Internal and External Audit Programme Implementation

[Shannon]

Hi all my name is Shannon,

I am new to this forum and am needing some advice in regards to implementing an audit programme following the guidlines of ISO 19011.

My question is, "What are some factors that should be considered when implimenting an audit programme for both internal and external audits?

[Jeff Frost]

Your Question: "What are some factors that should be considered when implimenting an audit programme for both internal and external audits?:

Some of the considerations for implementing an audit program are:

• To meet the internal audit requirements per a quality management standard such as ISO 9001 or AS9100.
• To meet the needs of the organization
• To meet applicable regulatory or statutory requirements
• To meet customer contract requirements.

The ISO 19011 standard itself is not directly required by ISO 9001 or AS9100 for internal audit programs the adoption of the standard is up to you. You will find that Section 5 of 19011 (2011) address areas Related to establishing and managing audit programs.

[Shannon]

Thanks Jeff,

My laboratory is accreditation complys with ISO 17025:2005, I work for a construction materials testing organisation and have been asked to fulfill an interal auditors role in the next 2months. I have been in the industry for about ten yrs and five of those yrs as a laboratory manager.

I am very competent when it comes to ISO 17025, as moving from being auditee to being the auditor I am still trying to find my feet in regards to auditing. As stated before my organisation has been accredited for some time now and have asked me to audit laboratories. Which in my eyes looks to be a tick and flick exercise to the top management without actually ensuring the full potential of auditing.

So I have decided to learn the right way in my own time to ensure I am competent enough to get the best out of my audits and benefit the organisation instead of it being a chore as some people would see it being.

Would timing, cost, size, locations, resources, competent auditors available be factors when implimenting an audit programme?

[Jennifer Kirley]

Good day Shannon, welcome!

I find myself struggling with your timing, cost, size, locations, resources, competent auditors available criteria.

How many locations do you have?

How is timing a factor?

Cost seems like a factor, but since internal auditing is usually considered overhead yet the need to audit is non-negotiable, I cannot consider this to be a variable.

Resources can include competent auditors, but also the needed training (including outside training if needed) to prepare technically competent audit "newbies" for their roles. But resources can also mean access to the standard (people sometimes ask us here "Must I purchase a copy of the standard?" To which we reply, "Yes you really should do so") and whatever hardware, software, file storage and physical space (a desk or office) needed to conduct the audit preparation and management.

Does this make sense?

[Shannon]

Hi Jennifer,

Our organisation has 3 Base laboratories and over 100 annex laboratories.

I think i am confusing myself between establishing and implimenting an audit programme.

[ssz102]

does the document is fully and completely in your company?
the record for inspection and production and instrument calibration and inner audit and customer audit or external audit prior to are retained?
the product quality are affected directly or indirectly by personel are trained?
and so on, the futher info you can read the standard ISO9001:2008

[RCBeyette]

I would suggest an external course the focuses on developing an audit program. However, if that is not an option, hopefully the Cove members can provide some guidance.

I'm in a role responsible for developing, establishing and implementing an internal assessment program. We don't use the word 'audit' because it can come across as scary and stressful. 'Assessment' sounds a bit softer.

We are not registered to any ISO standard, but we do have policies and procedures, as well as contractual requirements. These are my assessment criteria.

Below are the steps I've taken to help get to where we are right now in our implementation stage...the pilot. We just completed our first pilot assessment. Two more to go this month.

1. Project Charter - objective, scope, costs, resources...the guiding document for why we are doing this; to be approved by leadership
2. Work structure breakdown and Resource structure breakdown
3. Project plan
4. Communication plan
5. Training plan
6. Evaluation framework
7. Sustainability plan
8. Scoring methodology - we use a 0-4 range (avoiding your 'tick and flick' approach)
9. Critical process identification - (where process = practices + KPI(s))
10. Pilot assessment of identified processes (i.e., practices and KPIs assessed)
11. Scorecard development
12. Documentation development - policy, procedure(s), work instruction(s), form(s)
13. Training material for internal assessors
14. Survey reviews and lessons learned
15. Internal Assessment 2012 Schedule
16. Celebration