production & monitroing.doc

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Clause 7.5 Production and service provisionPosted March 21, 2009 - 09:27 by isohelpline

"Once you start a working on something, don't be afraid of failure and don't abandon it.People who work sincerely are the happiest."

Chanakya (Indian politician, strategist and writer, 350 BC-275 BC)

The clause 7.5 has following sub-clauses:

7.5.1 Control of production and service provision7.5.2 Validation of processes for production and service provision7.5.3 Identification and traceability7.5.4 Customer property7.5.5 Preservation of product

Clause 7.5.1 Control of production and serviceprovision

Posted March 21, 2009 - 09:35 by isohelpline

If the other fellow sells cheaper than you, it is called dumping. 'Course, if you sell cheaperthan him, that's mass production.

Will Rogers (a beloved humorist and humanitarian)

Section 7.1 states that operations need to be controlled in order to be able to provideacceptable product to customers. Section 7.5.1 requires some specific control mechanismsfor organizations, specifically:

The availability of information that specifies the characteristics of the product. For

example: in a foundry the exact specification to which the metal needs to be manufactured

will be needed; in travel agency specific flight information, airport information and

conditions for cancellation or change will be needed.

The availability of work instructions. These instructions only need to be

documented where the absence of such instructions could adversely affect the quality of

the product (see 7.1).

The use of suitable equipment for production and service operations. Ovens are

crucial pieces of equipment for foundries to have; computer systems with on-line

connection to airlines are probably equally important in travel agencies.

The availability and use of monitoring and measuring equipment (In 2008 edition,

term "device" is replaced by "equipment") and the implementation of monitoring activities

(see 7.6).

The implementation of release, delivery, and post-delivery activities. It should be

clear how product is released and delivered to the customer.

For example, delivery can be done by the organization itself or by a subcontractor. Or, the

customer can pick up the product. In some cases there is a (written or verbal) requirement

for the organization to perform additional activities after the delivery of the product to the

customer. Examples of these activities are warranties, software support, and after-


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installation services. If there is a requirement to perform these servicing activities, then it

should be clear how these activities are performed, and there should be procedures in

place for critical activities (as per 7.1).

In 2008 edition, a note is added at the end of clause 7.2.1 which explains that post delivery

activities include, for example, actions under warranty provisions, contractual obligationssuch as maintenance services, and supplementary services such as recycling and finaldisposal.

The same note will be applicable here while planning for production and service provision.It should include all the activities which are committed to customer (7.2.1, 7.2.2) anddetermined in quality management system (4.1).

Activities like recycling and final disposal is applicable to many industry sectors such asthose dealing in plastics, silicon chips, computer waste, asbestos waste etc. By includingrecycling and final disposal in product requirements and statutory and regulatoryrequirements in the scope of standard, organizations will need to provide evidence ofcontrol on larger dimension of product realization processes.

Clause 7.5.2 Validation of processes for productionand service provision


Verification/inspection of products before they are provided to the customer is a valuableopportunity to prevent delivery of product that does not meet customer's requirements.However, sometimes it is not possible to fully verify the quality of the product withoutusing or destroying it. For example, it is not possible to fully verify the strength of a weldunless a destructive test is performed or the product is actually used. Similarly, for manyservice industries, the service provided is instantaneous, which does not readily allowverification before delivery of that service.

For example, a lawyer who defends a client in court is obviously not able to verify hisservice before delivery. Failure to represent the client correctly will only be detected whenthe judge rules.

In these cases the activities can only be controlled (validated) with the use of qualifiedpersonnel, qualified equipment, and qualified processes based on specific procedures. Aprocess can be qualified, for example, by doing a destructive test on a sample of theproducts. The results of this destructive test can then represent other products with thesame characteristics.ISO 9001 requires that record be maintained for activities that require validation it shouldbe noted that validation is only necessary if there is a risk of providing product that doesnot meet customer's requirements. For example, aesthetic welding may not have to bevalidated if it does not affect the quality of the product.

