow diagram is used as the basis of the hazard analysis and should therefore contain sufficient technical detail for the study to progress. It should be constructed by the HACCP team. Each step within the specified area of operation should be analyzed for the particular part of the operation under consideration to produce the flow diagram. When applying HACCP to a given operation, consideration should be given to steps preceding and following the specified operation. When the process flow diagram is complete, it should be verified by The HACCP team. It should confirm the processing operation against the flow diagram during all stages and hours of operation and amend the flow diagram where appropriate.

3.2.4 Identify all hazards

When the process flow diagram is completed and verified, the HACCP team should list all the biological, chemical and physical hazards(See Principle1) that may be reasonably expected to occur at each step and describe the preventative measures that can be used to control these hazards. For inclusion in the list, hazards must be of a nature such that their elimination or reduction to acceptable levels is essential to the production of a safe food. The team must then consider what preventative measures, if any, exist which can be applied for each hazard. Preventative measures are those actions and activities that are required to eliminate hazards or reduce their impact or occurrence to acceptable levels. More than one preventative measure may be required to control a specific hazard(s) and more than one hazard may be controlled by a specified preventative measure.

3.2.5 Identify the Critical Control Points

A critical control point is a point/step/procedure where a food safety hazard can be prevented, eliminated or reduced to an acceptable levels. The identification of a CCP(See Principle 2) in the HACCP system is facilitated by the application of a decision tree(See Figure 3). All hazards that may be reasonably expected to occur, or be introduced at each step, should be considered. Training in the application of the decision tree may be required. If a hazard has been identified at a step where control is necessary for safety, and no preventative measure exists at that step, or any other, then the product or process should be modified at that step, or at any earlier or later stage, to include a preventative measure. Application of the decision tree determines whether the step is a CCP for the identified hazard. Application of the decision tree should be flexible, whether the operation is for production, processing, storage, distribution or other.

3.2.6 Establish critical limits for each CCP

Since the critical control point(See principle 3) define the boundaries between safe and unsafe products, it is vital that they are set at the correct level for each criteria. The HACCP team should therefore fully understand the criteria governing safety at each CCP in order to set the appropriate critical limits. Critical limits must be specified for each preventative measure. In some cases more than one critical limit will be elaborated at a particular step. Criteria often used include measurements of temperature, time, moisture level, pH, and available chlorine, and sensory parameters such as visual appearance and texture.

3.2.7 Establish a Monitoring System for Each CCP

Monitoring is one of the most important aspects of any HACCP system. It is the scheduled measurement or observation of a CCP relative to its critical limits. The monitoring procedures must be able to detect loss of control at the CCP (Principle 4). Further, monitoring should ideally provide this information in time for corrective action to be taken to regain control of the process before there is a need to reject the product. Data derived from monitoring must be evaluated by a designated person with knowledge and authority to carry out corrective actions when indicated. If monitoring is not continuous, then the amount or frequency of monitoring must be sufficient to guarantee the CCP is in control. Most monitoring procedures for CCPs will need to be done rapidly because they relate to on-line processes and there will not be time for lengthy analytical testing. Physical and chemical measurements are often preferred to microbiological testing because they may be done rapidly and can often indicate the microbiological control of the product. All records and documents associated with monitoring CCPs must be signed by the person(s) doing the monitoring and by a responsible reviewing official(s) of the company.

3.2.8 Establish Corrective Actions

Specific corrective actions (See Principle 5) must be developed for each CCP in the HACCP system in order to deal with deviations when they occur. The actions must ensure that the CCP has been brought out under control. Actions taken must also include proper disposition of the affected product. Deviation and product disposition procedures must be documented in the HACCP record keeping. Corrective action should also occur when monitoring results indicate a trend towards loss of control at a CCP. Action should be taken to bring the process back into control before the deviation leads to a safety hazard.

