16 replies to this topic

[Amirhosein]

Hi friends

I have implemented ISO 9001 and 22000 in a flour mill. I have confused with
monitoring usage in these two standards. I think in 22000 the monitoring
activities are measurements of process and inputs and verification is measurement
the ouputs. for example if we have a cloriform hazard in our water and we add
chlor to delete it we monitor if we are adding the required chlor and in correct
time interval or not. and in verification we count the amount of a cloriform of a
sample.
But in 9001 monitoring I think we directly count the cloriform. all in all I think
monitoring in 9001 is somehow equal to verification in 22000.
Is it correct or I am doing wrong?

[tsmith7858]

Can you clarify which sections of ISO 22000 and ISO 9000 you are comparing?

I am guessing that you are looking at section 7.6.4 (System for the monitoring of CCP)in 22000 and 8.3 (Control of monitoring/measuring) and possibly 8.2.3 (Monitor/Measure Process) and 8.2.4 (Monitor/Measure Product) in ISO 9000. ISO 9000 also uses "monitor" in 7.6 (Control of monitoring/measurement equipment).

I will wait for your clarification before answering your question.

TS

[Tony-C]

Hi friends
I have confused with monitoring usage in these two standards. I think in 22000 the monitoring activities are measurements of process and inputs and verification is measurement the ouputs.

Hi Amir,

Verification is the provision of evidence that requirements have been fulfilled.

Here are the references to monitoring in the 2 standards:

ISO 9001:2008

4 Quality management system
4.1 General requirements
d) ensure the availability of resources and information necessary to support the monitoring of processes
e) monitor these processes

7 Product realization
7.1 Planning of product realization
c) required monitoring activities specific to the product and the criteria for product acceptance

7.5 Production and service provision
7.5.1 Control of production and service provision
d) use of monitoring and measuring equipment
e) the implementation of monitoring

7.5.2 Validation of processes for production and service provision
The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement

7.5.3 Identification and traceability
Identify the product status with respect to monitoring and measurement requirements

7.6 Control of monitoring and measuring equipment

8 Measurement, analysis and improvement
8.1 General - plan and implement the monitoring processes needed

8.2 Monitoring and measurement
8.2.1 Customer satisfaction - monitoring customer perception
8.2.2 Internal audit - conduct internal audits at planned intervals

8.2.3 Monitoring and measurement of processes
The organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes. Consider the type and extent of monitoring or measurement

8.2.4 Monitoring and measurement of product - monitor and measure the characteristics of the product to verify that product requirements have been met.

8.4 Analysis of data - include data generated as a result of monitoring and measurement and from other relevant sources

ISO 22000:2005

6.2.2 Competence, awareness and training
c)ensure that personnel responsible for monitoring of the food safety management system are trained

7.4.4 Selection and assessment of control measures
b) feasibility for monitoring - ability to be monitored in a timely manner to enable immediate. corrections

7.5 Establishing the operational prerequisite programmes (PRPs)
c)monitoring procedures that demonstrate that the operational PRPs are implemented
f)record(s) of monitoring

7.6 Establishing the HACCP plan
7.6.1 HACCP plan
d)monitoring procedure(s) (see 7.6.4)
g)record(s) of monitoring

7.6.3 Determination of critical limits for critical control points
Critical limits shall be determined for the monitoring established for each CCP.

7.6.4 System for the monitoring of critical control points
A monitoring system shall be established for each CCP to demonstrate that the CCP is in control.
The monitoring system consisting of relevant procedures, instructions and records including:
- measurements or observations
- monitoring devices
- applicable calibration methods
- monitoring frequency
- responsibility and authority
- record requirements and methods.
The monitoring methods and frequency shall be capable of determining when the critical limits have been exceeded in time for the product to be isolated before it is used or consumed.

7.6.5 Actions when monitoring results exceed critical limits
Planned corrections and corrective actions to be taken when critical limits are exceeded shall be specified in the HACCP plan.