Records (4.2.4) relating to validation of process shall be maintained. These records shouldprovide evidence that process validation is done periodically (by keeping at least last 3process validation records) and records relating to following:

Qualification of personnel performing the process

Qualification of equipment used to perform the process

Evidence of adherence to specified process parameters or characteristics when

process is performed.

Clause 7.5.3 Identification and traceability


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Activities can only be controlled if it is clear what the status of the product is. Clearidentification of the product can avoid misunderstanding about what has happened to itand what still needs to happen. For example, product in the receiving area of amanufacturing plant should be clearly marked as to whether a receiving inspection hastaken place. If a receiving inspection has taken place, it should be clear what the result of

this inspection was (pass or fail). Similarly, material that is used in a machine shop shouldbe identifiable as to which specific job it belongs, and in which stage of production it is. Inthe service industry, this requirement may have similar importance. For example, a courierservice cannot function without clear identification on the packages as to which servicesare required (delivery time, registration, etc.), and a warehouse/distributor will need tohave some way of identifying the product in stock.

There are several ways of identifying products. The most obvious is using tags or stickerswith part numbers, bar codes, job numbers, etc. The identification may be engraved in theproduct itself, or the product may simple be marked by a colour. Sometimes it is morepractical to identify a product by its location. For example, deficient product may beidentified as nonconforming by segregating it and placing it in a specific area that ismarked.

In all cases ISO 9001 requires that it is clear if the product has been verified/inspected and

that the result of the inspection is also clear.

Sometimes traceability is a requirement (and even regulated). For example, in pressurevessel manufacturing, it is common for the identification of a given material to be recordedand traced through all manufacturing stages. In this way, the final component can betraced back to the original material certificate. If traceability is required, ISO 9001 statesthat the material be uniquely identified and the records are maintained to show evidenceof traceability.

Though clause 1.2 states that any requirement within clause 7 can be excluded, I do notsee any situation where product identification is excluded. Product identification also helpsin preservation of product (7.5.5). You can exclude traceability requirement that is toexclude requirement to keep record of identification at various product realization processto enable traceability.

Clause 7.5.4 Customer propertyPosted March 21, 2009 - 09:38 by isohelpline

The product of mental labour - science - always stands far below its value, because thelabour-time necessary to reproduce it has no relation at all to the labour-time required forits original production.

Karl Marx (Socialist thinker, 1818-1883, Germany)

What is customer property?

Products supplied by the customer to be incorporated in to the final product

Products provided by the customer to enable processing of final product

Tools or equipment provided by customer

Designs and drawing provided by customer or any other type of intellectual

property such as use of brand name.

Product received from customer for repairing / maintenance after sales at

organizations premises.

Product provided by customer for repairing /maintenance at customer premises

during after sales service operation.


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Brands owned by customer but used by organization under agreement.

If there are any products, materials, or tools on an organization's premises that are ownedby a customer, workers must exercise care with this property. This means that they mustensure that the product is not lost or damaged. If it is lost or damaged, this needs to berecorded and the customer needs to be notified.

Customer property should be identified and verified (for example, by performing areceiving inspection). Examples of customer property are: motor vehicles left for service orrepair, clothing that a customer left at a laundry or customer-owned material in awarehouse.

Clause 7.5.5 Preservation of productPosted March 21, 2009 - 09:39 by isohelpline

Obviously it is as important that an organization handle its own product/material with care,as it is to protect customer's property. Some common examples of where special handingtechniques are required are:

Metals handing where stainless steel can have corrosion resistance impaired if the

stainless steel is handled with ordinary steel grips or chains. Covering the grips, chains,

and other handing tools with rubber, plastics, or similar materials is the usual practice.

Most copper based metals are susceptible to corrosion from finger marks. Where corrosion

may affect performance, such as in printed circuit boards or decorative applications, gloves

need to be worn to prevent such marking.

Food handing where cleaning of utensils after use is very necessary, for health

reasons.

Electrical and electronic equipment where safe handing practices are required to

avoid damage from electrostatic discharges.

Similarly, packing or packaging needs to be done in such a way that it does affect

the product. Packaging should be appropriate to the product.

