Question
What is the difference between self-inspection and internal audit?
I know how I make both activities and what are the key spots to check when internal audit engagement and self-inspection in a GMP/ FDA certified pharmaceutical industry
All Answers (13)
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I work for an Institution with several Departments. Each Department have its proper Quality System for a specific norm. I run a SELF-INSPECTION in MY process. The personel belonging to another Department can run a INTERNAL AUDIT in MY process. Can see the difference? -
Self inspection is when you are rechecking or getting checked you own work with you own intention, but internal audit is a work performed by internal audit department to check whether company/organization is doing well in order to acheive its objective. -
Internal audit can also be performed/run by an external organization. Better be clear all concepts and definitions (internal audit, external audit, self inspection, first party audit, second party, third party,...). See ISO 19011.
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According to my smart knowledge Self inspection is a method to recheck your assignment and work done by you,and internal audit is an independent and objective functional activity, which gives
security and management advice for the proper management of public revenue and
expenditure, perfecting the activities of the public entity -
Self inspection is important to check and update own department's compliance of protocols. each HOD of the department will be responsible to cross check their own departments work as a pre-preparation for the internal audit. Internal audit will be carried out by two different department. Each department will cross check another departments compliance to the set protocols(it can be internal or external protocols). usually it will be carried out by HOD of the departments. -
Norms are to be understood and not interpreted. BETTER SEE ISO 19011 to definition of AUDIT (Internal - first party, external - second and third party).
SELF INSPECTION is not defined by ISO 19011, if I'm not wrong. To definition, I think, better dig in US-FDA or UNO-WHO sites. Self inspection must be regularly run by pharmaceutical industry. -
Formally there should be a difference between (first) second and third party audit but actually the main difference is based on know-how and background of the audit team.
Of course the standard is to have a third party auditor fond in checking the formal conformity to the norm; the aim usually is to found a way to certify your company raising some non conformities or recommendations.
Unfortunately the audit result depends also on who is paying for the audit and on the "age" of the audit team leader.
A second party audit is much more customer focused and, usually, a better knowledge of product and process is providing the company with an actual usefull result.
Internal audits may also be requested by dpt submitted to audit to push high direction to solve problems that, generally speaking, are absolutely not visible to third or second part audit team. Internal audits are often used only as a necessary step toward third part audit, it's a pity. The std is of course the aim established by the norm that's supposing a smart high direction.
Self audit is a different matter, as I understand, related to a real continuous improvement implementation (prior to doc. review or internal audit request). -
Self inspection is by the person who has carried out an activity like machining, heat treatment etc for dimensions or hardness before it is offered to the next stage of operation. It ensures that a defective product/service does not reach the next stage or customer
In case of internal audit the inspection of product or system ( procedures or records) is carried out by the person who does not belong to the process where the component or service is initially processed. It is also to ensure that internal auditor is specifically trained for the purpose of audit and is supposed to be unbiased -
Internal audit is usually more concerned with the financial aspect of the organization while self inspection is more liberal and can involve any or all of the organizations processes.
In my view internal audit is a subset of self inspection. -
In short and audit should be checking the adherence to process systems rather than the adherence to product specifications that can be done by inspection. For example a worker in the assembly line is inspecting a component in order to see whether satisfies the dimensional specifications. The quality manager on the other hand will be conducting an audit in order to assess whether the self-inspection process the worked used in order to ensure the product is right. Has he used the right tools for the inspection, are the tools calibrated, are the specifications clear to the worker, has the worker followed the procedural steps to do the self inspection and where those steps effective. -
Self inspection is assessment of resources in any field of operation by self (own department), whereas internal audit is an audit by a specific department in the same organization, for the purpose of ensuring the desired standard and ascertaining the meaningful uses. -
Self inspection is an activity done by the person(s) responsible for a process (for example process owner), while internal audit is something mandated by supervisors to an internal department who should check, evaluate, suggest improvements, classify best practices for a certain process and process owner(s) -
In most self inspection, the checks made is part of the control mechanism in a process to ensure a certain quality level is achieved. References will be made for eg. to calibration matrix for precision or checks made before an operation is carried out for safety reasons and so on. When internal audit is performed, an assessment is made on these self inspections to ensure that the controls instituted, as part of governance, are effective and efficiently conducted. As internal audit is carried out independently of those performing the self inspection, this gives the assurance to management and audit committee that internal controls established are in place.