7.10.2 Corrective actions
The organization shall establish and maintain documented procedures that specify appropriate actions:
b)reviewing trends in monitoring results

7.10.3.2 Evaluation for release
Each lot of product affected by the nonconformity shall only be released:
a) when evidence other than the monitoring system demonstrates that the control measures have been effective

8.3 Control of monitoring and measuring
Provide evidence that the specified monitoring and measuring methods and equipment are adequate to ensure the performance of the monitoring and measuring procedures.
The ability of computer software to satisfy the intended application shall be confirmed when used in the monitoring and measurement.

There is a table at the back of the 22000 standard that correlates the two standards.
This document correlates BRC, 9001, 22000 and PAS220 and may be useful to you.

 BRC_9001_22000_PAS_220_Requirements.pdf   491.68KB   216 downloads

ISO 22000 Definitions:

Monitoring - Conducting a planned sequence of observations or measurements to assess whether control measures are operating as intended

Verification - Confirmation through the provision of objective evidence, that specified requirements have been fulfilled

Regards,

Tony

[Amirhosein]

Can you clarify which sections of ISO 22000 and ISO 9000 you are comparing?

I am guessing that you are looking at section 7.6.4 (System for the monitoring of CCP)in 22000 and 8.3 (Control of monitoring/measuring) and possibly 8.2.3 (Monitor/Measure Process) and 8.2.4 (Monitor/Measure Product) in ISO 9000. ISO 9000 also uses "monitor" in 7.6 (Control of monitoring/measurement equipment).

I will wait for your clarification before answering your question.

TS

thanks a lot for your answer

I want the comparison of clause 4.2.8 monitoring and measurement of product in 9001 and 7.6.4 system for monitoring of critical control points.

I think they are different. the first take samples of each process output and makes sure that the results are in compliance with requirements but the second checks process and control measures at ccps to make sure controls are in place not taking sample of outputs.
for example in a sifter process which is in place to take impurities:
in 9001 4.2.8 I take sample of sifter output to see if impurities are found in flour
but in 7.6.4 22000 I check the sifter mesh to make sure it works correctly (and in verification 7.8 C I take samples of sifter to see if impurities are eliminated or not)

thank you

thank you

[tsmith7858]

thanks a lot for your answer

I want the comparison of clause 4.2.8 monitoring and measurement of product in 9001 and 7.6.4 system for monitoring of critical control points.

I think they are different. the first take samples of each process output and makes sure that the results are in compliance with requirements but the second checks process and control measures at ccps to make sure controls are in place not taking sample of outputs.
for example in a sifter process which is in place to take impurities:
in 9001 4.2.8 I take sample of sifter output to see if impurities are found in flour
but in 7.6.4 22000 I check the sifter mesh to make sure it works correctly (and in verification 7.8 C I take samples of sifter to see if impurities are eliminated or not)

thank you

thank you

To your original question, I would not say that monitoring in 22000 = verification in 9000.

As for your example above and your reference to 7.6.4 in 22000, I think it fits well. You are monitoring to ensure impurities are controlled or eliminated as defined in your CCP. As Tony's information provides, the definition for monitoring in 22000 is:

Conducting a planned sequence of observations or measurements to assess whether control measures are operating as intended

I am not finding your reference to 4.2.8, can you provide the statement from the section? 4.2 in ISO 9001:2008 is document control and makes no indication to monitoring.

As Tony indicated, Section 4.1 e) does use monitoring. In that case it would be similar to what you described in your example, monitoring to ensure your quality standards are met.

You will also see in Tony's response that monitoring is used frequently throughout each standard. I went through an ISO 22000 audit in April and just last week went through ISO 9000. The standard match fairly well but don't get caught up in making them mean the same thing. Tony provided a good comparison tool that shows the links.

Remember ISO 22000 is solely focused on providing a safe product. Some of the principles used to make it safe, make for a better quality but things we do to get good quality do not make it safe.

[Amirhosein]

To your original question, I would not say that monitoring in 22000 = verification in 9000.