3.2.9 Establish Verification Procedures

The HACCP system should include verification procedures (Principle 6) to provide assurance that HACCP system is being complied with on day-today basis. This can be done most effectively by using audit method. Establish procedures for verification that the HACCP system is working correctly. Monitoring and auditing methods, procedures and tests, including random sampling and analysis, can be used to determine if the HACCP system is working correctly. The frequency of verification should be sufficient to validate the HACCP system. Examples of verification activities include:

* Review of the HACCP system and its records.
* Review of deviations and product dispositions.
* Operations to determine if CCPs are under control.
* Validation of established critical limits.

3.2.10 Establish Record Keeping and Documentation

Efficient and accurate record keeping (Principle 7) is essential to the application of a HACCP system. Records need to be kept of all areas which are critical to product safety as written evidence that the HACCP system is in compliance with the documented system. Documentation of HACCP procedures at all steps should be included and assembled in a manual. Records are useful in providing a basis for analysis of trends as well as for internal investigation of any food safety incidents which may occur.

It is extremely useful to allocate a unique reference number to each HACCP record. The types of records that might be retained are as follows:

* HACCP plan,
* Amendment to HACCP plan,
* CCP monitoring records,
* Hold/trace/recall records,
* Training records,
* Audit records,
* Meeting records,
* HACCP system procedures.

4. HACCP THROUGH ISO 9000

4.1 ISO 9000 encompasses all of the activities of a company to ensure that it meets its quality objectives and HACCP system is directed towards ensuring safety of food. ISO 9000 and HACCP, concerned with quality and food safety management system respectively, have much in common. In fact quality in broader sense includes safety. Therefore, the best way is to use ISO 9000 route to manage HACCP to ensure quality and safety of food. Both the systems are quality assurance systems, designed to provide maximum confidence that a specified acceptable level of quality and safety are being achieved at an economic cost.

4.2 The seven principles of HACCP(See clause 2) and 20 elements of 9001, the most comprehensive model, are closely related (See Figure 1). Both require documented procedures for their operation. The ISO 9000 requires all activities affecting quality to be documented. If HACCP requirements are intertwined wit ISO 9000 documented system, it would be the most cost effective and efficient system to manage both quality and safety. A more detail comparison of HACCP and ISO 9000 is given in Table 1.

5. CONCLUSIONS

5.1 It may be seen how the two systems-ISO 9000 and HACCP- are vital for management of quality and safety of food to assure customers around the world. The regulatory agencies lay more emphasis on safety while businesses emphasize on both quality and safety as component of reliable quality. HACCP adds reliability to quality ie food is not only good at the point of manufacture but also through its shelflife period.

5.2 It is logical to select ISO 9000 route to implement HACCP as it is a well known widely practised system around the world with over 150 000 companies already certified. It would be much easier to induct HACCP in a n already operating ISO 9000 system with a little tailoring.

Figure 2

LOGIC SEQUENCE FOR APPLICATION OF HACCP

1. Assemble the HACCP Team

2. Describe Product

3. Identify Intended Use

4. Construct Flow Diagram

5. On-Site Verification of Flow Diagram

6. List All Identified Hazards Associated With Each Step and Consider Preventative Measures to Control Hazards

7. Apply HACCP Decision Tree to Each Step With Identified Hazard(s) (See Figure 3)

8. Establish Critical Limits for Each CCP

9. Establish a Monitoring System for Each CCP

10. Establish Corrective Action for Deviations that May Occur

11. Establish Verification Procedures

12. Establish Record Keeping Documentation

FIGURE 3

DECISION TREE

Q 1

Yes

Do Preventative Measure(s) Exist?

No

Modify step, process or product
Is control at this step for safety

YES

NO Not a CCP STOP(*)

Q 2 Is the Specifically Designed to Eliminate or Reduce the Likely

Yes

Occurrence of a Hazard to an

Acceptable Level?

No

Q 3

Could Contamination With Identified

Hazard(s) Occur in Excess or

Acceptable Level(s) or Could These

Increase to Unacceptable Level(s)?

Yes

No

Not a CCP Stop(*)

Q 4 Will a Subsequent Step Eliminate

Identified Hazards(s) or Reduce

Likely Occurrence to an Acceptable

Level?