For example, bulk grain may be packed by filling the carrying container, provided the

container does not contaminate the product. On the other hand, the packaging of certain

chemicals is regulated to ensure that they do not spill or contact with water.

Also, unsuitable storage can deteriorate the condition of product. Product in stock

must be protected, especially if the product has a limited shelf life. Checking the condition

of product in stock regularly can do this.

In 2008 edition, "in order to maintain conformity to requirements" added as objective ofpreservation and term "as applicable" added for preservation activities which are definedas identification, handling, packaging, storage and protection.

This should be seen as appropriate amendment for clarity, and a small appropriate changeto make the requirement suitable for a wider range of industry segment becausepreservation measures like identification, handling, packaging, storage and protection, allthese can not be made applicable all the time in all types of industry.

Damaged product can lead to added costs, reduction in customer satisfaction, and can bea danger in the warehouse.Damaged Product Product Stored Properly


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Clause 7.6 Control of monitoring and measuring

equipmentPosted March 21, 2009 - 09:41 by isohelpline

Verifications, inspections and tests are important ways to ensure that the product meetsthe customer's expectations. This can be done by monitoring and measuring thecharacteristics of the product (see 8.2.4).

For example, a pharmacist measures the exact amount and weight of the medicine beforeproviding it to the customer. However, if his measuring device (an electronic scale) ismeasuring incorrectly, or if it is not accurate enough, then the measurement is useless.

Therefore, this section of ISO 9001 requires organizations to ensure that measurementdevices are controlled so that they measure correctly.

Example, of measurements and monitoring devices are: scales, gages, thermometers,micrometers, callipers, and thickness meters.

They should be calibrated periodically. Calibration is the act of comparing the

measurement device against a reference standard to determine how accurate it is and

whether or not it is still capable of meeting the precision required for the measurement

made with it. Where necessary, the measuring device needs to be adjusted.

Organizations are free in determining the frequency of calibration, provided that

the frequency is consistent with the type of measurement device and intensity of use.

For a reference standard to have validity, it must be traceable back to an

appropriate recognized accurate source. This is normally a national or international

standard (such as a meter or a kilogram). If an international or national standard does not

exist, then the organization needs to define the reference standard on its own.

It is important to determine how accurate the measurements need to be. This will

depend upon how much tolerance is permissible in what is being measured. A measuring

device usually has to be capable of measuring to a much closer tolerance than the

tolerance specified for the item being measured. Also, there is no point in having

measurement devices calibrated to unnecessarily high precision if that precision is not

needed for the operation. A pharmacist typically needs high accuracy equipment, while the

accuracy of a wire cutter used by a distributor is relatively low.


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The results of the calibrations need to be recorded. If the measuring device

appears to be out of calibration, then it is necessary to look at the results of the

measurements that were previously taken with this device. For example, if a scale is out of

calibration, someone may need to re-inspect the product that was recently inspected with

this device (provided the product has not yet been shipped to the customer). Organizations

need to decide which corrective action is appropriate (see 8.5.2).

It is important to protect a measuring device from damage or deterioration. This

means that it must be suitably stored when not in use, and it must be correctly handled.

Also, adjustments may invalidate the calibration; a possible prevention method is to ensure

that only trained personnel is authorized to use the measuring device.

Sometimes computer software is used in the process of monitoring and measurement of

requirements. If this is the case, then the software must be checked if it performed the

required function. Where calibration of device is not possible or practically feasible than

verification should be done to fulfil the requirement of this standard.

In 2008 edition, term "device" is replaced by "equipment". A small appropriate change tomake the term suitable for a wider range of industry segment.

A note at the end of clause is added stating that confirmation of the ability of computersoftware to satisfy the intended application would typically include its verification andconfiguration management to maintain its suitability for use as computer software is nowbeing extensively used for quality assurance purposes in all types of industry and henceclarity was needed.

Guidance for Educational Institutions:

A school or college developing question paper for examination also falls under the categoryof monitoring and measuring equipment because it is used to measure the competencelevel of examinee.Control of (or Calibration of) question paper will be consisting of setting guidelines forpreparation of question paper so that entire syllabus is covered and then reviewing it toverify that question paper meets the set guidelines before releasing.