As for your example above and your reference to 7.6.4 in 22000, I think it fits well. You are monitoring to ensure impurities are controlled or eliminated as defined in your CCP. As Tony's information provides, the definition for monitoring in 22000 is:

Conducting a planned sequence of observations or measurements to assess whether control measures are operating as intended

I am not finding your reference to 4.2.8, can you provide the statement from the section? 4.2 in ISO 9001:2008 is document control and makes no indication to monitoring.

As Tony indicated, Section 4.1 e) does use monitoring. In that case it would be similar to what you described in your example, monitoring to ensure your quality standards are met.

You will also see in Tony's response that monitoring is used frequently throughout each standard. I went through an ISO 22000 audit in April and just last week went through ISO 9000. The standard match fairly well but don't get caught up in making them mean the same thing. Tony provided a good comparison tool that shows the links.

Remember ISO 22000 is solely focused on providing a safe product. Some of the principles used to make it safe, make for a better quality but things we do to get good quality do not make it safe.

thanks a lot smith

excuse me for mentioning the clause 4.2.8 I meant 8.2.4 (monitoring of products)
I don't want to say that monitoring in 22000 = verification in 9000 but also
I say monitoring in 9001 (monitoring of products) is equal to verification of ccp in 22000 and also I don't want to argue that they are equal in meaning view of point. I think
they act like another but they are in two different system, I guess in both clauses
we take sample of outputs. But someone told me that's not true. In 22000 monitoring of CCps you write process specifications like temperature and pressure and results together and in verification you only read monitoring records to check trends. But I thought that in 22000 8.4.2 clause (verification of individual results) we write the records and in 22000 8.4.3 we analyse the trends. I mention another example:

we add chlor to water to eliminate contamination. accept that this parameter be quality and safety parameter to make the example easier.

we define in our HACCP plan that 2 grams of chlor pouder should be added to 100 litre of water. I think the procedure is as below:

for HACCP monitoring section we only check for example every day that if the quantity of the chlor is correct or not and write the records:

2009/11/12 => chlor added = 2.01 g 2009/11/13=> chlor added= 1.99 g and .....

in 22000 8.4.2 (evaluation of individual verification results) we check every day if the contamination is in limits (consider coliforms limits 2-5 ppm) for example:

2009/11/12 => coliforms=2 ppm 2009/11/13=> coliforms=3 ppm

in 22000 8.4.3 (analysis of results of verification activities) we check if coliforms number have incremental trend or not.

but in 9001 8.2.4 (monitoring and measuring of the products) we check both chlor and coliform

2009/11/12 => chlor added= 2.01 g and coliforms=2ppm 2009/11/13 chlor=1.99 and coliforms=3

am I right?

thanx you.

[tsmith7858]

am I right?

You are not wrong. Let's look at this from the beginning using your example (with some educated guesses on my part):

• You determined that chlor level in water was critical (22000 - 7.6.2 Identification of CCP)
• You determined the level chlor needed to have safe water (22000 - 7.6.3 Determination of limits for CCP), but at the same time determine that to much chlor (although making the water "safer") does not help the flavor or quality (9000 - 7.3 Design and Development)
• You established a monitoring method to ensure minimum amount of chlor needed is added to the water to ensure safety (22000 - 7.6.4 Monitoring CCP), but again recognizing that to much is a quality issue you establish a quality limit and monitoring (9000 - 7.5.1 Control of Production, 8.2.3 Monitoring of Process, 8.2.4 Monitoring of Product) - In this case your monitoring for 22000 and 9000 is the same

You now have what you want and how you are going to monitor it for both 22000 and 9000, with of course provisions for calibration of any equipment used to measure the amounts or use of an accredited lab.

Section 8 for 22000 verifies that the monitoring is happening (looking at results, records, etc) and if the limit set is successful (proper reduction of coliform to make the water safe) and if trends indicate anything different you react by changing your limits

Section 8.4 of 9000 adds analysis, but only needs to be done if you deem it necessary, and uses the data or records you collect from monitoring or additional testing. You want to know that there was not to much chlor to change flavor. As strange as it sounds, for 9000 you may not care about the coliform level if it does not impact the quality, but safety of the food comes first!