Yes No Critical Control Point

Not a CCP

STOP(*)

(*) Proceed to the next identified hazard in the described process

TABLE 1 ISO 9001 AND ITS APPLICATION TO HACCP

4.1 Management-Quality policy may include HACCP and responsibility demonstrate management commitment.
- Responsibility and authority for HACCP must be defined

- Management review for ISO 9000 should include review of effectiveness of HACCP operation

4.2 Quality system

- HACCP specifically considers all activities which could impact on the safety of the product and ensures that they are consistently documented, a quality product is also a safe product.

4.3 Contract review

Like ISO 9000,it considers the relationship between the customer and supplier meet the requirements. Some raw materials may be CCP and it will be essential to have tight control over their supply.

4.4 Design control

HACCP process starts at the product concept stage, i.e. the design, and control through a Quality Management System .Design control must include HACCP at the concept stage - has it
been designed safely?

4.5 Document control

Like ISO 9000, HACCP documents including HACCP Plan, artwork for packaging need to be controlled and authorized . This will prevent the use of obsolete documents. Use of uncontrolled copies should be avoided.

Each HACCP document should bear a unique reference number for cross-referencing with CCP.

4.6 Purchasing

Everything purchased from raw material to subcontracted items should be clearly specified through written specifications.

Control of subcontractors should be through assessment and records kept.

This will include calibration, process equipment servicing, hygiene and pest control.

4.7 Customer-supplied

It is essential to ensure that ingredients and packing material when supplied by customer are included in the HACCP assessment. Product identification HACCP System requires tracebility of cation and batches of raw material to final traceability products in the event of a failure at a CCP.

A documented recall plan should be maintained for being able to trace and withdraw any defective product.

4.8 Identification and Traceability

4.9 Process control

HACCP includes the following key areas at all stages in the process:

i) Building - all facilities from raw material storage areas, through process and dispatch. Including employee amenities.

ii) Plant and equipment - process capability, preventative maintenance, hygienic design and cleaning.

iii) Personnel - training, health screening, meeting legislation.

iv) Cross-contamination - at all stages where this could be a risk.

v) Waste materials - clearly identified and segregated.

vi) Computer failure - contingency plans should be in place.

vii) Environmental control - atmosphere, ground water.

4.10 Inspection and Where raw material are CCPs, these testing should not be used until confirmation of conformance has been received.

Materials used before being certified as meeting specifications should be traceable in order to allow a recall at a later stage if necessary.

Finished products should be held until confirmation of all CCPs having been met in full has been received.

Records of all inspection and test results should be maintained.

Personnel carrying out testing should be trained as being capable for the job.

4.11 Inspection measuring

All equipment needed to monitor a CCP should be of known accuracy and precision and calibrated on a regular basis and status marked.

Equipment must be maintained and stored correctly in-between calibration in order to avoid damage.

Records of calibrations should be kept

4.12 Inspection and test status

There should be a clearly defined method for identification of the inspection and test status of any raw material, product, or equipment to prevent its being used inadvertently.

4.13 Control of non-HACCP should define who is responsible conforming product for taking corrective action in the event of a deviation. This must include what to do with product made
while the system was out of control, i.e. to rework, recycle to reject.

Procedures must be developed to ensure that all non-conformities at a CCP are recorded. This will enable trends to be analysed.

4.14 Corrective action

If a CCP is out of control the underlying cause must be identified in order for the problem to be permanently resolved and not repeated.

Corrective actions also include pest control audits and hygiene audits.

The effectiveness of any corrective action must be verified for confirmation. All corrective action must be recorded.

4.15 Handling, storage, Hazards may arise from improper packaging and handling and storage of a product or delivery raw material or use of unsuitable packaging material - unable to withstand distribution. Areas for consideration include:

food contact packaging
control of artwork
storage and distribution temperatures
stock rotation
shelf-life
contamination risks
environment conditions
hygiene and pest control

4.16 Quality records

HACCP records affecting safety should be controlled and retained for a specified period based on statutory regulations and product shelf-life as demonstration of the effective management of food safety.