Guidance for Software Companies:

Software testing tools and scripts developed to run on these tools will fall under thecategory of monitoring and measuring equipment.

To meet the requirement of the standard, verification of scripts prior to testing will be

needed.ISO 9000 defines verification as Confirmation, through the provision of objective evidence,that the specified requirements have been fulfilled.

Guidance for engineering companies:

1. Identify the measurements and measuring limits.

The measuring limit is a range under which product is acceptable.

These limits may be defined as % of value or as a fixed tolerance, either one sided or

both sided e.g.:

Length = 50 mm + 1 mm (Both sided fixed tolerance in absolute value) or

Length = 50 mm + 2 % (Both sided fixed tolerance in % of value) or


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Length = 50 mm + 1 mm (One sided fixed tolerance) or

Length = 50 mm (+ 1 mm, -0.5 mm), (Both sided fixed tolerance of different value) etc.

2. Select appropriate measuring devices and define control limits.

Selection of equipment should be based on importance of parameter in achieving

conformity i.e. accuracy needed.

Following parameters should be considered while selecting measuring and monitoring

device:

1. Range of measurement, required.

2. Least count

3. Accuracy

4. Repeatability

5. Reproducibility

1. Range of measurement:

Minimum and Maximum limit of values required to be measured.

2. Least count:

Minimum value that can be measured with the device with defined level of confidence

and accuracy.

3. Accuracy:

Closeness of the measured value to actual.

4. Repeatability:

Accuracy of measurement achieved when measurements are carried out by one person

under defined circumstance.

5. Reproducibility:

Accuracy of measurement achieved when measurements are carried out by different

persons under defined circumstances.

For all practical purposes we will consider "accuracy" means maximum of accuracy,

repeatability and reproducibility.

Example:

Say measurement requirement is:

Length = 50 mm + 1 mm

If you select measuring device as vernier having least count of 0.01 mm and accuracy

of 0.02 mm. The control limits will than be:

Length = 49.02 to 50.98 mm

Because the values 49.00 to 49.02 and 50.98 to 51.00 are suspect zone, i.e. the values

in this range might be lower than 49 or higher than 51 respectively because of the

accuracy of the instrument is 0.2 mm. As a thumb rule accuracy of device should be at

least 1/3 of measurement accuracy. A 1/4 or 1/5 is considered a better option.

3. Calibrate the measuring devices periodically, as appropriate

This periodicity may be prior to use, daily, weekly, monthly, bimonthly, six monthly,

yearly or even more.

The frequency of calibration will depend upon type of device and severity of use.


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In some cases, where high level of measurement accuracy, the devices are calibrated

prior to and after taking the measurement and if difference is observed in two

calibrations than either measured value is corrected accordingly or even provision is

made to repeat the measurement.

4. Reference standardsCalibration should be traceable to national or international standards, if such standards

exist. In cases, where national or international standard do not exist, than basis used for

calibration should be recorded.

In 1994 edition, the standard required "basis used for calibration should be

documented", which was interpreted as documenting the procedure or work instruction

for calibration of that device.

Recording the basis of calibration on the calibration certificate should be considered as

enough evidence of conformity to the requirement of 2000 edition of the standard.

Traceability to National / International standard is maintained as follows:

Level - I: Device in National/ International Physical Laboratory, it is a representative

sample with highest possible accuracy. Level - II: Device in National Physical Laboratory

used for calibration for tertiary devices.

Level - III : Device calibrated using second level device and used for calibration of

devices used for measurement and monitoring in day to day activities in production and

quality assurance. This device is often called "Master" or tertiary instrument (devices).

Level - IV: Device used for measurement and monitoring in day to day activities in

production and quality assurance.

The calibration certificate of device "under calibration" should identify the "Master" used

for calibration and its accuracy.

The calibration certificate of device used as "Master" should identify the National

Physical laboratory (NPL) device used and its accuracy.

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