Again, there is not a one for one relationship between 22000 and 9000 and some interpretation is needed. Hopefully some day they will tie them together a little better but until that point we can share our opinions and hope we get it right.

TS

[Charles.C]

Dear All,

Not really my scene but I might add a few comments.

I suggest Amirhosein also read ISO:22004. This clarifies some of the meanings / requirements of the 22000 items discussed above, eg it includes a greatly amplified discussion regarding verification.

eg -

"The concepts of validation, verification and monitoring are often confused.
- Validation is an assessment prior to operation, the role of which is to demonstrate that individual (or a combination of) control measures are capable of achieving the intended level of control.
- Verification is an assessment carried out during and after the operation, the role of which is to demonstrate that the intended level of control has actually been achieved.
- Monitoring is a procedure to detect any failures in the control measure."

"The frequency of verification depends on the degree of uncertainty in the effect(s) of the control measure(s) applied relative to the determined acceptable level(s) of food safety hazard(s) or predetermined performance(s), as well as on the ability of the monitoring procedures to detect loss of control. Hence, the frequency required will depend on the uncertainties associated with the result of validation and the functioning of the control measure (e.g. process variability). For instance, where validation demonstrates that the control measure delivers a hazard control significantly higher than the minimum required to meet acceptable levels, verification of the effectiveness of that control measure may be reduced or might not be required at all."

ISO 22000 (2005) was presumably obliged to use the (2000) version for any links to iso 9001, eg it’s definition of verification. Although I suppose this does not mean that the interpretation is also automatically identical.

@tsmith –

Remember ISO 22000 is solely focused on providing a safe product. Some of the principles used to make it safe, make for a better quality but things we do to get good quality do not make it safe

Slightly off-topic but, conveniently, ISO 22000 skips over a definition of quality. Some people might claim that if the safety of a product is not assured, it cannot be of acceptable “quality”.

Rgds / Charles.C

[tsmith7858]

Slightly off-topic but, conveniently, ISO 22000 skips over a definition of quality. Some people might claim that if the safety of a product is not assured, it cannot be of acceptable “quality”.

Rgds / Charles.C

Charles,

Great points as usual, 22004 is a good tool for clarification.

As for your last statement, in ISO terms, 22000 does not skip over quality, it excludes it!

There is a statement that I often hear in relation to food safety vs quality:

Quality is negotiable, food safety is not.

One may not sell an unsafe product as dictated by laws and regulations but if they choose to sell an inferior or low quality product, they are more than welcome to give it a go!

TS

[Charles.C]

Dear tsmith,


Re - Quality, nice classical quote but the reality is that "safety" is not an absolute unfortunately ("assured" is also an equally comforting but potentially misleading term .)(added - it is a praiseworthy feature of iso 22000 that it requires an initial detailed evaluation of the relevant safety related requirements, eg via FSOs) There is certainly a variety of member opinions here also, including with respect to 22000/9001 -

http://www.ifsqn.com...?showtopic=9338

@ Amirhosein, sorry for digression. Returning to yr original topic, note the repetitive use of "control measure" in my extracts above. This illustrates a particular HACCP re-focus of ISO 22000 as compared to traditional HACCP. I presume this procedure is operationally distinct to the 9001 usage (not my direct area).

Rgds / Charles.C

[Zeeshan]

"The concepts of validation, verification and monitoring are often confused.
- Validation is an assessment prior to operation, the role of which is to demonstrate that individual (or a combination of) control measures are capable of achieving the intended level of control.
- Verification is an assessment carried out during and after the operation, the role of which is to demonstrate that the intended level of control has actually been achieved.
- Monitoring is a procedure to detect any failures in the control measure."

Great work! .
It helped me a lot to clear the fog over my mind!!!

If you allow me to be more clear, please comment over following points.
---------------------------------------------------------------------------------------------------
As per ISO 22000:2005:

Monitoring = conducting a planned sequence of observations or measurements to assess whether control measures are operating as intended.

and

Verification = confirmation, through the provision of objective evidence, that specified requirements have been fulfilled

After reading your clarification, I re-read these definitions and wrote some other definitions as follows:

Monitoring = Collecting objective evidences that would later be used in verification of being observed process.