4.17 Internal Quality

HACCP System should be a part of internal audit system and audited regularly by members of the HACCP Team or internal auditors for its continued suitability and effectiveness paving the way for continued improvement of the HACCP System. Process Flow Diagrams must be audited as part of the verification.

4.18 Training

HACCP relies on the participation of knowledgeable and trained people across a wide range of disciplines. Areas training should reflect system changes, emerging food safety issues, new processes and corrective action skills.

Training records should be available for all staff and include all types of training - in-house, external, skills or awareness activities.

4.19 Servicing

This normally not applicable. But suppliers of vending equipment may require servicing of such equipment to be documented and controlled as Such equipment can be source of hazards if not cleaned and maintained correctly.

4.20 Statistical

For HACCP Control sampling regimes at each CCP needs to be documented. Statistical sampling plan may be used decisions of conformance are being based upon results of sampling and testing. Statistical techniques may also include process capability assessment and statistical process control during CCP monitoring.

HACCP CONTROL CHECK SHEET

Sl. Process Hazards Preventative CCP Critical Monitoring Corective
No. Steps Measures Limits Actions

original

TABLE 1 ISO 9001 AND ITS APPLICATION TO HACCP

ISO 9000 CLAUSES HACCP APPLICATION

4.1 Management - Quality policy may include HACCP and
responsibility demonstrate management commitment.
- Responsibility and authority for HACCP must be defined

- Management review for ISO 9000 should include review of effectiveness of HACCP operation

4.2 Quality system

- HACCP itself is a Quality System but this clause specifically considers all activities which could impact on the `Quality' (safety) of the product and ensures that they are consistently documented, a quality product is also a safe product.

4.3 Contract review

Particularly relevant to Supplier

Quality Assurance as it considers the relationship between the purchaser and suppler meet the requirements? Some raw materials may be Critical Control

Points and it will be essential to have tight control over their supply.

4.4 Design control

The design control clause is not included in ISO 9002 - usually the one that food companies go for. This is a pity because the HACCP process starts at the product concept stage, i.e. the design, and control through a Quality

Management System would be a real benefit. Design control must include a hazard analysis risk assessment at the concept stage - has it been designed safely?

4.5 Document control

All HACCP documents need to be controlled by being reviewed, signed and dated by authorized personnel.

This will prevent the use of out of date documents.

Each HACCP document should bear a unique reference number for cross-referencing with CCP log sheets for example.

When changes to the HACCP Plans are made new issues must go to listed copy-holders and obsolete documents destroyed.

Ad hoc photocopying of `uncontrolled' copies must be avoided and where necessary these copies should be clearly marked `Uncontrolled'.

Control of artwork for a packaging should be reviewed and signed off.

4.6 Purchasing

Purchasing covers everything from raw materials to subcontractors. Everything purchased should be clearly specified through written specifications.

Control of subcontractors should be through assessment and records kept.

This will include calibration, process equipment servicing, hygiene and pest control.

4.7 Purchaser-supplied

As this will apply to ingredients and products packaging materials which are supplied by the purchaser for processing into his products, it is essential to ensure that these items are included in the HACCP assessment and that as much information as is needed is available.

4.8 Product identifi-

Essential within the HACCP System to cation and be able to trace batches of raw traceability materials or products in the event of a failure at a CCP.

A written recall plan should be maintained in order to minimize the effect of any failure by being able to trace and withdraw any defective product.

4.9 Process control

Obviously highly relevant to HACCP and essential to include the following key areas at all stages in the process:

i) Building - all facilities from raw material storage areas, through process and dispatch. Including employee amenities.

ii) Plant and equipment - process capability, preventative maintenance, hygienic design and cleaning.

iii) Personnel - training, health screening, meeting legislation.

iv) Cross-contamination - at all stages where this could be a risk.

v) Waste materials - clearly identified and segregated.

vi) Computer failure - contingency plans should be in place.

vii) Environmental control - atmosphere, ground water.

4.10 Inspection and Where raw material are CCPs, these testing should not be used until confirmation of conformance has been received.

