Friday, September 29, 2017

QMS Questions answered: Audit frequencies

Within the QMS system the core business processes and the supporting 9001 standard requirements procedures/processes have been identified and separated with the specific intent of auditing them at different intervals within the 3-year cycle.

For example, the core business processes will be audited either weekly/monthly/quarterly/bi-annually/annually and the supporting 9001 standard requirements procedures/processes will be audited once within the 3-year cycle because the risk of change is considered low.

Should the auditing of the standard requirements take place each year within a 3-year cycle?

The periodicity of internal audits is not regulated by the requirements of ISO 9001:2015.

Therefore, any audit cycle is acceptable. However, the frequency greater than 1 year may cause difficulties in conducting annual supervisory audits to prove that the QMS is maintained.

A good and most common practice is to audit every process once a year.

ISO 9001:2015 Products ISO 14001:2015 Products ISO 50001:2011 Products
IMS Products

Monday, September 11, 2017

Nonconformity Management

What are the major changes to the nonconformity management procedure according to the new version of ISO 9001:2015 (vs. ISO 9001:2008)?

The answers to this question can be found in ISO 9001:2015 Transition Gap Analysis Transition Guidelines.

Nonconforming process outputs, products or services are the object of control (ISO 9001:2008 defined nonconforming products as an object of control).

Thus, the requirements where extended:
‘The organization shall deal with nonconforming outputs in one or more of the following ways:
a) correction (vs. ‘to eliminate the detected nonconformity’ in ISO 9001:2008 cl.8.3. a);
b) segregation, containment, return or suspension of provision of products and services;
c) informing the customer;
d) obtaining authorization for acceptance under concession: (In ISO 9001:2008 this was worded as follows: ‘by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer’ (cl.8.3. b)).

Conformity to the requirements shall be verified when nonconforming outputs are corrected.’
ISO 9001:2015 Cl.8.7.1

ISO 9001:2015 provides more details regarding retaining of documented information (records) that:
‘a) describes the nonconformity;
b) describes the actions taken;
c) describes any concessions obtained;
d) identifies the authority deciding the action in respect of the nonconformity.’

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Thursday, September 7, 2017

Contract Review Metrics

What factors can be used to measure the effectiveness of the Contract review process?

Some suggest to use a quote-hit ratio to obtain a metric on the percentage of orders obtained from quotes. Not in all companies this would be an effective or accurate method, since many quotes are done verbally or through e-mails.

Are there any other ways to determine effectiveness in this process?

There is a universal and well-proven method for any QMS process effectiveness evaluation – the Expert Evaluation.
Each of the 5-7 experts evaluates the effectiveness, for example, on a 10-point scale. The maximum and minimum ratings are discarded and the arithmetic mean is determined.

The main thing is the awareness of experts, as well as disinterest in obtaining certain result. This ensures objectivity.

To evaluate the effectiveness of Contract analysis, the following criteria can also be used:
  • the time taken to sign the contract;
  • the ratio of contracts completed in time to the total number of contracts signed;
  • the number of customer complaints (an absolute value or in relation to the total number of contracts) - this criterion is applicable to several processes, including Production and service provision process.
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