What are the most effective Quality Assurance audit and review practices?

Through my experience, I believe that the most powerful tool for internal audit success is precisely defining the audit objective. Unfortunately, the most common practice in determining audit objective is copying them form previous audits (conformity with the requirements or with the ISO standard at best) without any consideration for company's need, or current situation which is totally un effective tool Some tools that can help in define audit objective: Start always from Top Management to know their aspirations, to reflects it into real steps through auditing, which enhances the participation of senior management in QMS, Additionally to review lessons learned record, non-conformities log, improvement log and Quality objectives.

You need to standardize your processes. Create Standard Operating Procedures (SOPs) for procedures you want standard. Then connect each process with at least one KPI so that you can measure how effective your process. Monitor and optimize as you go.

Routine/Scheduled Internal Audit based on Company plan, objective & target, with reference to ISO QMS. What are you trying to achieve? Good implementation of QMS based on Company plan, objective & target. What are the criteria and indicators of success? No major findings and always initiate continuously improvement strategy/plan as per current conditions to enhance Company targets and achieved Costumer expectations.

As most commonly known, the objective of audit is compliance to a certain standard (most probably ISO). So, if you are auditing QMS you would refer to ISO9001, in case of energy management your reference point would be ISO 26000 and so on. However, the main objective of the audit in my perspective is to evaluate the potential risks and opportunities of the organizations whole end-to-end process and identify the strengths that are contributing to and weaknesses that are prohibiting from achieving organizations overall business strategy and vision. Any findings that you have as a result of audit should have some kind of relation to improvement in the system which will eventually stimulates company's success-driven factors.

I think the right approach for quality assurance is well inderstanding the objectives then identifying the scoop then plan based on risk assessment

Below I have given some effective quality assurance audit & review practices help organizations achieve their QA goals: 1. Management awareness and seriousness 2. Built a competent team 3. Set clear objectives 4. Set plan and communicate clearly among the stockholder 5. Procedures must be well documented 6. Set procedure of regular monitoring 7. Progress report need to submit regularly 8. Risk assessment 9. Sampling & randomization 10. Root cause analysis 11. Corrective & preventive measure 12. Introduce automation 13. Feedback loops 14. 3rd party audit 15. Continuous improvement

1. By checking effective communation and role clarity from Organizational top management to lower management. 2. By checking organization 's previous audit results and actions to improve quality. 3. By training and developing right mindset for moving from reactive to preventive measured(lot of training and it effectiveness measuring strategy required) 4. System under review continous improvement through internal audits both planned and rarely surprised, constructive management review meeting by involving right people and appreciating top performers.

Planning is the important thing, but it's important to make plans quickly - it couldn't to take a lot of time that you can invest in test run. The proffessional QA trick - is to share the first results of running soon after getting the first build.

Preparation of an audit calendar and identifying competent auditors are important during the audit planning phase. For internal audits, the frequency should be governed based on the risk assessment. Management should be aligned on this so that the auditees can spend quality time participating in the audits. Training to the auditors on communicating the audit findings (both positive and shortcomings) should be provided to ensure audit effectiveness and preserve auditee energy.

There is a need for audit/review. It's complexity depends on may factors: - state of product ( new / legacy / improvement / merge of many products / product split into pieces) - Team / time terms / technical debt - Potential risks / their fix costs Then QA determines primary business path (happypath and negative path) Then shift-left/shift-right moves to cover specific technical/business cases. Then QA makes conclusions about how complete their audit, and according to product ETA and available time - QA highlights risks and guaranties.

From my experience, audit is not to point out something, or pointing someone's mistakes. Asking is more easier and complying an observation. Auditor who issues the observation should be part of compliance and must suggest the way forward by educating the respective people then similar issues will not repeat further

It is very essential to conduct audits in unbiased manner. All the positive systems should be acknowledged and recorded followed by the areas of improvement based on their criticality. Auditees should be aligned to the findings of the audit to ensure successful conduct of audit. While sampling the data's for review, it is also important to interact with all levels of people in the department apart from auditees.

Communication is indeed one of the most important extracurricular skills an auditor must have. Many of us know experts on the letters of the codes/standards, but ineffectively run their audits. Furthermore, Analysis and Reporting are co-dependant. Good analysts who don't report effectively, are as much as a road block for the system as Good writers who don't analyze effectively. There's no discussion, auditor must Ace both.

The follow up review or inspection should be based on the level of non compliances observed during the audits. Reasonable timeframe to be given to the auditees to close the gaps in their system. More emphasis needs to be given on the corrective measures adopted since only this step will ensure sustainable closure of the non compliance. During internal audits, it is essential to communicate the requirement to adhere to the systems, otherwise the corrective actions will remain the the documentation itself.

Don't forget to set reasonable follow-up sessions for verification of efficacy and communicate that date for those involved. It is quite frustrating when you come to verify the metrics, and auditees are caught by surprise despite of having signed the report.

Auditors need to have excellent soft skills. Simply by showing up in somebody’s area and asking “strange questions” often makes people nervous, using the word “audit” doubly so. I’ve often referred to myself as being “from the department of stupid questions” to get a bit of a chuckle out of interviewees and put them at ease. I also find it helpful to remind them that I’m not auditing them, but the company, and it’s okay to not know the answer. If they don’t know, I usually make sure that they are directed to the correct information before I leave the area. I’ve had pretty good success with this approach and find that people seek me out when they have questions or concerns rather than waiting for it to turn up in an audit or NCR.

When auditors show they are reasonable in their follow-up requirements, or during an interview, being kind to people who are visibly anxious, audits become constructive tools for continuous improvement.