Internal Auditor Forum

Re: Case Study : Calibration of Equipment

Mon, 09 Nov 2009 10:16:06 CST

by Markus Fischer.

Background:
Audit in the production of a medium sized company.

Observation:
The measuring tools used in the production are not monitored and calibrated, even though this has to be done to ensure the reliability and conformity of the produced products. These were mainly old calipers, for which it is even more important to be checked regularly.
Additionally there is also no rule given which would specify which measuring tool has to be used for checking (measuring tool type / calibrated / non calibrated / etc.). Also the workers use both types (calibrated and non calibrated) measuring tools for measuring the product and could not identify the difference between the two calipers.

Classification:
This is major nc

Applied ISO clause:
7.6 Control of monitoring and measuring devices

Control of Records

Mon, 09 Nov 2009 07:05:41 CST

by Manjeesh TG.

An organisation is required to establish a minimum of Six documented "System" procedures. The second of these procedures, by order of appearance, cover the control of records, & is identified in clause 4.2.4 of the standard as follows:

"Records shall be established & maintained to provide evidence of conformity to requirements & the effective operation of the quality management system. Record shall remain legible, readily identifiable & retrievable. A document procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention tome & disposition of records".

Quality Policy

Mon, 09 Nov 2009 06:38:16 CST

by Manjeesh TG.

ISO 9001: 2008 required distribution control of all documents & data related to quality, with associated procedures describing the method of control. Quality documents are those that attest to the quality level of product & process performance, Including specifications, Procedures, Drawings, Blueprints, & many types of records. To avoid nitpicking, auditor must understand document control's & keep the big pictures in mind.

By definition, document control ensure both that current & correct documents are available where & when needed & that they are used from this, we can construct the following necessary for quality documents.

Identification
Collection
Indexing
Disposition
Amendment

Case Study: Control of production

Mon, 09 Nov 2009 06:38:10 CST

by Muralimanohar J.

Background: I was given a chance to do internal auditing for my company. Our company is basically a stem cells banking company. Stem cells are the primitive cells which can be differentiated into any body cells such as cardiac cells, lung cells, etc. This is how the whole human body has been developed from a single cell in mother’s uterus. Umbilical cord which connects baby in uterus with mother and blood within it are the richest sources of stem cells. These stem cells are of greater therapeutic use and can be used to treat/cure blood and tissue related disorders. Our company collects umbilical cord and blood during the birth of a baby, transport it to the lab, process it and preserve it for 21 years. If the child falls in illness and needs stem cell therapy, these stem cells can be retrieved and produced. The processing of stem cells needs controlled environment such as clean room. Clean room is a place/laboratory setup where particle count is very low and defined to ensure the sterility of the finished product before storage. Observation: The specifications of particle count to be maintained within the clean room were not defined, implemented and monitored periodically. Classification: Major Non-conformance Applicable clause: Clause No: 7.5.1, Control of production and service provision

Case Study: Preservation of product

Mon, 09 Nov 2009 06:36:04 CST

by Muralimanohar J.

Background: I was given a chance to do internal auditing for my company. Our company is basically a stem cells banking company. Stem cells are the primitive cells which can be differentiated into any body cells such as cardiac cells, lung cells, etc. This is how the whole human body has been developed from a single cell in mother’s uterus. Umbilical cord which connects baby in uterus with mother and blood within it are the richest sources of stem cells. These stem cells are of greater therapeutic use and can be used to treat/cure blood and tissue related disorders. Our company collects umbilical cord and blood during the birth of a baby, transport it to the lab, process it and preserve it for 21 years. If the child falls in illness and needs stem cell therapy, these stem cells can be retrieved and produced. Al the later stage of processing, a chemical is added to preserve the stem cells at -196°C and it prevents cells from damaging/losing physical stability. Observation: That particular chemical is a light sensitive and tends to lose its property with exposure to light. It was stored in the open & bright environment. It should have been wrapped with aluminum foil or so to prevent light. Classification: Major Non-conformance Applicable clause: Clause No: 7.5.5, Reason: Preservation shall also apply to the constituent parts of a product.

Case Study : Qualification of employees

Sun, 08 Nov 2009 23:40:10 CST

by Markus Fischer.

Background:
Audit in the production.

Observation:
During the audit there was observed a employee adjusting a inside micrometer screw which was clamped in a metalworker parallel vice (with one sheet of cloth for "protection" against damages) to adjust / check this with a micrometer screw. This employee was working for over 1 year for the organization and supposed to be used / trained in correct usage and handling of measuring tools.
There could be shown now prove of this workers skills / training in handling measuring tools.

Classification:
This is major nc

Applicable ISO Clause:
6.2.2 Competence training and awareness

Re: Customer Related Processes - Case Study

Sun, 08 Nov 2009 09:17:11 CST

by John Chepkwony.

Dear Charles,

I agree with your decision to classify the situation as a major NC. The requirement is very clear in ISO 9001 Clause 7.2.2. The fact that the documents were three versions behind the current is unacceptable as this may lead to compromise of the customer specifications.Given that the same document had undergone three other revisions,the chances of missing a revised aspect on QA Manual are high.

Secondly, I tend to take this as a double violation in the standard .Considering the requirements on clause 4.2.3 (control of documents) the need to need to identify the current revision status of the documents was overlooked.

What is your feeling on this?

Kind regards,

John Chepkwony.

Re: Control of Measuring And Monotoring Equipment

Sun, 08 Nov 2009 07:44:31 CST

by John Chepkwony.

Hi Simanga,

I agree with your NCR judgement. It is imperative to have a proper control of cooling facilities.Temperature control and monitoring plays a vital role in industries dealing with perishable product. It is critical to have the cold store temperatures at the correct range and have a regular calibration. A slight deviation from the standard may have a significant effect on the product quality.

Kind regards,

John Chepkwony.

Re: Case History- Internal Audit Training

Sun, 08 Nov 2009 02:16:12 CST

by Sheikh Mohsin Ali.

If taking into consideration the facts you have mentioned,

"SOME" equals to how many percentage of the total? 1% means not an issue nothing should be raised.

Some is a Vague figure.

I cannot say it to be a Minor NC, I would book it as OBSERVATION only.

Training relates to Clause 6.2.2 (e)

Records not kept related to Clause 4.2.4

Thank You

Sheikh Mohsin Ali

Re: Case History- Internal Audit Training

Fri, 06 Nov 2009 14:53:08 CST

by Charles Eldredge.

Unless the Internal Audit procedure clearly defines the requirement that the internal auditors must be trained and the training documented in their training records, this would indeed be a minor N/C (why would some of the auditors' records have this and some not?).

If the procedure requires the auditors to be trained and the training documented, then this would have to be a major non-conformance because the company would now be violating clause 6.2.2 (determining the necessary competence and/or training, AND not maintaining the appropriate records of training).