Materials used before being certified as meeting specifications should be traceable in order to allow a recall at a later stage if necessary.

Finished products should be held until confirmation of all CCPs having been met in full has been received.

Records of all inspection and test results should be maintained.

Personnel carrying out testing should be trained and qualified appropriately. They should also be assessed as being capable for the job.

4.11 Inspection measuring

Effective control of CCPs relies on test equipment accurate measuring methods or equipment. All equipment needed to monitor a CCP should be of known accuracy and precision and calibrated on a regular basis.

All measuring equipment should be status marked so as to make it clear to all personnel what is calibrated and what is to be used for general guidance only.

Equipment must be maintained and stored correctly in-between calibration in order to avoid damage.

Records of calibrations should be kept.

4.12 Inspection and test status

There should be a clearly defined method for identification of the inspection and test status of any raw material, product, or equipment to prevent its being used inadvertently.

4.13 Control of non-The HACCP Control Chart will define conforming product who is responsible for taking corrective action in the event of a deviation. This must include what to do with product made while the system was out of control, i.e. to rework, recycle to reject.

Procedures must be developed to ensure that all non-conformities at a CCP are recorded. This will enable trends to be analysed.

Once any non-conforming product has been brought back into specification it must be tested again to confirm conformance.

4.14 Corrective action
If a CCP is out of control the underlying cause must be identified in order for the problem to be permanently resolved and not repeated.
Corrective actions also include pest control audits and hygiene audits. the corrective action taken in the event of any problem arising must be the right corrective action - new hazards could arise if the wrong corrective action is taken. An example of this is to shroud a piece of equipment in polythene because the roof above is leaking.

The effectiveness of any corrective action must be verified for confirmation.

All corrective action must be recorded.

4.15 Handling, storage, Hazards may arise from improper packaging and handling and storage of a product or delivery raw material. Also if the packaging is unsuitable - unable to withstand distribution. Areas for consideration include:

food contact packaging
control of artwork (usage instructions, ingredients and nutritional data)

storage and distribution temperatures stock rotation shelf-life contamination risks environment and building fabric hygiene and pest control

4.16 Quality records

HACCP records will need to be retained in a controlled manner. They may form part of a due diligence defence or be needed during a regulatory inspection as demonstration of the effective
management of food safety.

Quality-related records include product and raw material specifications, the HACCP Plans, Process Control records including CCP log sheets, calibration records, minutes of HACCP/food safety meetings, audits.

Retention time must reflect both statutory regulations and product shelf-life. Three years as a minimum for those records that demonstrate system management.

4.17 Internal Quality

Process Flow Diagrams must be audited

Audits as part of the verification.

The HACCP System itself should be regularly audited by members of the HACCP Team in order to assess whether it is working, correct and applicable. Internal audits can act as a health check. Documented non-compliances raised must be corrected, allowing continued improvement of the HACCP System. The audit will be what makes the HACCP System live within the company and not remain as documentation on the shelf.

Auditors must be trained and independent of the department being audited and records of audit must be kept.

4.18 Training

Effective HACCP relies on the participation of knowledgeable and trained people across a wide range of disciplines.

HACCP and Food Safety Management will continue to develop. It is important therefore that future training needs are considered on an ongoing basis. Areas for inclusion may reflect system changes, emerging food safety issues, new processes and corrective action skills.

Training records should be available for all members of staff and include all types of training - in-house, external, skills or awareness activities.

4.19 Servicing

Often not considered relevant in manufacturing, but as an example, suppliers of vending equipment will be particularly aware of this clause as it required the servicing of such equipment to be documented and controlled. Such equipment can be a source of hazards if not cleaned and maintained correctly. This needs to be considered in line with the servicing frequency.

4.20 Statistical

The construction of the HACCP Control techniques

Chart requires sampling regimes at each CCP to be documented.

If decisions of conformance are being based upon results of sampling and testing then it must be ensured that schemes are mathematically based i.e. the use of statistical sampling plans.

Other relevant statistical techniques include process capability assessment and statistical process control during CCP monitoring.