Monitoring = Conducting a planned sequence of observations or measurements to enable later on verification of being observed process (including confirmation that operation of control measures is being carried out as intended.)

Verification = assessment of collected objective evidences to confirm that specified requirements of a process (including operation of control measures as intended, taking corrections when non-conformance occur, taking corrective actions etc.) have been fulfilled.

---------------------------------------------------------------------------------------------------

Hope I would be correct .

Regards:
Zeeshan.

[Tony-C]

Great work! .
It helped me a lot to clear the fog over my mind!!!

If you allow me to be more clear, please comment over following points.
---------------------------------------------------------------------------------------------------
As per ISO 22000:2005:

Monitoring = conducting a planned sequence of observations or measurements to assess whether control measures are operating as intended.

and

Verification = confirmation, through the provision of objective evidence, that specified requirements have been fulfilled

After reading your clarification, I re-read these definitions and wrote some other definitions as follows:

Monitoring = Collecting objective evidences that would later be used in verification of being observed process.

Monitoring = Conducting a planned sequence of observations or measurements to enable later on verification of being observed process (including confirmation that operation of control measures is being carried out as intended.)

Verification = assessment of collected objective evidences to confirm that specified requirements of a process (including operation of control measures as intended, taking corrections when non-conformance occur, taking corrective actions etc.) have been fulfilled.

---------------------------------------------------------------------------------------------------

Hope I would be correct .

Regards:
Zeeshan.

You are right and quoting from the 22000 standard but should Validation rather than Verification fit into some of these definitions?

Merry Christmas

Tony

[rosem]

Hi;

in my facility (hotel) we use chlor for sanitation of fruits& veg. (100 ppm)

it had worked with full performance according to analysis reports since last 2 months

Now E. coli is problem i dont understand everything is same in process (except result :) )

i need a legal or academic source for the limit& what's the harm when it (Chlor) used more than limit?

thnx for ur help.....


Regards

Rose...

[Modarres]

Hi friends

I have implemented ISO 9001 and 22000 in a flour mill. I have confused with
monitoring usage in these two standards. I think in 22000 the monitoring
activities are measurements of process and inputs and verification is measurement
the ouputs. for example if we have a cloriform hazard in our water and we add
chlor to delete it we monitor if we are adding the required chlor and in correct
time interval or not. and in verification we count the amount of a cloriform of a
sample.
But in 9001 monitoring I think we directly count the cloriform. all in all I think
monitoring in 9001 is somehow equal to verification in 22000.
Is it correct or I am doing wrong?

Hi!

In ISO 9001 clause 8.2.4 you should monitor or measurement a product in accordance with clause 7.1 but in 22000 monitoring is related to control measures only and could be about product or process parameters, it means maybe in some cases 22000 monitoring could be as same as 9001 monitoring in 8.4.2 or production control in 7.5.1.
22000 verification could use for final product test for assessment of acceptable level of hazards and it could do according to its planning (22000 7.8 or 9001 7.1) sometimes as same as 9001 8.2.4.


Thanks

[Simon]

Thanks for your input Modarres.

[Tony-C]

Hi!

In ISO 9001 clause 8.2.4 you should monitor or measurement a product in accordance with clause 7.1 but in 22000 monitoring is related to control measures only and could be about product or process parameters, it means maybe in some cases 22000 monitoring could be as same as 9001 monitoring in 8.4.2 or production control in 7.5.1.
22000 verification could use for final product test for assessment of acceptable level of hazards and it could do according to its planning (22000 7.8 or 9001 7.1) sometimes as same as 9001 8.2.4.


Thanks

Don't forget ISO 22000 clause 7.10.3.2 Evaluation for release.

Regards,

Tony

[Modarres]

Don't forget ISO 22000 clause 7.10.3.2 Evaluation for release.

Regards,

Tony

Dear Tony

22000 7.10.3.2 used when we faced affected product by a nonconformity after that monitoring detected a deviation,.... generally we can say clause 7.10.3 in 22000 is similar to clause 8.3 in 9001.

Modarres